Clinical trial NCT01377844
Conditions: Diabetes Mellitus
Keywords: Diabetes mellitus
Sponsor: Theracos
Start date: 2011-12-01; Completion date: 2013-12-01
Enrollment: 288 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the efficacy of EGT0001442 in lowering glycosylated Hemoglobin (HbA1c, A laboratory test to diagnose three months average of blood sugar)levels at 24th week from baseline, when compared to placebo group(no diabetic medication given). The secondary aim of the study is to evaluate the efficacy of EGT0001442 in lowering fasting blood glucose at the weeks 2 and 24 and comparing the results with placebo group. This study assess the efficacy of EGT0001442 based on the proportion of subjects who reach the American Diabetes Association (ADA) target of HbA1c of \< 7% in EGT0001442 group and comparison with placebo. The study also evaluates the effect of EGT0001442 on systolic, diastolic pressures, body weight and compare with the respective placebo groups.This study also assess the change from baseline in HbA1c overtime, from week 1 to week 96. Finally, to assess the safety of EGT0001442 in the Type 2 Diabetic patients (adult/maturity onset).

Detailed description:
EGT0001442 is a compound that may inhibit the effect of other compounds in the body known as sugar transporters. The use of EGT0001442 may enhance the elimination of glucose from the blood by increasing the amount of urine produced. Hence the blood glucose levels are significantly decreased and the efficacy of EGT001442 can be established by assessing the three months average blood glucose levels (HbA1c). Due to the increased urinary output, the effect of EGT001442 on blood pressure levels are also assessed.

Arms: arm 1: EGT0001442 capsule, 20 mg, daily, 96 weeks arm 2: Placebo
Interventions: intervention 1: EGT0001442 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Prot_000.pdf: 
 
 
Clinical Trial Protocol: THR-1442-C-418 
Study Title: 
Efficacy and safety of EGT0001442 compared with placebo in patients 
with type 2 diabetes mellitus inadequately controlled by diet and 
exercise and up to one oral anti-diabetes agent. 
Study Number: 
THR-1442-C-418 
Study Phase: 
3 
Product Name: 
EGT0001442 tablet 
IND Number: 
103822 
Indication: 
Type 2 diabetes mellitus 
Investigators: 
Multiple center 
Sponsor: 
Theracos, Inc. 
Sponsor Contact: 
Albert Collinson, Ph.D. 
Theracos, inc. 
550 Del Rey Avenue 
Sunnyvale, CA 94085 
Phone: 408-992-1100 
Sponsor protocol 
representative 
Monica Tettamanti 
185 Cambridge Street 
Boston, MA 02114 
Telephone number:  617-643-5696 
Fax number:  617-726-2879 
E-mail: mtettamanti@ccib.mgh.harvard.edu 
 
 
Date 
Original Protocol: 
02 February 2011 
 
Confidentiality Statement 
The following confidential information is the property of Theracos, Inc.  As long as the 
information contained in this protocol has not been published, it may only be used when 
permission has been obtained from Theracos 


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SYNOPSIS 
Sponsor: 
Theracos, Inc. 
Name of Finished Product: 
EGT0001442 tablet 
Name of Active Ingredient: 
EGT0001442 
Study Title:  
Efficacy and safety of EGT0001442 compared with placebo in patients with type 2 diabetes 
mellitus inadequately controlled by diet and exercise and up to one oral anti-diabetes agent.  
Study Number: 
THR-1442-C-418 
Study Phase: 3 
Primary Objective(s):  
To assess the efficacy of EGT0001442 in lowering HbA1c at week 24 compared with 
placebo 
Secondary Objective(s): 
 To assess the efficacy of EGT0001442 in lowering FPG at weeks 2 and 24 compared 
with placebo 
 To assess the efficacy of EGT0001442 based on the proportion of subjects in the 
EGT0001442 group reaches the American Diabetes Association (ADA) target HbA1c 
of <7% compared with placebo 
 To assess the effect of EGT0001442 on systolic and diastolic blood pressure 
compared with placebo 
 To assess the effect of EGT0001442 on body weight compared with placebo 
 To assess the change in HbA1c change over time, week 1 to week 96 
 To assess the safety of EGT0001442 in patients with T2DM 
 
Study Design: 
A multinational, 2 arm parallel groups, randomized, double-blind placebo-controlled study to 
compare the treatment of once daily EGT0001442 at 30 mg with matching placebo in 
treatment-naïve type 2 diabetic patients (i.e. not taking an antihyperglycaemic agent for ≥16 
weeks prior to study entry) or with diet and exercise in combination with one oral 
antidiabetes drug and an HbA1c of 7-10%.  Approximately 300 eligible subjects will start a 
2-week placebo run-in period prior to being randomly assigned to either once daily 
EGT0001442 or placebo in a 1:1 ratio for 24 weeks.  Subjects with hyperglycemia may 
receive approved anti-diabetic medication.  At week 24, subjects who have completed the 
main treatment period will continue to receive study drug until week 96.  In the treatment 


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extension period, subjects who have elevated HbA1c will have additional antidiabetic 
therapy added to the study drug consistent with treatment recommendations for type 2 
diabetes.   
 
Study Population and main eligibility criteria:  
Approximately 300 patients that are inadequately controlled by diet and exercise or by 
treatment with a single oral anti-diabetes agent, randomized 1:1 to placebo and EGT0001442 
 Type 2 diabetes per the American Diabetes Association criteria  
 Male or female 
 Age ≥ 18 years 
 Receiving one or no oral anti-diabetic agent and diet and exercise instruction 
 HbA1c between 7 and 10% at screening 
 Body mass index (BMI) ≤ 37 kg/m2 
 Fasting plasma glucose <250 mg/dL at screening for subjects not treated with oral 
anti-diabetic therapies 
 Fasting plasma glucose <240 mg/dL at screening for subjects treated with anti-
diabetic therapies 
 Fasting plasma glucose <250 mg/dL for all subjects at randomization 
Test Product, Dose, and Mode of Administration:  
EGT0001442 tablets 30 mg once daily by mouth 
Reference Therapy; Dose; and Mode of Administration: 
 Placebo – once daily by mouth 
Duration of Treatment:  
 98 week (2wk run-in, 24 week primary evaluation, 72 week extension) 
Statistical Methods:  
The primary objective of this trial is to assess the efficacy of EGT0001442 in treatment-naïve 
type-2 diabetic patients or patients on a single oral anti-diabetic drug in combination with 
diet and exercise with an HbA1c between 7 and 10%.  Efficacy is defined as a significant 
reduction in HbA1c at week 24 when compared to placebo.  The effect of EGT0001442 on 
fasting glucose, blood pressure, body weight and the general safety of EGT0001442 in 
patients with T2DM will also be explored. 
Statistical analyses and summaries of safety and tolerability will be performed using SAS® 
software (SAS Institute, Cary, NC).  In all cases, significance will be judged at the =0.05 
level.  No multiplicity adjustment will be required for the single primary endpoint. 
 
Date of Original Approved Protocol: 02 February 2011 


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TABLE OF CONTENTS 
SYNOPSIS .................................................................................................................................2 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS ............................................8 
NO OBSERVABLE ADVERSE EFFECT LEVEL ..................................................................9 
1 
INTRODUCTION ...........................................................................................................11 
1.1 
EGT0001442 for the treatment of type 2 diabetes mellitus ...................................11 
1.1.1 
Summary of non-clinical data with EGT0001442 .......................................12 
1.1.2 
Summary of Clinical data with EGT0001442 .............................................12 
2 
STUDY OBJECTIVES ....................................................................................................14 
2.1 
Primary Objective(s) ..............................................................................................14 
2.2 
Secondary Objective(s) ..........................................................................................14 
3 
INVESTIGATIONAL PLAN ..........................................................................................15 
3.1 
Overall Study Design and Plan ..............................................................................15 
3.2 
Rationale for Study Design and Control Group .....................................................17 
3.3 
Study Duration and Dates ......................................................................................18 
4 
STUDY POPULATION SELECTION ...........................................................................19 
4.1 
Study Population ....................................................................................................19 
4.2 
Inclusion Criteria ...................................................................................................19 
4.3 
Exclusion criteria ...................................................................................................19 
5 
STUDY TREATMENT(S) ..............................................................................................21 
5.1 
Description of Treatment(s) ...................................................................................21 
5.1.1 
Study Drug ...................................................................................................21 
5.1.2 
Placebo .........................................................................................................21 
5.1.3 
Rescue medications ......................................................................................21 
5.2 
Treatments Administered .......................................................................................22 
5.3 
Selection and Timing of Dose for Each Patient .....................................................22 
5.4 
Method of Assigning Patients to Treatment Groups ..............................................22 
5.5 
Blinding..................................................................................................................22 
5.6 
Concomitant Therapy.............................................................................................23 
5.7 
Restrictions ............................................................................................................24 
5.7.1 
Prior Therapy ...............................................................................................24 
5.7.2 
Fluid and Food Intake ..................................................................................24 
5.7.3 
Patient Activity Restrictions ........................................................................24 
5.8 
Treatment Compliance ...........................................................................................24 
5.9 
Packaging and Labeling .........................................................................................25 
5.9.1 
Study drug for main treatment period ..........................................................25 


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5.9.2 
Study drug for the treatment extension period .............................................25 
5.10 
Storage and Accountability ....................................................................................25 
5.11 
Investigational Product Retention at Study Site ....................................................25 
6 
STUDY PROCEDURES .................................................................................................26 
6.1 
Informed Consent...................................................................................................26 
6.2 
Medical History .....................................................................................................26 
6.3 
Physical Examination.............................................................................................27 
6.4 
Vital Signs ..............................................................................................................27 
6.5 
Electrocardiography ...............................................................................................27 
6.6 
Diet and exercise counseling .................................................................................27 
6.7 
Clinical Laboratory Tests .......................................................................................27 
6.7.1 
Laboratory Parameters .................................................................................27 
6.7.2 
Sample Collection, Storage, and Shipping ..................................................28 
6.7.2.1 
HEMATOLOGY AND BLOOD CHEMISTRY ...............................28 
6.7.2.2 
URINALYSIS ....................................................................................29 
6.8 
Dispensing Study Drug ..........................................................................................29 
6.9 
Adverse Events Assessments .................................................................................29 
6.9.1 
Definitions....................................................................................................29 
6.9.2 
Eliciting and Reporting Adverse Events ......................................................31 
6.9.3 
Immediately Reportable Adverse Events (IRAE) ........................................31 
6.9.4 
Pregnancy .....................................................................................................31 
6.9.5 
Procedure for Breaking the Blind ................................................................33 
6.9.6 
Follow-up of Adverse Events ......................................................................33 
6.9.6.1 
FOLLOW-UP OF NON-SERIOUS ADVERSE EVENTS ...............33 
6.9.6.2 
FOLLOW-UP OF POST STUDY SERIOUS ADVERSE 
EVENTS ............................................................................................33 
6.9.7 
Adverse event of special interest .................................................................34 
6.9.7.1 
GENITOURINARY INFECTIONS ..................................................34 
6.9.7.2 
RENAL AND URINARY DISORDERS ..........................................34 
6.9.7.3 
MAJOR ADVERSE CARDIOVASCULAR EVENT (MACE) .......34 
6.9.7.4 
HYPOGLYCEMIA............................................................................34 
6.10 
Concomitant Medication Assessments ..................................................................34 
6.11 
Removal of Patients from the Trial or Study Drug ................................................35 
6.12 
Other Study Procedures .........................................................................................35 
7 
STUDY ACTIVITIES .....................................................................................................36 
7.1.1 
Visit 1 - Screening (weeks –5 to -2) ............................................................36 
7.1.2 
Visit 2 – run-in period (day -14±3) ..............................................................36 


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7.2 
Primary Efficacy Phase ..........................................................................................37 
7.2.1 
Visit 3 – procedures (Day 1 in Week 0) ......................................................37 
7.2.2 
Visit 4 – Procedures (week 2) ......................................................................37 
7.2.3 
Visit 5 – Procedures (week 6) ......................................................................38 
7.2.4 
Visit 6 – Procedures (week 12) ....................................................................38 
7.2.5 
Visit 7 – Procedures (week 18) ....................................................................39 
7.2.6 
Visit 8 – Procedures (week 24) ....................................................................39 
7.3 
Extension Phase .....................................................................................................40 
7.3.1 
Visit 9 – Procedures (week 36) ....................................................................40 
7.3.2 
Visit 10 – Procedures (week 48) ..................................................................40 
7.3.3 
Visit 11 – Procedures (week 60) ..................................................................41 
7.3.4 
Visit 12 – Procedures (week 72) ..................................................................41 
7.3.5 
Visit 13 – Procedures (week 84) ..................................................................42 
7.3.6 
Visit 14 – Procedures (week 96) ..................................................................42 
7.3.7 
Visit 15 – Exit Visit (week 97) ....................................................................43 
7.4 
Early Termination Procedures ...............................................................................43 
8 
QUALITY CONTROL AND ASSURANCE .................................................................45 
9 
PLANNED STATISTICAL METHODS ........................................................................46 
9.1 
General Considerations ..........................................................................................46 
9.1.1 
Handling Dropouts, Multiples, Missing Data, and Outliers ........................46 
9.1.2 
Multiple Comparisons / Multiplicity ...........................................................46 
9.2 
Determination of Sample Size ...............................................................................46 
9.3 
Analysis Populations ..............................................................................................47 
9.4 
Demographics and Baseline Characteristics ..........................................................47 
9.5 
Analysis of Efficacy ...............................................................................................47 
9.5.1 
Primary Efficacy Endpoint ..........................................................................47 
9.5.2 
Secondary Efficacy Endpoints .....................................................................48 
9.5.3 
Additional Efficacy Endpoints .....................................................................48 
9.6 
Analysis of Safety ..................................................................................................49 
9.6.1 
Adverse Events ............................................................................................49 
9.6.2 
Adverse event of special interest .................................................................49 
9.6.2.1 
GENITOURINARY INFECTIONS ..................................................49 
9.6.2.2 
MAJOR ADVERSE CARDIOVASCULAR EVENT (MACE) .......49 
9.6.2.3 
HYPOGLYCEMIA............................................................................50 
9.6.2.4 
RENAL AND URINARY DISORDERS ..........................................50 
9.6.3 
Clinical and Laboratory Events and Analyses .............................................50 
9.6.4 
Concomitant Medications ............................................................................50 


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9.7 
Interim Analysis .....................................................................................................50 
10 ADMINISTRATIVE CONSIDERATIONS ....................................................................51 
10.1 
Investigators and Study Administrative Structure .................................................51 
10.2 
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) 
Approval ................................................................................................................51 
10.3 
Ethical Conduct of the Study .................................................................................51 
10.4 
Patient Information and Consent ...........................................................................52 
10.5 
Patient Confidentiality ...........................................................................................52 
10.6 
Study Monitoring ...................................................................................................52 
10.7 
Case Report Forms and Study Records .................................................................53 
10.8 
Protocol Violations/Deviations ..............................................................................53 
10.9 
Access to Source Documentation ..........................................................................53 
10.10 Data Generation and Analysis ...............................................................................54 
10.11 Retention of Data ...................................................................................................54 
10.12 Publication and Disclosure Policy .........................................................................54 
11 REFERENCE LIST .........................................................................................................56 
 
LIST OF IN-TEXT TABLES 
Table 1. 
List of Laboratory Tests .............................................................................27 
 
LIST OF APPENDICES 
Appendix 1 
Schedule of Events .....................................................................................57 
Appendix 2 
Estimating glomerular filtration rate ..........................................................59 
Appendix 3 
Sponsor Signatures.....................................................................................60 
Appendix 4 
Investigator’s Signature .............................................................................61 
 
 


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LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
ADA 
American Diabetes Association 
AE 
adverse event 
ALB 
albumin 
ALT 
alanine aminotransferase 
AP 
alkaline phosphatase 
AST 
aspartate aminotransferase  
AUC0-24 
area under the curve from 0 to 24 hours 
BMI 
body mass index 
BUN 
blood urea nitrogen 
Ca 
calcium 
CBC 
complete blood count 
CFR 
Code of Federal Regulations 
CI 
confidence interval 
Cl 
chloride 
Cmax 
observed maximum concentration 
CRF 
case report form 
CRO 
Contract Research Organization 
CV 
coefficient of variation 
CVA 
cerebral vascular accident 
DSMB 
Data and safety monitoring board 
EC 
ethics committee 
ECG 
electrocardiogram 
eGFR 
estimating glomerular filtration rate 
FDA 
Food and Drug Administration 
FPG 
fasting plasma glucose 
GCP 
Good Clinical Practice 
GLP-1 
glucagon-like peptide-1 


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GGT 
gamma glutamyl transferase 
HbA1c 
glycosylated hemoglobin A1c 
Hct 
hematocrit 
HDL-C 
high density lipoprotein cholesterol 
Hgb 
hemoglobin 
HIPAA 
Health Information Portability and Accountability Act 
HIV 
Human immunodeficiency virus 
ICH 
International Conference on Harmonisation  
IND 
Investigational New Drug  
IRAE 
Immediately Reportable Adverse Event 
IRB 
Institutional Review Board 
ITT 
intent-to-treat 
IVRS 
Interactive voice response system 
LDH 
lactic dehydrogenase 
LDL-C 
Low density lipoprotein cholesterol 
MACE 
Major Adverse Cardiovascular Event 
MAD 
multiple ascending dose 
MedDRA 
Medical Dictionary for Regulatory Activities 
MDRD 
Modification of Diet in Renal Disease 
NOAEL 
No observable adverse effect level 
NYHA 
New York Heart Association 
OAM 
oral anti-diabetic medications 
PD 
pharmacodynamics 
PK 
pharmacokinetics 
PP 
per protocol 
PT 
prothrombin  
RBC 
red blood cell (count) 
SAD 
single ascending dose 


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SAE 
serious adverse event 
SD 
standard deviation 
SMBG 
self monitored blood glucose 
T2DM 
type 2 diabetes mellitus 
TEAEs 
Treatment emergent adverse events 
tmax 
time to maximum concentration 
UGE0-24 
urinary glucose excretion from 0 to 24 h post dose 
ULRR 
Upper Limit of the Reference Range 
USP/NF 
The United States Pharmacopeia–National Formulary 
UTI 
urinary tract infections 
WBC 
white blood cell (count) 
WHODRUG 
World Health Organization Drug Dictionary 
WOCBP 
Women of childbearing potential 
 


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1 
INTRODUCTION 
Diabetes mellitus, characterized by hyperglycemia, is caused by defective insulin secretion, 
resistance to insulin action, or a combination of both.  Approximately 285 million people 
worldwide, or 6.6%, in the age group 20-79 have diabetes in 2010.  The prevalence of 
diabetes is projected to be 438 million or 7.8% of the adult population by 2030 (Sicree et al., 
2010). Over 90% of diabetic patients have type 2 diabetes mellitus (T2DM) and over 80% of 
the type 2 diabetic patients are overweight or obese.  Several classes of agents for type 2 
diabetes are available for treating hyperglycemic conditions including insulin secretagogues, 
PPAR agonists, metformin, alpha glucosidase inhibitors, glucagon-like peptide 1 (GLP-1) 
analogues, and dipeptidyl peptidase 4 (DPP4) inhibitors.  Insulin and its analogues also are 
prescribed for the treatment of type 2 diabetes as the disease progresses.  However, a rapid 
rise in the number of adult type 2 diabetics has led to an increasing recognition that 
additional therapeutic modalities are needed to provide safe and effective reductions of 
elevated plasma glucose levels. 
The renal Na+/glucose transporter SGLT2 (gene name SLC5A2) is a member of a sugar 
transporter family that actively transports extracellular hexoses into cells using the driving 
energy of the transmembrane electrochemical potential for sodium ions.  Individuals with 
disruptions in the gene encoding SGLT2 exhibit prominent glucosuria in the absence of 
significant comorbidities (Santer et al., 2003; van den Heuvel et al., 2002).  Significantly, 
neither hypoglycemia nor an increased incidence of urinary tract infections have been 
reported in these individuals. The elimination of glucose from the blood via urinary excretion 
has the potential to improve both fasting and postprandial hyperglycemia without increasing 
insulin secretion, causing weight gain, or inducing hypoglycemia.   
Phlorizin, a natural product inhibitor of SGLT1 and 2, has been shown to produce urinary 
glucose excretion (UGE) and lower plasma glucose levels in several animal models 
(Ehrenkranz et al., 2005).  Development of phlorizin was discontinued due to its rapid 
degradation by lactase-phlorizin hydrolase and poor absorption from the gastrointestinal 
tract.  Several SGLT2 inhibitors are in development (Han et al., 2008; Neumiller et al., 
2010).  Dapagliflozin is the SGLT2 inhibitor with the most extensive clinical data.  Early 
phase studies demonstrated sustained, dose-dependent glucosuria over 24 hours with once 
daily oral dosing (Komoroski et al., 2009a; Komoroski et al., 2009b).  A double blind, 
placebo controlled study showed that treatment with dapagliflozin for 6 months resulted in  
0.58% – 0.89% reduction of glycosylated hemoglobin A1c (HbA1c) from baseline compared 
with -0.23% in the placebo group with a placebo-subtracted changes in weight up to 1.1 kg 
(Ferrannini et al., 2010).  Increased numbers of urinary tract and genital infections were 
observed in the treated groups. 
1.1 
EGT0001442 for the treatment of type 2 diabetes mellitus 
EGT0001442, a candidate oral antidiabetic agent, is a potent, highly specific inhibitor of the 
renal Na+/glucose transporter SGLT2. It is a benzylbenzene C-glycoside of the same 


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chemical structural class as dapagliflozin.  EGT00001442 elicits a prominent and predictable 
glucosuria in laboratory animals and in healthy and diabetic subjects in clinical studies. 
Several previous non-clinical and clinical studies were conducted with EGT0001474, a now-
discontinued crystalline formulation of EGT0001442 and L-proline in 1:2 stoichiometry.  
The mass ratio of EGT0001474 to EGT0001442 is 1.5:1. In this protocol, all studies 
performed with EGT0001474 are described in terms of the EGT0001442 content. For 
example if a study used 50 mg of EGT0001474 it is described as 33 mg of EGT0001442 
(delivered as proline cocrystal).  EGT0001474 and EGT0001442 have similar solubility in 
water, similar dissolution rates when formulated as capsules, and show similar exposure in 
rat, monkey, and human studies. 
1.1.1 
Summary of non-clinical data with EGT0001442 
The potential adverse effects of EGT0001442 have been evaluated through safety 
pharmacology, genotoxicity, acute, chronic, and reproductive toxicity studies. Repeat dose 
toxicity studies performed in rats, dogs and monkeys found diarrhea and gastric irritation 
including sporadic ulceration, at the lowest observable effect level.  The NOAELs based on 
these studies are 6.7 and 20 mg/kg/day in rats and monkeys, respectively, representing safety 
multiples of 8.1 and 19.6 relative to anticipated exposures in diabetic patients at the planned 
clinical dose of 20 mg/day.  Chronic exposures produced similar toxicity profiles, with the 
additional finding of microvacuolization of renal cortical cells in monkeys after 39 weeks 
dosing.  This microscopic pathology occurred without clinical chemistry correlates, and the 
renal effects generally reversed during the recovery phase.  EGT0001442 does not affect 
fertility or in utero development up to the maximum tolerated doses in rats and rabbits.  
Details of the toxicology findings are described in the Investigator’s Brochure. 
1.1.2 
Summary of Clinical data with EGT0001442 
Clinical studies have been conducted to evaluate safety, tolerability, pharmacokinetics (PK), 
pharmacodynamics (PD), metabolism, and efficacy of EGT0001442.  No deaths or study 
drug related serious adverse events (AEs) have been reported in the clinical trials.  
EGT0001442 up to 100 mg for up to 14 days was safe and tolerated in healthy volunteers.  In 
a phase 2, double-blind, placebo-controlled study, subjects with type 2 diabetes mellitus were 
treated with EGT0001442 in doses of 5 to 50 mg or a placebo for 28 days.  The most 
frequently occurring AEs were headache (4% in the placebo and 11% in the treatment 
groups), pollakiuria (none in the placebo and 4% in the treatment groups), fatigue (7% in the 
placebo and 2% in the treated group), and nausea (4% in the placebo and 3% in the treated 
group).  No hypoglycemia was reported.  Genital and urinary tract infections were observed 
in some subjects in the EGT0001442 treated groups, including balanitis candida, urinary tract 
infection, bacterial vaginitis, vulvovaginal candidiasis, and vulvovaginal mycotic infection. 
Urinary glucose excretion (UGE) was measured in healthy and diabetic subjects.  
EGT0001442 increased UGE in a dose-dependent and saturable manner.  The plateau in 
UGE corresponded to dosages of EGT0001442 above 20 mg/day.  EGT0001442 treatment in 
subjects with T2DM for 4 weeks was effective in reducing FPG by 24 to 41.6 mg/dL in the 


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groups dosed with 5 to 50 mg/day EGT0001442.  Subjects receiving EGT0001442 also had a 
reduction in body weight, blood pressure, and postprandial glucose compared to the changes 
in the placebo group.  Details of the safety and efficacy information are described in the 
Investigator’s Brochure 


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2 
STUDY OBJECTIVES 
2.1 
Primary Objective(s)  
The primary objective of this study is to assess the efficacy of EGT0001442 in lowering 
HbA1c at week 24 compared with placebo. 
2.2 
Secondary Objective(s)  
The secondary objective(s) of this study is (are): 
 To assess the efficacy of EGT0001442 in lowering FPG at weeks 2 and 24 compared 
with placebo 
 To assess the efficacy of EGT0001442 based on the proportion of subjects in the 
EGT0001442 group reaches the American Diabetes Association (ADA) target HbA1c 
of <7% compared with placebo 
 To assess the effect of EGT0001442 on systolic and diastolic blood pressure 
compared with placebo 
 To assess the effect of EGT0001442 on body weight compared with placebo 
 To assess the change in HbA1c change over time, week 1 to week 96 
 To assess the safety of EGT0001442 in patients with T2DM 
 


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3 
INVESTIGATIONAL PLAN 
3.1 
Overall Study Design and Plan 
STUDY DESIGN 
THR-1442-C-418 is a multinational, 2 arm parallel groups, randomized, double-blind 
placebo-controlled study to compare the treatment of once daily EGT0001442 at 30 mg with 
matching placebo in treatment-naïve type 2 diabetic patients (i.e. not taking an 
antihyperglycaemic agent for ≥16 weeks prior to study entry) or with diet and exercise in 
combination with one oral antidiabetes drug and an HbA1c of 7-10%.  Approximately 300 
eligible subjects will start a 2-week placebo run-in period prior to being randomly assigned to 
either once daily EGT0001442 or placebo, using a computer-generated allocation schedule, 
in a 1:1 ratio for 24 weeks.  Subjects with hyperglycemia may receive approved anti-diabetic 
medication.  At the end of week 24, subjects who have completed the main treatment period 
will continue to receive study drug until week 96.  In the treatment extension period, subjects 
who have elevated HbA1c will have additional antidiabetic therapy added to the study drug 
consistent with treatment recommendations for type 2 diabetes.  The primary analysis is to 
assess whether EGT0001442 is superior to placebo based on HbA1c change from baseline to 
week 24.   
RESEARCH METHODS AND PROCEDURES 
At screening visit, subjects who meet all the inclusion criteria, none of the exclusion criteria, 
and who consent to participate in the study will receive counseling for appropriate diet and 
exercise.  Those who are on an oral antidiabetic medication (OAM) will discontinue the 
medication and receive placebo in this run-in prior for 14 ± 3 days.  Eligible diabetic subjects 
who are treatment naïve and who control their hyperglycemia through diet and exercise will 
also receive placebo and the hyperglycemia will be monitored to ensure that their fasting 
blood glucose levels remain below 250 mg/dL during this interval of 14 ± 3 days.   
After the run-in period, approximately 300 subjects will complete the baseline assessment on 
day 1 after overnight fasting to confirm their eligibility.  The subjects that remain eligible 
will be randomly assigned to one of the 2 treatment groups on day 1.  Randomization will be 
stratified by study center and based on screening HbA1c (≥7 to <8.5% or ≥8.5 to 10%). The 
planned doses are 30 mg/day of EGT0001442 or placebo.  Each subject will be provided with 
study drug for 6 weeks, dosing instructions and log, diet and exercise counseling, and a diary 
card for recording food and fasting glucose information on the days prior to each clinic visit. 
Each subject will be instructed to return to the clinic on weeks 2, 6, 12, 18, and 24 for safety 
monitoring and efficacy assessment including review of adverse events, concomitant 
medication, ECG, vital signs, physical examinations, testing of blood chemistry and 
hematology laboratory parameters, and a urinalysis. 
Subjects who complete the 24-week treatment period will continue receiving the study drug 
for an additional 72 weeks.  Subjects who receive rescue medication due to poor glycemic 


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control will continue to receive approved anti-diabetic medications and standard of care per 
investigator decision according to current treatment guidelines for 72 weeks.  In the treatment 
extension period, subjects must return to the clinic on weeks 36, 48, 60, 72, 84, and 96 for 
continuous safety monitoring and efficacy assessment, including review of HbA1c values, 
adverse events, concomitant medication, ECG, vital signs, and physical examinations.  A 
follow up exit visit will be conducted at 1 week after the last dose.  Subjects will be advised 
to see their primary physician and resume standard of treatment to control diabetes. 
GLYCEMIC CONTROL 
During the run-in period, subjects will be instructed to determine daily self-monitored blood 
glucose (SMBG) after an overnight fast.  The SMBG record will be reviewed by the 
investigator at each clinic visit.  If the fasting blood glucose is > 216 mg/dL (12 mmol/L) in 
two consecutive days, the subject should contact the clinical staff.  In addition, subjects will 
be instructed that they must contact the clinic within 24 h if SMBG is ≥ 270 mg/dL (15 
mmol/L).  If the fasting SMBG is ≥ 270 mg/dL (15 mmol/L) without explanations for the 
elevation, the investigator will review the SMBG record and determine if the subject should 
attempt to improve diet and exercise to maintain glycemic control or if the subject must 
discontinue from the study and resume diabetic medications.  Subjects with symptomatic 
hyperglycemia or hypoglycemia should be withdrawn if the symptoms are severe.   
During the 24-week main treatment period, study subjects will be advised to continue daily 
SMBG measurements and contact the clinic if the SMBG is ≥270 mg/dL (15 mmole/L) from 
week 1 (week of randomization) to week 6, ≥240 mg/dL (13.3 mmole/L) from week 6 to 
week 12, or ≥200 mg/dL (11.1 mmole/L) from week 12 to week 24.  During the 72-week 
extension period (weeks 25 to 96), subjects will continue to monitor the SMBG and contact 
the clinic if SMBG is ≥200 mg/dL (11.1 mmole/L).  Values of HbA1c will be evaluated in 
the extension period by the investigator and approved standard of oral therapy will be 
prescribed if HbA1c is elevated. 
The investigator must review the SMBG record and FPG values in every clinic visit and 
assess whether any subject should receive rescue medications to treat the hyperglycemic 
condition during the 24-week main treatment period.  The subject must be queried to assess 
compliance with a minimum of a 10 h fast prior to blood draw to ensure the FPG values can 
be accurately determined.  If a subject has not fasted for 10 h, the subject must return within 
a week after proper fasting. The investigator will provide diet and exercise counseling and 
determine if the subject should receive additional rescue medication as a result of the 
glucose.  A serum sample must be drawn prior to the rescue medication so that the last 
HbA1c value while the subject is on study drug only can be carried forward to 24 weeks for 
the primary end point analysis.   
OTHER SAFETY MONITORING ACTIVITIES 
The safety monitoring activities will include vital signs, physical examinations, urinalysis, 
adverse events, and concomitant medication use.  The occurrence of blood, liver, or skin 
disorders will be monitored through laboratory testing and adverse event documentation.  


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Adverse event of special interests will include any clinical signs and symptoms indicating 
either upper or non-upper urinary tract infections (UTIs) and genital infections.  Any adverse 
events that mapped to UTIs or genital infections must be documented. 
DATA AND SAFETY MONITORING BOARD (DSMB) 
An independent Data and Safety Monitoring Board (DSMB) will monitor the overall safety 
information during the EGT0001442 development.  The safety review activity and potential 
risk benefit assessment will be defined in the charter. 
MAJOR ADVERSE CARDIOVASCULAR EVENT ADJUDICATION 
An independent cardiovascular adjudication committee is established to review the 
cardiovascular events during the study in a blinded fashion.  These events include 
cardiovascular mortality, myocardial infarction, stroke, and hospitalization for acute coronary 
syndromes, urgent revascularization procedures, and, other possible serious cardiovascular 
events.  The adjudicated events will be documented and archived to allow a meta-analysis to 
be performed to assess if there is any increase of cardiovascular risk to an unacceptable 
extent at the time of completion of all phase 3 clinical studies.   
3.2 
Rationale for Study Design and Control Group 
THR-1442-C-418 is designed to evaluate the efficacy of EGT0001442 in the treatment of 
patients with T2DM.  A randomized, double-blind study is the most suitable design and 
placebo is the appropriate control to evaluate a new agent in diabetic subjects.  Diet and 
exercise counseling during the entire study will be provided to all participating subjects to 
reduce risks of worsening diabetic conditions.  Monitoring plan based on SMBG, FPG, and 
HbA1c measurements as well as criteria to initiate rescue medications are included in the 
protocol to prevent prolonged hyperglycemia. 
Results from published data in individuals with genetic mutations in the gene encoding 
SGLT2, subjects that have been treated with other SGLT2 inhibitors, and from previous 
clinical studies in healthy or diabetic subjects treated with EGT0001442 indicate that the risk 
of induced hypoglycemia as a consequence of the loss of SGLT2 activity should be minimal. 
Reduction in HbA1c directly reflects improvement in glycemic control and is considered a 
well validated surrogate for the long-term microvascular complications of diabetes mellitus.  
Results from study THR-1442-C-402 demonstrated that 4 weeks of treatment resulted with a 
dose dependent reduction of 24 – 42 mg/dL FPG in subjects receiving EGT0001442 5 – 50 
mg per day.  Thirty (30) mg/ day of EGT0001442 dosage was chosen in the proposed study 
based on the near saturation of UGE and FPG decrease in previous clinical studies in healthy 
or diabetic subjects.  Clinical data in the previous studies indicated that 30 mg/day 
EGT0001442 is well tolerated. 


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3.3 
Study Duration and Dates 
In the proposed study, diabetic subjects will be screened within 3 weeks of washout start.  
Eligible subjects who sign the written consent will receive placebo and start a 2 week run-in 
period prior to study drug administration.  Subjects will receive 24 weeks of treatment for the 
main efficacy study and will continue for an additional 72 weeks for additional safety and 
efficacy study.  All subjects will be followed for 1 week after the last dose.  The overall study 
duration from screening until follow-up could last a maximum of 102 weeks for the study 
subjects.  The duration of the overall study depends on the rate of patient accrual.  For details 
of the schedule and nature of the investigations, see the Trial Activities Charts in Appendix 1 


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4 
STUDY POPULATION SELECTION 
4.1 
Study Population 
The study population will include approximately 300 subjects diagnosed with T2DM that are 
inadequately controlled by diet and exercise or by treatment with a single oral anti-diabetes 
agent and have the HbA1c between 7% and 10%.  The study will recruit subjects from 
approximately 50 trial centers in 3 countries. 
4.2 
Inclusion Criteria 
1. Male or female subjects ≥18 years old  
2. Diagnosed with type 2 diabetes 
3. Body mass index (BMI) ≤ 37 kg/m2 
4. HbA1c between 7 and 10% (inclusive) at screening based on an upper limit of normal 
for the HbA1c assay being 6.5±0.2 % 
5. FPG <250 mg/dL at screening for subjects not treated with oral anti-diabetic therapies 
or FPG <240 mg/dL at screening for subjects treated with anti-diabetic therapies 
6. Diabetes currently treated with diet and exercise only or diet and exercise along with 
one approved oral anti-diabetic agent 
7. If taking anti-diabetic medication, dose and regimen must be stable for past 3 months 
8. If taking antihypertensive medication, dose and regimen must be stable for past 3 
months 
9. If taking lipid modifying therapy, dose and regimen must be stable for past 3 months 
10. Blood glucose <250 mg/dL based on finger stick blood glucose for all subjects at 
randomization 
11. Subjects willing and able to comply with the investigational nature of the study and 
able to communicate well with investigators.  
12. Able to comprehend and willing to provide written informed consent in accordance 
with institutional and regulatory guidelines.  
 
4.3 
Exclusion criteria 
Subjects meet any of the criteria will be excluded: 
1. Hemoglobinopathy that affects HbA1c measurement 
2. Current use of injected therapy for treatment of diabetes (insulin or GLP-1 receptor 
based therapy) 
3. Genitourinary tract infection within 6 weeks of screening 
4. Greater than 2 episodes of genitourinary tract infection in the past year 
5. History of kidney stones, bladder malfunction or other significant risk factor for 
urinary tract infections 


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6. eGFR, as calculated by the modification of diet in renal disease study equation 
(MDRD), < 50 mL/min/1.73 m2 (Appendix 2) 
7. Abnormal tests of liver function ALT, AST or bilirubin ≥ 3x ULRR 
8. Diagnosed with proliferative retinopathy 
9. Uncontrolled hypertension (blood pressure >150/95) 
10. Not willing to use effective birth control if female with child-bearing potential 
11. Female subjects who are pregnant or nursing 
12. Life expectancy < 2 years 
13. New York Heart Association (NYHA) Class 4 heart failure 
14. Sera positive of HCV, HIV, or positive on drug screen 
15. Currently participating another interventional trial 
16. Not able to comply the study scheduled visits 
 


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5 
STUDY TREATMENT(S) 
5.1 
Description of Treatment(s) 
5.1.1 
Study Drug 
Theracos, Inc. will provide EGT0001442 tablets in one of the four different strengths as 
follows: 
10 mg SR formulation (EGT0001442 SR Tablet, 10 mg) 
15 mg SR formulation (EGT0001442 SR Tablet, 15 mg) 
20 mg SR formulation (EGT0001442 SR Tablet, 20 mg) 
20 mg IR formulation (EGT0001442 IR Tablet, 20 mg) 
 
The SR tablet formulations consist of EGT0001442 (active pharmaceutical ingredient) and 
excipients including HPMC, lactose monohydrate, sodium bicarbonate, colloidal silicon 
dioxide and magnesium stearate in the 10, 15, and 20 mg dosages.  The IR tablet formulation 
consists of 20 mg EGT0001442 (active pharmaceutical ingredient) and excipients including 
microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, colloidal silicon 
dioxide, and magnesium stearate. 
All study drug supplies will be prepared and labeled according to the requirements of local 
law and legislation and will be kept in a secure storage facility at controlled room 
temperature, 15 – 30°C (59 – 86°F).  The pharmacist or designated CRO personnel will 
dispense the study drugs for each subject according to randomization assignment made in the 
IVRS. 
5.1.2 
Placebo  
Theracos, Inc. will provide placebo tablets.  The placebo control tablets consist of HPMC, 
lactose monohydrate, sodium bicarbonate, colloidal silicon dioxide and magnesium stearate. 
Placebo will be prepared in white opaque tablets of the same size and appearance as the 
active drug tablets.  All placebo supplies will be prepared and labeled according to the 
requirements of local law and legislation and will be kept in a secure storage facility at 
controlled room temperature, 15 – 30°C (59 – 86°F).  The placebo control is packaged in a 
manner identical to the active drug product.  The placebo tablets will be administered 
identically to the EGT0001442 tablets. 
5.1.3 
Rescue medications 
Approved anti-diabetic medications will be provided to subjects who met the criteria to 
receive rescue medication due to poor glycemic control. 


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5.2 
Treatments Administered 
Study drug will be provided to the pharmacist in bottles of 45 tablets per bottle.  Individual 
bottles of placebo will be provided for the run-in portion of the study.  For the first 24 weeks 
of the study, subject kits will be provided and each kit will contain 4 bottles containing 45 
tablets per bottle.  For study weeks 25 – 96, subject kits will contain 2 bottles of 45 tablets.  
Study drug, EGT0001442 10, 15, or 20 mg tablets or matching placebo, will be dispensed by 
the pharmacy or designated study staff every 6 - 12 weeks.  There will be no intra-subject 
dose escalation or back-titration. 
Subjects who require rescue medication due to hyperglycemia will receive standard care for 
treating type 2 diabetes in addition to the study drug.  The pharmacist will dispense the 
medications per investigator’s prescription.   
5.3 
Selection and Timing of Dose for Each Patient 
Dosing with either active drug or placebo will be based on randomized assignment.  All 
study subjects will be instructed to self-administer one capsule prior to breakfast once daily 
and complete the dosing log.  Subjects will be advised to take the study medication with a 
glass of water.  The tablets will be swallowed without chewing.  
On the day of scheduled clinic visits, subjects must fast for a minimum of 10 h prior to the 
visits at which blood samples will be drawn.  During fasting, only water will be permitted.  
Subjects will be asked to record the meals they consume and the time that they last ate prior 
to blood draw for FPG and other laboratory testing. 
5.4 
Method of Assigning Patients to Treatment Groups 
Eligible subjects who complete the 14 ± 3 day washout period to verify eligibility for the 
study and stability of their diabetes will be randomized to receive EGT0001442 or placebo 
according to a randomization code.  Subjects are assigned to placebo or EGT0001442 at 30 
mg/day in a 1:1 ratio.  The random assignment of study subjects to treatment groups will be 
centrally located and managed utilizing an Interactive Voice Response Systems (IVRS).  
Randomization will be stratified by study center and based on screening HbA1c (≥7 to 
<8.5% or ≥8.5 to 10%). This randomization protocol is designed to balance experimental 
treatments within each center and the baseline HbA1c. 
The study will be conducted at multiple investigative sites and will likely involve variable 
numbers of subjects at each site.  Enrollment will be on a competitive basis but will be 
capped at 30% of the total randomized subjects (90 subjects) from one center. 
5.5 
Blinding 
The study drug will be blinded to the sponsor, investigators, study coordinators, pharmacists, 
study subjects, and the cardiovascular adjudication committee members.  Upon 
randomization, each subject will receive a subject randomization number and a drug kit 


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assigned to the subject.  To maintain blinding of the treatment, the values of the HbA1c after 
dosing starts will remain blinded to all study personnel and patients until all subjects have 
completed the 24 week treatment period. 
If knowledge of the test substance is needed to manage the subject’s condition, the 
investigator will contact the IVRS to obtain the treatment assignment.  If unblinding occurs, 
the time and reason for unblinding will be recorded on the CRF and the sponsor must be 
notified within 24 h. 
A designated statistician who is not involved with the study operation will hold the treatment 
code.  The unblinded treatment information can be provided to the DSMB to facilitate the 
evaluation of any clinically important increase in the rate of a serious suspected adverse 
reaction or to the designated safety contact when the treatment information is required to 
determine if an expedited safety report must be submitted to regulatory agencies.  The 
treatment code will be unblinded when the clinical database is locked and data are to be 
analyzed. 
The treatment assignment will continue to be withheld from the cardiovascular adjudication 
committee members at the conclusion of the study until all phase 2 and phase 3 
investigational studies are completed and a meta-analysis to assess cardiovascular risk is 
conducted. 
5.6 
Concomitant Therapy 
Medications to control blood pressure, specified lipid lowering drugs, and aspirin are allowed 
during the study period.  Allowed anti-hypertensive medications include ACE inhibitors, 
angiotensin receptor blockers, calcium channel blockers, beta blockers and diuretics.  The 
antihypertensive medications should continue for 24 weeks without changing unless 
clinically indicated.  In the extension period, the investigators should evaluate the blood 
pressure of each subject and determine if adjustment of the anti-hypertension drug should be 
adjusted per guideline. 
Subjects may receive any medications for adverse events that are necessary in the 
investigators’ judgment.  Subjects are permitted to take their prescription medications or 
medicinal supplements. 
Concomitant medications administered at the time of randomization and during the study are 
to be recorded on the CRF.  The medication name, dose, frequency, route of administration, 
date(s) of administration and reason for administration must be recorded.  Glucose for the 
treatment of hypoglycemia will be considered concomitant medication and must be recorded 
on the CRF.  This documentation should continue through the treatment period and the 
follow up period.  Medications that a subject receives after enrollment to the study and prior 
to randomization must be recorded in the CRF. 


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5.7 
Restrictions 
5.7.1 
Prior Therapy 
Medications for controlling diabetes, hypertension, hyperlipidemia, and aspirin as specified 
in the eligibility criteria are allowed as prior therapy.  No subject shall have been treated with 
an investigational drug within 30 days or 7 half lives, nor have used steroids within 14 days 
prior to the first dose of study medication.  Use of acetaminophen or multivitamins in this 
interval is permitted.   
5.7.2 
Fluid and Food Intake  
Enrolled diabetic subjects will receive counseling regarding an appropriate diet to achieve 
glycemic control based on standards of medical care in diabetes (ADA, 2008).  The diet 
should be low in saturated fat, high in fiber, and low in simple carbohydrates and contain 
appropriate caloric intake to maintain weight. 
Subjects will fast for a minimum of 10 h prior to any of the visits at which blood samples 
will be drawn.  During fasting, only water will be permitted.  Subjects will be asked to record 
the meals they consume and the time that they last ate prior to blood draw for FPG and other 
laboratory testing.  
5.7.3 
Patient Activity Restrictions 
Throughout the study period, subjects are advised to perform at least 150 min/week of 
physical activity that is appropriate for their physical condition. 
5.8 
Treatment Compliance 
To ensure the treatment compliance, subjects will be provided with dosing instruction and a 
dosing record.  The dosing record will be reviewed with the study staff during each visit and 
drug accountability will be performed and recorded at the end of the treatment period for 
each subject. 
Approximately 0.5 mL plasma sample will be collected and stored at -20oC at each clinic 
visit during the treatment period.  The samples will be shipped to the analytical laboratory in 
batches.  EGT0001442 plasma concentration may be determined from all or a portion of the 
samples to verify the drug exposure.  The results of the analysis will not be disclosed to the 
study team during the 24 week main treatment period until the clinical data for the primary 
analysis are locked. 


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5.9 
Packaging and Labeling 
5.9.1 
Study drug for main treatment period 
EGT0001442 tablets and placebo are packaged in high density polyethylene (HDPE) bottles 
sealed with a child resistant closure.   Each kit will include 4 bottles of study drug.  The 
product is packaged with 45 tablets per bottle including a 3 tablet overage in each bottle for 
accidental loss of study drug during the treatment period between visits. 
Study drug bottles will be labeled with the protocol number, product identification, lot 
number, kit number, Sponsor’s name and address, and the investigational drug caution 
statement. 
5.9.2 
Study drug for the treatment extension period 
The study drug EGT0001442 tablets and placebo are packaged in HDPE bottles sealed with a 
child resistant closure.   Study drug bottles will be labeled with the protocol number, product 
identification lot number, the sponsor’s name and address, and the investigational drug 
caution statement. 
5.10 Storage and Accountability 
EGT0001442 tablets and matching placebo will be stored at controlled room temperature, 15 
– 30°C (59 – 86°F).  The rescue medications will be stored in conditions specified in the 
manufacturers’ labeling information. 
5.11 Investigational Product Retention at Study Site 
The investigational products should be stored in a secure area with limited access.  The drug 
storage facility must comply with the medication storage instructions. EGT0001442 or 
placebo should be stored at controlled room temperature until ready for dispensing to study 
subjects.  The trial staff must record the amount of investigational product dispensed to each 
subject on the dosing record.  To ensure adequate record keeping, subjects must return all 
trial products at the end of the treatment period and the remaining tablets will be accounted 
for in the CRF and drug accountability forms provided. The procedures for obtaining drug 
resupply will be provided by the sponsor.  At the completion of the trial, all used and unused 
bottles must be destroyed after drug accountability is verified by Theracos or its designee. 


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6 
STUDY PROCEDURES 
6.1 
Informed Consent 
All subjects will be informed of the nature and purpose of the study and their written 
informed consent will be obtained during the pre-study screening procedures conducted 
within three weeks prior to the start of the run-in period. A copy of the Informed Consent 
form, including subject information, will be provided to each subject in his native language. 
6.2 
Medical History 
The following information will be collected at the screening period: 
• Demographic information including age, sex, race, and whether a female subject is of 
childbearing potential or not 
• Significant medical, surgical history with dates. 
• History of kidney stones, bladder malfunction, or frequent urinary tract infections 
• Incident of genitourinary tract infections in the previous 6 weeks  
• History of smoking, alcohol or drug dependence or abuse 
• History of diagnosis with HIV sero-positive acquired immunodeficiency syndrome 
(AIDS) or Hepatitis B/C 
• Use of any investigational drug in the previous 30 days or seven half-lives, whichever is 
longer 
• Prior treatment with EGT0001474 or EGT0001442.  Currently participating another 
interventional trial or not. 
• Use of aspirin, and use of cholesterol-lowering drugs and any other medications 
including over the counter drugs, vitamins, or dietary supplements within 14 days 
• Type of diabetes and time of first diagnosis 
• Anti- diabetic or hypertension medication history 
• History of cardiovascular events including angina, hypertension, congestive heart failure, 
atherosclerotic cardiovascular disease, myocardial infarction and diagnosis based on the 
New York Heart Association class, peripheral edema, and cerebrovascular ischemia (TIA 
or CVA). 
• History of cardiac procedures including any re-vascularization procedures or 
hospitalization for chest pain.  
 


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6.3 
Physical Examination 
A complete physical examination will be performed by the investigator at screening and at 
the termination visit.  A complete physical examination will include measurement of body 
weight and height (height will be measured only at screening), general assessment of all body 
systems including the skin, head, eyes, ears, nose, throat, neck, thyroid, lungs, heart, 
abdomen, lymph nodes, and extremities. 
An abbreviated physical examination will include body weight and general assessment of the 
skin, heart, lungs and abdomen.  Abbreviated physical examinations will be performed by the 
investigator at all other time points, unless clinically indicated. 
The body weight must be determined using a scale that is calibrated regularly and no less 
than annually. 
6.4 
Vital Signs 
Vitals signs include pulse, systolic and diastolic blood pressure at sitting position after a 
subject has been sitting for 5 minutes, respiration rate, and temperature.  Vital signs must be 
taken twice with at least 3 minutes apart. 
6.5 
Electrocardiography 
A 12-lead electrocardiogram (ECG) will be conducted as listed in study activity chart in 
Appendix 1 and whenever clinically indicated. 
6.6 
Diet and exercise counseling 
Enrolled diabetic subjects will receive counseling regarding an appropriate diet to aid in  
glycemic control based on standards of medical care in diabetes throughout the study (ADA, 
2008). 
6.7 
Clinical Laboratory Tests 
6.7.1 
Laboratory Parameters 
Subjects will be in a seated or supine position during blood collection.  Schedule of each 
laboratory test is outlined in Appendix 1.  Clinical laboratory tests will include the following: 
Table 1. 
List of Laboratory Tests 
Hematology: 
- 
Hematocrit (Hct) 
- 
Hemoglobin (Hgb) 
- 
Platelet count 
Serum Chemistry: 
- 
Albumin (ALB) 
- 
Alanine aminotransferase (ALT;  
- 
Aspartate aminotransferase (AST;  


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- 
Red blood cell (RBC) count  
- 
White blood cell (WBC) count with 
differential  
 
Urinalysis:  
- 
Appearance 
- 
Bilirubin 
- 
Color 
- 
Glucose 
- 
Ketones 
- 
Microscopic examination of 
sediment  
- 
Nitrite  
- 
Occult blood 
- 
pH 
- 
Protein 
- 
Specific gravity 
- 
Urobilinogen 
 
Hepatitis screening HBsAg, HBcAg, and 
HCV 
 
Urine drug screen 
 
Urine human chorionic gonadotropin 
(hCG) (only for females who are not 
diagnosed as postmenopausal)  
 
- 
Blood urea nitrogen (BUN) 
- 
Calcium (Ca) 
- 
Carbon dioxide (CO2) 
- 
Chloride (Cl) 
- 
Creatinine 
- 
Glucose 
- 
Phosphorus 
- 
Potassium (K) 
- 
Sodium (Na) 
- 
Magnesium 
- 
Total bilirubin 
- 
Direct bilirubin 
- 
Total cholesterol 
- 
High density lipoprotein 
cholesterol (HDL-C) 
- 
Low density lipoprotein 
cholesterol (LDL-C, calculated) 
- 
ApoB  
- 
Total protein 
- 
Triglycerides 
- 
Uric acid 
- 
Fasting plasma glucose  
- 
HbA1c  
 
Coagulation:  
- 
Prothrombin time (PT) 
 
6.7.2 
Sample Collection, Storage, and Shipping 
6.7.2.1 
Hematology and blood chemistry 
Blood samples for hematology, coagulation, and chemistry will be collected.  Timing of 
collection is described in the Schedule of Events (see Appendix 1). 
The study staff will contact each subject prior to a scheduled clinic visit to confirm the time 
of the visit and to remind the subject of appropriate diet and exercise control, proper fasting, 
and to record the diary card with meals of the day and time that the subject ate prior to the 


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clinic visit.  A subject must be queried to assess compliance with a minimum of a 10 hour 
fast prior to blood draw to ensure the FPG and triglycerides values can be accurately 
determined.  If a subject has not fasted for 10 hours, the subject must return as soon as can be 
arranged (within 7 days) after proper fasting.  If the 10 h fast is not collected within 7 days of 
the visit, the fasting plasma glucose will be considered missing. 
6.7.2.2 
Urinalysis 
Clean-catch, midstream urine samples will be collected per schedule outlined in Section 7. 
Dipstick urinalysis will be conducted.  Microscopy will be conducted if the subject has a 
positive result on any of the dipstick tests that require microscopic follow-up to clarify their 
significance. 
6.8 
Dispensing Study Drug 
Study drug will be dispensed by the pharmacist or designated personnel on day 1 with self 
administered dosing instructions and a dosing log. 
6.9 
Adverse Events Assessments 
6.9.1 
Definitions 
An adverse event (AE) is defined as any new medical problem, or exacerbation of an 
existing problem, experienced by a subject while enrolled in the study, whether or not it is 
considered drug-related by the investigator. 
A serious adverse event (SAE) includes any event that results in any of the following 
outcomes: 
- 
death 
- 
life-threatening, i.e., the subject was, in the opinion of the investigator, at immediate 
risk of death from the event as it occurred.  It does not include an event that, had it 
occurred in a more severe form, might have caused death. 
- 
persistent or significant disability/incapacity 
- 
requires in-patient hospitalization or prolongs hospitalization 
- 
congenital anomaly/birth defect 
- 
other medically significant events that, based upon appropriate medical judgment, 
may jeopardize the subject and may require medical or surgical intervention to 
prevent one of the outcomes listed above, e.g., allergic bronchospasm requiring 
intensive treatment in an emergency room or home, blood dyscrasias or convulsions 
that do not result in hospitalization, or the development of drug dependency or drug 
abuse. 
 


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Non-serious adverse events are all events that do not meet the criteria for a "serious" adverse 
event. 
Immediately Reportable Adverse Event (IRAE):  Any serious adverse event or any 
adverse event that necessitates discontinuation of study drug, including pregnancy. 
Clinical Laboratory Changes:  It is the investigator’s responsibility to review the results of 
all laboratory tests as they become available.  For each abnormal laboratory test result, the 
investigator needs to ascertain if this is an abnormal (i.e., clinically significant) change from 
baseline for that individual subject. (This determination, however, does not necessarily need 
to be made the first time an abnormal value is observed.  The investigator may repeat the 
laboratory test or request additional tests to verify the results of the original laboratory tests).  
If this laboratory value is determined to be an abnormal change from baseline for that 
subject, this is considered an AE.  
High serum or plasma glucose (hyperglycemia) and high HbA1c, the disease related 
morbidity, are being followed as the study endpoints and will not be documented as adverse 
events.  If, however, the event fulfills any of the criteria for a “serious” adverse event, it must 
be recorded and reported as such. 
Hypoglycemia will be defined as any FPG or SMBG value < 70 mg/dL. 
Any increase in liver function tests (AST, ALT, or bilirubin) greater than 3X the ULN for the 
laboratory utilized will be considered a clinical laboratory adverse event. 
Increase in creatinine from baseline by 0.5 mg/dL or more will be reported as a laboratory 
adverse event. 
Severity:  Adverse events will be graded on a 3-point scale and reported as indicated on the 
CRF.  The intensity of an adverse experience is defined as follows: 
1 = Mild: Discomfort noticed, but no disruption to daily activity. 
2 = Moderate: Discomfort sufficient to reduce or affect normal daily activity. 
3 = Severe: 
Inability to work or perform normal daily activity. 
 
Study Drug Causality: Relationship of an adverse event to treatment will be assessed as 
follows: 
- 
Definite: There is a reasonable causal relationship between the study drug and the 
AE, when the event responds to withdrawal of the study drug (dechallenge), and 
recurs with rechallenge by administration of the study drug. 
- 
Probable: There is a reasonable causal relationship between the study drug and the 
AE.  The event responds to dechallenge.  Rechallenge not required. 
- 
Possible: There is a reasonable causal relationship between the study drug and the 
AE.  Dechallenge is lacking or unclear. 


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- 
Not Likely: There is a temporal relationship to study drug administration, but there is 
not a reasonable causal relationship between the study drug and the event. 
- 
Unrelated: There is not a temporal or causal relationship to the study drug 
administration. 
 
6.9.2 
Eliciting and Reporting Adverse Events 
The investigator will periodically assess subjects for the occurrence of adverse events.  In 
order to avoid bias in eliciting adverse events, subjects should be asked the following non-
leading question: "How have you felt since your last visit?"  All adverse events (serious and 
non-serious) reported by the subject must be recorded on the source documents and CRFs 
provided by the sponsor.   
In addition, Theracos or its designated personnel must be notified immediately by telephone 
or fax of any immediately reportable adverse events according to the procedure outlined 
below.  Special attention should be paid to recording hospitalization and concomitant 
medications. 
6.9.3 
Immediately Reportable Adverse Events (IRAE) 
The investigator must report any serious adverse event or pregnancy, by telephone or by fax 
to Theracos immediately after the investigator becomes aware of the event.  An Immediately 
Reportable Adverse Event (IRAE) form should be completed and sent by fax or overnight 
courier to the sponsor within 24 hours of knowledge of the event by the site. 
Non-serious events that require discontinuation of study drug (including laboratory 
abnormalities) should be reported to Theracos within 3 working days.  The IRAE form 
should be completed and sent by fax or overnight courier to the sponsor.   
Subjects experiencing serious adverse events should be followed clinically until their health 
has returned to baseline status or until all parameters have returned to normal, or have 
otherwise been explained.  It is expected that the investigator will provide or arrange 
appropriate supportive care for the subject.  
6.9.4 
Pregnancy 
Women of childbearing potential (WOCBP) who are sexually active must use an effective 
method of birth control during the course of the study, in a manner such that risk of failure is 
minimized.  Unless the subject and his/her partner(s) are sterile (i.e., women who have had a 
hysterectomy or have been postmenopausal for at least 12 consecutive months) or remain 
abstinent, two of the following precautions must be used: vasectomy, tubal ligation, vaginal 
diaphragm, intrauterine device (IUD), birth control pills, birth control implant, condom or 
sponge with spermicide.  Any single method of birth control, including vasectomy and tubal 
ligation, may fail, leading to pregnancy. 


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Before enrolling WOCBP in this clinical trial, investigators must review guidelines about 
study participation for WOCBP.  The topics should generally include: 
- 
General information 
- 
Informed consent form 
- 
Pregnancy prevention information 
- 
Drug interactions with hormonal contraceptives. 
- 
Contraceptives in current use. 
- 
Guidelines for the follow-up of a reported pregnancy. 
 
Prior to study enrollment, WOCBP must be advised of the importance of avoiding pregnancy 
during trial participation and the potential risk factors for an unintentional pregnancy.  The 
subject must sign an informed consent form stating that the above-mentioned risk factors and 
the consequences were discussed with her. 
During the study, all WOCBP should be instructed to contact the investigator immediately if 
they suspect they might be pregnant (e.g., missed or late menstrual cycle). 
If a subject or investigator suspects that the subject may be pregnant prior to study drug 
administration, the study drug administration must be withheld until the results of blood and 
urine pregnancy tests are available.  If the pregnancy is confirmed, the subject must not 
receive the study drug and must not be enrolled in the study.  If pregnancy is suspected while 
the subject is receiving study treatment, the study drug must be withheld immediately (if 
reasonable, taking into consideration any potential withdrawal risks) until the result of the 
pregnancy is known.  If pregnancy is confirmed, the study drug will be permanently 
discontinued in an appropriate manner (e.g., dose tapering if necessary for subject safety) and 
the subject withdrawn from the trial.  [Exceptions to study discontinuation may be considered 
for life-threatening conditions only after consultations with a Theracos Medical Monitor (see 
Appendix III).] 
The investigator must immediately notify the Medical Monitor of any female subject who 
becomes pregnant within 30 days after study drug exposure.  The investigator must record 
the event on the Pregnancy Surveillance form and forward it to Theracos Clinical Drug 
Safety. 
Protocol required procedures for study discontinuation and follow-up must be performed on 
the subject unless contraindicated by pregnancy (e.g., x-ray studies).  Other appropriate 
pregnancy follow-up procedures should be considered if indicated.  In addition, the 
investigator must report to Theracos, on appropriate Pregnancy Surveillance form(s), follow-
up information regarding the course of the pregnancy, including perinatal and neonatal 
outcome.  Infants will be followed for a minimum of six months. 


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6.9.5 
Procedure for Breaking the Blind  
The investigator should remain blinded of the subject treatment during the entire study 
UNLESS knowledge of the subject’s treatment is required for the clinical care and safety.  
Emergency Code Break module in the IVRS is used for such emergency situations.  The 
investigator must confirm the intention to unblind the subject’s treatment to obtain the dose 
information.  Upon completion of the unblinding, the system will send an alert to designated 
study team members that an unblinding event occurred.  Documentation of breaking the blind 
should be recorded in the subject’s medical record with the date and time the blind was 
broken, and the names of the personnel involved. 
6.9.6 
Follow-up of Adverse Events  
6.9.6.1 
Follow-up of Non-serious Adverse Events 
Non-serious adverse events that are identified on the last scheduled contact must be recorded 
on the AE CRF with the current status noted.  All non-serious events that are ongoing at this 
time will be recorded as ongoing on the CRF. 
6.9.6.2 
Follow-up of Post Study Serious Adverse Events 
Serious adverse events that are identified on the last scheduled contact must be recorded on 
the AE CRF page and reported to Theracos according to the reporting procedures outlined in 
Section 6.9.3.   This may include unresolved previously reported serious adverse events, or 
new serious adverse events.  The investigator should follow these serious adverse events until 
the events are resolved, or the subject is lost to follow-up.  Resolution means the subject has 
returned to the baseline state of health, or the investigator does not expect any further 
improvement or worsening of the subject’s condition.  The investigator should continue to 
report any significant follow-up information to Theracos up to the point the event has been 
resolved.   
Any new serious adverse events reported by the subject to the investigator that occur after the 
last scheduled contact, and are determined by the investigator to be reasonably associated 
with the use of the study drug, should be reported to Sponsor.  This may include serious 
adverse events that are captured on follow-up telephone contact or at any other time point 
after the defined study period (i.e., up to last scheduled contact). The investigator should 
follow serious related adverse events identified after the last scheduled contact until the 
events are resolved, or the subject is lost to follow-up.  The investigator should continue to 
report any significant follow-up information to Sponsor up to the point the event has been 
resolved.   
Any serious adverse events reported by the subject to the investigator that occur after the last 
scheduled visit, and are determined by the investigator to be reasonably associated with the 
use of the study drug, should be reported to Sponsor.  This study requires that subjects be 
actively monitored for serious adverse events at least 14 days after discharge from the study. 


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6.9.7 
Adverse event of special interest 
6.9.7.1 
Genitourinary infections  
Events representing genitourinary infection (e.g. cystitis, urethritis, pyelonephritis, balanitis, 
vulvovaginitis should be carefully evaluated and documentation of signs, symptoms, 
infectious agent (bacterial or fungal), and treatment should be undertaken. 
6.9.7.2 
Renal and urinary disorders 
Events that may be related to the diuretic effect of an SGLT2 inhibitor (e.g. nocturia, 
pollakiuria, polyuria, and dysuria) should be carefully evaluated and documented. 
6.9.7.3 
Major Adverse Cardiovascular Event (MACE) 
Evaluation of major adverse cardiovascular events will be undertaken across the 
development program for EGT0001442.  All events that potentially represent myocardial 
infarction, cerebrovascular accident (stroke), acute coronary syndrome, or cardiovascular 
death are to be evaluated by an adjudication committee. 
6.9.7.4 
Hypoglycemia 
Severe hypoglycemia is defined as hypoglycemia with documented blood glucose 2.8 
mmol/L (50 mg/dL) or symptoms that promptly resolve with oral carbohydrate, intravenous 
glucose, or glucagon that require the assistance of medical or paramedical personnel. 
6.10 Concomitant Medication Assessments 
A concomitant medication is any medication the patient enters the trial using and is expected 
to continue using for some portion of the trial as well as any medication the patient uses 
during the course of the trial.  All concomitant medications recorded at trial entry must have 
a related concomitant illness listed under the medical history as ongoing at the time of patient 
entry into the trial unless the medication is an allowed treatment for the disease under study.   
EGT0001442 or placebo are the study drugs and are not considered concomitant 
medications.  The rescue medications for controlling hyperglycemia must be recorded as 
concomitant medications. 
All prescription and over-the-counter medications patients receive pre-study and continue 
during the trial as well as any new medications started during the trial must be documented 
on the CRF.  This documentation should continue until one week from the end of the last 
treatment.  
Concomitant medications will be coded using the World Health Organization dictionary 
(WHODRUG). A table of concomitant medications based on the anatomic therapeutic 
chemical classification (ATC) and preferred name will be produced.  A listing of 
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Any medications taken prior to the start of the study medication will be listed and 
summarized. 
6.11 Removal of Patients from the Trial or Study Drug 
The investigator may withdraw a patient from any of the following reasons: 
• A protocol violation occurs, 
• A serious or intolerable adverse event occurs, 
• A clinically significant change in a laboratory parameter occurs,  
• The sponsor or investigator terminates the study, or 
• The patient requests to be discontinued from the study. 
 
6.12 Other Study Procedures 
Approximately 0.5 mL plasma sample will be collected and stored at -20oC at each clinic 
visit during the treatment period.  The samples will be shipped to the analytical laboratory in 
batches.  EGT0001442 plasma concentration may be determined from all or a portion of the 
samples to verify the drug exposure. 


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7 
STUDY ACTIVITIES 
The study activities in each clinic visit are listed below and are presented in Appendix A.  
Screening period may last up to 21 days (Visit 1 to Visit 2), Run-in period is to be 14±3 days 
(Visit 2 to Visit 3), Visit 3 to Visit 4 window is 14±3 days.  All other visit windows are the 
nominal duration from randomization ± 7 days. 
7.1.1 
Visit 1 - Screening (weeks –5 to -2) 
The screening can be performed up to 3 weeks from the start of study activities.  During the 
screening period, the following information will be gathered or the indicated procedure will 
be performed: 
• Informed Consent and medical history obtained, and Inclusion/Exclusion criteria 
evaluated 
• Complete physical examination including height and weight 
• Vital Signs: blood pressure, pulse, temperature, respiratory rate taken in the sitting 
position after at least 5 minutes of rest.  Blood pressure must be measured twice with at 
least 3 min apart 
• 12 lead ECG taken in the supine position after at least 5 minutes of rest 
• Blood draw for hematology (CBC with platelets, WBC with differential), serum 
chemistry including FPG, and coagulation as detailed in section 6.7.1 
• Urinalysis 
• Urine screen for drugs of abuse.  Drug screening includes amphetamines, barbiturates, 
cocaine metabolites, opiates, benzodiazepines, and cannabinoids.  
• Urine pregnancy test (only for females who are not postmenopausal) 
• The subject must be queried to assess compliance with a minimum of a 10 h fast prior to 
blood draw to ensure the FPG values can be accurately determined.  If a subject has not 
fasted for 10 h, the subject should return within a week after proper fasting. 
 
7.1.2 
Visit 2 – run-in period (day -14±3) 
• Confirm eligibility  
• Diet and exercise counseling 
• Glucometer dispensing and training for SMBG determination 
• Discontinue anti-diabetic medication 
• Vital Signs: blood pressure, pulse, temperature, respiratory rate taken in the sitting 
position after at least 5 minutes of rest.  Blood pressure must be measured twice with at 
least 3 min apart 


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• Dispense study medication for the run-in period 
 
7.2 
Primary Efficacy Phase 
7.2.1 
Visit 3 – procedures (Day 1 in Week 0) 
 The subject must be queried to assess compliance with a minimum of a 10 h fast prior to 
blood draw to ensure the FPG values can be accurately determined.  Only water is 
permitted.  If a subject has not fasted for 10 h, the subject should return within a week 
after proper fasting. 
• Confirm eligibility  
• Diary and SMBG review 
• Adverse events and pre-treatment medications assessment 
• Randomization 
• Vital Signs: blood pressure, pulse, temperature, respiratory rate taken in the sitting 
position after at least 5 minutes of rest.  Blood pressure must be measured twice with at 
least 3 min apart 
• 12 lead ECG taken in the supine position after at least 5 minutes of rest 
• Dispense study medication based on randomization assignment 
• Blood draw for hematology (CBC with platelets, WBC with differential), serum 
chemistry including FPG, and coagulation as detailed in section 6.7.1 
• Urinalysis 
 
7.2.2 
Visit 4 – Procedures (week 2) 
 The subject must be queried to assess compliance with a minimum of a 10 h fast prior to 
blood draw to ensure the FPG values can be accurately determined.  Only water is 
permitted.  If a subject has not fasted for 10 h, the subject should return within a week 
after proper fasting. 
• Diary and SMBG review 
• Vital Signs: blood pressure, pulse, temperature, respiratory rate taken in the sitting 
position after at least 5 minutes of rest.  Blood pressure must be measured twice with at 
least 3 min apart 
• Blood draw for hematology (CBC with platelets, WBC with differential), serum 
chemistry including FPG, and coagulation as detailed in section 6.7.1 
• Urinalysis 


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• Collect plasma sample for drug exposure verification 
• Assess adverse events and record concomitant medications 
 
7.2.3 
Visit 5 – Procedures (week 6) 
 The subject must be queried to assess compliance with a minimum of a 10 h fast prior to 
blood draw to ensure the FPG values can be accurately determined.  Only water is 
permitted.  If a subject has not fasted for 10 h, the subject should return within a week 
after proper fasting. 
• Diary and SMBG review 
• Vital Signs: blood pressure, pulse, temperature, respiratory rate taken in the sitting 
position after at least 5 minutes of rest.  Blood pressure must be measured twice with at 
least 3 min apart 
• Dispense study medication 
• Blood draw for hematology (CBC with platelets, WBC with differential), serum 
chemistry including FPG, and coagulation as detailed in section 6.7.1 
• Urinalysis 
• Collect plasma sample for drug exposure verification 
• Assess adverse events and record concomitant medications 
 
7.2.4 
Visit 6 – Procedures (week 12) 
 The subject must be queried to assess compliance with a minimum of a 10 h fast prior to 
blood draw to ensure the FPG values can be accurately determined.  Only water is 
permitted.  If a subject has not fasted for 10 h, the subject should return within a week 
after proper fasting. 
• Diary and SMBG review 
• Diet and exercise counseling 
• Physical examination 
• Vital Signs: blood pressure, pulse, temperature, respiratory rate taken in the sitting 
position after at least 5 minutes of rest.  Blood pressure must be measured twice with at 
least 3 min apart 
• Dispense study medication 
• Blood draw for hematology (CBC with platelets, WBC with differential), serum 
chemistry including FPG, and coagulation as detailed in section 6.7.1 


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• Urinalysis 
• Collect plasma sample for drug exposure verification 
• Assess adverse events and record concomitant medications 
 
7.2.5 
Visit 7 – Procedures (week 18) 
 The subject must be queried to assess compliance with a minimum of a 10 h fast prior to 
blood draw to ensure the FPG values can be accurately determined.  Only water is 
permitted.  If a subject has not fasted for 10 h, the subject should return within a week 
after proper fasting. 
• Diary and SMBG review 
• Vital Signs: blood pressure, pulse, temperature, respiratory rate taken in the sitting 
position after at least 5 minutes of rest.  Blood pressure must be measured twice with at 
least 3 min apart 
• Dispense study medication 
• Blood draw for hematology (CBC with platelets, WBC with differential), serum 
chemistry including FPG, and coagulation as detailed in section 6.7.1 
• Urinalysis 
• Collect plasma sample for drug exposure verification 
• Assess adverse events and record concomitant medications 
 
7.2.6 
Visit 8 – Procedures (week 24) 
 The subject must be queried to assess compliance with a minimum of a 10 h fast prior to 
blood draw to ensure the FPG values can be accurately determined.  Only water is 
permitted.  If a subject has not fasted for 10 h, the subject should return within a week 
after proper fasting. 
• Diary and SMBG review 
• Diet and exercise counseling 
• Physical examination 
• Vital Signs: blood pressure, pulse, temperature, respiratory rate taken in the sitting 
position after at least 5 minutes of rest.  Blood pressure must be measured twice with at 
least 3 min apart 
• 12 lead ECG taken in the supine position after at least 5 minutes of rest 
• Dispense study medication 


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• Blood draw for hematology (CBC with platelets, WBC with differential), serum 
chemistry including FPG, and coagulation as detailed in section 6.7.1 
• Urinalysis 
• Collect plasma sample for drug exposure verification 
• Assess adverse events and record concomitant medications 
 
7.3 
Extension Phase 
7.3.1 
Visit 9 – Procedures (week 36) 
 The subject must be queried to assess compliance with a minimum of a 10 h fast prior to 
blood draw to ensure the FPG values can be accurately determined.  Only water is 
permitted.  If a subject has not fasted for 10 h, the subject should return within a week 
after proper fasting. 
• Diary and SMBG review 
• Vital Signs: blood pressure, pulse, temperature, respiratory rate taken in the sitting 
position after at least 5 minutes of rest.  Blood pressure must be measured twice with at 
least 3 min apart 
• Dispense study medication 
• Blood draw for hematology (CBC with platelets, WBC with differential), serum 
chemistry including FPG, and coagulation as detailed in section 6.7.1 
• Urinalysis 
• Collect plasma sample for drug exposure verification 
• Assess adverse events and record concomitant medications 
 
7.3.2 
Visit 10 – Procedures (week 48) 
 The subject must be queried to assess compliance with a minimum of a 10 h fast prior to 
blood draw to ensure the FPG values can be accurately determined.  Only water is 
permitted.  If a subject has not fasted for 10 h, the subject should return within a week 
after proper fasting. 
• Diary and SMBG review 
• Diet and exercise counseling 
• Physical examination 


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• Vital Signs: blood pressure, pulse, temperature, respiratory rate taken in the sitting 
position after at least 5 minutes of rest.  Blood pressure must be measured twice with at 
least 3 min apart 
• Dispense study medication 
• Blood draw for hematology (CBC with platelets, WBC with differential), serum 
chemistry including FPG, and coagulation as detailed in section 6.7.1 
• Urinalysis 
• Collect plasma sample for drug exposure verification 
• Assess adverse events and record concomitant medications 
 
7.3.3 
Visit 11 – Procedures (week 60) 
 The subject must be queried to assess compliance with a minimum of a 10 h fast prior to 
blood draw to ensure the FPG values can be accurately determined.  Only water is 
permitted.  If a subject has not fasted for 10 h, the subject should return within a week 
after proper fasting. 
• Diary and SMBG review 
• Vital Signs: blood pressure, pulse, temperature, respiratory rate taken in the sitting 
position after at least 5 minutes of rest.  Blood pressure must be measured twice with at 
least 3 min apart 
• 12 lead ECG taken in the supine position after at least 5 minutes of rest 
• Dispense study medication 
• Blood draw for hematology (CBC with platelets, WBC with differential), serum 
chemistry including FPG, and coagulation as detailed in section 6.7.1 
• Urinalysis 
• Collect plasma sample for drug exposure verification 
• Assess adverse events and record concomitant medications 
 
7.3.4 
Visit 12 – Procedures (week 72) 
 The subject must be queried to assess compliance with a minimum of a 10 h fast prior to 
blood draw to ensure the FPG values can be accurately determined.  Only water is 
permitted.  If a subject has not fasted for 10 h, the subject should return within a week 
after proper fasting. 


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• Diary and SMBG review 
• Diet and exercise counseling 
• Physical examination 
• Vital Signs: blood pressure, pulse, temperature, respiratory rate taken in the sitting 
position after at least 5 minutes of rest.  Blood pressure must be measured twice with at 
least 3 min apart 
• Dispense study medication 
• Blood draw for hematology (CBC with platelets, WBC with differential), serum 
chemistry including FPG, and coagulation as detailed in section 6.7.1 
• Urinalysis 
• Collect plasma sample for drug exposure verification 
• Assess adverse events and record concomitant medications 
 
7.3.5 
Visit 13 – Procedures (week 84) 
 The subject must be queried to assess compliance with a minimum of a 10 h fast prior to 
blood draw to ensure the FPG values can be accurately determined.  Only water is 
permitted.  If a subject has not fasted for 10 h, the subject should return within a week 
after proper fasting. 
• Diary and SMBG review 
• Vital Signs: blood pressure, pulse, temperature, respiratory rate taken in the sitting 
position after at least 5 minutes of rest.  Blood pressure must be measured twice with at 
least 3 min apart 
• Dispense study medication 
• Blood draw for hematology (CBC with platelets, WBC with differential), serum 
chemistry including FPG, and coagulation as detailed in section 6.7.1 
• Urinalysis 
• Collect plasma sample for drug exposure verification 
• Assess adverse events and record concomitant medications 
 
7.3.6 
Visit 14 – Procedures (week 96) 
 The subject must be queried to assess compliance with a minimum of a 10 h fast prior to 
blood draw to ensure the FPG values can be accurately determined.  Only water is 


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permitted.  If a subject has not fasted for 10 h, the subject should return within a week 
after proper fasting. 
• Diary and SMBG review 
• Physical examination 
• Vital Signs: blood pressure, pulse, temperature, respiratory rate taken in the sitting 
position after at least 5 minutes of rest.  Blood pressure must be measured twice with at 
least 3 min apart 
• 12 lead ECG taken in the supine position after at least 5 minutes of rest 
• Blood draw for hematology (CBC with platelets, WBC with differential), serum 
chemistry including FPG, and coagulation as detailed in section 6.7.1 
• Urinalysis 
• Collect plasma sample for drug exposure verification 
• Assess adverse events and record concomitant medications 
 
7.3.7 
Visit 15 – Exit Visit (week 97) 
Follow-up is planned at approximately one week after the last dose is administered.  If 
subjects have an ongoing adverse event, the subject will be followed until the adverse event 
is resolved or returns to baseline. All possible attempts will be made to document resolution 
of acute and chronic toxicities. Diary and SMBG review 
• Physical examination 
• Vital Signs: blood pressure, pulse, temperature, respiratory rate taken in the sitting 
position after at least 5 minutes of rest.  Blood pressure must be measured twice with at 
least 3 min apart 
• 12 lead ECG taken in the supine position after at least 5 minutes of rest 
• Blood draw for hematology (CBC with platelets, WBC with differential), serum 
chemistry including FPG, and coagulation as detailed in section 6.7.1 
• Urinalysis 
• Assess adverse events and record concomitant medications 
 
7.4 
Early Termination Procedures 
Subjects removed from study due to drug related toxicity will be followed until resolution or 
stabilization of the adverse event.  Sponsor must be notified in the event that a subject 
withdraws or is withdrawn from the study. 


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Subjects who withdraw consent and have received study drug will have a follow-up 
examination, including a complete physical examination, vital signs, ECG, CBC, urinalysis, 
and serum chemistry tests. 
 


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8 
QUALITY CONTROL AND ASSURANCE 
The clinical research facility will be monitored by the study monitor to ensure correct 
performance of the study procedures and assure that the study will be conducted according to 
the protocol and relevant regulatory requirements.  CRF entries will be verified with the 
source documentation. 
Quality control principles will be applied throughout the performance of this study by 
following the SOPs of the CRO and the sponsor. Review procedures will be implemented at 
the CRO for all documents that are generated in relation to the study. 


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9 
PLANNED STATISTICAL METHODS 
9.1 
General Considerations 
The primary objective of this trial is to assess the efficacy of EGT0001442 in treatment-naïve 
type-2 diabetic patients or patients on a single oral anti-diabetic drug in combination with 
diet and exercise with an HbA1c between 7 and 10%.  Efficacy, in this case, is defined as a 
significant reduction in HbA1c at week 24 when compared to placebo.  The effect of 
EGT0001442 on fasting glucose, blood pressure, body weight and the general safety of 
EGT0001442 in patients with T2DM will also be explored. 
Statistical analyses and summaries of safety and tolerability will be performed using SAS® 
software (SAS Institute, Cary, NC).  In all cases, significance will be judged at the =0.05 
level.  No multiplicity adjustment will be required for the single primary endpoint. 
9.1.1 
Handling Dropouts, Multiples, Missing Data, and Outliers 
Discontinuation criteria are explained in Section 6.11.  Patients who discontinue will not be 
replaced.  Data will be evaluated for any bias in the pattern of missing data prior to inference 
testing.  Absence of a discernable pattern will be taken as a reliable indication that the 
incidences of missing data are random occurrences and will not be addressed further.  
Clinically relevant patterns of missing data will be summarized in the Clinical Trial Report 
and summarized as notes to any affected tables and listings.  Missing data will not be 
imputed and the observation for that subject will be effectively deleted for that subject.   
9.1.2 
Multiple Comparisons / Multiplicity 
There is a single primary endpoint in this study and no correction for multiple comparisons is 
needed.  Important secondary endpoints are considered exploratory and will not be corrected. 
9.2 
Determination of Sample Size 
Approximately 300 patients will be enrolled and equitably allocated to receive either 20 
mg/day EGT0001442 or placebo.   
The sample size of 150 subjects per group was calculated based on the following 
assumptions:  
1.  This effect size is the mean difference between baseline and week 24.  The active 
doses will decrease the HbA1c by 0.4%. 
2. The placebo will not experience a substantive average decrease in mean HbA1c from 
baseline to week 24 
3. The standard deviation of this difference is the same for both groups and is 1.0%.   
4. The study design is balanced and the two-sided significance level for the hypothesis 
is 0.05.  
 


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Under the above assumptions, an evaluable sample size of 131 evaluable patients per 
treatment arm yields approximately 90% power that EGT0001442 treatment will be found to 
be significantly different from placebo.  A sample size of 150 subjects per treatment arm will 
be enrolled to account for any subject lost-to-follow-up. 
9.3 
Analysis Populations  
This study will be conducted at multiple investigative sites and will likely involve variable 
numbers of subjects at each site.  Enrollment will be on a competitive basis but will be 
capped at 90 subjects in one center. 
All patients in the Intent-to-Treatment (ITT) sample will be analyzed according to the 
treatment they were randomized to receive, and not according to what they actually received, 
if different.  All efficacy analyses will be performed on the ITT sample. All patients in the 
Per Protocol (PP) sample will be analyzed according to the treatment actually received, and 
not according to the treatment they were randomized to receive, in the event there is a 
discrepancy.  The analyses of primary efficacy endpoint and selected secondary efficacy 
endpoints will be performed on the PP sample.  The Safety sample will include all 
randomized patients who have received study drug.  The safety sample will be used for safety 
analysis. 
9.4 
Demographics and Baseline Characteristics 
Patients must meet all inclusion criteria and none of the exclusion criteria in order to 
participate in the study.  Demographic characteristics include age, gender, race, ethnicity, and 
study center.  Baseline characteristics include baseline HbA1c values, blood pressure, Body 
Mass Index (BMI in kg/m2), whether treatment naïve or not.  Summary descriptive statistics 
will include counts and percentages for discrete variables and estimation of means, standard 
deviations, medians, inter-quartile range, minimum and maximum for continuous metrics. 
9.5 
Analysis of Efficacy 
Efficacy data includes HbA1c, FPG, body weight, systolic and diastolic blood pressure, and 
% of subject who achieve HbA1c <7% at week 24.  Observed data will be summarized as 
counts and percentages for discrete variables and estimation of means, standard deviations, 
medians, inter-quartile range, minimum and maximum for continuous metrics.  All data will 
be presented in by-subject listings and included in the clinical trial report. 
9.5.1 
Primary Efficacy Endpoint 
The primary hypothesis is that EGT0001442 reduces HbA1c after 24 weeks of treatment 
when compared to placebo controls.  Change in HbA1c will be estimated as HbA1c at 24 
weeks minus HbA1c at baseline.  The two groups will be compared with a t-test at a 
significance level of 0.05.  For subjects that receive rescue medication due to hyperglycemia, 
the last HbA1c prior to receiving rescue medication will be carried forward to week 24.   


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9.5.2 
Secondary Efficacy Endpoints 
The secondary endpoints are considered exploratory and will not be corrected for 
multiplicity.  The first secondary hypothesis is that EGT0001442 reduces FPG at weeks 2 
and 24 when compared to controls.  Change in FPG for each follow up visit will be estimated 
as follow-up minus baseline and the two treatment groups will be compared with two paired 
t-tests. 
The second hypothesis is that EGT0001442 reduces the HbA1c to less that 7% of more 
patients when compared to placebo.  HbA1c categories will be assessed for each patient as 
<7% or ≥7% of each subject.  The 2x2 contingency table of treatment by HbA1c category 
will be analyzed with a test.  
The third hypothesis is that EGT0001442 reduces blood pressure compared to placebo.  
Systolic and Diastolic blood pressure will be measured at baseline and at weeks 2 and weeks 
24.  Change in each blood pressure metric for both follow up visits will be estimated as 
follow-up minus baseline and the two treatment groups will be compared with four paired t-
tests. 
The fourth hypothesis is that EGT0001442 reduces body weight compared to placebo.  Body 
weight will be measured at baseline and at weeks 2 and weeks 24.  Change in body weight 
for both follow up visits will be estimated as follow-up minus baseline and the two treatment 
groups will be compared with two paired t-tests. 
The final secondary hypothesis is that EGT0001442 induced change in HbA1c is evident 
over time, present at week 24 and maintained over the 96 weeks of the study.  HbA1c is 
collected at baseline and weeks 2, 6, 12, 24, 36, 48, 60, 72, 84 and 96.  Repeated measures of 
HbA1c will be analyzed with a linear mixed effect model to assess the overall treatment 
effect.  Subsequently the change in each time point will be estimated as described for the 
primary endpoint and evaluated with 10 t-tests. 
9.5.3 
Additional Efficacy Endpoints 
As with HbA1c, repeated measures are available for body weight, systolic and diastolic 
blood pressure, and fasting plasma glucose. Repeated measures of these variables will be 
analyzed individually with a linear mixed effect model to assess the overall treatment effect.  
Subsequently the change in each time point will be estimated as described for the primary 
endpoint and evaluated with t-tests.   
The effect of demographic covariates such as gender, race, age, treatment center, will be 
evaluated on the primary endpoint and selected secondary endpoints (FPG, blood pressure, 
and body weight) using Analysis of Covariance.  Demographic variables will be included in 
the model of change in the dependent variable with treatment. 


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9.6 
Analysis of Safety  
Safety data includes adverse events (AEs), physical exam results, vital signs, ECG results, 
and clinical lab results including serum chemistry, hematology, and urinalysis. Observed data 
will be described as counts and percentages for discrete variables and estimation of means, 
standard deviations, medians, inter-quartile range, minimum and maximum for continuous 
metrics.  All patients will be included in the safety analysis.  All safety data will be presented 
in by-subject listings and included in the clinical trial report. 
9.6.1 
Adverse Events 
Adverse events will be mapped to preferred term and body system using the Medical 
Dictionary for Regulatory Activities (MedDRA) dictionary. The number and percentage of 
patients reporting adverse events will be determined by relationship to treatment and by 
severity of the event. Drug-related adverse events will be considered those to be at least 
possibly related to EGT0001442 administration. 
Adverse event listings will be provided for the following subsets: 
• All treatment emergent AEs (TEAEs) 
• All TEAEs at least possibly related to EGT0001442 
• Serious TEAEs (if any) 
• TEAEs leading to study discontinuation (if any) 
 
AEs are treatment emergent if occurring on or after EGT0001442 administration. TEAEs 
will be considered at least possibly related to EGT0001442 based on the investigators 
assessment. Only TEAEs will be tabulated in summary tables. 
Tabulations will display TEAEs by severity, and relationship to EGT0001442. 
9.6.2 
Adverse event of special interest  
9.6.2.1 
Genitourinary infections  
Genitourinary infections as defined in Section 6.9.7.1 will be summarized.  Event terms, 
signs, symptoms, infectious agent (bacterial or fungal), and treatment undertaken will be 
documented in the listing. 
9.6.2.2 
Major Adverse Cardiovascular Event (MACE) 
All events that potentially represent myocardial infarction, cerebrovascular accident (stroke), 
acute coronary syndrome, or cardiovascular death are to be evaluated by an independent 
adjudication committee.  There will not be any analysis performed. 


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9.6.2.3 
Hypoglycemia 
Severe hypoglycemia as defined in Section 6.9.7.3 will be presented in a listing and 
summarized. 
9.6.2.4 
Renal and Urinary disorders 
Events as defined in Section 6.9.7.1 will be summarized.  Event terms, signs, and symptoms 
will be documented in the listing. 
9.6.3 
Clinical and Laboratory Events and Analyses 
Clinical and laboratory metrics are measured at baseline and weeks 2, 6, 12 and 24 during the 
study.  During the treatment extension they are measured every 12 weeks up to a total of 96 
weeks.  These variables include vital signs (blood pressure, respiration, and temperature), 
Clinical laboratory (see section 6.7 for a complete list) and ECGs. 
Laboratory data will be summarized using Low-Normal-High shift tables.  ECG results will 
be summarized as changes from baseline in intervals.  Abnormalities as well as changes from 
previous assessment will be listed. 
9.6.4 
Concomitant Medications 
Concomitant medications will be coded using the World Health Organization Drug 
Dictionary (WHODRUG).  A by-subject listing of concomitant medications will include all 
medications taken during the study.  All medications started prior to the administration of the 
study drug will be included in the data but will be flagged as prior.  Only the concomitant 
medication use will be summarized. 
9.7 
Interim Analysis 
An independent Data and Safety Monitoring Board (DSMB) will monitor the safety of this 
study.  The objectives of the DSMB are to assess drug safety and allow for protocol 
modification or early stopping due to safety concerns.  The DSMB members will include at 
least one statistician, one clinician of relevant specialty, and one endocrinologist that is 
familiar with the care of patients with type 2 diabetes.  No interim efficacy assessment will 
be performed. 


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10 ADMINISTRATIVE CONSIDERATIONS 
10.1 Investigators and Study Administrative Structure 
Information regarding key personnel involved in the conduct of the study, including names 
and contact details of participating investigators, monitors, clinical laboratories, technical 
departments and/or institutions, as well as information on members of additional study 
committees, will be found in the study files of the study sites. 
10.2 Institutional Review Board (IRB) or Independent Ethics Committee 
(IEC) Approval 
This protocol, informed consent document, relevant supporting information, and all types of 
subject recruitment or advertisement information must be submitted to the IEC or IRB for 
review and must be approved by The Sponsor and the IEC/IRB before the study is initiated.  
Any amendments or addenda to the protocol must also be approved by the IEC/IRB prior to 
implementing changes in the study.  The Investigator is responsible for keeping the IEC/IRB 
apprised of the progress of the study and of any changes made to the protocol as deemed 
appropriate, but in any case at least once a year.  The Investigator must also keep the 
IEC/IRB informed of any SAEs occurring to subjects under their supervision. 
10.3 Ethical Conduct of the Study 
The procedures set out in this protocol, pertaining to the conduct, evaluation, and 
documentation of this study, are designed to ensure that the sponsor and investigator abide by 
Good Clinical Practice Guidelines and under the guiding principles detailed in the 
Declaration of Helsinki. The study will also be carried out in keeping with applicable local 
law(s) and regulation(s). This may include an inspection by the sponsor representatives 
and/or their designee and/or FDA representatives at any time. The investigator must agree to 
the inspection of study-related records by the FDA/sponsor representatives, and must allow 
direct access to source documents to the FDA/sponsor representatives. 
The investigator is responsible for complying with the protocol and all appropriate 
regulations and guidelines governing global clinical research. Additionally, he/she is 
responsible for ensuring that all participating staff members are adequately trained and 
competent to perform his/her assigned tasks. 
Modifications to the study protocol will not be implemented by either the sponsor or the 
investigator without agreement by both parties. However, the investigator may implement a 
deviation form, or a change of, the protocol to eliminate an immediate hazard(s) to the trial 
subjects without prior IRB/sponsor approval/favorable opinion. As soon as possible, the 
implemented deviation or change, the reasons for it and if appropriate the proposed protocol 
amendment should be submitted to the IRB/sponsor. 
Any deviations from the protocol must be fully explained and documented by the 
investigator. The circumstances, action taken and impact of the deviation on the trial must be 


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communicated by the Principal Investigator to the designated Medical Monitor. Any 
subsequent actions will be assessed by the designated Medical Monitor and documented. 
10.4 Patient Information and Consent 
Prior to the beginning of the study, the investigator must have the EC/IRB written approval/ 
favorable opinion of the written Informed Consent Form and any other written information to 
be provided to subjects. The written approval of the EC/IRB together with the approved 
subject information/Informed Consent Forms must be filed in the study files. The Informed 
Consent Form must contain all elements required by the FDA under 21 CFR Part 50 and the 
International Conference on Harmonisation (ICH) Good Clinical Practices (GCP) Guidelines 
(E6) in addition to any other elements required by state, local or institutional policy.  
Written informed consent must be obtained before any study specific procedure takes place. 
Participation in the study and date of informed consent given by the subject should be 
documented appropriately in the subject’s files. A copy of the signed informed consent form 
must be provided to the subject.  If applicable, it will be provided in a certified translation in 
the language understood by the subject if not English.  Signed consent forms must remain in 
each subject’s study file and must be available for verification by study monitors at any time. 
10.5 Patient Confidentiality 
The information obtained during the conduct of this clinical study is confidential, and 
disclosure to third parties other than those noted below is prohibited.  Information obtained 
during the conduct of this study will be used by The Sponsor in connection with the 
development of the study drug.  The study Investigator is obliged to provide the Sponsor with 
complete test results and all data developed in this study.  Subject-specific information may 
be provided to other appropriate medical personnel only with the subject’s permission.  To 
ensure compliance with current ICH guidelines, data generated by this study must be 
available for inspection upon request by representatives of national and local health 
authorities, the Sponsor and the IRB for each study site. 
Subject names and other identifiers, such as photographs, audio or videotapes, may not be 
disclosed in any publication without prior written authorization from the subject. 
10.6 Study Monitoring 
An authorized Sponsor representative will conduct site visits to inspect study data, subjects’ 
medical records and CRFs in accordance with ICH guidelines, GCPs and the respective local 
and national government regulations and guidelines. 
The Investigator will permit authorized representatives of the Sponsor and the respective 
national or local health authorities to inspect facilities and records relevant to this study. 


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10.7 Case Report Forms and Study Records 
For each subject consented, a case report form (CRF) will be supplied and maintained by the 
CRO staff and signed by the investigator or authorized designee to indicate that he/she has 
reviewed and agrees with the entered data. This also applies to those subjects who fail to 
complete the trial. The reason a subject is withdrawn must be recorded in the case report 
form. 
Entries made in the CRF must be verifiable against source documents. Source documents are 
defined as all medical records, medical notes, laboratory results, ECG traces and any 
additional document other than the CRF that has original subject information contained 
within it.  The diary card that subjects will complete with meal information will be archived 
but meal information will not be entered in the database.  Whether the subject was fasting for 
10 hr or not prior to sample collection will be captured in the CRF. 
All CRFs and source documents should be completed following GCPs and the CRO’s 
standard operating procedures. 
10.8 Protocol Violations/Deviations 
Protocol “violations” include deviations from the inclusion and exclusion criteria, 
concomitant medication restrictions, and any other protocol requirement that results in a 
significant added risk to the patient or has an impact on the quality of the data collected or 
the outcome of the study.  Protocol violations must be reported to the Ethics Committee or 
Institutional Review Board in a timely manner. Protocol violations must be reported in the 
final study report. 
A protocol deviation occurs when there is non-adherence to study procedures or schedules, as 
specified by the protocol, which does not involve inclusion/exclusion criteria or the primary 
endpoint and which does not place the patient at any added risk or affect the data quality or 
study outcome.  If deviations occur, such as a missed visit or missed sampling window, the 
investigator must decide whether to proceed, for example, whether or not to complete the 
visit or sample collection outside of the protocol-defined window.  The sponsor’s medical 
monitor must be notified immediately when protocol deviations are discovered so that a 
decision can be made about the continued participation of the subject in the study. 
A departure from the protocol for an individual subject can only be made without the 
Sponsor approval in the event of an emergency.  The nature and reasons for the protocol 
deviation will be recorded in the CRF and the Principal Investigator must notify the Sponsor. 
10.9 Access to Source Documentation 
Authorized Sponsor representatives will conduct site visits to inspect study data, subject 
medical records and CRFs in accordance with ICH guidelines, GCP and the respective local 
and national government regulations and guidelines. 


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The Investigator will permit authorized representatives of the Sponsor and the respective 
national or local health authorities to inspect facilities and records relevant to this study. 
Each center will be visited at regular intervals by a monitor to ensure compliance with the 
study protocol, GCP and legal aspects. This will include on-site checking of the case report 
forms (CRF) for completeness and clarity, cross-checking with source documents, and 
clarification of administrative matters. 
All CRF data will be entered into a clinical database.  Following the correction of any errors, 
the clinical database will be locked. 
10.10 Data Generation and Analysis 
For each subject who is randomized to receive study drug, a case report form (CRF) must be 
maintained by a trial coordinator and signed by the investigator or authorized designee to 
indicate that he/she has reviewed and agrees with the entered data.  This also applies to those 
subjects who fail to complete the trial.  The reason a subject is withdrawn must be recorded 
in the CRF.  Subjects whose eligibility is not confirmed on day 1 are considered screen 
failure and no CRF will be maintained for those subjects. 
Entries made in the CRF must be either verifiable against source documents, or have been 
directly entered into the CRF, in which case the entry in the CRF will be considered as the 
source data.  Source documents are defined as all medical records, medical notes, laboratory 
results, ECG traces and any additional document other than the CRF that has original patient 
information contained within it. 
All source documents must be legible.  Errors must be lined out and the correction must be 
made, initialed and dated by the person making the correction. 
The Sponsor or designated CRO is responsible for data processing and data query.  The 
investigator or designated staff is responsible for query resolution and data clarification. 
10.11 Retention of Data 
The study file and all source data should be retained until notification given by the sponsor 
for destruction.  If the investigator withdraws from the trial and relinquishes his/her 
responsibility for the maintenance and retention of records, he/she must notify the Sponsor in 
writing so arrangements can be made to properly store the trial materials. 
10.12 Publication and Disclosure Policy 
All data and results and all intellectual property rights in the data and results derived from the 
study will be the property of the Sponsor, who may utilize the data in various ways, such as 
for submission to government regulatory authorities or disclosure to other investigators. 


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No publication or disclosure of study results will be permitted except as specified in a 
separate, written agreement between Theracos, Inc. and the investigator.  If results of this 
study are reported in medical journals or at meetings, all subjects’ identities will remain 
confidential. 


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11 REFERENCE LIST 
ADA (2008). Standards of medical care in diabetes--2008. Diabetes Care 31 Suppl 1, S12-54. 
Ehrenkranz, J.R., Lewis, N.G., Kahn, C.R., and Roth, J. (2005). Phlorizin: a review. Diabetes 
Metab Res Rev 21, 31-38. 
Ferrannini, E., Ramos, S.J., Salsali, A., Tang, W., and List, J.F. (2010). Dapagliflozin 
monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and 
exercise: a randomized, double-blind, placebo-controlled, phase 3 trial. Diabetes Care 33, 
2217-2224. 
Han, S., Hagan, D.L., Taylor, J.R., Xin, L., Meng, W., Biller, S.A., Wetterau, J.R., 
Washburn, W.N., and Whaley, J.M. (2008). Dapagliflozin, a selective SGLT2 inhibitor, 
improves glucose homeostasis in normal and diabetic rats. Diabetes 57, 1723-1729. 
Komoroski, B., Vachharajani, N., Boulton, D., Kornhauser, D., Geraldes, M., Li, L., and 
Pfister, M. (2009a). Dapagliflozin, a novel SGLT2 inhibitor, induces dose-dependent 
glucosuria in healthy subjects. Clin Pharmacol Ther 85, 520-526. 
Komoroski, B., Vachharajani, N., Feng, Y., Li, L., Kornhauser, D., and Pfister, M. (2009b). 
Dapagliflozin, a novel, selective SGLT2 inhibitor, improved glycemic control over 2 weeks 
in patients with type 2 diabetes mellitus. Clin Pharmacol Ther 85, 513-519. 
Neumiller, J.J., White, J.R., Jr., and Campbell, R.K. (2010). Sodium-glucose co-transport 
inhibitors: progress and therapeutic potential in type 2 diabetes mellitus. Drugs 70, 377-385. 
Santer, R., Kinner, M., Lassen, C.L., Schneppenheim, R., Eggert, P., Bald, M., Brodehl, J., 
Daschner, M., Ehrich, J.H., Kemper, M., et al. (2003). Molecular analysis of the SGLT2 gene 
in patients with renal glucosuria. J Am Soc Nephrol 14, 2873-2882. 
Sicree, R., Shaw, J., and Zimmet, P. (2010). The Global Burden - Diabetes and Impaired 
Glucose Tolerance (Baker IDI Heart and Diabetes Institute). 
van den Heuvel, L.P., Assink, K., Willemsen, M., and Monnens, L. (2002). Autosomal 
recessive renal glucosuria attributable to a mutation in the sodium glucose cotransporter 
(SGLT2). Hum Genet 111, 544-547. 
 
 


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Appendix 1 
Schedule of Events 
 
Screening 
& Run-in 
Primary Efficacy Phase 
Extension Phase 
Visit Number 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
14 
ET 
Time Relative to Randomization Visit 
(weeks)1 
-5 
-2 
0 
2 
6 
12 
18 
24 
36 
48 
60 
72 
84 
96 
 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Screening for I/E criteria 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Diet & exercise counseling 
 
X 
 
 
 
X 
 
X 
 
X 
 
X 
 
 
 
Diary Review 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Discontinue anti-diabetic medication 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Randomization 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Physical exam 
X 
 
 
 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
Vital signs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
ECG 
X 
 
X 
 
 
 
 
X 
 
 
X 
 
 
X 
X 
Dispense study medication 
 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Blood draw for clinical lab test2 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
PK sample 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Urinalysis3 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
AE4 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Con Med 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 


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1 
Screening period may last up to 21 days (V1 to V2), Run-in period is to be 14±3 days (V2 to V3), V3 to V4 window is 14±3 days, all other visit windows 
are the nominal duration from randomization ± 7 days. 
2 
Blood sample for these lab tests at the designated visit: 
V1: CBC, electrolytes, BUN, creatinine, Lipids (TG, TC, HDL-C), ALT, AST, bilirubin (total and direct), PT, HbA1c, FPG, TSH, aPTT, Hepatitis Screen 
(HBsAg, HBcAg, HCV) 
V3: CBC, electrolytes, BUN, creatinine, Lipids (TG, TC, HDL-c), ALT, AST, bilirubin (total and direct), HbA1c, FPG 
V4: CBC, electrolytes, BUN, creatinine, HbA1c, FPG 
V5: CBC, electrolytes, BUN, creatinine, HbA1c, FPG 
V6: CBC, electrolytes, BUN, creatinine, Lipids (TG, TC, HDL-c), ALT, AST, bilirubin (total and direct), HbA1c, FPG 
V7: CBC, electrolytes, BUN, creatinine, HbA1c, FPG 
V8-V14 and ET: CBC, electrolytes, BUN, creatinine, Lipids (TG, TC, HDL-c), ALT, AST, bilirubin (total and direct), HbA1c, FPG 
3 
Clean catch sample to be collected at each visit. If urine is dipstick positive for WBC or blood sample is to be sent for microscopic evaluation and culture.  
Urine pregnancy test and drug screen on screening (visit 1) 
4 
Adverse events of special interest are specified to be: 
 
Cardio- and cerebro- vascular events,  
 
Genitourinary infections  
 
Increase in creatinine from baseline by 0.5 mg/dL or more  
 
Increase in ALT, AST or bilirubin to >3x ULRR 
 
 


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Appendix 2 
Estimating glomerular filtration rate 
Estimating the glomerular filtration rate (eGFR), as calculated by the modification of diet in 
renal disease study equation (MDRD), should be calculated based on following equation: 
GFR (mL/min/1.73 m2) = 175 x (Scr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.212 if African 
American) (conventional units) 
 


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Appendix 3 
Sponsor Signatures 
Study Title: 
Efficacy and safety of EGT0001442 compared with placebo in 
patients with type 2 diabetes mellitus inadequately controlled by diet 
and exercise and up to one oral anti-diabetes agent. 
Study Number: 
THR-1442-C-418 
Final Date: 
02 February 2011 
 
This clinical study protocol was subject to critical review and has been approved by the 
sponsor. The following personnel contributed to writing and/or approving this protocol: 
 
 
Signed: 
 
 
Date:  
 
Yuan-Di Halvorsen, Ph.D.  
Protocol Originator 
Consultant for Theracos, Inc. 
 
 
Signed: 
 
 
Date:  
 
R. Paul Aftring, M.D., Ph.D.  
Medical Director 
Consultant for Theracos, Inc. 
 
 
Signed: 
 
 
Date:  
 
Ulrich Granzer, Ph.D.  
Regulatory Affairs 
Consultant for Theracos Inc. 


EGT0001442 tablet 
 
Theracos, Inc. 
Clinical Trial Protocol: THR-1442-C-418 
 
02 February 2011  
 
 
 
 
Confidential 
Page 61 of 61 
 
Appendix 4 
Investigator’s Signature 
Study Title: 
Efficacy and safety of EGT0001442 compared with placebo in 
patients with type 2 diabetes mellitus inadequately controlled by diet 
and exercise and up to one oral anti-diabetes agent. 
Study Number: 
THR-1442-C-418 
Final Date: 
02 February 2011 
I have read the protocol described above. I agree to comply with all applicable regulations 
and to conduct the study as described in the protocol.  
 
 
 
Signed: 
 
 
Date:  
 
Principal Investigator 
 
 
 

SAP_001.pdf: 


Protocol THR-1442-C-418:  Statistical Analysis Plan                            
 
Final – 22November2011 
CONFIDENTIAL  
       Page 1 of 30 
 
 
 
 
STATISTICAL ANALYSIS PLAN 
 
 
INC RESEARCH PROJECT: 
 
021815 
 
AUTHOR: 
 
Vicky Pan 
 
INC RESEARCH PROJECT 
LEADER: 
Nancy Chau 
 
DATE OF ISSUE: 
22 November 2011 
 
SAP VERSION: 
Final 
 
SPONSOR: 
Theracos, Inc. 
 
STUDY TITLE: 
Efficacy and safety of EGT0001442 compared 
with placebo in patients with type 2 diabetes 
mellitus inadequately controlled by diet and 
exercise and up to one oral anti-diabetes agent  
 
PROTOCOL NUMBER: 
Protocol THR-1442-C-418 
 
PROTOCOL VERSION/DATE: 
Amendment 3 (12 September 2011) 
 
 
 
Confidentiality Statement 
The following confidential information is the property of Theracos, Inc.  As long as the 
information contained in this document has not been published, it may only be used when 
permission has been obtained from Theracos 
 


Protocol THR-1442-C-418:  Statistical Analysis Plan                            
 
Final – 22November2011 
CONFIDENTIAL  
       Page 2 of 30 
 
Signature Page 
 
 
I confirm that I have reviewed this document and agree with the content. 
 
Theracos, Inc. 
  
Signature: 
 
 
 
 
  Yuan-Di Halvorsen 
Senior Clinical Research Project Leader 
 
Date 
  
Signature: 
 
 
 
  Monica Tettamanti 
Clinical Trial Manager 
 
Date 
  
Signature: 
 
 
 
      
Mason Freeman 
Medical Monitor 
 
Date 
 
 
 
 
INC Research, LLC 
 
Signature: 
 
 
 
  Vicky Pan 
Project Biostatistician 
 
Date 
 
Signature: 
 
 
 
  Karen Snowdon-Way, MS 
Reviewing Biostatistician  
 
Date 
 
Signature: 
 
 
 
  Ashley Kesler 
Lead Statistical Programmer 
 
Date 
  
     Signature: 
 
 
 
 
Nancy Chau 
Project Leader 
 
Date 


Protocol THR-1442-C-418:  Statistical Analysis Plan                            
 
Final – 22November2011 
CONFIDENTIAL  
       Page 3 of 30 
 
Table of Contents 
List of Abbreviations and Definitions of Terms ............................................................................. 5 
1 
General Considerations ............................................................................................................ 7 
1.1 
Purpose ............................................................................................................................. 7 
1.2 
Responsibilities ................................................................................................................ 7 
2 
Study Objectives ...................................................................................................................... 7 
2.1 
Primary Objective ............................................................................................................ 7 
2.2 
Secondary Objectives ....................................................................................................... 7 
3 
Study Design............................................................................................................................ 8 
3.1 
Brief Description .............................................................................................................. 8 
3.2 
Subject Selection .............................................................................................................. 9 
3.3 
Assessment Schedule ....................................................................................................... 9 
3.4 
Blinding, Randomization, and Bias ................................................................................ 12 
3.5 
Sample Size Justification ............................................................................................... 13 
3.6 
PLANNED ANALYSES ............................................................................................... 13 
3.6.1 
Week 24 Analysis ................................................................................................... 13 
3.6.2 
Final Analysis ......................................................................................................... 14 
4 
Analysis Sets ......................................................................................................................... 14 
4.1 
Safety Analysis Set......................................................................................................... 14 
4.2 
Full Analysis Set ............................................................................................................ 14 
4.3 
Per Protocol Analysis Set ............................................................................................... 14 
4.4 
Deviations from Assigned Treatment ............................................................................ 14 
5 
General Consideration for Data Analyses ............................................................................. 15 
5.1 
Protocol Deviations ........................................................................................................ 15 
5.2 
Multiple Comparisons and Multiplicity ......................................................................... 15 
5.3 
Missing Data Algorithm ................................................................................................. 15 
5.3.1 
Last Observation Carried Forward.......................................................................... 16 
5.3.2 
Post-rescue Measurements ...................................................................................... 16 
5.4 
Assessment Windows ..................................................................................................... 17 
5.4.1 
Study Day................................................................................................................ 17 
5.4.2 
Visit Slotting Algorithm ......................................................................................... 17 
5.4.3 
Multiple Evaluations ............................................................................................... 18 
5.5 
Site Pooling .................................................................................................................... 19 
6 
Demographics, Baseline Characteristics, and Medications ................................................... 19 
6.1 
Subject Disposition and Withdrawals ............................................................................ 19 
6.2 
Demographics and Subject Characteristics at Baseline ................................................. 19 
6.3 
Medical History .............................................................................................................. 20 
6.4 
Prior/Concomitant Medications ..................................................................................... 20 


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CONFIDENTIAL  
       Page 4 of 30 
 
7 
Efficacy .................................................................................................................................. 21 
7.1 
Primary Efficacy Analyses ............................................................................................. 21 
7.2 
Secondary Efficacy Analyses ......................................................................................... 21 
7.2.1 
HbA1c Change from Baseline over Time ............................................................... 21 
7.2.2 
FPG Change from Baseline over Time ................................................................... 22 
7.2.3 
Body Weight Change from Baseline over Time ..................................................... 22 
7.2.4 
Blood Pressure Change from Baseline over Time .................................................. 22 
7.2.5 
Proportion of Subjects who Achieved HbA1c < 7% Response Levels .................. 23 
7.3 
Exploratory Efficacy Analyses ....................................................................................... 23 
7.3.1 
Repeated Measures Analyses .................................................................................. 23 
7.3.2 
Analysis of Covariance ........................................................................................... 24 
7.3.3 
Sensitivity Analyses ................................................................................................ 24 
8 
Exposure and Compliance ..................................................................................................... 25 
8.1 
Extent of Exposure to Study Drug ................................................................................. 25 
8.2 
Subject Compliance ........................................................................................................ 25 
9 
Safety ..................................................................................................................................... 25 
9.1 
Adverse Events ............................................................................................................... 26 
9.1.1 
All and Treatment Emergent AEs ........................................................................... 26 
9.1.2 
Deaths, Serious AEs, and AEs That Led to Discontinuation .................................. 26 
9.1.3 
Adverse Events of Special Interest ......................................................................... 27 
9.2 
Labs ................................................................................................................................ 27 
9.2.1 
Hematology, Chemistry and Urinalysis .................................................................. 27 
9.2.2 
Drug Screen Results ................................................................................................ 28 
9.2.3 
Pregnancies ............................................................................................................. 28 
9.2.4 
Nuclear Mitotic Apparatus Protein 22 (NMP22) Testing Results .......................... 28 
9.3 
Vital Signs and Physical Exams ..................................................................................... 28 
9.3.1 
Vital Signs ............................................................................................................... 28 
9.3.2 
Physical Exam ......................................................................................................... 28 
9.4 
ECGs .............................................................................................................................. 29 
10 Changes in the Conduct of the Study or Planned Analyses .................................................. 29 
Appendix 1:  Table, Figure and Listing Shells ............................................................................. 30 
 
 


Protocol THR-1442-C-418:  Statistical Analysis Plan                            
 
Final – 22November2011 
CONFIDENTIAL  
       Page 5 of 30 
 
 
List of Abbreviations and Definitions of Terms 
Abbreviation 
Definition of Term 
ADA 
American Diabetes Association 
AE 
adverse event 
AESI 
adverse events of special interest 
ALT 
alanine aminotransferase 
ANCOVA 
analysis of covariance 
ANOVA 
analysis of variance 
AST 
aspartate aminotransferase  
ATC 
anatomical/therapeutic/chemical 
BMI 
body mass index 
BUN 
blood urea nitrogen 
CBC 
complete blood count 
CRF 
case report form 
CVE 
cardiovascular event 
DSMB 
data and safety monitoring board 
ECG 
electrocardiogram 
FAS 
full analysis set 
FPG 
fasting plasma glucose 
HbA1c 
glycosylated hemoglobin A1c 
IWRS 
interactive web response system 
LOCF 
last observation carried forward 
MedDRA 
Medical Dictionary for Regulatory Activities 
NMP22 
nuclear mitotic apparatus protein 22 
OC 
observed case 


Protocol THR-1442-C-418:  Statistical Analysis Plan                            
 
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CONFIDENTIAL  
       Page 6 of 30 
 
PT 
preferred term 
RBC 
red blood cell 
SAP 
statistical analysis plan 
SOC 
system organ class 
T2DM 
type 2 diabetes mellitus 
TEAE 
treatment emergent adverse event 
ULN 
upper limit of normal 
WBC 
white blood cell 
WHODRUG 
World Health Organization Drug Dictionary 


Protocol THR-1442-C-418:  Statistical Analysis Plan                            
 
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CONFIDENTIAL  
       Page 7 of 30 
 
1 General Considerations 
1.1 Purpose 
The purpose of this Statistical Analysis Plan (SAP) is to describe the analyses that will be 
performed, to ensure that the data listings, summary tables and figures that will be produced and 
the statistical methodologies that will be used are complete and appropriate to reach valid 
conclusions regarding the study objectives.  In particular, this SAP addresses analyses and 
reports to be provided using data from the following study: 
Clinical Trial Protocol THR-1442-C-418: Efficacy and safety of EGT0001442 compared with 
placebo in subjects with type 2 diabetes mellitus inadequately controlled by diet and exercise and 
up to one oral anti-diabetes agent.  
1.2 Responsibilities 
The INC Research Data Management department maintains the clinical database for the trial.  
The INC Research Biostatistics and Statistical Programming departments will provide data 
summaries. 
2 Study Objectives 
2.1 
Primary Objective  
The primary objective of this study is to assess the efficacy of EGT0001442 in lowering HbA1c 
at week 24 compared with placebo. 
2.2 
Secondary Objectives  
The secondary objectives of this study are: 
• To assess the efficacy of EGT0001442 in lowering FPG at weeks 2 and 24 compared 
with placebo 
• To assess the efficacy of EGT0001442 based on the proportion of subjects who reach the 
American Diabetes Association (ADA) target HbA1c of <7% in the EGT0001442 group 
compared with placebo 
• To assess the effect of EGT0001442 on systolic and diastolic blood pressure compared 
with placebo 
• To assess the effect of EGT0001442 on body weight compared with placebo 
• To assess the change in HbA1c change over time, week 1 to week 96 


Protocol THR-1442-C-418:  Statistical Analysis Plan                            
 
Final – 22November2011 
CONFIDENTIAL  
       Page 8 of 30 
 
• To assess the safety of EGT0001442 in patients with T2DM 
3 Study Design 
3.1 Brief Description 
THR-1442-C-418 is a multinational, 2 arm parallel group, randomized, double-blind placebo-
controlled study to compare treatment with once daily EGT0001442, 20 mg capsules to matching 
placebo in either treatment-naïve type 2 diabetic subjects (i.e. those not taking an anti-
hyperglycemic agent for ≥16 weeks prior to study entry) or subjects treated  with one oral anti-
diabetes drug.  The study design consists of a screening period, a 2-week placebo run-in 
(washout) period, and a 96-week double-blind treatment period.  The primary analysis will take 
place after 24 weeks of double-blind treatment. 
In the proposed study, diabetic subjects will be screened within 3 weeks of washout start.  At 
screening visit, subjects who meet all the inclusion criteria, none of the exclusion criteria, and 
who consent to participate in the study will receive counseling for appropriate diet and exercise.  
Those who are on an oral anti-diabetic medication will discontinue the medication and receive 
placebo in this run-in period for 14 ± 3 days.  Eligible diabetic subjects who are treatment naïve 
and who control their hyperglycemia through diet and exercise will also receive placebo and the 
hyperglycemia will be monitored to ensure that their fasting blood glucose levels remain below 
250 mg/dL during this interval of 14 ± 3 days.   
After the run-in period, approximately 300 subjects will complete the baseline assessment on day 
1, after overnight fasting to confirm their eligibility.  The subjects that remain eligible will be 
randomly assigned in a 1:1 ratio to receive either once daily EGT0001442 in 20 mg capsules or 
matching placebo, using a computer-generated allocation schedule.  Randomization will be 
stratified by study center and screening HbA1c (≥7 to <8.5% or ≥8.5 to ≤10%).  Each subject 
will be provided with study drug for 24 weeks, dosing instructions, diet and exercise counseling, 
and a glycemic control card for recording food and fasting glucose information on the days prior 
to each clinic visit. 
Each subject will be instructed to return to the clinic on weeks 2, 6, 12, 18, and 24 for safety 
monitoring and efficacy assessment including review of adverse events, concomitant medication, 
vital signs, ECG, physical examination, testing of blood chemistry and hematology laboratory 
parameters, and a urinalysis.   
Subjects who complete the 24-week treatment period will continue receiving the study drug for 
an additional 72 weeks.  Subjects who receive rescue medication due to poor glycemic control 
will continue to receive approved anti-diabetic medications and standard of care per investigator 


Protocol THR-1442-C-418:  Statistical Analysis Plan                            
 
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CONFIDENTIAL  
       Page 9 of 30 
 
decision, according to current treatment guidelines, during the 72 week follow-on period.  In the 
weeks 25 to 96 treatment period, subjects must return to the clinic on weeks 36, 48, 60, 72, 84, 
and 96 for continuous safety monitoring and efficacy assessment, including review of HbA1c 
values, adverse events, concomitant medication, ECG, vital signs, and physical examinations.  A 
follow up exit visit will be conducted one week after the last dose.   
The overall study duration from screening until follow-up could last a maximum of 102 weeks 
for study subjects.   
An independent Data and Safety Monitoring Board (DSMB) will monitor overall safety 
information during the EGT0001442 development program including this study.  The safety 
review activity and potential risk benefit assessments utilized by the DSMB are documented in 
DSMB charter and a separate DSMB statistical analysis plan.  
An independent cardiovascular adjudication committee is established to review cardiovascular 
events (CVE) occurring during the study, in a blinded fashion.  These events include 
cardiovascular mortality, myocardial infarction, stroke, and hospitalization for acute coronary 
syndromes, urgent revascularization procedures, and other possible serious cardiovascular 
events.  The adjudicated events will be documented and archived to allow a meta-analysis to be 
performed to assess if there is any increase in cardiovascular risk to an unacceptable extent at the 
time of completion of all phase 2 and 3 clinical studies.  The evaluation and analysis of 
adjudicated cardiovascular events will be documented in a separate CVE statistical analysis plan.  
This reporting and analysis plan for protocol THR-1442-C-418 will examine several efficacy and 
safety endpoints at planned analyses time points (described in Section 3.6).  Two independent 
statistical teams from INC Research will analyze data from this study.  One team will perform all 
planned blinded analyses during study conduct, as well as the final end-of-study unblinded 
analysis (i.e., after all subjects have completed 96 weeks and final follow-up, and the database 
has been locked.)  The second team will perform planned unblinded analyses during the study 
conduct for continuous safety assessment by the DSMB and interim Week 24 analysis.  
3.2 Subject Selection 
The study population will include approximately 300 subjects diagnosed with T2DM that are 
inadequately controlled by diet and exercise or by treatment with a single oral anti-diabetes agent 
and who have an HbA1c level between 7% and 10%.  The study will recruit subjects from 
approximately 35 trial centers in 4 countries. 
3.3 Assessment Schedule 
The study activities at each clinic visit are presented in the following table.  


Protocol THR-1442-C-418:  Statistical Analysis Plan                            
 
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CONFIDENTIAL  
       Page 10 of 30 
 
Table 1: Schedule of Events 
 
Screening 
& Run-in 
Treatment weeks 1 to 24 
Treatment weeks 25 to 96 
Follow 
Up8 
Visit Number 
1 
2
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
14 
15 
Time to Randomization Visit (weeks)1 
-5 
-2 
0 
2 
6 
12 
18 
24 
36 
48 
60 
72 
84 
96 
1 wk 
f/u 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Screening for I/E criteria 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Diet & exercise counseling2 
 
X 
 
 
 
X 
 
X 
 
X 
 
X 
 
 
 
Diary & glucometer record review 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Discontinue anti-diabetic medication 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Randomization 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Physical exam3 
X 
 
 
 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
Vital signs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
ECG 
X 
 
X 
 
 
 
 
X 
 
 
X 
 
 
X 
X 
Dispense study medication 
 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Blood draw for clinical lab test4 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Urinalysis5 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
NMP22 testing6 
X 
 
X 
 
 
 
 
X 
 
X 
 
X 
 
X 
 
AE7 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Con Med 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
1 
Screening period may last up to 21 days (V1 to V2), Run-in period is to be 14±3 days (V2 to V3), V3 to V8 window is ±3 days, all other visit windows are 
the nominal duration from randomization ± 6 days. 
2 
Glucose meter will be dispensed at visit 2. Training on using glucometer and recording hyper- or hypoglycemia will be conducted on visit 2. 


Protocol THR-1442-C-418:  Statistical Analysis Plan                            
 
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CONFIDENTIAL  
       Page 11 of 30 
 
3 
A complete physical examination will be performed by the investigator at screening and at the termination visit.  An abbreviated physical examination will 
include body weight and general assessment of the skin, heart, lungs and abdomen.  Abbreviated physical examinations will be performed by the investigator 
at all other time points, unless clinically indicated. 
4 
Blood sample for these lab tests at the designated visit are listed as following.  Fasting state must be confirmed. 
V1: CBC, electrolytes, BUN, creatinine, Lipids (TG, TC, HDL-C), ALT, AST, bilirubin (total and direct), PT, HbA1c, FPG, TSH, Hepatitis Screen (HBsAg, 
HBcAb, HCV), serum pregnancy for women of childbearing potential 
V3: CBC, electrolytes, BUN, creatinine, Lipids (TG, TC, HDL-c), ALT, AST, bilirubin (total and direct), HbA1c, FPG 
V4: CBC, electrolytes, BUN, creatinine, HbA1c, FPG 
V5: CBC, electrolytes, BUN, creatinine, HbA1c, FPG 
V6: CBC, electrolytes, BUN, creatinine, Lipids (TG, TC, HDL-c), ALT, AST, bilirubin (total and direct), HbA1c, FPG 
V7: CBC, electrolytes, BUN, creatinine, HbA1c, FPG 
V8-V15 and ET: CBC, electrolytes, BUN, creatinine, Lipids (TG, TC, HDL-c), ALT, AST, bilirubin (total and direct), HbA1c, FPG.  PT only at V8, and 
V15 or ET. 
5 
Clean catch sample to be collected at each visit and sent to the central lab. Urine  drug screen on screening (visit 1).  On-site urine dipstick to be performed 
at all visits except V2. 
6 
NMP22 testing will be performed at screening (V1), randomization (V3), and at weeks 24 (V8), 48 (V10), 72 (V12), and 96 (V14) or when clinically 
indicated.  For subjects who do not have baseline NMP22 testing following Protocol Amendment 1 (11 April, 2011), NMP22 testing will be performed in 
the next visit or within 4 weeks after Amendment is approved, whichever comes first. 
7 
Adverse events of special interest are specified to be: 
• 
Cardio- and cerebro- vascular events,  
• 
Genitourinary infections  
• 
Increase in creatinine from baseline by 0.5 mg/dL or more  
• 
Increase in ALT, AST or bilirubin to >3x ULN 
8 
Visit to be conducted one week after last dose of study drug whether subject early terminates from study or completes V14. 


Protocol THR-1442-C-418:  Statistical Analysis Plan                            
 
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CONFIDENTIAL  
       Page 12 of 30 
 
3.4 Blinding, Randomization, and Bias 
Eligible subjects who complete the 14 ± 3 day run-in period and meet all study 
inclusion/exclusion requirements will be randomized in a 1:1 ratio to receive EGT0001442 20 
mg/day or placebo according to a computer-generated randomization schedule.  Subjects will be 
assigned to treatment groups in sequential order as they qualify for the study, using a centrally 
located and managed interactive web response system (IWRS).  Randomization will be stratified 
by study center and screening HbA1c (≥7 to <8.5% or ≥8.5 to 10%).  The study will be 
conducted at multiple investigative sites and will likely involve variable numbers of subjects at 
each site.  Enrollment will be on a competitive basis but each site will be capped at 15% of the 
total randomized subjects (45 subjects). 
The study drug will be blinded to the sponsor, investigators, study coordinators, pharmacists, 
study subjects, and the cardiovascular adjudication committee members.  Upon randomization, 
each subject will receive a subject randomization number and drug kit(s) assigned to the subject.  
To maintain blinding of the treatment, the values of the HbA1c after dosing starts will remain 
blinded to all study personnel and subjects until all subjects have completed the 24 week 
treatment period.  After all subjects have completed the 24 week treatment period, all previous 
and subsequent HbA1c values will be made available to the sponsor, investigators, study 
coordinators, pharmacists, and the study subjects for close monitoring of subjects’ safety 
including assessment of providing rescue medication.  Subjects’ treatment assignment will 
continue to be held from all study personnel so the remainder of the study can be conducted in a 
blinded fashion.    
If knowledge of the test substance is needed to manage the subject’s condition, the investigator 
will contact the IWRS to obtain the treatment assignment.  If unblinding occurs for any reason, 
the time and reason for unblinding will be recorded on the case report form (CRF) and the 
sponsor must be notified within 24 hours.  
A designated statistician who is not involved with the study operation will hold the treatment 
code.  The unblinded treatment information can be provided to the DSMB to facilitate the 
evaluation of any clinically important increase in the rate of a serious suspected adverse reaction 
or to the designated safety contact when the treatment information is required to determine if an 
expedited safety report must be submitted to regulatory agencies.   
The treatment code will be unblinded after all subjects have completed the planned 96 weeks of 
blinded study treatment and the subsequent follow-up phase, and the clinical database has been 
locked. 


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CONFIDENTIAL  
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The treatment assignment will continue to be withheld from the cardiovascular adjudication 
committee members at the conclusion of the study until all phase 2 and 3 investigational studies 
are completed and a meta-analysis to assess cardiovascular risk is conducted. 
3.5 Sample Size Justification 
Approximately 300 subjects will be enrolled and equitably allocated to receive either 
EGT0001442 20 mg capsules or placebo.   
The sample size of 150 subjects per group was calculated based on the following assumptions:  
• The mean change from baseline to Week 24 in HbA1c in the active dose group will be 
approximately -0.4%.   
• The placebo group will not experience a substantive mean change in HbA1c from 
baseline to week 24. 
• The standard deviation of this change is the same for both groups and is 1.0%.   
• The two groups are independent, the study design is balanced, and the two-sided 
significance level for the hypothesis is 0.05.  
Under the above assumptions, an evaluable sample size of 133 evaluable subjects per treatment 
arm yields approximately 90% power that EGT0001442 treatment will be found to be 
significantly different from placebo.  A sample size of 150 subjects per treatment arm will be 
enrolled to account for any subject lost-to-follow-up. 
3.6 PLANNED ANALYSES 
Tests of programming and statistical analyses will commence after data have been collected and 
are available in the database.  This initial testing phase will be performed using dummy treatment 
codes to maintain the treatment blind.  
3.6.1 Week 24 Analysis 
A limited unblinded analysis will be performed after all subjects have achieved the Week 24 
primary efficacy endpoint (at the Week 24 visit), after all subject data up to Week 24 have been 
cleaned and locked. The purpose of the analysis will be to support management decisions about 
continuing the EGT0001142 development program.  The unblinded results will be provided to a 
limited number of recipients at Theracos, and will not be made available to any other personnel 
involved in the study conduct.  Subjects will continue to receive their randomized treatment in a 
blinded manner for the remainder of the planned 96 weeks of treatment and the follow-up phase.  


Protocol THR-1442-C-418:  Statistical Analysis Plan                            
 
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CONFIDENTIAL  
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The Week 24 analysis will be treated as an interim analysis with regard to the blinding and data 
handling.  Since the primary efficacy analysis is conducted once at the Week 24 time point, no 
multiplicity adjustment will be used for the interim analysis.  
3.6.2 Final Analysis 
After all subjects have completed the planned 96 weeks of blinded study treatment and the 
subsequent follow-up phase, the final analysis for the clinical study report will be completed.  At 
this time, the database will be frozen, and the treatment codes will be unblinded.  
4 Analysis Sets  
4.1 Safety Analysis Set 
All subjects who are randomized and administered at least one dose of double-blind study 
medication will be included in the Safety Analysis Set.  The safety analysis set will be used in 
safety analysis detailed in Section 9.  All analyses using the safety analysis set will be analyzed 
according to treatment received. 
4.2 Full Analysis Set 
The full analysis set (FAS) will include all subjects in the safety analysis set who have a baseline 
and at least one post-baseline HbA1c measurement.  The full analysis set will be used in efficacy 
analysis detailed in Section 7.  All analyses of the full analysis set will be based on randomly 
assigned treatment. 
4.3 Per Protocol Analysis Set 
The Per Protocol Analysis set will include all subjects in the full analysis set who meet the study 
inclusion requirements and who have no major protocol deviations that would affect the validity 
of the efficacy measurements.  The definition of major protocol deviations that would result the 
subject being excluded from the per protocol analysis set is detailed in Section 5.1.  
The per protocol analysis set will be used in sensitivity efficacy analyses detailed in Section 
7.3.3.  All analyses using the per protocol analysis set will be based on randomly assigned 
treatment. 
4.4 Deviations from Assigned Treatment 
If a subject’s actual treatment deviates from the randomly assigned treatment, the extent of the 
deviation and the type of data being analyzed will be considered in deciding how to assign the 
subject for analysis.  


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• If a subject takes the unassigned study medication for only part of the study, the subject 
will be analyzed based on the randomized treatment assignment for both safety and 
efficacy. 
• If a subject takes the unassigned study medication for the entire study, the subject will be 
analyzed based on the treatment actually taken for safety analyses.  However, the subject 
will be analyzed according to randomized treatment for efficacy per the intent-to-treat 
principle. 
5 General Consideration for Data Analyses 
Statistical analyses and summaries of safety and tolerability will be performed using SAS® 
software version 9.2 or later (SAS Institute, Cary, NC).  In all cases, statistical testing and 
confidence intervals will be two-tailed and significance will be judged at the α=0.05 level.   
5.1 Protocol Deviations 
Subject compliance to the protocol will be evaluated prior to unblinding the study and subjects 
with major protocol deviations will be identified.  Specific criteria for what constitutes a major 
protocol deviation will be determined by the study team. The following criteria will be 
considered: 
• Failure to meet key inclusion/exclusion criteria 
• Use of prohibited concomitant medications 
• Noncompliance with the study medication dosing schedule 
Protocol deviations will be tracked by the clinical team using TrialWatch on an on-going basis 
and will be listed by subject.  A table summary by treatment group and listing of major protocol 
deviations will be presented by subject for all randomized subjects.   
5.2 Multiple Comparisons and Multiplicity 
There is a single primary endpoint in this study and no correction for multiple comparisons is 
needed.  All other secondary and exploratory analyses which do not qualify for formal statistical 
testing will not be corrected for multiplicity, and will have results presented with confidence 
intervals and nominal p-values.  
5.3 Missing Data Algorithm 


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Imputation of partial or missing dates for the determination of prior/concomitant medication 
status is addressed in Section 6.4 of this SAP.  Imputation of partial or missing dates for the 
determination of treatment-emergence of adverse events, and handling of missing adverse event 
data related to event severity or relationship to study drug, are addressed in Section 9.1.  
Subjects who discontinue from the study early will not be replaced.  For some analyses, the last 
non-missing observation for a subject may be carried forward (LOCF).   
5.3.1 Last Observation Carried Forward 
Imputation for missing observations will be applied to selected efficacy endpoints by using the 
last observation carried forward method.  For subjects who withdraw from the study, the last 
valid observation recorded on treatment (scheduled or unscheduled) will be carried forward to all 
remaining visits.  Also, for subjects in efficacy analyses who had missing observations prior to 
their last observation on treatment, the closest previous non-missing on-treatment observation 
will be carried forward to missing visits.  If a subject had missing observation(s) immediately 
after baseline, the baseline observation will not be carried forward and the visit(s) will be left as 
missing.  
In general, the LOCF method will be used for all efficacy endpoints that are evaluated at or 
before Week 24.  Beyond Week 24, all analyses will not impute any missing data; this non-
imputation method will be referred to as the observed case (OC).  The descriptive summaries of 
endpoints by study medication group will include the count of missing values at each visit.  The 
detail of which analysis utilizes LOCF algorithm is available in Section 7. 
It is expected that 24 weeks of treatment is required to obtain the full treatment effect; shorter 
treatment periods may result in the observation of only a partial (smaller) treatment effect.  
Therefore, assuming that subject discontinuation of study drug or early termination from study 
will occur equally and at random in both treatment groups and in each stratum, this LOCF 
imputation approach is expected to provide a statistically conservative estimate for the treatment 
effect.   
5.3.2 Post-rescue Measurements 
For subjects who are rescued for hyperglycemia, their post-rescue measurements of efficacy 
parameters will be handled in the same manner as missing values for the efficacy analyses.  Post-
rescue measurements of efficacy parameters may be included in limited exploratory analyses.  
Post-rescue measurements of safety parameters will be included in analyses without any special 
handling.  


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5.4 Assessment Windows 
5.4.1 Study Day 
When study day is used for display or in comparisons the following algorithm will be used: 
• study day = date of assessment - date of first dose +1, if date of assessment ≥ first dose 
date 
• study day = date of assessment - date of first dose, if date of assessment < first dose date. 
Note that the date of first dose is Day 1 and the day before the date of first dose is Day -1 (there 
is no Day 0). 
5.4.2 Visit Slotting Algorithm 
For all safety and efficacy parameters to be summarized or analyzed by visit, data records will be 
slotted to one of the protocol specified visits using the following algorithm:  
a) Determine the study day for all records using the algorithms from Section 5.4.1 
b) For all records (including unscheduled visit records, early withdrawal records and repeat 
visit records), use the study day determined above with the slotting intervals in the 
analysis visit window table below to slot the record to the appropriate analysis visit. 


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Table 2: Analysis Visit Windows 
Scheduled Visit 
Target Study Day of Visit 
Slotting Intervals 
Week -5 (Screening) 
-35 
<=-25 
Week -2 
-14 
-24 to -4 days 
Baseline (Week 0) 
1 
-3 to 1 days 
Week 2 
15 
2 to 29 days 
Week 6 
43 
30 to 64 days 
Week 12 
85 
65 to 106 days 
Week 18 
127 
107 to 148 days 
Week 24 
169 
149 to 211 days 
Week 36 
253 
212 to 295 days 
Week 48 
337 
296 to 379 days 
Week 60 
421 
380 to 463 days 
Week 72 
505 
464 to 547 days 
Week 84 
589 
548 to 631 days 
Week 96 (End of Treatment 
Visit)* 
673 
632 to (last dose date) 
Week 97** 
680 
>Last dose date + 7 days 
1 Week Follow-up Visit** 
Last dose date + 7 days 
>Last dose date + 7 days 
* Week 96 is the end of treatment visit for those subjects completing the study per protocol.  For subjects who 
withdraw early from active treatment, the end of treatment visit will be assigned to an analysis visit based on the 
visit slotting algorithm using study day. 
** Week 97 is the 1 week post-treatment follow-up visit for those subjects completing the study per protocol.  
The 1 Week Follow-up Visit is the 1 week post-treatment follow-up visit for those subjects who withdraw early 
from active treatment.  
 
For parameters which were not scheduled to be collected at all visits, still use the all-inclusive 
visit intervals defined for all visits (that is, the visit window table above) to slot records.  
However, if a value is slotted to a visit unscheduled for a parameter, it will not be summarized 
except for summaries focusing on extreme values such as laboratory shift tables.  These records  
will also be included in data listings. 
5.4.3 Multiple Evaluations 
After all the records have been slotted based on study day, if there are multiple valid records for 
an assessment within an assigned analysis visit, only one of these records will be used for 
summary statistics and analyses.  The record to be used is determined using the following 
hierarchy (in decreasing order): 
• the record closest to the target visit day 
• the record with an original nominal visit that matches the analysis visit 


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• the record earliest in time 
For missing values prior to Week 24 where the LOCF algorithm is applied, it is always the last 
valid assessment on treatment carried forward even though this might not be the assessment 
obtained by the above hierarchy and used in the summaries by visit. 
5.5 Site Pooling 
The study will be conducted at approximately 35 US and international study sites and 4 countries 
(United States, Mexico, Columbia, and India).  Sites will be pooled if appropriate for exploratory 
efficacy analyses detailed in Section 7.3.  Within each country, all sites will be pooled together 
to form one pooled site, so that a total of 4 pooled sites are available for analyses   At the end of 
the study, if any single country (such us United States) enrolls significantly more subjects than 
any other country, a further break-down within that country might be considered as part of the 
pooling strategy (i.e., regions within United States may be utilized as pooled sites).  
6 Demographics, Baseline Characteristics, and Medications 
6.1 Subject Disposition and Withdrawals 
The number of subjects who were randomized and the number of subjects within each analysis 
set (Safety, Full, Per Protocol) will be summarized for each treatment group.  A summary of 
subjects randomized by country and site will also be provided by treatment group.  
Subject status in study participation will be summarized in relation to completion of active 
treatment through Week 24, and in relation to completion of study.  Reasons for early 
discontinuation of study will be summarized for each treatment group.  
Subject disposition data will be listed as well.  All disposition summaries will be performed 
using all randomized subjects.  A by-country summary will be provided as well. 
The number of subjects who were run-in failures, and the number of subjects who failed to fulfill 
one or more of the inclusion/exclusion criteria will be tabulated and listed for all run-in failure 
subjects. 
6.2 Demographics and Subject Characteristics at Baseline 
Demographic data (age, gender, race, ethnicity), baseline characteristics (height, weight, BMI, 
child bearing potential, baseline HbA1c category) will be summarized. 


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Subject age (years) will be calculated as the full years passed since birth date until the date of 
informed consent signed: 
Age=integer part of [(date of informed consent signed – date of birth + 1) / 365.25].  
The BMI will be calculated in kg/m²: 
BMI = body weight [kg] / (height [m])² 
Demographic data and baseline characteristics will be tabulated for each analysis set.  Baseline 
comparability of treatments for demographic and baseline characteristics will be assessed using 
ANOVA model statistics for continuous variables and chi-square statistics for categorical 
variables.  A by-country summary will be provided using the safety analysis set.  
Summary of substance (alcohol, tobacco, and drug) use (both categorical and quantitative) will 
be produced as well as a by-subject listing.  All summaries will be performed using the safety 
analysis set. 
6.3 Medical History 
The number and percentage of subjects with medical history condition will be reported by 
treatment group.  A summary of duration of diabetes disease history in years will be provided.  
The duration of diabetes disease history is calculated as the years lapsed between screening visit 
date and type 2 diabetes diagnosis date.  For partial missing diagnosis date, the missing month is 
imputed as January and the missing day is imputed as the first of the month to calculate duration.  
All other detailed diabetes medical history will be summarized in total, and by country.    
In addition, a by-subject listing for detailed diabetes medical history will be provided, and all 
other medical history data will be listed. All summaries will be performed using the safety 
analysis set. 
6.4 Prior/Concomitant Medications 
Any prior and concomitant medication used during the study will be recorded and coded using 
World Health Organization Drug Dictionary (WHODRUG) enhanced version June 2011 to 
obtain a preferred term (PT) and an anatomical/therapeutic/chemical (ATC) level 4 term.  
Summary of all medications by treatment group, ATC level 4 term and preferred term will be 
provided.   
The date and time of first dose of study drug will be used as cutoff time point for definition of 
prior and concomitant medication.  Prior medications are those started before the first dose of 
double-blind study drug.  Concomitant medications are those taken at any time on or after the 


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day of the first dose of double-blind study drug, including those medications that were started 
prior to randomization but were continued into the double-blind treatment period.  
Partial start dates of prior and concomitant medications will be assumed to be the earliest 
possible date consistent with the partial date.  In the case of a missing year, the year will be 
assumed to be the year part of informed consent date of that subject.  In the case of a completely 
missing start date, the start date will be assumed to be prior to date of the first administration of 
study drug.  Partial stop dates of prior and concomitant medications will be assumed to be the 
latest possible date consistent with the partial date.  In the case of completely missing stop date, 
medication will be assumed to be ongoing.  
All recorded anti-diabetic medications will be included in the medication summaries described 
above.  Those anti-diabetic medications that the investigators indicated as being rescue 
medications for hyperglycemia will also be summarized separately by treatment group.  The 
number and percent of subject who are rescued for hyperglycemia over time will be tabulated. 
All prior and concomitant medications will be listed.  All summaries will be performed using the 
safety analysis set. 
7 Efficacy 
7.1 Primary Efficacy Analyses 
The primary efficacy endpoint is HbA1c change from baseline at Week 24.  The primary 
hypothesis is that EGT0001442 reduces HbA1c after 24 weeks of treatment when compared to 
placebo controls.  The Week 24 mean change from baseline will be analyzed using a 2 sample t-
test between treatment groups.  The primary analyses will be performed on the full analysis set 
using the LOCF algorithm. Subjects who are rescued for hyperglycemia before Week 24 will 
have their HbA1c recorded at the time of rescue and carried forward for primary analyses.  
Subjects who discontinue from active treatment due to any reason before Week 24 will also have 
their last post-baseline HbA1c observation carried forward for the analyses. 
7.2 Secondary Efficacy Analyses 
7.2.1 HbA1c Change from Baseline over Time 
The continuous secondary efficacy endpoint of HbA1c change from baseline by visit will be 
analyzed analogous to the primary endpoint using a 2 sample t-test.  One analysis will be 
performed using the LOCF algorithm for all visits, and a separate analysis will be performed 
using OC algorithm.  The OC algorithm analysis will exclude any post-rescue values. 


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The pattern of HbA1c over time and change from baseline over time will be evaluated both 
descriptively using summary statistics and graphically at each scheduled visit during the entire 
duration of the study, excluding post-rescue measurements.  Descriptive summaries will also be 
provided including post-rescue measurements.  
The analyses will be performed on the full analysis set and all data will be listed. 
7.2.2 FPG Change from Baseline over Time 
The continuous secondary efficacy endpoints of FPG change from baseline at Week 2 and Week 
24 and FPG change from baseline by visit will be analyzed analogous to the primary endpoint 
using a 2 sample t-test.  One analysis will be performed using the LOCF algorithm for all visits, 
and a separate analysis will be performed using OC algorithm.  The OC algorithm analysis will 
exclude any post-rescue values. 
The pattern of FPG over time and change from baseline over time will be evaluated both 
descriptively using summary statistics and graphically at each scheduled visit during the entire 
duration of the study, excluding post-rescue measurements.  Descriptive summaries will also be 
provided including post-rescue measurements.  
The analyses will be performed on the full analysis set and all data will be listed. 
7.2.3 Body Weight Change from Baseline over Time 
The continuous secondary efficacy endpoint of body weight change from baseline at Week 2 and 
Week 24 and body weight change from baseline by visit will be analyzed analogous to the 
primary endpoint using a 2 sample t-test.  One analysis will be performed using the LOCF 
algorithm for all visits, and a separate analysis will be performed using OC algorithm.  The OC 
algorithm analysis will exclude any post-rescue values. 
The pattern of weight over time and change from baseline over time will be evaluated both 
descriptively using summary statistics and graphically at each scheduled visit during the entire 
duration of the study, excluding post-rescue measurements.  Descriptive summaries will also be 
provided including post-rescue measurements.  
The analysis will be performed on the full analysis set and all data will be listed. 
7.2.4 Blood Pressure Change from Baseline over Time 
The continuous secondary efficacy endpoints of blood pressure (both systolic and diastolic) 
change from baseline at Week 2 and Week 24 and blood pressure change from baseline by visit 
will be analyzed analogous to the primary endpoint using a 2 sample t-test.  Multiple 


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measurements made on the same day will be averaged to measure blood pressure on that day.   
One analysis will be performed using the LOCF algorithm for all visits, and a separate analysis 
will be performed using OC algorithm.  The OC algorithm analysis will exclude any post-rescue 
values. 
The pattern of blood pressure over time and change from baseline over time will be evaluated 
both descriptively using summary statistics and graphically at each scheduled visit during the 
entire duration of the study, excluding post-rescue measurements.  Descriptive summaries will 
also be provided including post-rescue measurements.  
The analysis will be performed on the full analysis set and all data will be listed. 
7.2.5 Proportion of Subjects who Achieved HbA1c < 7% Response Levels 
The categorical secondary efficacy endpoint of the proportion of subjects achieving HbA1c < 7% 
response level by visit will be analyzed by treatment comparisons that utilize a chi-square test.  
One analysis will be performed using the LOCF algorithm for all visits, and a separate analysis 
will be performed by visit using the OC algorithm.  The OC algorithm analysis will exclude any 
post-rescue values. 
The pattern of the response data over time will be evaluated descriptively using summary 
statistics at each scheduled visit during the entire duration of the study, excluding post-rescue 
measurements.  Descriptive summaries will also be provided including post-rescue 
measurements.  
The analysis will be performed on the full analysis set and all data will be listed. 
7.3 Exploratory Efficacy Analyses 
7.3.1 Repeated Measures Analyses  
To assess treatment as an effect over time on HbA1c change from baseline, a repeated measures 
analysis will be performed in supportive of the primary and secondary efficacy analyses.   All 
observed measurements, excluding post-rescue measurements, of change from baseline in 
HbA1c through Week 96 will be included in the linear mixed effect model as repeated measures.  
Intercept and slope for time (entered as continuous variable) will be specified as random 
covariates, which may be simplified as fixed covariates depending on the assessment of the 
model fit.  The PROC MIXED procedure in SAS will be used.  The unstructured correlation for 
repeated HbA1c change from baseline will be specified; if the model fails to converge, an 
alternative correlation matrix will be specified.  


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As with HbA1c, repeated measures analyses will also be performed on change from baseline of 
body weight, systolic blood pressure, diastolic blood pressure, and FPG.  A linear effect model 
will be utilized for each of the change from baseline measures similarly to that being used for 
HbA1c change from baseline.  All analyses will be performed on the full analysis set.  
7.3.2 Analysis of Covariance  
To assess treatment effect adjusted for important covariates on HbA1c change from baseline, an 
analysis of covariance (ANCOVA) model will be performed in supportive of the primary and 
secondary efficacy analyses.  HbA1c change from baseline by visit will be analyzed using an 
ANCOVA model with treatment group, site (pooled as necessary), gender (male versus female), 
race (categorized as white, black, and other non-white), and age (categorized as <65 years, and 
≥65 years) as factors and baseline HbA1c as a continuous covariate.  One analysis will be 
performed using the LOCF algorithm for all visits, and a separate analysis will be performed 
using OC algorithm.  The OC algorithm analysis will exclude any post-rescue values. 
As with HbA1c, ANCOVA analyses will also be performed on change from baseline of body 
weight, systolic blood pressure, diastolic blood pressure, and FPG.  For each of these endpoint, 
the ANCOVA model will include treatment group, site (pooled as necessary), gender (male 
versus female), race (categorized as white, black, and other non-white), age (categorized as <65 
years, and ≥65 years), and baseline HbA1c category (≥7 to <8.5% versus ≥8.5 to ≤10%) as 
factors and corresponding baseline endpoint measures (i.e., baseline FPG for FPG change from 
baseline ANCOVA mode) as a continuous covariate.  All analyses will be performed on the full 
analysis set.   
7.3.3 Sensitivity Analyses  
When subjects’ compliance to the protocol are poor and would affect the validity of the efficacy 
measurements, sensitivity analyses will be conducted on selected efficacy endpoints by 
excluding those subjects (i.e., using the per protocol analysis set).  
For HbA1c change from baseline by visit, similar analyses of those performed using the full 
analysis set will be performed using the per protocol analysis set.  Both t-test and ANCOVA 
analyses will be repeated using the LOCF algorithm for all visits.  Additionally, the pattern of 
HbA1c over time and change from baseline over time will be evaluated descriptively using 
summary statistics at each scheduled visit during the entire duration of the study, excluding post-
rescue measurements.   
Other efficacy endpoints to be used in sensitivity analyses include FPG change from baseline 
over time, body weight change from baseline over time, systolic and diastolic blood pressure 
change from baseline over time, and proportion of subjects achieving HbA1c < 7% response 


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level over time.  The analysis of each of the endpoint will follow the same process described 
above for HbA1c.  All analyses will be performed on the per protocol analysis set.   
8 Exposure and Compliance 
8.1 Extent of Exposure to Study Drug 
Descriptive summary statistics including the number of subjects, mean, standard deviation, 
median, minimum, and maximum for the duration of study drug exposure will be presented by 
treatment group.  The duration of study drug exposure is defined as the number of weeks 
between the date of the first dose and the date of the last dose plus 1 day (that is, exposure in 
weeks = [date of last dose - date of first dose + 1 day] / 7.)   
The number and percent of subject who receive at least one dose of double-blind study 
medication, and the number and percent who complete at least 2, 6, 12, 18, 24, 36, 48, 60, 72, 84, 
and 96 weeks of treatment will be tabulated. 
A by-subject listing of study drug administration will also be presented. 
8.2 Subject Compliance 
Subjects will be given the investigational double-blind drug beginning at Day 1 (Week 0) 
through Week 96.  Investigational product accountability will be done at each study visit after 
the Week 0 visit through the end-of-treatment visit.  Subjects will be instructed to return all 
unused investigational product at the Week 96 visit in order to perform drug accountability and 
determine compliance.  
The number of administered capsules will be calculated as the number dispensed minus (the 
number returned plus the number reported as lost/missing and not taken).  Treatment compliance 
will be calculated as total number of administered capsules divided by total number of capsules 
which should have been taken based on the last completed visit during active treatment period.  
Treatment compliance will be summarized for all subjects.  Summary statistics for treatment 
compliance percentages, as well as the number and percentage of subjects who are <80%, and 
≥80% compliant will be reported for the safety analysis set.  Individual subject compliance 
information will be listed also.  
9 Safety 
All safety summaries and analyses will be performed using the safety analysis set.  


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9.1 Adverse Events 
9.1.1 All and Treatment Emergent AEs 
All AEs will be coded using MedDRA version 14.0.  A treatment-emergent adverse event 
(TEAE) is one with a start date on or after the date of the first administration of study drug.  
Only TEAEs will be included in summary tables.  All AEs will be included in listings.   
Partial start dates of AE will be assumed to be the earliest possible date consistent with the 
partial date.  In the case of a missing year, the year will be assumed to be the year part of 
informed consent date of that subject.  In the case of a completely missing start date, the start 
date will be assumed to be prior to date of the first administration of study drug.   
In general, AEs will be presented in descending order from the system organ class (SOC) with 
the highest total incidence (that is, summed across all treatment groups) for any adverse event 
within the class to the SOC with the lowest total incidence.  Within the SOC level, AEs will be 
presented in descending order from the MedDRA preferred term (PT) with the highest total 
incidence to the PT with the lowest total incidence.  If the total incidence for any two or more 
PTs within an SOC is equal, the PTs will be presented in alphabetical order.  A PT will not be 
presented if no adverse events occur within the level.  At each SOC and PT level of 
summarization, a subject will be counted once if he/she reports 1 or more events at that level.  
A summary of the number and percentage of subjects with TEAEs by severity (mild, moderate, 
and severe) will be produced.  Subjects who experience the same event several times, with 
different severity will only be counted once according to the maximum severity experienced at 
each level of summarization.  AEs with missing severity will be considered to be severe for the 
purposes of summarization. 
TEAEs will also be summarized in a table by relationship to study drug (related versus not 
related to study drug).  Events reported as not related or unlikely will be categorized as not 
related; events reported as possible, probable, definite, unknown will be categorized as related.  
If a relationship to the study drug is missing or unknown, it will be assumed, for the purpose of 
analyses, to be treatment-related. 
A summary of most common TEAEs, defined as any AE on the preferred term level that has an 
incidence rate >5% among the subjects in either treatment groups, will be produced by treatment. 
9.1.2 Deaths, Serious AEs, and AEs That Led to Discontinuation  


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Serious treatment emergent adverse events will be summarized.  Data will be categorized and 
presented in a manner similar to that described above for the general AE summaries by treatment 
group.  By subject listings of deaths and serious non-fatal AEs will be presented.  
A summary of the number and percentage of subjects with TEAEs leading to treatment 
discontinuation will also be presented by treatment group.  A by-subject listing of all AEs 
leading to treatment discontinuation will be produced. 
9.1.3 Adverse Events of Special Interest 
Categories of adverse events of special interest (AESIs) include:  
• Cardiovascular events: myocardial infarction, cerebrovascular stroke, acute coronary 
syndrome, cardiovascular death, new or exacerbated congestive heart failure, and etc.  
• Hypoglycemic events 
• Renal and urinary disorders: nocturia, pollakiuria, polyuria, dysuria, and etc.  
• Genitourinary infection: cystitis, urethritis, pyelonephritis, balanitis, vulvovaginitis and 
etc. 
• Liver related events.  
• Cancer events. 
• Bone fracture events.  
All AESIs will be identified by appropriate MedDRA preferred term.  A by-subject listing of 
each category of AESI will be produced.  Additional information collected for hypoglycemic 
events including ADA severity and intervention will be tabulated and listed.   
9.2 Labs 
9.2.1 Hematology, Chemistry and Urinalysis 
Laboratory parameters include the following tests: hematology, chemistry, and urinalysis. 
Established or generally acknowledged methods, normal ranges, and quality control procedures 
will be supplied by the local and central laboratory for the study records.  
Hematology parameters used in summaries include hematocrit, hemoglobin, platelet count, red 
blood cell (RBC) count, and white blood cell (WBC) count with differential.   Chemistry 


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parameters (including lipids) used in summaries include albumin, ALT, AST, blood urea 
nitrogen, calcium, bicarbonate, chloride, direct bilirubin, glucose, magnesium, phosphorus, 
potassium, sodium, total bilirubin, total protein, uric acid,  total cholesterol, LDL cholesterol, 
HDL cholesterol, triglycerides, and ApoB.  Urinalysis parameters used in summaries include 
appearance, bilirubin, color, glucose, ketones, microscopic examination of sediment, nitrites, 
occult blood, pH, protein, specific gravity, and urobilinogen.  
All laboratory parameters will be summarized for each treatment group, at every assessed time 
point using descriptive statistics and graphical displays of the means and standard deviations 
over time.  In addition, for hematology and chemistry laboratory parameters, changes from 
baseline in these quantitative tests will be summarized by treatment group and at every assessed 
post-baseline time point.   
Shift tables will be developed by first classifying the subject laboratory results as low, normal, or 
high in comparison to the applicable laboratory reference range. The number and percentage of 
subjects with indicated shifts (low, normal, high) in their results from baseline to each post-
baseline assessment will be presented for all hematology, chemistry and applicable urinalysis 
parameters.  All laboratory data will be listed. 
9.2.2 Drug Screen Results 
All laboratory data will be listed including urine drug screen and virology results at screening. 
Such laboratory parameters include HBsAG, HBcAG, HCV Ab, amphetamines, barbiturates, 
cocaine, metabolites, opiates, benzodiazepines and cannabinoids.  
9.2.3 Pregnancies 
A listing of subject pregnancies confirmed by serum pregnancy test will be provided. 
9.2.4 Nuclear Mitotic Apparatus Protein 22 (NMP22) Testing Results 
NMP22 testing results will be summarized for each treatment group, at every assessed time 
point, as well as presented in a by-subject listing.   
9.3 Vital Signs and Physical Exams 
9.3.1 Vital Signs 
The vital sign summary and analysis will be based on the recordings of the variables pulse, 
temperature and respiration rate.  Each vital sign parameter at every assessed time point will be 
summarized using descriptive statistics and presented graphically.  Change from baseline will 
also be summarized, and all vital sign data will be listed.  
9.3.2 Physical Exam 


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The number and percentage of subjects with normal or abnormal findings in each assessment 
time point will be reported for each treatment groups and body systems.  All physical exam data 
will be listed.  
9.4 ECGs 
Each ECG parameter at each assessed time point will be summarized by treatment group using 
descriptive statistics and presented graphically.  Change from baseline will also be summarized. 
A summary of the number and percentage of subjects on overall ECG interpretation and 
abnormal findings will be displayed by treatment group.   
Additionally, a summary of the number and percent of subjects who experience QT ≥450 msec, 
QT ≥480 msec, QT ≥500 msec, QTcB ≥450 msec, QTcB ≥480 msec, QTcB ≥500 msec, QTcF 
≥450 msec, QTcF ≥480 msec, and QTcF ≥500 msec will be provided,  
All ECG data will be listed. 
10 Changes in the Conduct of the Study or Planned Analyses 
Not applicable.  
 
 


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Appendix 1:  Table, Figure and Listing Shells 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
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Table, Listing, and Figure Shells 
 
Table 14.1-1.1.1 Subject Disposition for Run-in Failures (All Enrolled Subjects) ............................................................... 6 
Table 14.1-1.1.2 Subject Disposition for Randomized Subjects (All Randomized Subjects) ................................................. 7 
Table 14.1-1.1.3 Subject Disposition for Randomized Subjects by Country (All Randomized Subjects) ....................... 9 
Table 14.1-1.2 Subjects Randomized by Country and Study Site (All Randomized Subjects) ............................................... 10 
Table 14.1-1.3 Inclusion/Exclusion Criteria Not Met (All Run-in Failures) .............................................................................. 11 
Table 14.1-1.4.1 Demographics and Baseline Characteristics (Safety Analysis Set) ............................................................. 13 
Table 14.1-1.4.2 Demographics and Baseline Characteristics (Full Analysis Set) .................................................................. 16 
Table 14.1-1.4.3 Demographics and Baseline Characteristics (Per Protocol Analysis Set) ............................................... 16 
Table 14.1-1.4.4 Demographics and Baseline Characteristics by Country (Safety Analysis Set) ................................... 16 
Table 14.1-1.5 Substance Use (Safety Analysis Set) ..................................................................................................................................... 17 
Table 14.1-2.1 Medical History (Safety Analysis Set) ................................................................................................................................ 18 
Table 14.1-2.2 Diabetes Disease History (Safety Analysis Set) ........................................................................................................... 19 
Table 14.1-2.3 Diabetes Disease History by Country (Safety Analysis Set)................................................................................. 20 
Table 14.1-3.1 Prior Medications (Safety Analysis Set) ........................................................................................................................... 21 
Table 14.1-3.2 Concomitant Medications (Safety Analysis Set) ............................................................................................................. 22 
Table 14.1-3.3 Hyperglycemia Rescue Medications (Safety Analysis Set) ........................................................................................ 23 
Table 14.1-3.4 Proportion of Subjects with Hyperglycemia Rescue (Safety Analysis Set) .................................................. 24 
Table 14.1-4.1 Treatment Exposure (Safety Analysis Set) ......................................................................................................................... 25 
Table 14.1-4.2 Treatment Compliance (Safety Analysis Set) .................................................................................................................... 26 
Figure 14.2-1.1 Line Graph of Mean (+/- SE) Change from Baseline in HbA1c (%), Excluding Post-Rescue Values 
(Full Analysis Set - OC) ................................................................................................................................................................................................... 27 
Figure 14.2-1.2 Line Graph of Mean (+/- SE) HbA1c (%), Excluding Post-Rescue Values (Full Analysis Set - 
OC) ..................................................................................................................................................................................................................................................... 28 
Figure 14.2-2.1 Line Graph of Mean (+/- SE) Change from Baseline in Fasting Plasma Glucose (mmol/L), 
Excluding Post-Rescue Values (Full Analysis Set - OC) .............................................................................................................................. 28 
Figure 14.2-2.2 Line Graph of Mean (+/- SE) Fasting Plasma Glucose (mmol/L), Excluding Post-Rescue Values 
(Full Analysis Set - OC) ................................................................................................................................................................................................... 28 
Figure 14.2-3.1 Line Graph of Mean (+/- SE) Change from Baseline in Weight (kg), Excluding Post-Rescue 
Values (Full Analysis Set - OC) .................................................................................................................................................................................. 29 
Figure 14.2-3.2 Line Graph of Mean (+/- SE) Weight (kg), Excluding Post-Rescue Values (Full Analysis Set - 
OC) ..................................................................................................................................................................................................................................................... 29 
Figure 14.2-4.1 Line Graph of Mean (+/- SE) Change from Baseline in Systolic Blood Pressure (mmHg), 
Excluding Post-Rescue Values  (Full Analysis Set - OC) ........................................................................................................................... 29 
Figure 14.2-4.2 Line Graph of Mean (+/- SE) Systolic Blood Pressure (mmHg), Excluding Post-Rescue Values  
(Full Analysis Set - OC) ................................................................................................................................................................................................... 30 


Theracos, Inc.  
Protocol: THR-1442-C-418 
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Final – 22November2011                         CONFIDENTIAL                                     Page 2 of 106 
 
Figure 14.2-5.1 Line Graph of Mean (+/- SE) Change from Baseline in Diastolic Blood Pressure (mmHg), 
Excluding Post-Rescue Values  (Full Analysis Set - OC) ........................................................................................................................... 30 
Figure 14.2-5.2 Line Graph of Mean (+/- SE) Diastolic Blood Pressure (mmHg), Excluding Post-Rescue Values  
(Full Analysis Set - OC) ................................................................................................................................................................................................... 30 
Table 14.2-1.1 Analysis of Change from Baseline in HbA1c (%) at Week 24 (Full Analysis Set - LOCF) ................... 31 
Table 14.2-1.2 Analysis of Change from Baseline in HbA1c (%) (Full Analysis Set - LOCF) .............................................. 32 
Table 14.2-1.3 Analysis of Change from Baseline in HbA1c (%), Excluding Post-Rescue Values (Full Analysis 
Set - OC)....................................................................................................................................................................................................................................... 33 
Table 14.2-1.4 Repeated Measures Analysis of Change from Baseline in HbA1c (%) at Week 96, Excluding Post-
rescue Values (Full Analysis Set - OC) ................................................................................................................................................................. 34 
Table 14.2-1.5 Summary Statistics for HbA1c (%) (Full Analysis Set - OC) ................................................................................. 35 
Table 14.2-1.6 Analysis of Change from Baseline in HbA1c (%) (Per Protocol Analysis Set - LOCF) .......................... 37 
Table 14.2-2.1 Analysis of Change from Baseline in Fasting Plasma Glucose (mmol/L) at Week 24 (Full 
Analysis Set - LOCF) ............................................................................................................................................................................................................ 37 
Table 14.2-2.2 Analysis of Change from Baseline in Fasting Plasma Glucose (mmol/L) (Full Analysis Set - 
LOCF) ................................................................................................................................................................................................................................................ 38 
Table 14.2-2.3 Analysis of Change from Baseline in Fasting Plasma Glucose (mmol/L), Excluding Post-rescue 
Values (Full Analysis Set- OC)..................................................................................................................................................................................... 39 
Table 14.2-2.4 Repeated Measures Analysis of Change from Baseline in Fasting Plasma Glucose (mmol/L) at 
Week 96, Excluding Post-rescue Values (Full Analysis Set - OC) ........................................................................................................ 39 
Table 14.2-2.5 Summary Statistics for Fasting Plasma Glucose (mmol/L) (Full Analysis Set- OC)............................... 40 
Table 14.2-2.6 Analysis of Change from Baseline in Fasting Plasma Glucose (mmol/L) (Per Protocol Analysis 
Set - LOCF) .................................................................................................................................................................................................................................. 40 
Table 14.2-3.1 Analysis of Change from Baseline in Weight (kg) at Week 24 (Full Analysis Set - LOCF) .............. 41 
Table 14.2-3.2 Analysis of Change from Baseline in Weight (kg) (Full Analysis Set - LOCF) ........................................ 41 
Table 14.2-3.3 Analysis of Change from Baseline in Weight (kg), Excluding Post-rescue Values (Full Analysis 
Set- OC) ......................................................................................................................................................................................................................................... 42 
Table 14.2-3.4 Repeated Measures Analysis of Change from Baseline in Weight (kg) at Week 96, Excluding 
Post-rescue Values (Full Analysis Set - OC) ...................................................................................................................................................... 42 
Table 14.2-3.5 Summary Statistics for Weight (kg) (Full Analysis Set- OC) .............................................................................. 43 
Table 14.2-3.6 Analysis of Change from Baseline in Weight (kg) (Per Protocol Analysis Set - LOCF) ..................... 43 
Table 14.2-4.1 Analysis of Change from Baseline in Systolic Blood Pressure (mmHg) at Week 24 (Full Analysis 
Set - LOCF) .................................................................................................................................................................................................................................. 44 
Table 14.2-4.2 Analysis of Change from Baseline in Systolic Blood Pressure (mmHg) (Full Analysis Set - 
LOCF) ................................................................................................................................................................................................................................................ 44 
Table 14.2-4.3 Analysis of Change from Baseline in Systolic Blood Pressure (mmHg), Excluding Post-rescue 
Values (Full Analysis Set- OC)..................................................................................................................................................................................... 45 


Theracos, Inc.  
Protocol: THR-1442-C-418 
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Final – 22November2011                         CONFIDENTIAL                                     Page 3 of 106 
 
Table 14.2-4.4 Repeated Measures Analysis of Change from Baseline in Systolic Blood Pressure (mmHg) at Week 
96, Excluding Post-rescue Values (Full Analysis Set - OC) .................................................................................................................... 45 
Table 14.2-4.5 Summary Statistics for Systolic Blood Pressure (mmHg) (Full Analysis Set- OC) ................................. 46 
Table 14.2-4.6 Analysis of Change from Baseline in Systolic Blood Pressure (mmHg) (Per Protocol Analysis 
Set - LOCF) .................................................................................................................................................................................................................................. 46 
Table 14.2-5.1 Analysis of Change from Baseline in Diastolic Blood Pressure (mmHg) at Week 24 (Full 
Analysis Set - LOCF) ............................................................................................................................................................................................................ 47 
Table 14.2-5.2 Analysis of Change from Baseline in Diastolic Blood Pressure (mmHg) (Full Analysis Set - 
LOCF) ................................................................................................................................................................................................................................................ 47 
Table 14.2-5.3 Analysis of Change from Baseline in Diastolic Blood Pressure (mmHg), Excluding Post-rescue 
Values (Full Analysis Set- OC)..................................................................................................................................................................................... 48 
Table 14.2-5.4 Repeated Measures Analysis of Change from Baseline in Diastolic Blood Pressure (mmHg) at 
Week 96, Excluding Post-rescue Values (Full Analysis Set - OC) ........................................................................................................ 48 
Table 14.2-5.5 Summary Statistics for Diastolic Blood Pressure (mmHg) (Full Analysis Set- OC)............................... 49 
Table 14.2-5.6 Analysis of Change from Baseline in Diastolic Blood Pressure (mmHg) (Per Protocol Analysis 
Set - LOCF) .................................................................................................................................................................................................................................. 49 
Table 14.2-6.1 Analysis of Proportion of Subjects Achieving HbA1c <7%  (Full Analysis Set- LOCF) ....................... 50 
Table 14.2-6.2 Analysis of Proportion of Subjects Achieving HbA1c <7%, Excluding Post-Rescue Values  (Full 
Analysis Set- OC) ................................................................................................................................................................................................................... 51 
Table 14.2-6.3 Summary Statistics for Proportion of Subjects Achieving HbA1c <7% by Visit  (Full Analysis 
Set- OC) ......................................................................................................................................................................................................................................... 52 
Table 14.2-6.4 Analysis of Proportion of Subjects Achieving HbA1c <7%  (Per Protocol Analysis Set- LOCF) .... 53 
Figure 14.3-2.1 Line Graph of Mean (+/- SE) Results for Hematology (Safety Analysis Set) .......................................... 54 
Figure 14.3-2.2 Line Graph of Mean (+/- SE) Results for Chemistry (Safety Analysis Set) ............................................. 54 
Figure 14.3-3.1 Line Graph of Mean (+/- SE) Results for Vital Signs (Safety Analysis Set) ........................................ 55 
Figure 14.3-4.1 Line Graph of Mean (+/- SE) ECG Results (Safety Analysis Set) ..................................................................... 55 
Table 14.3-1.1 Overall Summary of Adverse Events  (Safety Analysis Set) ................................................................................... 56 
Table 14.3-1.2 Treatment Emergent Adverse Events  (Safety Analysis Set) ................................................................................... 57 
Table 14.3-1.3 Treatment Emergent Adverse Events by Severity (Safety Analysis Set) ......................................................... 58 
Table 14.3-1.4 Treatment Emergent Adverse Events by Relationship to Study Drug (Safety Analysis Set) .............. 59 
Table 14.3-1.5 Most Common Treatment Emergent Adverse Events  (Safety Analysis Set) ...................................................... 60 
Table 14.3-1.6 Serious Treatment Emergent Adverse Events  (Safety Analysis Set) ................................................................ 60 
Table 14.3-1.7 Treatment Emergent Adverse Events Leading to Treatment Discontinuation  (Safety Analysis 
Set) .................................................................................................................................................................................................................................................. 61 
Table 14.3-1.8 Treatment Emergent Hypoglycemic Events by Severity and Intervention  (Safety Analysis Set) .. 62 
Table 14.3-2.1 Change from Baseline in Hematology (Safety Analysis Set) ................................................................................... 63 
Table 14.3-2.2 Change from Baseline in Chemistry (Safety Analysis Set) ..................................................................................... 64 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
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Table 14.3-2.3 Urinalysis (Safety Analysis Set) ............................................................................................................................................ 65 
Table 14.3-2.4 Shift in Hematology (Safety Analysis Set) ....................................................................................................................... 66 
Table 14.3-2.5 Shift in Chemistry (Safety Analysis Set) ......................................................................................................................... 67 
Table 14.3-2.6 Shift in Urinalysis (Safety Analysis Set) ....................................................................................................................... 67 
Table 14.3-3.1 Change from Baseline in Vital Signs (Safety Analysis Set)................................................................................. 68 
Table 14.3-4.1 Change from Baseline in ECG Values (Safety Analysis Set) ................................................................................... 68 
Table 14.3-4.2 Overall ECG Interpretations and Abnormal Findings (Safety Analysis Set) ............................................... 69 
Table 14.3-4.3 ECG Results by Category and Visit (Safety Analysis Set) ..................................................................................... 70 
Table 14.3-5.1 Physical Examination (Safety Analysis Set) .................................................................................................................... 71 
Table 14.3-6.1 NMP22 Test Results (Safety Analysis Set) ......................................................................................................................... 72 
Listing 14.3-1.1 Deaths  (Safety Analysis Set) .............................................................................................................................................. 73 
Listing 14.3-2.1 Serious Non-fatal Adverse Events  (Safety Analysis Set)................................................................................. 74 
Listing 14.3-3.1 Adverse Events Leading to Treatment Discontinuation (Safety Analysis Set) ...................................... 74 
Listing 14.3-4.1 Cardiovascular Adverse Events (Safety Analysis Set) .......................................................................................... 75 
Listing 14.3-5.1 Hypoglycemic Adverse Event (Safety Analysis Set) ................................................................................................. 75 
Listing 14.3-6.1 Severe Hypoglycemic Adverse Events (Safety Analysis Set) .............................................................................. 76 
Listing 14.3-7.1 Renal and Urinary Adverse Events (Safety Analysis Set) ................................................................................... 76 
Listing 14.3-8.1 Genitourinary Adverse Events (Safety Analysis Set) ............................................................................................ 77 
Listing 14.3-9.1 Liver Adverse Events (Safety Analysis Set) ............................................................................................................... 77 
Listing 14.3–10.1 Cancer Adverse Events (Safety Analysis Set) ........................................................................................................... 78 
Listing 14.3–11.1 Bone Fracture Adverse Events (Safety Analysis Set) .......................................................................................... 78 
Listing 14.3-12.1 Clinically Significant Abnormal Hematology Laboratory Evaluations  (Safety Analysis Set) 79 
Listing 14.3-12.2 Clinically Significant Abnormal Chemistry Laboratory Evaluations  (Safety Analysis Set) .. 80 
Listing 14.3-12.3 Clinically Significant Abnormal Urinalysis Laboratory Evaluations  (Safety Analysis Set) 80 
Listing 16.1-1.1 Randomized Allocation to Treatment (All Randomized Subjects) ..................................................................... 81 
Listing 16.2-1.1 Subject Disposition (All Randomized Subjects) ........................................................................................................ 82 
Listing 16.2-2.1 Inclusion/Exclusion Criteria Not Met  (All Run-in Failures) ....................................................................... 83 
Listing 16.2-2.2 Protocol Deviations  (All Randomized Subjects) ...................................................................................................... 84 
Listing 16.2-2.3 Major Protocol Deviations  (All Randomized Subjects) ........................................................................................ 85 
Listing 16.2-3.1 Analysis Populations  (All Randomized Subjects) .................................................................................................... 86 
Listing 16.2-4.1 Demographic Characteristics  (Safety Analysis Set) ............................................................................................ 87 
Listing 16.2-4.2 Substance Use  (Safety Analysis Set) .............................................................................................................................. 88 
Listing 16.2-4.3 Drug Screen Results  (Safety Analysis Set) ............................................................................................................... 89 
Listing 16.2-4.4 Medical History  (Safety Analysis Set) ......................................................................................................................... 90 
Listing 16.2-4.5 Diabetes Medical History  (Safety Analysis Set) .................................................................................................... 91 
Listing 16.2-5.1 Prior and Concomitant Medications  (Safety Analysis Set) .............................................................................. 92 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
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Final – 22November2011                         CONFIDENTIAL                                     Page 5 of 106 
 
Listing 16.2-6.1 Study Drug Administration (Safety Analysis Set) .................................................................................................... 93 
Listing 16.2-7.1 HbA1c (%) (Full Analysis Set) .............................................................................................................................................. 94 
Listing 16.2-7.2 Fasting Plasma Glucose (mmol/L) (Full Analysis Set) .......................................................................................... 95 
Listing 16.2-7.3 Weight(kg) (Full Analysis Set) ............................................................................................................................................ 95 
Listing 16.2-7.4 Systolic Blood Pressure (mmHg) (Full Analysis Set) ............................................................................................ 96 
Listing 16.2-7.5 Diastolic Blood Pressure (mmHg) (Full Analysis Set) .......................................................................................... 97 
Listing 16.2-8.1 Adverse Events  (Safety Analysis Set) ........................................................................................................................... 97 
Listing 16.2-8.2 Hypoglycemic Events Supplemental Information  (Safety Analysis Set) .................................................... 98 
Listing 16.2-9.1 Hematology Laboratory Evaluations  (Safety Analysis Set) .............................................................................. 99 
Listing 16.2-9.2 Chemistry Laboratory Evaluations  (Safety Analysis Set)............................................................................... 100 
Listing 16.2-9.3 Urinalysis Laboratory Evaluations  (Safety Analysis Set) ............................................................................ 100 
Listing 16.2-10.1 Vital Signs (Safety Analysis Set)................................................................................................................................. 101 
Listing 16.2-10.2 ECG Values (Safety Analysis Set) ................................................................................................................................... 102 
Listing 16.2-10.3 Overall ECG Interpretations and Abnormal Findings (Safety Analysis Set) ...................................... 103 
Listing 16.2-10.4 Physical Examinations (Safety Analysis Set) ......................................................................................................... 104 
Listing 16.2-10.5 Pregnancies (Safety Analysis Set)................................................................................................................................. 105 
Listing 16.2-10.6 NMP22 Testing Results (Safety Analysis Set) ......................................................................................................... 106 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 6 of 106 
 
Table 14.1-1.1.1 
Subject Disposition for Run-in Failures 
(All Enrolled Subjects) 
 
 
 
 
 
 
 
 
 
 
Total 
 
 
 
 
(N=xxx) 
 
 
 
 
 
All Enrolled Subjects 
 
 
 
xxx 
All Randomized Subjects 
 
 
 
xxx (xx.x%) 
Discontinued Prior to Randomization (Run-in Failures) 
 
 
 
xxx (xx.x%)
 
 
 
 
 
Reasons Discontinued Prior to Randomization 
 
 
 
xxx (xx.x%)
  Withdrew Consent 
 
 
 
xxx (xx.x%)
  Failed Inclusion/Exclusion Criteria 
 
 
 
xxx (xx.x%)
  Other 
 
 
 
xxx (xx.x%)
     XXXXXXXXXXXXXXXXXXX 
 
 
 
xxx (xx.x%)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Percentages are calculated using the number of subjects enrolled as the denominator.  
Source Data: Listing 16.2-2.1 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
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Final – 22November2011                         CONFIDENTIAL                                     Page 7 of 106 
 
Table 14.1-1.1.2 
Subject Disposition for Randomized Subjects 
(All Randomized Subjects) 
 
 
 
 
 
 
 
 
EGT0001442 
Placebo 
Total 
 
 
(N=xxx) 
(N=xxx) 
(N=xxx) 
 
 
 
 
 
Safety Analysis Set  
 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
Full Analysis Set  
 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
Per Protocol Analysis Set 
 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
 
 
 
 
 
Completed Active Treatment through Week 24 
 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
Discontuned Study before Week 24 
 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
 
 
 
 
 
Reason for Discontinuing Study before Week 24 
 
 
 
 
  Clinically Significant Change in a Laboratory 
 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
  Investigator Terminates the Study 
 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
  Patient Request to be Discontinued from the Study   
 
xxx (xx.x%) 
xxx (xx.x%) 
xxx (xx.x%) 
  Protocol Violation 
 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
  Serious or Intolerable Adverse Event 
 
xxx (xx.x%) 
xxx (xx.x%) 
xxx (xx.x%) 
  Sponsor Termiantes the Study 
 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
  Other 
 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
    XXXXXXXXXXXXXXXXXXX 
 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
    XXXXXXXXXXXXXXXXXXX 
 
xxx (xx.x%) 
xxx (xx.x%) 
xxx (xx.x%) 
 
 
 
 
 
 
 
 
 
 
Note: Percentages are calculated using the number of subjects randomized as the denominator.  
Source Data: Listing 16.2-1.1 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 8 of 106 
 
Table 14.1-1.1.2 
Subject Disposition for Randomized Subjects 
(All Randomized Subjects) 
 
 
 
 
 
 
 
 
EGT0001442 
Placebo 
Total 
 
 
(N=xxx) 
(N=xxx) 
(N=xxx) 
 
 
 
 
 
Completed Study 
 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
Discontinued Study Early 
 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
 
 
 
 
 
Reason for Discontinuing Study Early 
 
 
 
 
  Clinically Significant Change in a Laboratory 
 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
  Investigator Terminates the Study 
 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
  Patient Request to be Discontinued from the Study   
 
xxx (xx.x%) 
xxx (xx.x%) 
xxx (xx.x%) 
  Protocol Violation 
 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
  Serious or Intolerable Adverse Event 
 
xxx (xx.x%) 
xxx (xx.x%) 
xxx (xx.x%) 
  Sponsor Termiantes the Study 
 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
  Other 
 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
    XXXXXXXXXXXXXXXXXXX 
 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
    XXXXXXXXXXXXXXXXXXX 
 
xxx (xx.x%) 
xxx (xx.x%) 
xxx (xx.x%) 
 
 
 
 
 
Note: Percentages are calculated using the number of subjects randomized as the denominator.  
Source Data: Listing 16.2-1.1 
 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 9 of 106 
 
Table 14.1-1.1.3 
Subject Disposition for Randomized Subjects by Country 
(All Randomized Subjects) 
 
Same layout as Table 14.1-1.1.2. Display ‘Country: United States’ on the header of the table. Use the following 
footnote. 
Note: Percentages are calculated using the number of subjects randomized as the denominator.  
Source Data: Listing 16.2-1.1 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 10 of 106 
 
Table 14.1-1.2 
Subjects Randomized by Country and Study Site 
(All Randomized Subjects) 
 
 
 
 
 
 
Country   
 
EGT0001442 
Placebo 
Total 
  Site 
 
(N=xxx) 
(N=xxx) 
(N=xxx) 
 
 
 
 
 
XXXXX 
 
xxx (xx.x%) 
xxx (xx.x%) 
xxx (xx.x%) 
  XXXXXX 
 
xxx (xx.x%) 
xxx (xx.x%) 
xxx (xx.x%) 
  XXXXXX 
 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
 
 
 
 
 
XXXXX 
 
xxx (xx.x%) 
xxx (xx.x%) 
xxx (xx.x%) 
  XXXXXX 
 
xxx (xx.x%) 
xxx (xx.x%) 
xxx (xx.x%) 
  XXXXXX 
 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
  XXXXXX 
 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
 
 
 
 
 
 
Source Data: Listing 16.2-1.1 
 
 
 
 
 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 11 of 106 
 
Table 14.1-1.3 
Inclusion/Exclusion Criteria Not Met 
(All Run-in Failures) 
 
 
Protocol Version Dated 2011-04-11 
  IN01: 
  IN02: 
  IN03: 
  … 
  EX01: 
  EX02: 
 
Protocol Versions Dated 2011-08-18, and 2011-09-12 
  IN01: 
 
 
 
Note: All inclusion and exclusion criteria codes and full text are listed on page 1 of this summary. 
Source Data: Listing 16.2-2.1 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
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Final – 22November2011                         CONFIDENTIAL                                     Page 12 of 106 
 
Table 14.1-1.3 
Inclusion/Exclusion Criteria Not Met 
(All Run-in Failures) 
 
 
 
 
 
 
 
 
 
 
Total 
 
 
 
 
(N=xxx) 
 
 
 
 
 
Subjects with Any Inclusion or Exclusion Criterion 
 Deviations 
 
 
 
xxx (xx.x%) 
 
 
 
 
 
Protocol Version Dated 2011-04-11 
 
 
 
 
  IN01 
 
 
 
xxx (xx.x%)
  … 
 
 
 
 
  IN10 
 
 
 
xxx (xx.x%) 
 
 
 
 
 
  EX01 
 
 
 
xxx (xx.x%) 
  … 
 
 
 
 
  EX16 
 
 
 
xxx (xx.x%) 
 
 
 
 
 
Protocol Versions Dated 2011-08-18, and 2011-09-12 
 
 
 
 
  IN01 
 
 
 
xxx (xx.x%)
  … 
 
 
 
 
  IN10 
 
 
 
xxx (xx.x%) 
 
 
 
 
 
  EX01 
 
 
 
xxx (xx.x%) 
  … 
 
 
 
 
  EX19 
 
 
 
xxx (xx.x%) 
 
 
 
 
 
 
Note: All inclusion and exclusion criteria codes and full text are listed on page 1 of this summary. 
Source Data: Listing 16.2-2.1 
  


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 13 of 106 
 
 Table 14.1-1.4.1 
Demographics and Baseline Characteristics 
(Safety Analysis Set) 
 
 
 
 
 
 
 
 
 
EGT0001442 
Placebo 
Total 
 
 
 
(N=xxx) 
(N=xxx) 
(N=xxx) 
p-value [1] 
 
 
 
 
 
Age (years) 
 
 
 
 
0.xxxx 
  n 
 
xxx 
xxx 
xxx 
 
  Mean (SD) 
 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
  Median 
 
xx.x 
xx.x 
xx.x 
 
  Min, Max 
 
xx, xx 
xx, xx 
xx, xx 
 
 
 
 
 
 
 
Gender 
 
 
 
 
0.xxxx 
  n 
 
xxx 
xxx 
xxx 
 
  Female 
 
xxx (xx.x%) 
xxx (xx.x%) 
xxx (xx.x%) 
 
  Male 
 
xxx (xx.x%) 
xxx (xx.x%) 
xxx (xx.x%) 
 
 
 
 
 
 
 
Ethnicity 
 
 
 
 
0.xxxx
  n 
 
xxx 
xxx 
xxx 
 
  Hispanic or Latino 
 
xxx (xx.x%) 
xxx (xx.x%) 
xxx (xx.x%) 
 
  Not Hispanic or Latino 
 
xxx (xx.x%) 
xxx (xx.x%) 
xxx (xx.x%) 
 
 
 
 
 
 
 
Child Bearing Potential 
 
 
 
 
0.xxxx
  n 
 
xxx 
xxx 
xxx 
 
  Yes 
 
xxx (xx.x%) 
xxx (xx.x%) 
xxx (xx.x%) 
 
  No 
 
xxx (xx.x%) 
xxx (xx.x%) 
xxx (xx.x%) 
 
 
 
 
 
 
 
 
[1] P-value is for testing the null hypotheses that summary statistics (mean or proportion) are equal among 
treatment groups. All tests are two-sided. * indicates statistical significance at 0.05 level. 
Source Data: Listing 16.2-4.1 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 14 of 106 
 
Table 14.1-1.4.1 
Demographics and Baseline Characteristics 
(Safety Analysis Set) 
 
 
 
 
 
 
 
 
 
EGT0001442 
Placebo 
Total 
 
 
 
(N=xxx) 
(N=xxx) 
(N=xxx) 
p-value [1] 
 
 
 
 
 
 
Race 
 
 
 
 
0.xxxx
  n 
 
xxx 
xxx 
xxx 
 
  White or Caucasian 
 
xxx (xx.x%) 
xxx (xx.x%) 
xxx (xx.x%) 
 
  Black or African American 
 
xxx (xx.x%) 
xxx (xx.x%) 
xxx (xx.x%) 
 
  American Indian or Alaskan Native 
 
xxx (xx.x%) 
xxx (xx.x%) 
xxx (xx.x%) 
 
  Asian 
 
xxx (xx.x%) 
xxx (xx.x%) 
xxx (xx.x%) 
 
  Native Hawaiian or Other Pacific Islander 
 
xxx (xx.x%) 
xxx (xx.x%) 
xxx (xx.x%) 
 
  Other 
 
xxx (xx.x%) 
xxx (xx.x%) 
xxx (xx.x%) 
 
    XXXXXX 
 
xxx (xx.x%) 
xxx (xx.x%) 
xxx (xx.x%) 
 
    XXXXXX 
 
xxx (xx.x%) 
xxx (xx.x%) 
xxx (xx.x%) 
 
    XXXXXX 
 
xxx (xx.x%) 
xxx (xx.x%) 
xxx (xx.x%) 
 
 
 
 
 
 
 
Baseline HbA1c Category 
 
 
 
 
0.xxxx
  n 
 
xxx 
xxx 
xxx 
 
  >=7% to <8.5% 
 
xxx (xx.x%) 
xxx (xx.x%) 
xxx (xx.x%) 
 
  >=8.5% to <=10% 
 
xxx (xx.x%) 
xxx (xx.x%) 
xxx (xx.x%) 
 
 
 
 
 
 
 
 
[1] P-value is for testing the null hypotheses that summary statistics (mean or proportion) are equal among treatment 
groups. All tests are two-sided. * indicates statistical significance at 0.05 level. 
Source Data: Listing 16.2-4.1 
 


Theracos, Inc.  
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Final – 22November2011                         CONFIDENTIAL                                     Page 15 of 106 
 
Table 14.1-1.4.1 
Demographics and Baseline Characteristics 
(Safety Analysis Set) 
 
 
 
 
 
 
 
 
 
EGT0001442 
Placebo 
Total 
 
 
 
(N=xxx) 
(N=xxx) 
(N=xxx) 
p-value [1] 
 
 
 
 
 
 
Height (cm) 
 
 
 
 
0.xxxx 
  n 
 
xxx 
xxx 
xxx 
 
  Mean (SD) 
 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
  Median 
 
xx.x 
xx.x 
xx.x 
 
  Min, Max 
 
xx, xx 
xx, xx 
xx, xx 
 
 
 
 
 
 
 
Weight (kg) 
 
 
 
 
0.xxxx 
  n 
 
xxx 
xxx 
xxx 
 
  Mean (SD) 
 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
  Median 
 
xx.x 
xx.x 
xx.x 
 
  Min, Max 
 
xx, xx 
xx, xx 
xx, xx 
 
 
 
 
 
 
 
Body Mass Index (BMI) (kg/m2) 
 
 
 
 
0.xxxx
  n 
 
xxx 
xxx 
xxx 
 
  Mean (SD) 
 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
  Median 
 
xx.x 
xx.x 
xx.x 
 
  Min, Max 
 
xx, xx 
xx, xx 
xx, xx 
 
 
 
 
 
 
 
 
[1] P-value is for testing the null hypotheses that summary statistics (mean or proportion) are equal among treatment 
groups. All tests are two-sided. * indicates statistical significance at 0.05 level. 
Source Data: Listing 16.2-4.1 
 
 


Theracos, Inc.  
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Final – 22November2011                         CONFIDENTIAL                                     Page 16 of 106 
 
Table 14.1-1.4.2 
Demographics and Baseline Characteristics 
(Full Analysis Set) 
 
Same layout as Table 14.1-1.4.1. Use the following footnote.  
 
[1] P-value is for testing the null hypotheses that summary statistics (mean or proportion) are equal among treatment 
groups. All tests are two-sided. * indicates statistical significance at 0.05 level. 
Source Data: Listing 16.2-4.1 
 
 
 
Table 14.1-1.4.3 
Demographics and Baseline Characteristics 
(Per Protocol Analysis Set) 
 
Same layout as Table 14.1-1.4.1. Use the following footnote.  
 
[1] P-value is for testing the null hypotheses that summary statistics (mean or proportion) are equal among treatment 
groups. All tests are two-sided. * indicates statistical significance at 0.05 level. 
Source Data: Listing 16.2-4.1 
 
 
Table 14.1-1.4.4 
Demographics and Baseline Characteristics by Country 
(Safety Analysis Set) 
 
Same layout as Table 14.1-1.4.1. Display ‘Country: United States’ on the header of the table. Use the following 
footnote.  
 
[1] P-value is for testing the null hypotheses that summary statistics (mean or proportion) are equal among treatment 
groups. All tests are two-sided. * indicates statistical significance at 0.05 level. 
Source Data: Listing 16.2-4.1 


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Final – 22November2011                         CONFIDENTIAL                                     Page 17 of 106 
 
Table 14.1-1.5 
Substance Use 
(Safety Analysis Set) 
 
 
 
 
 
 
 
 
EGT0001442 
Placebo 
Total 
 
 
(N=xxx) 
(N=xxx) 
(N=xxx) 
 
 
 
 
 
Alcohol Consumption 
 
xxx 
xxx 
xxx 
  n  
 
xxx (xx.x%) 
xxx (xx.x%) 
xxx (xx.x%) 
  Yes 
 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
  No 
 
 
 
 
 
 
 
 
 
Alcohol Units Consumed Per Week 
 
 
 
 
  n 
 
xxx  
xxx 
xxx 
  Mean (SD) 
 
xx.x (xx.xx) 
xx.x (xx.xx) 
xx.x (xx.xx) 
  Median 
 
xx.x 
xx.x 
xx.x 
  Min, Max 
 
xx, xx 
xx, xx 
xx, xx 
 
 
 
 
 
Tobacco Use 
 
 
 
 
  n 
 
xxx 
xxx 
xxx 
  Never Used 
 
xxx (xx.x%) 
xxx (xx.x%) 
xxx (xx.x%) 
  Current User 
 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
  Former User 
 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
 
 
 
 
 
Drug Dependency or Abuse 
 
xxx 
xxx 
xxx 
  n  
 
xxx (xx.x%) 
xxx (xx.x%) 
xxx (xx.x%) 
  Yes 
 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
  No 
 
 
 
 
 
 
 
 
 
 
Source Data: Listing 16.2-4.2 
 


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Final – 22November2011                         CONFIDENTIAL                                     Page 18 of 106 
 
Table 14.1-2.1 
Medical History 
(Safety Analysis Set) 
 
 
 
 
 
 
 
EGT0001442 
Placebo 
 
 
(N=xxx) 
(N=xxx) 
 
 
 
 
Subjects with Any Conditions 
 
xxx (xx.x%) 
xxx (xx.x%) 
 
 
 
 
XXXXXXXX 
 
xxx (xx.x%)
xxx (xx.x%)
XXXXXXXX 
 
xxx (xx.x%)
xxx (xx.x%)
OTHER 
 
xxx (xx.x%)
xxx (xx.x%)
 
 
 
 
 
 
 
 
 
 
Source Data: Listing 16.2-4.4 
 


Theracos, Inc.  
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Final – 22November2011                         CONFIDENTIAL                                     Page 19 of 106 
 
Table 14.1-2.2 
Diabetes Disease History 
(Safety Analysis Set) 
 
 
 
 
 
 
 
EGT0001442 
Placebo 
 
 
(N=xxx) 
(N=xxx) 
 
 
 
 
Duration of Diabetes (years) [1] 
 
 
 
  n 
 
xxx 
xxx 
  Mean (SD) 
 
xx.x (xx.xxx) 
xx.x (xx.xxx) 
  Median 
 
xx.x 
xx.x 
  Min, Max 
 
xx, xx 
xx, xx 
 
 
 
 
Baseline Diabetes Therapy 
 
 
 
  n 
 
xxx 
xxx 
  Treatment Naive 
 
xxx (xx.x%) 
xxx (xx.x%) 
  Treated with One Anti-diabetic Agent  
 
xxx (xx.x%) 
xxx (xx.x%) 
 
 
 
 
Blindness 
 
 
 
  n 
 
xxx 
xxx 
  Yes 
 
xxx (xx.x%) 
xxx (xx.x%) 
  No  
 
xxx (xx.x%) 
xxx (xx.x%) 
 
 
 
 
Cataracts 
 
 
 
Retinopathy 
 
 
 
Laser Treatment to Either Eye 
 
 
 
Foot Ulceration 
 
 
 
Peripheral Neuropathy 
 
 
 
Lower Limb Amputation 
 
 
 
Diabetic Nephropathy 
 
 
 
Current Microalbuminuria 
 
 
 
Current Proteinuria 
 
 
 
Dialysis 
 
 
 
Kidney Transplantation 
 
 
 
Major Hypoglycemic Event 
 
 
 
Documented Hypoglycemic Event 
 
 
 
 
 
 
 
 
[1] To calculate duration from a partial diagnosis date, a missing month is imputed as January and a missing day is 
imputed as the first of the month. 
Source Data: Listings 16.2-4.4 and 16.2-4.5 
 
 


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Final – 22November2011                         CONFIDENTIAL                                     Page 20 of 106 
 
 
Table 14.1-2.3 
Diabetes Disease History by Country 
(Safety Analysis Set) 
Same layout as Table 14.1-2.3. Display ‘Country: United States’ on the header of the table. Use the following footnote 
 
[1] To calculate duration from a partial diagnosis date, a missing month is imputed as January and a missing day is 
imputed as the first of the month. 
Source Data: Listings 16.2-4.4 and 16.2-4.5 
 


Theracos, Inc.  
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Final – 22November2011                         CONFIDENTIAL                                     Page 21 of 106 
 
Table 14.1-3.1 
Prior Medications 
(Safety Analysis Set) 
 
 
 
 
 
ATC Level 4 Term  
 
EGT0001442 
Placebo 
  Preferred Term   
 
(N=xxx) 
(N=xxx) 
 
 
 
 
Subjects with Any Medications 
 
xxx (xx.x%) 
xxx (xx.x%) 
 
 
 
 
ATC Level 4 Term #1 
 
xxx (xx.x%) 
xxx (xx.x%) 
  Preferred Term #1 
 
xxx (xx.x%) 
xxx (xx.x%) 
  Preferred Term #2 
 
xxx (xx.x%) 
xxx (xx.x%) 
 
 
 
 
ATC Level 4 Term #2 
 
xxx (xx.x%)
xxx (xx.x%)
XXXXXX 
 
xxx (xx.x%)
xxx (xx.x%)
XXXXXX 
 
xxx (xx.x%)
xxx (xx.x%)
XXXXXX 
 
xxx (xx.x%)
xxx (xx.x%)
XXXXXX 
 
xxx (xx.x%) 
xxx (xx.x%) 
XXXXXX 
 
xxx (xx.x%)
xxx (xx.x%)
 
 
 
 
 
 
 
 
 
Note: At each level of summarization, a subject is counted once if the subject reported one or more medications. 
Medications are coded using WHODRUG enhanced version June 2011. Prior medications are those started before the 
first dose of study medication. 
Source Data: Listing 16.2-5.1 
 


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Final – 22November2011                         CONFIDENTIAL                                     Page 22 of 106 
 
Table 14.1-3.2 
Concomitant Medications 
(Safety Analysis Set) 
 
 
 
 
 
ATC Level 4 Term  
 
EGT0001442 
Placebo 
  Preferred Term   
 
(N=xxx) 
(N=xxx) 
 
 
 
 
Subjects with Any Medications 
 
xxx (xx.x%) 
xxx (xx.x%) 
 
 
 
 
ATC Level 4 Term #1 
 
xxx (xx.x%) 
xxx (xx.x%) 
  Preferred Term #1 
 
xxx (xx.x%) 
xxx (xx.x%) 
  Preferred Term #2 
 
xxx (xx.x%) 
xxx (xx.x%) 
 
 
 
 
ATC Level 4 Term #2 
 
xxx (xx.x%)
xxx (xx.x%)
XXXXXX 
 
xxx (xx.x%)
xxx (xx.x%)
XXXXXX 
 
xxx (xx.x%)
xxx (xx.x%)
XXXXXX 
 
xxx (xx.x%)
xxx (xx.x%)
XXXXXX 
 
xxx (xx.x%) 
xxx (xx.x%) 
XXXXXX 
 
xxx (xx.x%)
xxx (xx.x%)
 
 
 
 
 
 
 
 
 
Note: At each level of summarization, a subject is counted once if the subject reported one or more medications.  
      Medications are coded using WHODRUG enhanced version June 2011. Concomitant medications are those taken at any 
time on or after the day of the first dose of study medication, including those started prior to randomization 
but were continuing during the study period. 
Source Data: Listing 16.2-5.1 
 


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Final – 22November2011                         CONFIDENTIAL                                     Page 23 of 106 
 
Table 14.1-3.3 
Hyperglycemia Rescue Medications 
(Safety Analysis Set) 
 
 
 
 
 
ATC Level 4 Term  
 
EGT0001442 
Placebo 
  Preferred Term   
 
(N=xxx) 
(N=xxx) 
 
 
 
 
Subjects with Any Rescue Medications 
 
xxx (xx.x%) 
xxx (xx.x%) 
 
 
 
 
ATC Level 4 Term #1 
 
xxx (xx.x%) 
xxx (xx.x%) 
  Preferred Term #1 
 
xxx (xx.x%) 
xxx (xx.x%) 
  Preferred Term #2 
 
xxx (xx.x%) 
xxx (xx.x%) 
 
 
 
 
ATC Level 4 Term #2 
 
xxx (xx.x%)
xxx (xx.x%)
XXXXXX 
 
xxx (xx.x%)
xxx (xx.x%)
XXXXXX 
 
xxx (xx.x%)
xxx (xx.x%)
XXXXXX 
 
xxx (xx.x%)
xxx (xx.x%)
XXXXXX 
 
xxx (xx.x%) 
xxx (xx.x%) 
XXXXXX 
 
xxx (xx.x%)
xxx (xx.x%)
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: Only concomitant anti-hyperglycemia medications that are indicated by the investigator as being used for 
hyperglycemia rescue are included in this summary. At each level of summarization, a subject is counted once if 
the subject reported one or more medications. Medications are coded using WHODRUG enhanced version June 2011. 
Concomitant rescue medications are those taken at any time on or after the day of the first dose of study 
medication. 
Source Data: Listing 16.2-5.1 
  
 
 


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Final – 22November2011                         CONFIDENTIAL                                     Page 24 of 106 
 
Table 14.1-3.4 
Proportion of Subjects with Hyperglycemia Rescue 
(Safety Analysis Set) 
 
 
 
 
 
 
EGT0001442 
Placebo 
 
 
(N=xxx) 
(N=xxx) 
 
 
 
 
Number of Subjects Rescued by Time of First Rescue 
 
 
 
  <=2 weeks 
 
xxx (xx.x%)
xxx (xx.x%)
  >2 weeks - <=6 weeks 
 
xxx (xx.x%)
xxx (xx.x%)
  >6 weeks - <=12 weeks 
 
xxx (xx.x%)
xxx (xx.x%)
  >12 weeks - <=18 weeks 
 
xxx (xx.x%)
xxx (xx.x%)
  >18 weeks - <=24 weeks 
 
xxx (xx.x%)
xxx (xx.x%)
  >24 weeks - <=36 weeks 
 
xxx (xx.x%)
xxx (xx.x%)
  >36 weeks - <=48 weeks 
 
xxx (xx.x%)
xxx (xx.x%)
  >48 weeks - <=60 weeks 
 
xxx (xx.x%)
xxx (xx.x%)
  >60 weeks - <=72 weeks 
 
xxx (xx.x%)
xxx (xx.x%)
  >72 weeks - <=84 weeks 
 
xxx (xx.x%)
xxx (xx.x%)
  >84 weeks - <=96 weeks 
 
xxx (xx.x%)
xxx (xx.x%)
 
 
 
 
 
Source Data: Listing 16.2-5.1 
 
 
 
 
 
 
 


Theracos, Inc.  
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Final – 22November2011                         CONFIDENTIAL                                     Page 25 of 106 
 
Table 14.1-4.1 
Treatment Exposure 
(Safety Analysis Set) 
 
 
 
 
 
 
EGT0001442 
Placebo 
 
 
(N=xxx) 
(N=xxx) 
 
 
 
 
Duration of Exposure (weeks)  
 
 
 
  n 
 
xxx 
xxx 
  Mean (SD) 
 
xx.x (xx.xxx) 
xx.x (xx.xxx) 
  Median 
 
xx.x 
xx.x 
  Min, Max 
 
xx, xx 
xx, xx 
 
 
 
 
Number (%) of Subjects with Exposure of 
 
 
 
  1 Dose 
 
xxx (xx.x%) 
xxx (xx.x%) 
  >1 Dose - <=2 weeks 
 
xxx (xx.x%) 
xxx (xx.x%) 
  >2 weeks - <=6 weeks 
 
xxx (xx.x%) 
xxx (xx.x%) 
  >6 weeks - <=12 weeks 
 
xxx (xx.x%) 
xxx (xx.x%) 
  >12 weeks - <=18 weeks 
 
xxx (xx.x%) 
xxx (xx.x%) 
  >18 weeks - <=24 weeks 
 
xxx (xx.x%) 
xxx (xx.x%) 
  >24 weeks - <=36 weeks 
 
xxx (xx.x%) 
xxx (xx.x%) 
  >36 weeks - <=48 weeks 
 
xxx (xx.x%) 
xxx (xx.x%) 
  >48 weeks - <=60 weeks 
 
xxx (xx.x%) 
xxx (xx.x%) 
  >60 weeks - <=72 weeks 
 
xxx (xx.x%) 
xxx (xx.x%) 
  >72 weeks - <=84 weeks 
 
xxx (xx.x%) 
xxx (xx.x%) 
  >84 weeks - <=96 weeks 
 
xxx (xx.x%) 
xxx (xx.x%) 
  >96 weeks  
 
xxx (xx.x%) 
xxx (xx.x%) 
 
 
 
 
 
Note: Duration of exposure (weeks) = (date of last dose - date of first dose + 1)/7. 
 
Source Data: Listing 16.2-6.1 
 


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Final – 22November2011                         CONFIDENTIAL                                     Page 26 of 106 
 
Table 14.1-4.2 
Treatment Compliance 
(Safety Analysis Set) 
 
 
 
 
 
 
 
EGT0001442 
Placebo 
 
 
(N=xxx) 
(N=xxx) 
 
 
 
 
Compliance (%)  
 
 
 
  n 
 
xxx 
xxx 
  Mean (SD) 
 
xx.x (xx.xxx) 
xx.x (xx.xxx) 
  Median 
 
xx.x 
xx.x 
  Min, Max 
 
xx, xx 
xx, xx 
 
 
 
 
Compliance Category  
 
 
 
  n 
 
xxx
xxx
  <80% 
 
xxx (xx.x%) 
xxx (xx.x%) 
  >=80% 
 
xxx (xx.x%)
xxx (xx.x%)
 
 
 
 
 
Note: Treatment compliance is calculated as total number of administered capsules divided by total number of capsules 
which should have been taken based on the last completed visit during active treatment period. 
Source Data: Listing 16.2-6.1 
 
 
 


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Final – 22November2011                         CONFIDENTIAL                                     Page 27 of 106 
 
Figure 14.2-1.1 
Line Graph of Mean (+/- SE) Change from Baseline in HbA1c (%), Excluding Post-Rescue Values 
(Full Analysis Set - OC) 
 
Source Data: Table 14.2-1.3  
 
 
Programming Note: Display treatment group identifiers identical to those in summary tables instead of using TRT A and 
TRT B as shown in the shell.  Also, this shell only shows through Week 52 but our data and plot will go through Week 
97. 


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Final – 22November2011                         CONFIDENTIAL                                     Page 28 of 106 
 
 
Figure 14.2-1.2 
Line Graph of Mean (+/- SE) HbA1c (%), Excluding Post-Rescue Values 
(Full Analysis Set - OC) 
 
See Figure 14.2-1.1 for layout and general programming notes. Use footnotes below. 
 
Source Data: Table 14.2-1.3 
 
 
 
 
Figure 14.2-2.1 
Line Graph of Mean (+/- SE) Change from Baseline in Fasting Plasma Glucose (mmol/L), Excluding Post-Rescue Values 
(Full Analysis Set - OC) 
 
See Figure 14.2-1.1 for layout and general programming notes. Use footnotes below. 
 
Source Data: Table 14.2-2.3 
 
 
 
Figure 14.2-2.2 
Line Graph of Mean (+/- SE) Fasting Plasma Glucose (mmol/L), Excluding Post-Rescue Values 
(Full Analysis Set - OC) 
 
See Figure 14.2-1.1 for layout and general programming notes. Use footnotes below. 
 
Source Data: Table 14.2-2.3 
 
 
 
 
 


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Final – 22November2011                         CONFIDENTIAL                                     Page 29 of 106 
 
Figure 14.2-3.1 
Line Graph of Mean (+/- SE) Change from Baseline in Weight (kg), Excluding Post-Rescue Values 
(Full Analysis Set - OC) 
 
See Figure 14.2-1.1 for layout and general programming notes. Use footnotes below. 
 
Source Data: Table 14.2-3.3 
 
 
 
 
Figure 14.2-3.2 
Line Graph of Mean (+/- SE) Weight (kg), Excluding Post-Rescue Values 
(Full Analysis Set - OC) 
 
See Figure 14.2-1.1 for layout and general programming notes. Use footnotes below. 
 
Source Data: Table 14.2-3.3 
 
 
 
 
Figure 14.2-4.1 
Line Graph of Mean (+/- SE) Change from Baseline in Systolic Blood Pressure (mmHg), Excluding Post-Rescue Values  
(Full Analysis Set - OC) 
 
See Figure 14.2-1.1 for layout and general programming notes. Use footnotes below. 
 
Source Data: Table 14.2-4.3 
 
 
 
 
 
 


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Final – 22November2011                         CONFIDENTIAL                                     Page 30 of 106 
 
Figure 14.2-4.2 
Line Graph of Mean (+/- SE) Systolic Blood Pressure (mmHg), Excluding Post-Rescue Values  
(Full Analysis Set - OC) 
 
See Figure 14.2-1.1 for layout and general programming notes. Use footnotes below. 
 
Source Data: Table 14.2-4.3 
 
 
 
 
 
Figure 14.2-5.1 
Line Graph of Mean (+/- SE) Change from Baseline in Diastolic Blood Pressure (mmHg), Excluding Post-Rescue Values  
(Full Analysis Set - OC) 
 
See Figure 14.2-1.1 for layout and general programming notes. Use footnotes below. 
 
Source Data: Table 14.2-5.3 
 
 
Figure 14.2-5.2 
Line Graph of Mean (+/- SE) Diastolic Blood Pressure (mmHg), Excluding Post-Rescue Values  
(Full Analysis Set - OC) 
 
See Figure 14.2-1.1 for layout and general programming notes. Use footnotes below. 
 
Source Data: Table 14.2-5.3 


Theracos, Inc.  
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Final – 22November2011                         CONFIDENTIAL                                     Page 31 of 106 
 
Table 14.2-1.1 
Analysis of Change from Baseline in HbA1c (%) at Week 24 
(Full Analysis Set - LOCF) 
Week 24 
 
 
EGT0001442 
Placebo 
 
 
(N=xxx) 
(N=xxx) 
 
 
 
 
Number of Subjects [1] 
 
xxx 
xxx 
Number (%) of Values Carried Forward 
 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
Baseline 
 
 
 
  Mean (SD) 
 
xx.xx (xx.xxx) 
xx.xx (xx.xxx) 
  Median 
 
xx.xx 
xx.xx 
  Min, Max 
 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
Week 24 
 
 
 
  Mean (SD) 
 
xx.xx (xx.xxx) 
xx.xx (xx.xxx) 
  Median 
 
xx.xx 
xx.xx 
  Min, Max 
 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
Change from Baseline 
 
 
 
  Mean (SD) 
 
xx.xx (xx.xxx) 
xx.xx (xx.xxx) 
  Median 
 
xx.xx 
xx.xx 
  Min, Max 
 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
p-value [2] 
 
0.xxxx 
 
 
 
 
 
Model-Adjusted Change from Baseline [3] 
 
 
 
  LS Mean (SE) 
 
xx.xx (xx.xxx)
xx.xx (xx.xxx)
  95% Confidence Interval 
 
(xx.xx, xx.xx) 
(xx.xx, xx.xx) 
 
 
 
 
Difference from Placebo [3] 
 
 
 
  Difference of LS Means 
 
xx.xx 
 
  95% Confidence Interval 
 
(xx.xx, xx.xx) 
 
  p-value 
 
0.xxxx 
 
Note: This analysis uses the last observation carried forward (LOCF) method for missing post-baseline values as well 
as for values obtained after hyperglycemia rescue. * indicates statistical significance at 0.05 level. 
[1] Number of subjects with a value at baseline and at the specified visit. 
[2] The p-value is from a two-sided t-test for the difference in means of change from baseline.  
[3] Based on ANCOVA: Change = trt + baseline HbA1c + site + age category + gender + race.  
Source Data: Listing 16.2-7.1 
   


Theracos, Inc.  
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Final – 22November2011                         CONFIDENTIAL                                     Page 32 of 106 
 
Table 14.2-1.2 
Analysis of Change from Baseline in HbA1c (%) 
(Full Analysis Set - LOCF) 
Week 2 
 
 
EGT0001442 
Placebo 
 
 
(N=xxx) 
(N=xxx) 
 
 
 
 
Number of Subjects [1] 
 
xxx 
xxx 
Number (%) of Values Carried Forward 
 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
Baseline 
 
 
 
  Mean (SD) 
 
xx.xx (xx.xxx) 
xx.xx (xx.xxx) 
  Median 
 
xx.xx 
xx.xx 
  Min, Max 
 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
Week 2 
 
 
 
  Mean (SD) 
 
xx.xx (xx.xxx) 
xx.xx (xx.xxx) 
  Median 
 
xx.xx 
xx.xx 
  Min, Max 
 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
Change from Baseline 
 
 
 
  Mean (SD) 
 
xx.xx (xx.xxx) 
xx.xx (xx.xxx) 
  Median 
 
xx.xx 
xx.xx 
  Min, Max 
 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
p-value [2] 
 
0.xxxx 
 
 
 
 
 
Model-Adjusted Change from Baseline [3] 
 
 
 
  LS Mean (SE) 
 
xx.xx (xx.xxx)
xx.xx (xx.xxx)
  95% Confidence Interval 
 
(xx.xx, xx.xx) 
(xx.xx, xx.xx) 
 
 
 
 
Difference from Placebo [3] 
 
 
 
  Difference of LS Means 
 
xx.xx 
 
  95% Confidence Interval 
 
(xx.xx, xx.xx) 
 
  p-value 
 
0.xxxx 
 
Note: This analysis uses the last observation carried forward (LOCF) method for missing post-baseline values as well 
as for values obtained after hyperglycemia rescue. * indicates statistical significance at 0.05 level. 
[1] Number of subjects with a value at baseline and at the specified visit. 
[2] The p-value is from a two-sided t-test for the difference in means of change from baseline.  
[3] Based on ANCOVA: Change = trt + baseline HbA1c + site + age category + gender + race.  
Source Data: Listing 16.2-7.1 
Programming Note: present for Weeks 2, 6, 12, 18, 24, 36, 48, 60, 72, 84, 96, 97 and 1 week follow-up.  
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 33 of 106 
 
Table 14.2-1.3 
Analysis of Change from Baseline in HbA1c (%), Excluding Post-Rescue Values 
(Full Analysis Set - OC) 
Week 2 
 
 
EGT0001442 
Placebo 
 
 
(N=xxx) 
(N=xxx) 
 
 
 
 
Number of Subjects [1] 
 
xxx 
xxx 
 
 
 
 
Baseline 
 
 
 
  Mean (SD) 
 
xx.xx (xx.xxx) 
xx.xx (xx.xxx) 
  Median 
 
xx.xx 
xx.xx 
  Min, Max 
 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
Week 2 
 
 
 
  Mean (SD) 
 
xx.xx (xx.xxx) 
xx.xx (xx.xxx) 
  Median 
 
xx.xx 
xx.xx 
  Min, Max 
 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
Change from Baseline 
 
 
 
  Mean (SD) 
 
xx.xx (xx.xxx) 
xx.xx (xx.xxx) 
  Median 
 
xx.xx 
xx.xx 
  Min, Max 
 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
p-value [2] 
 
0.xxxx 
 
 
 
 
 
Model-Adjusted Change from Baseline [3] 
 
 
 
  LS Mean (SE) 
 
xx.xx (xx.xxx)
xx.xx (xx.xxx)
  95% Confidence Interval 
 
(xx.xx, xx.xx) 
(xx.xx, xx.xx) 
 
 
 
 
Difference from Placebo [3] 
 
 
 
  Difference of LS Means 
 
xx.xx 
 
  95% Confidence Interval 
 
(xx.xx, xx.xx) 
 
  p-value 
 
0.xxxx 
 
Note: This analysis uses observed values excluding those obtained after hyperglycemia rescue; no missing data 
imputation is performed. * indicates statistical significance at 0.05 level. 
[1] Number of subjects with a value at baseline and at the specified visit. 
[2] The p-value is from a two-sided t-test for the difference in means of change from baseline.  
[3] Based on ANCOVA: Change = trt + baseline HbA1c + site + age category + gender + race. 
Source Data: Listing 16.2-7.1 
 
Programming Note: present for Weeks 2, 6, 12, 18, 24, 36, 48, 60, 72, 84, 96, 97 and 1 week follow-up.  


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 34 of 106 
 
Table 14.2-1.4 
Repeated Measures Analysis of Change from Baseline in HbA1c (%) at Week 96, Excluding Post-rescue Values 
(Full Analysis Set - OC) 
 
 
 
 
 
 
 
EGT0001442 
Placebo 
 
 
(N=xxx) 
(N=xxx) 
 
 
 
 
Model-Adjusted Change from Baseline at Week 96 [1] 
 
 
 
  n (# of Subjects) 
 
xx 
xx 
  k (# of Post-baseline Visits) 
 
xx 
xx 
  LS Mean (SE) 
 
xx.xx (xx.xxx)
xx.xx (xx.xxx)
  95% Confidence Interval 
 
(xx.xx, xx.xx) 
(xx.xx, xx.xx) 
 
 
 
 
Difference from Placebo [1] 
 
 
 
  Difference of LS Means 
 
xx.xx 
 
  95% Confidence Interval 
 
(xx.xx, xx.xx) 
 
  p-value 
 
0.xxxx 
 
 
 
 
 
 
 
 
 
 
Note: This analysis uses all observed values excluding those obtained after hyperglycemia rescue; no missing data 
imputation is performed. * indicates statistical significance at 0.05 level. 
[1] Based on repeated measure model including treatment and visit as factors.  
Source Data: Listing 16.2-7.1 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 35 of 106 
 
Table 14.2-1.5 
Summary Statistics for HbA1c (%) 
(Full Analysis Set - OC) 
Screening 
 
 
 
 
 
 
EGT0001442 
Placebo 
 
 
(N=xxx) 
(N=xxx) 
 
 
 
 
Number of Subjects [1] 
 
xxx 
xxx 
 
 
 
 
Screening 
 
 
 
  Mean (SD) 
 
xx.xx (xx.xxx) 
xx.xx (xx.xxx) 
  Median 
 
xx.xx 
xx.xx 
  Min, Max 
 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
 
Note: This summary uses all observed values; no missing data imputation is performed. Baseline is defined as the last 
available assessment on or prior to the first dose of study drug. 
[1] For Screening and Week 0 the number of subjects with a value at the specified visit is displayed. For all post-
baseline visits, the number of subjects with a value at baseline and at the specified visit is displayed. 
Source Data: Listing 16.2-7.1 
 
 
Programming Note: Use page 1 shell for Screening and Week 0, use pages 2 shell for the remaining post-baseline visits 
(Weeks 2, 6, 12, 18, 24, 36, 48, 60, 72, 84, 96, 97 and 1 week follow-up). 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 36 of 106 
 
Table 14.2-1.5 
Summary Statistics for HbA1c (%) 
(Full Analysis Set - OC) 
Week 2 
 
 
 
 
 
 
EGT0001442 
Placebo 
 
 
(N=xxx) 
(N=xxx) 
 
 
 
 
Number of Subjects [1] 
 
xxx 
xxx 
 
 
 
 
Baseline 
 
 
 
  Mean (SD) 
 
xx.xx (xx.xxx) 
xx.xx (xx.xxx) 
  Median 
 
xx.xx 
xx.xx 
  Min, Max 
 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
Week 2 
 
 
 
  Mean (SD) 
 
xx.xx (xx.xxx) 
xx.xx (xx.xxx) 
  Median 
 
xx.xx 
xx.xx 
  Min, Max 
 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
Change from Baseline 
 
 
 
  Mean (SD) 
 
xx.xx (xx.xxx) 
xx.xx (xx.xxx) 
  Median 
 
xx.xx 
xx.xx 
  Min, Max 
 
xx.x, xx.x 
xx.x, xx.x 
 
 
 
 
 
Note: This summary uses all observed values; no missing data imputation is performed. Baseline is defined as the last 
available assessment on or prior to the first dose of study drug. 
[1] For Screening and Week 0 the number of subjects with a value at the specified visit is displayed. For all post-
baseline visits, the number of subjects with a value at baseline and at the specified visit is displayed. 
Source Data: Listing 16.2-7.1 
  
Programming Note: present for Weeks 2, 6, 12, 18, 24, 36, 48, 60, 72, 84, 96, 97 and 1 week follow-up.  
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 37 of 106 
 
Table 14.2-1.6 
Analysis of Change from Baseline in HbA1c (%) 
(Per Protocol Analysis Set - LOCF) 
 
Programming Note: See Table 14.2-1.1 for layout. Use footnotes below. 
 
Note: This analysis uses the last observation carried forward (LOCF) method for missing post-baseline values as well 
as for values obtained after hyperglycemia rescue. * indicates statistical significance at 0.05 level. 
[1] Number of subjects with a value at baseline and at the specified visit. 
[2] The p-value is from a two-sided t-test for the difference in means of change from baseline.  
[3] Based on ANCOVA: Change = trt + baseline HbA1c + site + age category + gender + race.  
Source Data: Listing 16.2-7.1 
Programming Note: present for Weeks 2, 6, 12, 18, 24, 36, 48, 60, 72, 84, 96, 97 and 1 week follow-up.  
 
 
 
Table 14.2-2.1 
Analysis of Change from Baseline in Fasting Plasma Glucose (mmol/L) at Week 24 
(Full Analysis Set - LOCF) 
 
Programming Note: See Table 14.2-1.1 for layout. Use footnotes below. 
 
Note: This analysis uses the last observation carried forward (LOCF) method for missing post-baseline values as well 
as for values obtained after hyperglycemia rescue. * indicates statistical significance at 0.05 level. 
[1] Number of subjects with a value at baseline and at the specified visit. 
[2] The p-value is from a two-sided t-test for the difference in means of change from baseline.  
[3] Based on ANCOVA: Change = trt + baseline FPG + baseline HbA1c category + site + age category + gender + race.  
 
Source Data: Listing 16.2-7.2 
 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 38 of 106 
 
Table 14.2-2.2 
Analysis of Change from Baseline in Fasting Plasma Glucose (mmol/L) 
(Full Analysis Set - LOCF) 
 
Programming Note: See Table 14.2-1.2 for layout. Use footnotes below. 
 
Note: This analysis uses the last observation carried forward (LOCF) method for missing post-baseline values as well 
as for values obtained after hyperglycemia rescue. * indicates statistical significance at 0.05 level. 
[1] Number of subjects with a value at baseline and at the specified visit. 
[2] The p-value is from a two-sided t-test for the difference in means of change from baseline.  
[3] Based on ANCOVA: Change = trt + baseline FPG + baseline HbA1c category + site + age category + gender + race.  
 
Source Data: Listing 16.2-7.2 
 
Programming Note: present for Weeks 2, 6, 12, 18, 24, 36, 48, 60, 72, 84, 96, 97 and 1 week follow-up.  


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 39 of 106 
 
Table 14.2-2.3 
Analysis of Change from Baseline in Fasting Plasma Glucose (mmol/L), Excluding Post-rescue Values 
(Full Analysis Set- OC) 
 
Programming Note: See Table 14.2-1.3 for layout. Use footnotes below. 
 
Note: This analysis uses observed values excluding those obtained after hyperglycemia rescue; no missing data 
imputation is performed. * indicates statistical significance at 0.05 level. 
[1] Number of subjects with a value at baseline and at the specified visit. 
[2] The p-value is from a two-sided t-test for the difference in means of change from baseline.  
[3] Based on ANCOVA: Change = trt + baseline FPG + baseline HbA1c category + site + age category + gender + race. 
 
Source Data: Listing 16.2-7.2 
Programming Note: present for Weeks 2, 6, 12, 18, 24, 36, 48, 60, 72, 84, 96, 97 and 1 week follow-up.  
 
 
 
 
 
Table 14.2-2.4 
Repeated Measures Analysis of Change from Baseline in Fasting Plasma Glucose (mmol/L) at Week 96, Excluding Post-rescue 
Values 
(Full Analysis Set - OC) 
Programming Note: See Table 14.2-1.4 for layout. Use footnotes below. 
 
Note: This analysis uses all observed values excluding those obtained after hyperglycemia rescue; no missing data 
imputation is performed. * indicates statistical significance at 0.05 level. 
[1] Based on repeated measure model including treatment and visit as factors. 
Source Data: Listing 16.2-7.2 
 
 
 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 40 of 106 
 
Table 14.2-2.5 
Summary Statistics for Fasting Plasma Glucose (mmol/L) 
(Full Analysis Set- OC) 
 
Programming Note: See Table 14.2-1.5 for layout. Use footnotes below. 
 
Note: This summary uses all observed values; no missing data imputation is performed. Baseline is defined as the last 
available assessment on or prior to the first dose of study drug. 
[1] For Screening and Week 0 the number of subjects with a value at the specified visit is displayed. For all post-
baseline visits, the number of subjects with a value at baseline and at the specified visit is displayed. 
Source Data: Listing 16.2-7.2 
 
Programming Note: Use page 1 shell for Screening and Week 0, use pages 2 shell for the remaining post-baseline visits 
(Weeks 2, 6, 12, 18, 24, 36, 48, 60, 72, 84, 96, 97 and 1 week follow-up). 
 
 
 
 
 
  
 
Table 14.2-2.6 
Analysis of Change from Baseline in Fasting Plasma Glucose (mmol/L) 
(Per Protocol Analysis Set - LOCF) 
 
Programming Note: See Table 14.2-1.2 for layout. Use footnotes below. 
 
Note: This analysis uses the last observation carried forward (LOCF) method for missing post-baseline values as well 
as for values obtained after hyperglycemia rescue. * indicates statistical significance at 0.05 level. 
[1] Number of subjects with a value at baseline and at the specified visit. 
[2] The p-value is from a two-sided t-test for the difference in means of change from baseline.  
[3] Based on ANCOVA: Change = trt + baseline FPG + baseline HbA1c category + site + age category + gender + race. 
Source Data: Listing 16.2-7.2 
 
Programming Note: present for Weeks 2, 6, 12, 18, 24, 36, 48, 60, 72, 84, 96, 97 and 1 week follow-up.  
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 41 of 106 
 
Table 14.2-3.1 
Analysis of Change from Baseline in Weight (kg) at Week 24 
(Full Analysis Set - LOCF) 
 
Programming Note: See Table 14.2-1.1 for layout. Use footnotes below. 
 
Note: This analysis uses the last observation carried forward (LOCF) method for missing post-baseline values as well 
as for values obtained after hyperglycemia rescue. * indicates statistical significance at 0.05 level. 
[1] Number of subjects with a value at baseline and at the specified visit. 
[2] The p-value is from a two-sided t-test for the difference in means of change from baseline.  
[3] Based on ANCOVA: Change = trt + baseline weight + baseline HbA1c category + site + age category + gender + race.  
 
Source Data: Listing 16.2-7.3 
 
 
 
 
Table 14.2-3.2 
Analysis of Change from Baseline in Weight (kg) 
(Full Analysis Set - LOCF) 
 
Programming Note: See Table 14.2-1.2 for layout. Use footnotes below. 
 
Note: This analysis uses the last observation carried forward (LOCF) method for missing post-baseline values as well 
as for values obtained after hyperglycemia rescue. * indicates statistical significance at 0.05 level. 
[1] Number of subjects with a value at baseline and at the specified visit. 
[2] The p-value is from a two-sided t-test for the difference in means of change from baseline.  
[3] Based on ANCOVA: Change = trt + baseline weight + baseline HbA1c category + site + age category + gender + race.  
 
Source Data: Listing 16.2-7.3 
 
Programming Note: present for Weeks 12, 24, 48, 72, 96, 97 and 1 week follow-up.  
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 42 of 106 
 
 
Table 14.2-3.3 
Analysis of Change from Baseline in Weight (kg), Excluding Post-rescue Values 
(Full Analysis Set- OC) 
 
Programming Note: See Table 14.2-1.3 for layout. Use footnotes below. 
 
Note: This analysis uses observed values excluding those obtained after hyperglycemia rescue; no missing data 
imputation is performed. * indicates statistical significance at 0.05 level. 
[1] Number of subjects with a value at baseline and at the specified visit. 
[2] The p-value is from a two-sided t-test for the difference in means of change from baseline.  
[3] Based on ANCOVA: Change = trt + baseline weight + baseline HbA1c category + site + age category + gender + race. 
 
Source Data: Listing 16.2-7.3 
 
Programming Note: present for Weeks 12, 24, 48, 72, 96, 97 and 1 week follow-up.  
 
 
 
 
 
Table 14.2-3.4 
Repeated Measures Analysis of Change from Baseline in Weight (kg) at Week 96, Excluding Post-rescue Values 
(Full Analysis Set - OC) 
Programming Note: See Table 14.2-1.4 for layout. Use footnotes below. 
 
Note: This analysis uses all observed values excluding those obtained after hyperglycemia rescue; no missing data 
imputation is performed. * indicates statistical significance at 0.05 level. 
[1] Based on repeated measure model including treatment and visit as factors. 
Source Data: Listing 16.2-7.3 
 
 
 
 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 43 of 106 
 
Table 14.2-3.5 
Summary Statistics for Weight (kg) 
(Full Analysis Set- OC) 
 
Programming Note: See Table 14.2-1.5 for layout. Use footnotes below. 
 
Note: This summary uses all observed values; no missing data imputation is performed. Baseline is defined as the last 
available assessment on or prior to the first dose of study drug. 
[1] For Screening and Week 0 the number of subjects with a value at the specified visit is displayed. For all post-
baseline visits, the number of subjects with a value at baseline and at the specified visit is displayed. 
Source Data: Listing 16.2-7.3 
 
 
Programming Note: use page 1 shell for Screening, and use page 2 shell for the remaining post-baseline visits (Weeks 
12, 24, 48, 72, 96, 97 and 1 week follow-up). 
 
 
  
 
 
Table 14.2-3.6 
Analysis of Change from Baseline in Weight (kg) 
(Per Protocol Analysis Set - LOCF) 
 
Programming Note: See Table 14.2-1.2 for layout. Use footnotes below. 
 
Note: This analysis uses the last observation carried forward (LOCF) method for missing post-baseline values as well 
as for values obtained after hyperglycemia rescue. * indicates statistical significance at 0.05 level. 
[1] Number of subjects with a value at baseline and at the specified visit. 
[2] The p-value is from a two-sided t-test for the difference in means of change from baseline.  
[3] Based on ANCOVA: Change = trt + baseline weight + baseline HbA1c category + site + age category + gender + race. 
Source Data: Listing 16.2-7.3 
 
Programming Note: present for Weeks 12, 24, 48, 72, 96, 97 and 1 week follow-up.  
 
 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 44 of 106 
 
Table 14.2-4.1 
Analysis of Change from Baseline in Systolic Blood Pressure (mmHg) at Week 24 
(Full Analysis Set - LOCF) 
 
Programming Note: See Table 14.2-1.1 for layout. Use footnotes below. 
 
Note: This analysis uses the last observation carried forward (LOCF) method for missing post-baseline values as well 
as for values obtained after hyperglycemia rescue. * indicates statistical significance at 0.05 level. 
[1] Number of subjects with a value at baseline and at the specified visit. 
[2] The p-value is from a two-sided t-test for the difference in means of change from baseline.  
[3] Based on ANCOVA: Change = trt + baseline SBP + baseline HbA1c category + site + age category + gender + race.  
 
Source Data: Listing 16.2-7.4 
 
 
 
 
 
Table 14.2-4.2 
Analysis of Change from Baseline in Systolic Blood Pressure (mmHg) 
(Full Analysis Set - LOCF) 
 
Programming Note: See Table 14.2-1.2 for layout. Use footnotes below. 
 
Note: This analysis uses the last observation carried forward (LOCF) method for missing post-baseline values as well 
as for values obtained after hyperglycemia rescue. * indicates statistical significance at 0.05 level. 
[1] Number of subjects with a value at baseline and at the specified visit. 
[2] The p-value is from a two-sided t-test for the difference in means of change from baseline.  
[3] Based on ANCOVA: Change = trt + baseline SBP + baseline HbA1c category + site + age category + gender + race.  
 
Source Data: Listing 16.2-7.4 
 
Programming Note: present for Weeks 2, 6, 12, 18, 24, 36, 48, 60, 72, 84, 96, 97 and 1 week follow-up.  
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 45 of 106 
 
 
Table 14.2-4.3 
Analysis of Change from Baseline in Systolic Blood Pressure (mmHg), Excluding Post-rescue Values 
(Full Analysis Set- OC) 
 
Programming Note: See Table 14.2-1.3 for layout. Use footnotes below. 
 
Note: This analysis uses observed values excluding those obtained after hyperglycemia rescue; no missing data 
imputation is performed. * indicates statistical significance at 0.05 level. 
[1] Number of subjects with a value at baseline and at the specified visit. 
[2] The p-value is from a two-sided t-test for the difference in means of change from baseline.  
[3] Based on ANCOVA: Change = trt + baseline SBP + baseline HbA1c category + site + age category + gender + race. 
 
Source Data: Listing 16.2-7.4 
 
Programming Note: present for Weeks 2, 6, 12, 18, 24, 36, 48, 60, 72, 84, 96, 97 and 1 week follow-up.  
 
 
 
 
 
Table 14.2-4.4 
Repeated Measures Analysis of Change from Baseline in Systolic Blood Pressure (mmHg) at Week 96, Excluding Post-rescue 
Values 
(Full Analysis Set - OC) 
Programming Note: See Table 14.2-1.4 for layout. Use footnotes below. 
 
Note: This analysis uses all observed values excluding those obtained after hyperglycemia rescue; no missing data 
imputation is performed. * indicates statistical significance at 0.05 level. 
[1] Based on repeated measure model including treatment and visit as factors. 
Source Data: Listing 16.2-7.4 
 
 
 
 
 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 46 of 106 
 
Table 14.2-4.5 
Summary Statistics for Systolic Blood Pressure (mmHg) 
(Full Analysis Set- OC) 
 
Programming Note: See Table 14.2-1.5 for layout. Use footnotes below. 
 
Note: This summary uses all observed values; no missing data imputation is performed. Baseline is defined as the last 
available assessment on or prior to the first dose of study drug. 
[1] For Screening and Week 0 the number of subjects with a value at the specified visit is displayed. For all post-
baseline visits, the number of subjects with a value at baseline and at the specified visit is displayed. 
Source Data: Listing 16.2-7.4 
 
 
Programming Note: Use page 1 shell for Screening, Week -2 and Week 0, use pages 2 shell for the remaining post-
baseline visits (Weeks 2, 6, 12, 18, 24, 36, 48, 60, 72, 84, 96, 97 and 1 week follow-up). 
 
 
 
  
 
Table 14.2-4.6 
Analysis of Change from Baseline in Systolic Blood Pressure (mmHg) 
(Per Protocol Analysis Set - LOCF) 
 
Programming Note: See Table 14.2-1.2 for layout. Use footnotes below. 
 
Note: This analysis uses the last observation carried forward (LOCF) method for missing post-baseline values as well 
as for values obtained after hyperglycemia rescue. * indicates statistical significance at 0.05 level. 
[1] Number of subjects with a value at baseline and at the specified visit. 
[2] The p-value is from a two-sided t-test for the difference in means of change from baseline.  
[3] Based on ANCOVA: Change = trt + baseline SBP + baseline HbA1c category + site + age category + gender + race. 
Source Data: Listing 16.2-7.4 
 
Programming Note: present for Weeks 2, 6, 12, 18, 24, 36, 48, 60, 72, 84, 96, 97 and 1 week follow-up.  
 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 47 of 106 
 
Table 14.2-5.1 
Analysis of Change from Baseline in Diastolic Blood Pressure (mmHg) at Week 24 
(Full Analysis Set - LOCF) 
 
Programming Note: See Table 14.2-1.1 for layout. Use footnotes below. 
 
Note: This analysis uses the last observation carried forward (LOCF) method for missing post-baseline values as well 
as for values obtained after hyperglycemia rescue. * indicates statistical significance at 0.05 level. 
[1] Number of subjects with a value at baseline and at the specified visit. 
[2] The p-value is from a two-sided t-test for the difference in means of change from baseline.  
[3] Based on ANCOVA: Change = trt + baseline DBP + baseline HbA1c category + site + age category + gender + race.  
 
Source Data: Listing 16.2-7.5 
 
 
 
 
 
 
Table 14.2-5.2 
Analysis of Change from Baseline in Diastolic Blood Pressure (mmHg) 
(Full Analysis Set - LOCF) 
 
Programming Note: See Table 14.2-1.2 for layout. Use footnotes below. 
 
Note: This analysis uses the last observation carried forward (LOCF) method for missing post-baseline values as well 
as for values obtained after hyperglycemia rescue. * indicates statistical significance at 0.05 level. 
[1] Number of subjects with a value at baseline and at the specified visit. 
[2] The p-value is from a two-sided t-test for the difference in means of change from baseline.  
[3] Based on ANCOVA: Change = trt + baseline DBP + baseline HbA1c category + site + age category + gender + race.  
 
Source Data: Listing 16.2-7.5 
 
Programming Note: present for Weeks 2, 6, 12, 18, 24, 36, 48, 60, 72, 84, 96, 97 and 1 week follow-up.  
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 48 of 106 
 
 
 
Table 14.2-5.3 
Analysis of Change from Baseline in Diastolic Blood Pressure (mmHg), Excluding Post-rescue Values 
(Full Analysis Set- OC) 
 
Programming Note: See Table 14.2-1.3 for layout. Use footnotes below. 
 
Note: This analysis uses observed values excluding those obtained after hyperglycemia rescue; no missing data 
imputation is performed. * indicates statistical significance at 0.05 level. 
[1] Number of subjects with a value at baseline and at the specified visit. 
[2] The p-value is from a two-sided t-test for the difference in means of change from baseline.  
[3] Based on ANCOVA: Change = trt + baseline DBP + baseline HbA1c category + site + age category + gender + race. 
 
Source Data: Listing 16.2-7.5 
Programming Note: present for Weeks 2, 6, 12, 18, 24, 36, 48, 60, 72, 84, 96, 97 and 1 week follow-up.  
 
 
 
 
 
 
 
 
 
Table 14.2-5.4 
Repeated Measures Analysis of Change from Baseline in Diastolic Blood Pressure (mmHg) at Week 96, Excluding Post-rescue 
Values 
(Full Analysis Set - OC) 
Programming Note: See Table 14.2-1.4 for layout. Use footnotes below. 
 
Note: This analysis uses all observed values excluding those obtained after hyperglycemia rescue; no missing data 
imputation is performed. * indicates statistical significance at 0.05 level. 
[1] Based on repeated measure model including treatment and visit as factors. 
Source Data: Listing 16.2-7.5 
 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 49 of 106 
 
 
Table 14.2-5.5 
Summary Statistics for Diastolic Blood Pressure (mmHg) 
(Full Analysis Set- OC) 
 
Programming Note: See Table 14.2-1.5 for layout. Use footnotes below. 
 
Note: This summary uses all observed values; no missing data imputation is performed. Baseline is defined as the last 
available assessment on or prior to the first dose of study drug. 
[1] For Screening and Week 0 the number of subjects with a value at the specified visit is displayed. For all post-
baseline visits, the number of subjects with a value at baseline and at the specified visit is displayed. 
Source Data: Listing 16.2-7.5 
 
Programming Note: Use page 1 shell for Screening, Week -2 and Week 0, use pages 2 shell for the remaining post-
baseline visits (Weeks 2, 6, 12, 18, 24, 36, 48, 60, 72, 84, 96, 97 and 1 week follow-up). 
 
 
  
 
Table 14.2-5.6 
Analysis of Change from Baseline in Diastolic Blood Pressure (mmHg) 
(Per Protocol Analysis Set - LOCF) 
 
Programming Note: See Table 14.2-1.2 for layout. Use footnotes below. 
 
Note: This analysis uses the last observation carried forward (LOCF) method for missing post-baseline values as well 
as for values obtained after hyperglycemia rescue. * indicates statistical significance at 0.05 level. 
[1] Number of subjects with a value at baseline and at the specified visit. 
[2] The p-value is from a two-sided t-test for the difference in means of change from baseline.  
[3] Based on ANCOVA: Change = trt + baseline DBP + baseline HbA1c category + site + age category + gender + race. 
Source Data: Listing 16.2-7.5 
 
Programming Note: present for Weeks 2, 6, 12, 18, 24, 36, 48, 60, 72, 84, 96, 97 and 1 week follow-up.  
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 50 of 106 
 
Table 14.2-6.1 
Analysis of Proportion of Subjects Achieving HbA1c <7%  
(Full Analysis Set- LOCF) 
 
 
 
 
 
 
EGT0001442 
Placebo 
 
 
(N=xxx) 
(N=xxx) 
 
 
 
 
Week 2 
 
 
 
  Number of Subjects [1] 
 
xxx 
xxx 
  Number (%) of Values Carried Forward 
 
xx (xx.x%) 
xx (xx.x%) 
  Subjects Achieving HbA1c <7% 
 
xx (xx.x%)
xx (xx.x%) 
  p-value [2] 
 
  0.xxxx 
 
 
 
 
 
Week 6 
 
 
 
  Number of Subjects [1] 
 
xxx 
xxx 
  Number (%) of Values Carried Forward 
 
xx (xx.x%) 
xx (xx.x%) 
  Subjects Achieving HbA1c <7% 
 
xx (xx.x%)
xx (xx.x%) 
  p-value [2] 
 
  0.xxxx 
 
 
 
 
 
 
 
 
 
Week 12 
 
 
 
  Number of Subjects [1] 
 
xxx 
xxx 
  Number (%) of Values Carried Forward 
 
xx (xx.x%) 
xx (xx.x%) 
  Subjects Achieving HbA1c <7% 
 
xx (xx.x%)
xx (xx.x%) 
  p-value [2] 
 
  0.xxxx 
 
 
 
 
 
 
 
Note: This analysis uses the last observation carried forward (LOCF) method for missing post-baseline values as well 
as for values obtained after hyperglycemia rescue. * indicates statistical significance at 0.05 level. 
[1] Number of subjects with a value at baseline and at the specified visit. 
[2] The p-value is from a chi-square test for the difference in proportions.  
 
Source Data: Listing 16.2-7.1 
 
 
Programming Note: present for Weeks 2, 6, 12, 18, 24, 36, 48, 60, 72, 84, 96, 97 and 1 week follow-up.  


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 51 of 106 
 
Table 14.2-6.2 
Analysis of Proportion of Subjects Achieving HbA1c <7%, Excluding Post-Rescue Values 
 (Full Analysis Set- OC) 
 
 
 
 
 
 
 
EGT0001442 
Placebo 
 
 
(N=xxx) 
(N=xxx) 
 
 
 
 
Week 2 
 
 
 
  Number of Subjects [1] 
 
xxx 
xxx 
  Subjects Achieving HbA1c <7% 
 
xx (xx.x%)
xx (xx.x%) 
  p-value [2] 
 
  0.xxxx 
 
 
 
 
 
Week 6 
 
 
 
  Number of Subjects [1] 
 
xxx 
xxx 
  Subjects Achieving HbA1c <7% 
 
xx (xx.x%)
xx (xx.x%) 
  p-value [2] 
 
  0.xxxx 
 
 
 
 
 
 
 
 
 
Week 12 
 
 
 
  Number of Subjects [1] 
 
xxx 
xxx 
  Subjects Achieving HbA1c <7% 
 
xx (xx.x%)
xx (xx.x%) 
  p-value [2] 
 
  0.xxxx 
 
 
 
 
 
 
 
Note: This analysis uses observed values excluding those obtained after hyperglycemia rescue; no missing data 
imputation is performed. * indicates statistical significance at 0.05 level. 
[1] Number of subjects with a value at baseline and at the specified visit. 
[2] The p-value is from a chi-square test for the difference in proportions.  
  
Source Data: Listing 16.2-7.1 
 
 
Programming Note: present for Weeks 2, 6, 12, 18, 24, 36, 48, 60, 72, 84, 96, 97 and 1 week follow-up.  


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 52 of 106 
 
Table 14.2-6.3 
Summary Statistics for Proportion of Subjects Achieving HbA1c <7% by Visit  
(Full Analysis Set- OC) 
 
 
 
 
 
 
 
EGT0001442 
Placebo 
 
 
(N=xxx) 
(N=xxx) 
 
 
 
 
Screening 
 
xxx (xx.x%)
xxx (xx.x%)
Week 0 
 
xxx (xx.x%)
xxx (xx.x%)
Week 2 
 
xxx (xx.x%)
xxx (xx.x%)
Week 6 
 
xxx (xx.x%)
xxx (xx.x%)
Week 12 
 
xxx (xx.x%)
xxx (xx.x%)
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: This analysis uses all observed values; no missing data imputation is performed.  
Source Data: Listing 16.2-7.1 
 
Programming Note: present for Screening, Weeks 0, 2, 6, 12, 18, 24, 36, 48, 60, 72, 84, 96, 97 and 1 week follow-up. 
 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 53 of 106 
 
  
Table 14.2-6.4 
Analysis of Proportion of Subjects Achieving HbA1c <7%  
(Per Protocol Analysis Set- LOCF) 
 
Programming Note: See Table 14.2-6.1 for layout. Use footnotes below. 
 
Note: This analysis uses the last observation carried forward (LOCF) method for missing post-baseline values as well 
as for values obtained after hyperglycemia rescue. * indicates statistical significance at 0.05 level. 
[1] Number of subjects with a value at baseline and at the specified visit. 
[2] The p-value is from a chi-square test for the difference in proportions.  
 
Source Data: Listing 16.2-7.1 
 
 
Programming Note: present for Weeks 2, 6, 12, 18, 24, 36, 48, 60, 72, 84, 96, 97 and 1 week follow-up.  


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 54 of 106 
 
Figure 14.3-2.1 
Line Graph of Mean (+/- SE) Results for Hematology 
(Safety Analysis Set) 
 
See Figure 14.2-1.1 for layout and general programming notes. Use footnotes below. 
 
Source Data: Table 14.3-2.1 
 
 
 
 
 
 
Figure 14.3-2.2 
Line Graph of Mean (+/- SE) Results for Chemistry 
(Safety Analysis Set) 
 
See Figure 14.2-1.1 for layout and general programming notes. Use footnotes below. 
 
Source Data: Table 14.3-2.2 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 55 of 106 
 
 
Figure 14.3-3.1 
Line Graph of Mean (+/- SE) Results for Vital Signs 
(Safety Analysis Set) 
 
See Figure 14.2-1.1 for layout and general programming notes. Use footnotes below. 
 
Source Data: Table 14.3-3.1 
 
 
 
 
 
 
 
 
Figure 14.3-4.1 
Line Graph of Mean (+/- SE) ECG Results 
(Safety Analysis Set) 
 
See Figure 14.2-1.1 for layout and general programming notes. Use footnotes below. 
 
Source Data: Table 14.3-4.1 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 56 of 106 
 
Table 14.3-1.1 
Overall Summary of Adverse Events  
(Safety Analysis Set) 
 
 
 
 
 
 
 
 
EGT0001442 
Placebo 
Total 
 
 
 
(N=xxx) 
(N=xxx) 
(N=xxx) 
 
 
 
Number of Subjects with at Least One AE
xx (xx.x%) 
xx (xx.x%)
xx (xx.x%)
 
 
 
 
 
 
Number of Subjects With at Least One TEAE
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
 
 
 
Number of Subjects With at Least One Treatment-  
 related TEAE 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
 
 
 
Number of Subjects With at Least One Serious TEAE
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
 
 
 
Number of Subjects With at Least One TEAE Leading to 
 Treatment Discontinuation 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
 
 
 
Number of Subjects With at Least One TEAE Leading to  
 Death 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
Note: For each level of summarization, a subject is counted once if the subject reported one or more events. 
Percentages are based on the number of subjects in each treatment group.  
 
Source Data: Listing 16.2-8.1 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 57 of 106 
 
Table 14.3-1.2 
Treatment Emergent Adverse Events  
(Safety Analysis Set) 
 
 
 
 
 
 
System Organ Class 
 
EGT0001442 
Placebo 
Total 
 
  Preferred Term 
 
(N=xxx) 
(N=xxx) 
(N=xxx) 
 
 
 
Total Number of Events 
 
xx 
xx 
xx 
 
 
 
 
 
 
 
Number of Subjects With at Least One Event 
 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
 
 
 
System Organ Class #1  
 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
  Preferred Term #1 
 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
  Preferred Term #2 
 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
  Preferred Term #3 
 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
  … 
 
 
 
 
 
 
 
 
 
 
 
System Organ Class #2 
 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
  Preferred Term #1 
 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
  Preferred Term #2 
 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
  Preferred Term #3 
 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
  … 
 
Note: For each level of summarization, a subject is counted once if the subject reported one or more events. 
Percentages are based on the number of subjects in each treatment group. The system organ class (SOC) and 
preferred term within the SOC are presented by decreasing frequency of incidence for all treatment groups 
combined. 
 
Source Data: Listing 16.2-8.1 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 58 of 106 
 
Table 14.3-1.3 
Treatment Emergent Adverse Events by Severity 
(Safety Analysis Set) 
System Organ Class 
 
 
 
  Preferred Term 
EGT0001442 
Placebo 
Total 
    Severity 
(N=xxx) 
(N=xxx) 
(N=xxx) 
 
 
 
 
Number of Subjects With at Least One Event 
xxx (xx.x%) 
xxx (xx.x%) 
xxx (xx.x%) 
    Mild 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
    Moderate 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
    Severe 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
 
 
 
 
System Organ Class #1 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
    Mild 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
    Moderate 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
    Severe 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
 
 
 
 
  Preferred Term #1 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
    Mild 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
    Moderate 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
    Severe 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
 
 
 
 
  Preferred Term #2 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
    Mild 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
    Moderate 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
    Severe 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
... 
 
 
 
 
Note: AEs with missing severity are considered severe in this summary. Percentages are based on the number of 
subjects in each treatment group. For each level of summarization, a subject is counted once according to the 
maximum severity experienced if the subject reported one or more events. The system organ class (SOC) and 
preferred term within the SOC are presented by decreasing frequency of incidence for all treatment groups 
combined. 
Source Data: Listing 16.2-8.1 
 
Programming Note: Only display severity level rows if there are subjects who have experienced that maximum severity 
level. Present SOC and PT within SOC by decreasing frequency of overall incidence. (Sort order should match 14.3-1.1) 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 59 of 106 
 
Table 14.3-1.4 
Treatment Emergent Adverse Events by Relationship to Study Drug 
(Safety Analysis Set) 
System Organ Class 
 
 
 
  Preferred Term 
EGT0001442 
Placebo 
Total 
    Relationship to Study Drug 
(N=xxx) 
(N=xxx) 
(N=xxx) 
 
 
 
 
Number of Subjects With at Least One Event 
xxx (xx.x%) 
xxx (xx.x%) 
xxx (xx.x%) 
    Related 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
    Not Related 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
 
 
 
 
System Organ Class #1 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
    Related 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
    Not Related 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
 
 
 
 
  Preferred Term #1 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
    Related 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
    Not Related 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
 
 
 
 
  Preferred Term #2 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
    Related 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
    Not Related 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
... 
 
 
 
 
Note: Related includes the relationship judged by investigators as possible, probable, and definite. Not related 
includes not related and unlikely. AEs with missing relationship to study drug are considered related in this 
summary. For each level of summarization, a subject is counted once according to the greatest relationship to 
study drug if the subject reported one or more events. Percentages are based on the number of subjects in each 
treatment group. The system organ class (SOC) and preferred term within the SOC are presented by decreasing 
frequency of incidence for all treatment groups combined. 
Source Data: Listing 16.2-8.1 
 
Programming Note: Only display relationship rows if there are subjects who have experienced that maximum intensity 
level. Present SOC and PT within SOC by decreasing frequency of overall incidence. (Sort order should match 14.3-1.1) 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 60 of 106 
 
 
Table 14.3-1.5 
Most Common Treatment Emergent Adverse Events  
(Safety Analysis Set) 
 
See Table 14.3-1.1 for layout.  Use footnotes below. 
 
Note: This summary presents AEs that occur in >5% of the subjects in either of the treatment groups. For each level 
of summarization, a subject is counted once if the subject reported one or more events. Percentages are based on 
the number of subjects in each treatment group. The system organ class (SOC) and preferred term within the SOC 
are presented by decreasing frequency of incidence for all treatment groups combined. 
Source Data: Listing 16.2-8.1 
 
 
 
 
 
 
Table 14.3-1.6 
Serious Treatment Emergent Adverse Events  
(Safety Analysis Set) 
 
See Table 14.3-1.1 for layout.  Use footnotes below. 
 
Note: For each level of summarization, a subject is counted once if the subject reported one or more events. 
Percentages are based on the number of subjects in each treatment group. The system organ class (SOC) and 
preferred term within the SOC are presented by decreasing frequency of incidence for all treatment groups 
combined. 
 
Source Data: Listing 16.2-8.1 
 
 
 
 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 61 of 106 
 
Table 14.3-1.7 
Treatment Emergent Adverse Events Leading to Treatment Discontinuation  
(Safety Analysis Set) 
 
See Table 14.3-1.1 for layout.  Use footnotes below. 
 
Note: For each level of summarization, a subject is counted once if the subject reported one or more events. 
Percentages are based on the number of subjects in each treatment group. The system organ class (SOC) and 
preferred term within the SOC are presented by decreasing frequency of incidence for all treatment groups 
combined. 
Source Data: Listing 16.2-8.1 
 
 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 62 of 106 
 
Table 14.3-1.8 
Treatment Emergent Hypoglycemic Events by Severity and Intervention  
(Safety Analysis Set)  
 
 
 
 
 
 
 
 
EGT0001442 
Placebo 
Total 
 
 
 
(N=xxx) 
(N=xxx) 
(N=xxx) 
 
 
 
Total Number of Events 
 
xx 
xx 
xx 
 
 
 
 
 
 
 
Number of Subjects With at Least One Event 
 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
 
 
 
Severity 
 
 
 
 
 
  Severe 
 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
  Documented Symptomatic 
 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
  Asymptomatic 
 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
  Probable Symptomatic 
 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
  Relative 
 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
  Not Applicable 
 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
  Missing 
 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
 
 
 
 
 
Intervention [1] 
 
 
 
 
 
  Extensive 
 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
  Immediate 
 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
  Minor 
 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
  None 
 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
  Missing 
 
xx (xx.x%) 
xx (xx.x%) 
xx (xx.x%) 
 
 
Note: For each level of summarization, a subject is counted in all severity or intervention categories if the subject 
reported one or more events. Percentages are based on the number of subjects in each treatment group.  
[1] Extensive = glucose injection/infusion/glucagon; Immediate = glucose drinks or supplements; Minor = administered 
sugary drinks or sweets; None = no intervention. 
 
Source Data: Listing 16.2-8.1 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 63 of 106 
 
  
Table 14.3-2.1 
Change from Baseline in Hematology 
(Safety Analysis Set) 
 
 
EGT0001442 
 
Placebo 
 
(N=xxx) 
 
(N=xxx) 
 
 
Change from 
 
 
Change from 
 
Result 
Baseline 
 
Result 
Baseline 
 
 
 
 
 
 
Lab Test #1 (unit) 
 
 
 
 
 
 
 
 
 
 
 
  Baseline  
 
 
 
 
 
    n 
xxx 
 
 
xxx 
 
    Mean (SD) 
xx.x (xx.xx) 
 
 
xx.x (xx.xx) 
 
    Median 
xx.x 
 
 
xx.x 
 
    Min, Max 
xx, xx 
 
 
xx, xx 
 
 
 
 
 
 
 
  Week 2 
 
 
 
 
 
    n 
xxx 
xxx 
 
xxx 
xxx 
    Mean (SD) 
xx.x (xx.xx) 
xx.x (xx.xx) 
 
xx.x (xx.xx) 
xx.x (xx.xx) 
    Median 
xx.x 
xx.x 
 
xx.x 
xx.x 
    Min, Max 
xx, xx 
xx, xx 
 
xx, xx 
xx, xx 
 
 
 
 
 
 
  Week 6 
 
 
 
 
 
    … 
 
 
 
 
 
 
Note: Baseline is defined as the last available assessment on or prior to the first dose of study medication. 
Source Data: Listing 16.2-9.1 
 
Programming note: use timepoints of Baseline, Week 2, 6, 12, 18, 24, 36, 48, 60, 72, 84, 96, 97 and 1 week follow-up.   


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 64 of 106 
 
Table 14.3-2.2 
Change from Baseline in Chemistry 
(Safety Analysis Set) 
 
See table 14.3-2.1 for layout. Use footnote below.  
 
Note: Baseline is defined as the last available assessment on or prior to the first dose of study medication.  
Source Data: Listing 16.2-9.2 
 
Programming note: use timepoints of Baseline, Week 2, 6, 12, 18, 24, 36, 48, 60, 72, 84, 96, 97 and 1 week follow-up.   
 
  


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 65 of 106 
 
Table 14.3-2.3 
Urinalysis 
(Safety Analysis Set) 
 
 
 
 
 
 
 
EGT0001442 
Placebo 
 
 
(N=xxx) 
(N=xxx) 
 
 
 
 
Albumin (unit) 
 
 
 
  Screening 
 
 
 
    n 
 
xxx 
xxx 
    Mean (SD) 
 
xx.x (xx.xx) 
xx.x (xx.xx) 
    Median 
 
xx.x 
xx.x 
    Min, Max 
 
xx, xx 
xx, xx 
 
 
 
 
  Week 0 
 
 
 
  … 
 
 
 
 
 
 
 
Urinary Protein 
 
 
 
  Screening 
 
 
 
    n 
 
xxx (xx.x%) 
xxx (xx.x%) 
    4 
 
xxx (xx.x%) 
xxx (xx.x%) 
    5 
 
xxx (xx.x%) 
xxx (xx.x%) 
    …. 
 
 
 
 
 
 
 
 
Source Data: Listing 16.2-9.3 
 
Programming note: use timepoints of Screening, Week 0, 2, 6, 12, 18, 24, 36, 48, 60, 72, 84, 96, 97 and 1 week follow-
up.   


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 66 of 106 
 
Table 14.3-2.4 
Shift in Hematology 
(Safety Analysis Set) 
 
 
EGT0001442 
 
Placebo 
 
(N=xxx) 
 
(N=xxx) 
 
 
Baseline  
 
 
 
Baseline  
 
 
Low 
Normal 
High 
 
Low 
Normal 
High 
 
 
 
 
 
 
 
 
Lab Test #1 (unit) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  Week 2  
 
n = xxx
 
 
 
n = xxx
 
    Low  
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
    Normal  
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
    High  
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
 
 
 
 
 
 
 
 
  Week 6 
 
n = xxx
 
 
 
n = xxx
 
    Low  
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
    Normal  
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
    High  
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
 
xxx (xx.x%)
xxx (xx.x%)
xxx (xx.x%)
 
 
 
 
 
 
 
 
 
Note: Baseline is defined as the last available assessment on or prior to the first dose of study medication. The 
number of subjects with a value at baseline and at the specified visit is displayed.  
Source Data: Listing 16.2-9.1 
 
Programming note: use all available timepoints per data following order such as Baseline, Week 2, 6, 12, 18, 24, 36, 
48, 60, 72, 84, 96, 97 and 1 week follow-up.   


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 67 of 106 
 
Table 14.3-2.5 
Shift in Chemistry 
(Safety Analysis Set) 
 
See table 14.3-2.4 for layout. Use footnotes below.  
 
Note: Baseline is defined as the last available assessment on or prior to the first dose of study medication. The 
number of subjects with a value at baseline and at the specified visit is displayed.  
Source Data: Listing 16.2-9.2 
 
Programming note: use all available timepoints per data following order such as Baseline, Week 2, 6, 12, 18, 24, 36, 
48, 60, 72, 84, 96, 97 and 1 week follow-up.   
 
 
 
 
 
Table 14.3-2.6 
Shift in Urinalysis 
(Safety Analysis Set) 
 
See table 14.3-2.4 for layout. Use footnotes below.  
 
Note: Baseline is defined as the last available assessment on or prior to the first dose of study medication. The 
number of subjects with a value at baseline and at the specified visit is displayed.  
Source Data: Listing 16.2-9.3 
 
Programming note: use all available timepoints per data following order such as Baseline, Week 2, 6, 12, 18, 24, 36, 
48, 60, 72, 84, 96, 97 and 1 week follow-up.   
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 68 of 106 
 
Table 14.3-3.1 
Change from Baseline in Vital Signs 
(Safety Analysis Set) 
 
See table 14.3-2.1 for layout. Use footnote below.  
 
Note: Baseline is defined as the last available assessment on or prior to the first dose of study medication.  
Source Data: Listing 16.2-10.1 
 
Programming note: use timepoints of Baseline, Week 2, 6, 12, 18, 24, 36, 48, 60, 72, 84, 96, 97 and 1 week follow-up.   
Use the following parameters: Pulse, Temprature and Respiration Rate (3 parameters).  
 
 
 
 
 
 
 
Table 14.3-4.1 
Change from Baseline in ECG Values 
(Safety Analysis Set) 
 
 
See table 14.3-2.1 for layout. Use footnote below.  
 
Note: Baseline is defined as the last available assessment on or prior to the first dose of study medication.  
Source Data: Listing 16.2-10.2 
 
Programming note: use timepoints of Baseline, Week 24, 60, 96, 97 and 1 week follow-up.   
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
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Final – 22November2011                         CONFIDENTIAL                                     Page 69 of 106 
 
Table 14.3-4.2 
Overall ECG Interpretations and Abnormal Findings 
(Safety Analysis Set) 
 
 
 
 
Visit 
 
EGT0001442 
Placebo 
  Assessment 
 
(N=xxx) 
(N=xxx) 
 
 
 
 
Screening 
 
 
 
  n 
 
xxx
xxx
  Normal 
 
xxx (xx.x%)
xxx (xx.x%)
  Abormal 
 
xxx (xx.x%)
xxx (xx.x%)
    Clinically Significant 
 
xxx (xx.x%) 
xxx (xx.x%) 
    Not Clinically Significant 
 
xxx (xx.x%) 
xxx (xx.x%) 
  Missing 
 
xxx (xx.x%)
xxx (xx.x%)
 
 
 
 
Week 0 
 
 
 
  n 
 
xxx
xxx
  Normal 
 
xxx (xx.x%)
xxx (xx.x%)
  Abormal 
 
xxx (xx.x%)
xxx (xx.x%)
    Clinically Significant 
 
xxx (xx.x%) 
xxx (xx.x%) 
    Not Clinically Significant 
 
xxx (xx.x%) 
xxx (xx.x%) 
  Missing 
 
xxx (xx.x%)
xxx (xx.x%)
 
 
 
 
 
Source Data: Listing 16.2-10.3 
 
Programming note: use all available timepoints per data following order such as Screening, Week 0, 24, 60, 96, 97 and 1 
week follow-up.   
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 70 of 106 
 
Table 14.3-4.3 
ECG Results by Category and Visit 
(Safety Analysis Set) 
 
 
 
 
Parameter 
EGT0001442 
Placebo 
 
  Visit 
(N=xxx) 
(N=xxx) 
 
 
 
 
 
QT Range (msec) 
 
 
 
  Week -5 
 
 
 
    n 
xxx
xxx
 
    < 450 
xxx (xx.x%) 
xxx (xx.x%) 
 
    >= 450 - < 480 
xxx (xx.x%)
xxx (xx.x%)
 
    >= 480 - < 500 
xxx (xx.x%)
xxx (xx.x%)
 
    >= 500 
xxx (xx.x%)
xxx (xx.x%)
 
 
 
 
 
  Week 0  
 
 
 
    n 
xxx
xxx
 
    < 450 
xxx (xx.x%)
xxx (xx.x%)
 
    >= 450 - < 480 
xxx (xx.x%)
xxx (xx.x%)
 
    >= 480 - < 500 
xxx (xx.x%)
xxx (xx.x%)
 
    >= 500 
xxx (xx.x%)
xxx (xx.x%)
 
 
 
 
 
QTcB Range (msec) 
 
 
 
  Week -5 
 
 
 
    n 
xxx
xxx
 
    < 450 
xxx (xx.x%) 
xxx (xx.x%) 
 
    >= 450 - < 480 
xxx (xx.x%)
xxx (xx.x%)
 
    >= 480 - < 500 
xxx (xx.x%)
xxx (xx.x%)
 
    >= 500 
xxx (xx.x%)
xxx (xx.x%)
 
 
 
 
 
QTcF Range (msec) 
 
 
 
  Week -5 
 
 
 
    n 
xxx
xxx
 
    < 450 
xxx (xx.x%) 
xxx (xx.x%) 
 
    >= 450 - < 480 
xxx (xx.x%)
xxx (xx.x%)
 
    >= 480 - < 500 
xxx (xx.x%)
xxx (xx.x%)
 
    >= 500 
xxx (xx.x%)
xxx (xx.x%)
 
 
 
 
 
 
Source Data: Listing 16.2-10.2 
Programming Note: use all available timepoints per data following order such as Week -5, 0, 24, 60, 96, 97 and 1 week 
follow-up.   


Theracos, Inc.  
Protocol: THR-1442-C-418 
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Final – 22November2011                         CONFIDENTIAL                                     Page 71 of 106 
 
Table 14.3-5.1 
Physical Examination 
(Safety Analysis Set) 
 
 
 
 
Visit 
 
EGT0001442 
Placebo 
  Body System 
 
(N=xxx) 
(N=xxx) 
 
 
 
 
Screening 
 
 
 
  Body System #1  
 
 
 
    n 
 
xxx
xxx
    Normal 
 
xxx (xx.x%) 
xxx (xx.x%) 
    Abnormal 
 
xxx (xx.x%)
xxx (xx.x%)
    Not Done 
 
xxx (xx.x%)
xxx (xx.x%)
 
 
 
 
  Body System #2  
 
 
 
    n 
 
xxx
xxx
    Normal 
 
xxx (xx.x%) 
xxx (xx.x%) 
    Abnormal 
 
xxx (xx.x%)
xxx (xx.x%)
    Not Done 
 
xxx (xx.x%)
xxx (xx.x%)
… 
 
 
 
  Other 
 
 
 
    n 
 
xxx
xxx
    Normal 
 
xxx (xx.x%) 
xxx (xx.x%) 
    Abnormal 
 
xxx (xx.x%)
xxx (xx.x%)
 
 
 
 
Week 0 
 
 
 
 
 
 
 
 
 
 
 
 
Source Data: Listing 16.2-10.4 
 
Programming note: use timepoints of Screening, Week 0, 2, 6, 12, 18, 24, 36, 48, 60, 72, 84, 96, 97 and 1 week follow-
up. Complete physical exam is done at Screening, Week 12, 24, 48, 72, 96, 97 and 1 week follow-up. Brief physical exam 
is done at all other visits. Use all available timepoints per data following order above.    
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
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<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 72 of 106 
 
Table 14.3-6.1 
NMP22 Test Results 
(Safety Analysis Set) 
 
 
 
 
 
 
EGT0001442 
Placebo 
Visit   
 
(N=xxx) 
(N=xxx) 
 
 
 
 
Screening 
 
 
 
  n 
 
xxx
xxx
  Negative 
 
xxx (xx.x%) 
xxx (xx.x%) 
  Positive 
 
xxx (xx.x%)
xxx (xx.x%)
 
 
 
 
Week 0 
 
 
 
 
 
 
 
 
 
 
 
 
Source Data: Listing 16.2-10.6 
 
Programming note: use all available timepoints per data.  
 
 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
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<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 73 of 106 
 
Listing 14.3-1.1 
Deaths  
(Safety Analysis Set) 
Treatment: EGT0001442 
Subject ID/ 
Age/ Sex/ Race [1]  
Preferred Term/ 
 Vertatim Text 
Treatment 
Emergent 
Flag 
Onset Date/ 
Date of 
 Resolution 
Severity/ 
Outcome 
 
Serious/ 
Withdrawn? 
Action Taken/ 
Related to 
 Study Drug? 
 
  
 
 
 
 
 
 
XXXXXX/  
 XX/ X/ X 
 DROWNING/ 
 ACCIDENTAL 
   DROWNING 
Y 
2009-07-25/ 
2009-07-25 
SEVERE/ 
DEATH DUE TO AE 
YES/ 
YES 
 
STUDY DRUG 
DISCONTINURED/ 
NO 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
 
 
 
 
Programming Note: Present EGT0001442, and then Placebo treatment groups with each treatment group starting on a new 
page. 
  
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
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<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 74 of 106 
 
 
Listing 14.3-2.1 
Serious Non-fatal Adverse Events  
(Safety Analysis Set) 
See Listing 14.3-1.1 for layout. Use footnotes below.   
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
 
 
 
 
 
 
 
 
 
Listing 14.3-3.1 
Adverse Events Leading to Treatment Discontinuation 
(Safety Analysis Set) 
See Listing 14.3-1.1 for layout. Use footnotes below.   
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 75 of 106 
 
 
 
 
Listing 14.3-4.1 
Cardiovascular Adverse Events 
(Safety Analysis Set) 
See Listing 14.3-1.1 for layout. Use footnotes below.   
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
 
 
 
 
 
 
 
Listing 14.3-5.1 
Hypoglycemic Adverse Event 
(Safety Analysis Set) 
See Listing 14.3-1.1 for layout. Use footnotes below.   
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
 
 
 
 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 76 of 106 
 
Listing 14.3-6.1 
Severe Hypoglycemic Adverse Events 
(Safety Analysis Set) 
See Listing 14.3-1.1 for layout. Use footnotes below.   
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
 
 
 
 
 
 
 
 
 
 
Listing 14.3-7.1 
Renal and Urinary Adverse Events 
(Safety Analysis Set) 
See Listing 14.3-1.1 for layout. Use footnotes below.   
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
 
 
 
 
 
 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 77 of 106 
 
Listing 14.3-8.1 
Genitourinary Adverse Events 
(Safety Analysis Set) 
See Listing 14.3-1.1 for layout. Use footnotes below.   
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
 
 
 
 
 
 
 
 
Listing 14.3-9.1 
Liver Adverse Events 
(Safety Analysis Set) 
See Listing 14.3-1.1 for layout. Use footnotes below.   
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 78 of 106 
 
 
Listing 14.3–10.1 
Cancer Adverse Events 
(Safety Analysis Set) 
See Listing 14.3-1.1 for layout. Use footnotes below.   
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
 
 
 
 
 
 
Listing 14.3–11.1 
Bone Fracture Adverse Events 
(Safety Analysis Set) 
See Listing 14.3-1.1 for layout. Use footnotes below.   
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
 
 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 79 of 106 
 
Listing 14.3-12.1 
Clinically Significant Abnormal Hematology Laboratory Evaluations  
(Safety Analysis Set) 
Treatment: EGT0001442 
Subject ID/ 
Age/ Sex/ Race 
[1] 
Visit 
Assessment 
Date 
Study 
Day 
Analysis 
Visit 
Lab Test 
 
 
Value 
(Unit) 
Normal Range 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
XXXXXX/  
 XX/ X/ X 
xxxx 
xxx 
xxx 
xxx 
xxx 
xxx (xx) 
xxx - xxx 
 
 
 
xxxx 
xxx 
xxx 
xxx 
xxx 
xxx (xx) 
xxx - xxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other.  
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 80 of 106 
 
Listing 14.3-12.2 
Clinically Significant Abnormal Chemistry Laboratory Evaluations  
(Safety Analysis Set) 
 
See listing 14.3-12.1 for layout. Use the following footnote. 
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
 
 
 
 
Listing 14.3-12.3 
Clinically Significant Abnormal Urinalysis Laboratory Evaluations  
(Safety Analysis Set) 
 
  
See listing 14.3-12.1 for layout. Use the following footnote. 
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 81 of 106 
 
Listing 16.1-1.1 
Randomized Allocation to Treatment 
(All Randomized Subjects) 
 
Subject ID/ 
Age/ Sex/ Race [1] 
 
Randomization Number 
Treatment Number 
Treatment Description 
 
 
 
 
 
XXXXXX/  
 XX/ X/ X 
 
xxxxx  
xxx 
xxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 [1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
 
 
 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 82 of 106 
 
Listing 16.2-1.1 
Subject Disposition 
(All Randomized Subjects) 
Treatment: EGT0001442 
Subject ID/ 
Age/ Sex/ Race [1] 
 
Informed 
ConsentDate/ 
Randomization 
Date 
Date of 
First Dose/ 
Last Dose 
Date of Last 
Visit  
Study Completion/ 
Reason (if no) 
Unblinded during 
the Study/Date & 
Reason (if yes) 
 
 
 
 
 
 
 
 
 
 
XXXXXX/  
 XX/ X/ X 
 
xxxxx/ 
 xxxxx 
xxxx/ 
 xxxx 
xxxx 
xxx 
xxxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
 
 
 
 
 
 
  
 
 
 
  
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 83 of 106 
 
Listing 16.2-2.1 
Inclusion/Exclusion Criteria Not Met  
(All Run-in Failures) 
 
Subject ID/ 
Age/ Sex/ Race [1] 
 
Protocol 
Version Date 
Criterion Number 
Criterion Description 
 
 
 
 
 
XXXXXX/  
 XX/ X/ X 
 
yyyy-mm-dd 
IN01 
xxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 [1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
 
 
 
 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 84 of 106 
 
Listing 16.2-2.2 
Protocol Deviations  
(All Randomized Subjects) 
Treatment: EGT0001442 
Subject ID/ 
Age/ Sex/ Race [1] 
 
Visit/ 
Visit Date 
Protocol Deviation 
 
  
 
XXXXXX/  
 XX/ X/ X 
 Week 12/ 
xxxxxxxx 
 
 yyyy-mm-dd 
 
 
  
 
 
  
 
 
 [1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
 
 
 
 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 85 of 106 
 
Listing 16.2-2.3 
Major Protocol Deviations  
(All Randomized Subjects) 
Treatment: EGT0001442 
Subject ID/ 
Age/ Sex/ Race [1] 
 
Major Protocol Deviation 
 
 
 
XXXXXX/  
 XX/ X/ X 
 
xxxxxxxxxxxxxxxxxxxxxx 
 
 
 
 
 
 
 
 
 
 
 [1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
 
 
 
 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 86 of 106 
 
Listing 16.2-3.1 
Analysis Populations  
(All Randomized Subjects) 
Treatment: EGT0001442 
Subject ID/ 
Age/ Sex/ Race [1] 
 
Randomized 
Full Analysis Set 
Safety Analysis Set 
Per Protocol Analysis Set 
 
 
 
 
 
 
XXXXXX/  
 XX/ X/ X 
 
Yes 
Yes 
Yes 
No 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
 
 
 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 87 of 106 
 
Listing 16.2-4.1 
Demographic Characteristics  
(Safety Analysis Set) 
Treatment: EGT0001442 
Subject ID/ 
Age/ Sex/ 
Race [1] 
Country/
Site 
Date of 
Birth 
Race 
Ethnicity 
Child 
Bearing 
Potential 
Height 
(cm) 
Body Mass Index 
(BMI) (kg/m2) 
Baseline HbA1c 
Category 
 
 
 
 
 
 
 
 
 
XXXXXX/  
 XX/ X/ X 
xxx 
xxx 
OTHER: xxx 
xxx 
xxx 
xxx 
xxx 
xxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 88 of 106 
 
Listing 16.2-4.2 
Substance Use  
(Safety Analysis Set) 
Treatment: EGT0001442 
Subject ID/ 
Age/ Sex/ Race [1] 
 
Screening Visit 
Date 
Consume Alcohol?/ 
If Yes, Units per 
Week 
Tobacco Use?/If 
Available, Last 
Tobacco Use Date 
Drug Dependecy?/ 
If Yes, Detail/ 
Last Drug Use Date 
 
 
 
 
 
 
XXXXXX/  
 XX/ X/ X 
 
xxxxx 
xxxxx 
xxxx/xxx 
xxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 [1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 89 of 106 
 
Listing 16.2-4.3 
Drug Screen Results  
(Safety Analysis Set) 
Treatment: EGT0001442 
Subject ID/ 
Age/ Sex/ Race [1] 
 
Assessment Date 
Parameter 
Result (unit) 
 
 
 
 
 
XXXXXX/  
 XX/ X/ X 
 
xxxxx 
HBsAG 
Negative 
 
 
 
HBcAG 
Negative 
 
 
 
HCV Ab 
xxx 
 
 
 
Amphetamines 
xxx 
 
 
 
Barbiturates 
xxx 
 
 
 
Cocaine 
xxx 
 
 
 
Metabolites 
xxx 
 
 
 
Opiates 
xxx 
 
 
 
Benzodiazepines 
xxx 
 
 
 
Cannabinoids 
xxx 
 
 
 
 
 
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian 
or Other Pacific Islander, O=Other. 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 90 of 106 
 
Listing 16.2-4.4 
Medical History  
(Safety Analysis Set) 
Treatment: EGT0001442 
Subject ID/ 
Age/ Sex/ Race [1] 
 
Condition 
 
Start Date 
End Date 
 
 
 
 
 
 
 
XXXXXX/  
 XX/ X/ X 
 
xxxxx 
 
 
xxxxx 
xxxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 [1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
 
 
 
 
  
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 91 of 106 
 
Listing 16.2-4.5 
Diabetes Medical History  
(Safety Analysis Set) 
Treatment: EGT0001442 
Subject ID/ 
Age/ Sex/ Race [1] 
 
Condition 
Assessment 
Result 
 
 
 
 
 
 
 
 
XXXXXX/  
 XX/ X/ X 
 
Blindness 
Eye Affected 
 
Left 
 
 
 
 
Date of Onset 
 
xxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 [1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
 
 
 
  
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 92 of 106 
 
  
Listing 16.2-5.1 
Prior and Concomitant Medications  
(Safety Analysis Set) 
Treatment: EGT0001442 
Subject ID/ 
Age/ Sex/ Race 
[1] 
Preferred Term/ 
 Vertatim Text 
Med. Type 
[2] 
Dose/ 
Units/ 
Freq/ 
Route 
Date 
 Started/ 
Date 
 Stopped 
Indication 
Anti-
diabetic 
Med? 
Rescue 
Med? 
Used to 
Treat an AE?
 
 
 
 
 
 
 
 
 
 
XXXXXX/  
 XX/ X/ X 
ATENOLOL/ 
 ATENOLOL 
Prior, Con 50/ 
MILLIGRAM/ 
ONCE DAILY/ 
ORAL 
2007/xxxx 
xxxxxxx 
Yes 
Yes 
Yes 
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
[2] Prior=Prior medication, Con=Concomitant medication. 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 93 of 106 
 
Listing 16.2-6.1 
Study Drug Administration 
(Safety Analysis Set) 
Treatment: EGT0001442 
Subject ID/ 
Age/ Sex/ Race [1] 
 
Visit 
Dispensed?/If No, 
Reason 
Dispense 
Date 
# of 
Capsules 
Dispensed 
Kit(s) 
Dispensed 
# of 
Capsules 
Returned 
Kit(s) 
Returned 
 
 
 
 
 
 
 
 
 
 
XXXXXX/  
 XX/ X/ X 
 
xxx 
xxx 
xxx 
xxx 
xxx 
xxx 
xxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
 
 
  
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 94 of 106 
 
  
Listing 16.2-7.1 
HbA1c (%) 
(Full Analysis Set) 
Treatment: EGT0001442 
Subject ID/ 
Age/ Sex/ Race [1] 
Visit 
Assessment 
Date 
Study Day 
Analysis 
Visit 
Post-
rescue? 
Value 
Baseline 
[2] 
Change from 
Baseline 
 
 
 
 
 
 
 
 
 
 
 
XXXXXX/  
 XX/ X/ X 
xxx 
xxx 
xxx 
xxx 
No 
xxx 
xxx 
xxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other.  
[2] Baseline is defined as the last available assessment on or prior to the first dose of study medication. 
 
 
 
  
 
 
  
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 95 of 106 
 
Listing 16.2-7.2 
Fasting Plasma Glucose (mmol/L) 
(Full Analysis Set) 
 
 
See Listing 16.2-7.1 for layout. Use footnotes below.   
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other.  
[2] Baseline is defined as the last available assessment on or prior to the first dose of study medication. 
 
 
 
 
 
  
 
Listing 16.2-7.3 
Weight(kg) 
(Full Analysis Set) 
See Listing 16.2-7.1 for layout. Use footnotes below.   
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other.  
[2] Baseline is defined as the last available assessment on or prior to the first dose of study medication. 
 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 96 of 106 
 
Listing 16.2-7.4 
Systolic Blood Pressure (mmHg) 
(Full Analysis Set) 
 
 
 Treatment: EGT0001442 
Subject ID/ 
Age/ Sex/ 
Race [1] 
Visit 
Assessment 
Date 
Study Day 
Analysis 
Visit 
Post-
rescue? 
1st/ 
2nd 
Measure 
Mean of 2 
Measures 
Baseline 
[2] 
Change 
from 
Baseline 
 
 
 
 
 
 
 
 
 
 
 
 
XXXXXX/  
 XX/ X/ X 
xxx 
xxx 
xxx 
xxx 
No 
xxxx 
xxx 
xxx 
xxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other.  
[2] Baseline is defined as the last available assessment on or prior to the first dose of study medication. 
 
 
 
 
 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 97 of 106 
 
  
Listing 16.2-7.5 
Diastolic Blood Pressure (mmHg) 
(Full Analysis Set) 
See Listing 16.2-7.4 for layout. Use footnotes below.   
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other.  
[2] Baseline is defined as the last available assessment on or prior to the first dose of study medication. 
 
 
 
  
 
 
 Listing 16.2-8.1 
Adverse Events  
(Safety Analysis Set) 
See Listing 14.3-1.1 for layout.   
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
 
 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 98 of 106 
 
Listing 16.2-8.2 
Hypoglycemic Events Supplemental Information  
(Safety Analysis Set) 
 
Treatment: EGT0001442 
Subject ID/ 
Age/ Sex/ Race [1]  
Preferred Term/ 
 Vertatim Text 
Treatment 
Emergent 
Flag 
Onset Date/ 
Date of 
 Resolution 
ADA Severity 
Intervention  
 
  
 
 
 
 
 
 
XXXXXX/  
 XX/ X/ X 
 DROWNING/ 
 ACCIDENTAL 
   DROWNING 
Y 
2009-07-25/ 
2009-07-25 
xxxxxxx 
xxxxxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 99 of 106 
 
Listing 16.2-9.1 
Hematology Laboratory Evaluations  
(Safety Analysis Set) 
Treatment: EGT0001442 
Subject ID/ 
Age/ Sex/ Race 
[1] 
Visit 
Assessment 
Date 
Study 
Day 
Analysis 
Visit 
Lab Test 
 
Flag [2] 
Value 
(Unit) 
Normal Range 
NR 
CS 
 
 
 
 
 
 
 
 
 
 
 
 
XXXXXX/  
 XX/ X/ X 
xxxx 
xxx 
xxx 
xxx 
xxx 
xxx (xx) 
xxx - xxx 
xx 
xx 
 
xxxx 
xxx 
xxx 
xxx 
xxx 
xxx (xx) 
xxx - xxx 
xx 
xx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
[2] NR for Normal Range flag, CS for Clinical Significance flag. H=Above range, L=Below range. CS=Clinically 
significant, NCS=Not clinically significant.  
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 100 of 106 
 
Listing 16.2-9.2 
Chemistry Laboratory Evaluations  
(Safety Analysis Set) 
 
See listing 16.2-9.1 for layout. Use the following footnote. 
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
[2] NR for Normal Range flag, CS for Clinical Significance flag. H=Above range, L=Below range. CS=Clinically 
significant, NCS=Not clinically significant. 
 
 
 
 
Listing 16.2-9.3 
Urinalysis Laboratory Evaluations  
(Safety Analysis Set) 
 
  
See listing 16.2-9.1 for layout. Use the following footnote. 
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
[2] NR for Normal Range flag, CS for Clinical Significance flag. H=Above range, L=Below range. CS=Clinically 
significant, NCS=Not clinically significant. 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 101 of 106 
 
Listing 16.2-10.1 
Vital Signs 
(Safety Analysis Set) 
Treatment: EGT0001442 
Subject ID/ 
Age/ Sex/ Race [1] 
Visit 
Assessment Date 
Study Day 
Analysis Visit 
Parameter 
Result (Unit) 
 
 
 
 
 
 
 
 
 
 
XXXXXX/  
 XX/ X/ X 
xxx 
xxxx 
xx 
xxx 
xx 
xx (xx) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
 
 
Programming note: use the following parameters: Pulse, Temprature and Respiration Rate (3 parameters).  


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 102 of 106 
 
Listing 16.2-10.2 
ECG Values 
(Safety Analysis Set) 
 
See listing 16.2-10.1 for layout. Use the following footnote. 
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 103 of 106 
 
Listing 16.2-10.3 
Overall ECG Interpretations and Abnormal Findings 
(Safety Analysis Set) 
Treatment: EGT0001442 
Subject ID/ 
Age/ Sex/ Race [1] 
Visit 
Assessment 
Date 
Study Day 
Analysis 
Visit 
Overall 
Interpretation 
Abnormal 
Findings 
CS Flag [2] 
 
 
 
 
 
 
 
 
 
XXXXXX/  
 XX/ X/ X 
xxx 
xxxx 
xx 
xxx 
Abnormal 
xxx 
xxx 
 
 
xxx 
xxxx 
xx 
xxx 
xxx 
xxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
[2] CS flag for Clinical Significance flag. CS=Clinically significant, NCS=Not clinically significant. 
 
 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 104 of 106 
 
Listing 16.2-10.4 
Physical Examinations 
(Safety Analysis Set) 
Treatment: EGT0001442 
Subject ID/ 
Age/ Sex/ Race [1] 
Visit 
Assessment 
Date 
Study Day 
Analysis 
Visit 
Assessment 
Status 
Specify if 
Abnormality  
 
 
 
 
 
 
 
 
 
XXXXXX/  
 XX/ X/ X 
xxx 
xxxx 
xx 
xxx 
xxx 
Normal 
 
 
 
xxx 
xxxx 
xx 
xxx 
xxx 
Abnormal 
xxx 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 105 of 106 
 
Listing 16.2-10.5 
Pregnancies 
(Safety Analysis Set) 
Treatment: EGT0001442 
Subject ID/ 
Age/ Sex/ Race [1] 
 
 
 
XXXXXX/  
 XX/ X/ X 
 
 
 
 
 
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other. 
 
 
 
Programming note: Display only ‘There are no observations to this table.’ If no events.  
 
 
 
 
  
 
 
 
 


Theracos, Inc.  
Protocol: THR-1442-C-418 
Page x of y 
<DIRECTORY PATH>PROGRAM NAME  Executed: DDMMMYYYY hh:mm  Data Extracted: DDMONYYYY 
 
Final – 22November2011                         CONFIDENTIAL                                     Page 106 of 106 
 
  
 
 
  
Listing 16.2-10.6 
NMP22 Testing Results 
(Safety Analysis Set) 
Treatment: EGT0001442 
Subject ID/ 
Age/ Sex/ Race [1] 
Visit 
Assessment 
Date 
Study Day 
Assessment 
If Positive, Urine 
Culture?/Culture Result 
Investigator 
Comment  
 
 
 
 
 
 
 
 
XXXXXX/  
 XX/ X/ X 
xxx 
xxxx 
xx 
Positive 
Yes/xxxxx 
xxx 
 
 
xxx 
xxxx 
xxx 
Negative 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[1] Sex: F=Female, M=Male; Race: W=White, B=Black, A=Asian, I=American Indian or Alaska Native, H=Native Hawaiian or 
Other Pacific Islander, O=Other.