Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 650
Healthy volunteers: no

Brief summary:
This research study of subjects with inadequately controlled type 2 diabetes mellitus (T2DM) will compare the glycemic control (measured by HbA1c) in subjects co-administered saxagliptin and dapagliflozin, in addition to metformin with or without sulfonylurea, to subjects receiving insulin glargine, in addition to metformin with or without sulfonylurea, over a treatment period of 52 weeks.

Detailed description:
CV181-369; A 24 Week International, Open-Label Trial With a 28 Week Extension to Evaluate the Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects With Type 2 Diabetes on Metformin With or Without Sulfonylurea Therapy

Arms:
arm 1: Oral route. Saxagliptin/Dapa adminsitered once daily for 24 weeks at a dose of 5 mg Saxagliptin and 10 mg Dapagliflozin arm 2: Insulin glargine administered once a day with starting dose of 0.2 Unit per kg or 10 units.

Interventions: intervention 1: Saxagliptin, Onglyza intervention 2: Dapagliflozin, Farxiga intervention 3: Glargine insulin intervention 4: Metformin
Intervention descriptions: intervention 1: Tablets, Oral, 5mg , Once daily, 24 weeks intervention 2: Tablets, Oral, 10mg , Once daily, 24 weeks intervention 3: 100 Units/ml solution for injection in a prefilled SoloStar pen intervention 4: Tablets, Oral, ≥ 1500mg/≤ 2500mg, Once daily, 24 weeks

Protocol document:
Prot_001.pdf: 
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TABLE OF CONTENTS 
TITLE PAGE ................................................................................................................ 
DOCUMENT HISTORY .............................................................................................. 
SYNOPSIS .................................................................................................................... 
TABLE OF CONTENTS .............................................................................................. 
1 INTRODUCTION AND STUDY RATIONALE ..................................................... 
1.1 Study Rationale ................................................................................................. 
1.2 Research Hypothesis ......................................................................................... 
1.3 Objectives ......................................................................................................... 
1.3.1 Primary Objective .................................................................................... 
1.3.2 Secondary Objectives ............................................................................... 
1.3.3 Exploratory Objectives ............................................................................ 
1.3.4 Safety Objective ....................................................................................... 
1.4 Product Development Background ................................................................... 
1.5 Overall Risk/Benefit Assessment ..................................................................... 
2 ETHICAL CONSIDERATIONS ............................................................................... 
2.1 Good Clinical Practice ...................................................................................... 
2.2 Institutional Review Board/Independent Ethics Committee ............................. 
2.3 Informed Consent.............................................................................................. 
3 INVESTIGATIONAL PLAN .................................................................................... 
3.1 Study Design and Duration ............................................................................... 
3.1.1 Screening Period ...................................................................................... 
3.1.2 Lead-In Period ......................................................................................... 
3.1.3 Short-term Treatment Period ................................................................... 
3.1.4 Long-term Treatment Period ................................................................... 
3.1.5 Continuous Glucose Monitoring (CGM) Sub-Study ................................ 
3.2 Post Study Access to Therapy ........................................................................... 
3.3 Study Population ............................................................................................... 
3.3.1 Inclusion Criteria ..................................................................................... 
3.3.2 Exclusion Criteria .................................................................................... 
3.3.3 Women of Childbearing Potential ........................................................... 
3.4 Concomitant Treatments ................................................................................... 
3.4.1 Prohibited and/or Restricted Treatments................................................. 
3.4.2 Other Restrictions and Precautions ......................................................... 
3.5 Discontinuation of Subjects following any Treatment with Study Drug .......... 
3.5.1 Discontinuation Guidelines due to Sustained Elevated Serum Creatinine
.....................................................................................................................
3.5.2 Discontinuation Guidelines due to Sustained Elevated Liver Function 
Tests ............................................................................................................ 
3.5.3 Procedures for Handling Subjects Incorrectly Enrolled or Randomized 
3.5.4 Rescue Guidelines for Subjects with Protocol-Defined Lack of Glycemic 
Control ........................................................................................................ 
3.5.5 Discontinuation Guidelines due to Protocol-Defined Hypoglycemia 
Episodes ...................................................................................................... 
3.5.6 Discontinuation Guidelines due to Ketoacidosis ..................................... 
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3.6 Post-Study Drug Follow up .............................................................................. 
3.6.1 Withdrawal of Consent ............................................................................ 
3.6.2 Lost to Follow-Up .................................................................................... 
4 STUDY DRUG .......................................................................................................... 
4.1 Investigational Product ..................................................................................... 
4.2 Non-investigational Product ............................................................................. 
4.3 Storage and Dispensing..................................................................................... 
4.4 Method of Assigning Subject Identification ..................................................... 
4.5 Selection and Timing of Dose for Each Subject ............................................... 
4.6 Blinding/Unblinding ......................................................................................... 
4.7 Treatment Compliance ...................................................................................... 
4.8 Destruction of Study Drug ................................................................................ 
4.9 Return of Study Drug ........................................................................................ 
4.10 Retained Samples for Bioavailability / Bioequivalence ................................. 
5 STUDY ASSESSMENTS AND PROCEDURES ..................................................... 
5.1 Flow Chart/Time and Events Schedule ............................................................. 
5.1.1 Retesting During Screening or Lead-in Period ....................................... 
5.2 Study Materials ................................................................................................. 
5.3 Safety Assessments ........................................................................................... 
5.3.1 Self-Monitored Blood Glucose (SMBG) and Guidance on Management 
and Reporting of Hypoglycemia Episodes .................................................. 
5.3.1.1 Self-Monitoring of Blood Glucose (SMBG) .................................... 
5.3.1.2 6-point SMBG profiles .................................................................... 
5.3.1.3 Guidance on Management and Reporting of Hypoglycemia 
Episodes ................................................................................................ 
5.3.2 Guidance on Assessment of Urinary Infections & Hematuria ................. 
5.3.2.1 Guidance on Assessment of Urinary Tract Infections .................... 
5.3.2.2 Guidance on Assessment of Hematuria .......................................... 
5.3.3 Guidance on Assessment of Cardiovascular Events ................................ 
5.3.4 Guidance on Assessment of Hepatic Laboratory Abnormalities ............. 
5.3.5 Physical Examination .............................................................................. 
5.3.6 Blood Pressure and Heart Rate ............................................................... 
5.3.7 Guidance on Volume Depletion ............................................................... 
5.3.8 Ketoacidosis ............................................................................................. 
5.3.9 Electrocardiograms ................................................................................. 
5.3.10 Supplemental Visits ................................................................................ 
5.3.10.1 Rescue or Discontinuation of Treatment Visit .............................. 
5.3.10.2 Other Supplemental (Unscheduled) Visits .................................... 
5.4 Efficacy Assessments ........................................................................................ 
5.5 Pharmacokinetic Assessments .......................................................................... 
5.6 Biomarker Assessments .................................................................................... 
5.7 Outcomes Research Assessments ..................................................................... 
5.7.1 Patient-reported outcomes (PRO) ........................................................... 
5.8 Other Assessments ............................................................................................ 
5.8.1 Diet and Exercise Counseling .................................................................. 
5.8.2 Weight ...................................................................................................... 
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5.8.3 Height and Body Mass Index (BMI) ........................................................ 
5.8.4 Survey of Subject Vital Status .................................................................. 
5.9 Continuous Glucose Monitoring (CGM) Sub-study ......................................... 
5.10 Results of Central Assessments ...................................................................... 
6 ADVERSE EVENTS ................................................................................................. 
6.1 Serious Adverse Events .................................................................................... 
6.1.1 Serious Adverse Event Collection and Reporting .................................... 
6.2 Non-serious Adverse Events ............................................................................. 
6.2.1 Non-serious Adverse Event Collection and Reporting ............................ 
6.3 Laboratory Test Result Abnormalities .............................................................. 
6.4 Pregnancy .......................................................................................................... 
6.5 Overdose ........................................................................................................... 
6.6 Potential Drug Induced Liver Injury (DILI) ..................................................... 
6.7 Other Safety Considerations ............................................................................. 
6.7.1 AEs of Special Interest ............................................................................. 
7 DATA MONITORING COMMITTEE AND OTHER EXTERNAL COMMITTEES
................................................................................................................................. 
7.1 Cardiovascular Adjudication Committee .......................................................... 
7.2 Hepatic Adjudication Committee ..................................................................... 
8 STATISTICAL CONSIDERATIONS....................................................................... 
8.1 Sample Size Determination ............................................................................... 
8.2 Populations for Analyses .................................................................................. 
8.3 Endpoints .......................................................................................................... 
8.3.1 Primary Endpoint(s) ................................................................................ 
8.3.2 Secondary Endpoint(s) ............................................................................. 
8.3.3 Exploratory Endpoint(s) .......................................................................... 
8.4 Analyses ............................................................................................................ 
8.4.1 Subject Disposition .................................................................................. 
8.4.2 Demographics and Baseline Characteristics........................................... 
8.4.3 Concomitant medications......................................................................... 
8.4.4 Extent of Exposure ................................................................................... 
8.4.5 Efficacy Analyses ..................................................................................... 
8.4.5.1 Primary Efficacy Analyses .............................................................. 
8.4.5.2 Secondary Efficacy Analyses .......................................................... 
8.4.5.3 Exploratory Efficacy Analyses ........................................................ 
8.4.6 Safety Analyses......................................................................................... 
8.4.7 Pharmacokinetic Analyses ....................................................................... 
8.4.8 Biomarker Analyses ................................................................................. 
8.4.9 Outcomes Research Analyses .................................................................. 
8.4.10 Subgroup Analysis ................................................................................. 
8.4.11 Other Analysis ........................................................................................ 
8.5 Interim Analyses ............................................................................................... 
9 STUDY MANAGEMENT ........................................................................................ 
9.1 Compliance ....................................................................................................... 
9.1.1 Compliance with the Protocol and Protocol Revisions ........................... 
9.1.2 Monitoring ............................................................................................... 
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9.1.2.1 Source Documentation .................................................................... 
9.1.3 Investigational Site Training.................................................................... 
9.2 Records ............................................................................................................. 
9.2.1 Records Retention .................................................................................... 
9.2.2 Study Drug Records ................................................................................. 
9.2.3 Case Report Forms .................................................................................. 
9.2.4 Subject Diaries ......................................................................................... 
9.3 Clinical Study Report and Publications ............................................................ 
10 GLOSSARY OF TERMS ........................................................................................ 
11 LIST OF ABBREVIATIONS .................................................................................. 
12 REFERENCES ........................................................................................................ 
APPENDIX 1 NEW YORK HEART ASSOCIATION FUNCTIONAL CLASS ....... 
APPENDIX 2 CENTRAL LABORATORY ASSESSMENTS ................................... 
APPENDIX 3 ALGORITHM FOR MICROSCOPIC HEMATURIA ......................... 
APPENDIX 4 SUSTAINED ELEVATED LIVER SAFETY ABNORMALITIES 
FLOW CHART ....................................................................................................... 
APPENDIX 5 GUIDANCE ON CONTRACEPTION ................................................. 
APPENDIX 6 INSULIN GLARGINE FIXED DOSE TITRATION SCHEDULE ..... 
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PPD


Page:
1
Protocol Number:
CV181369
IND Number:
63,634
EUDRACT Number
2015-001702-33
Date:
17-Mar-2016
Protocol CV181369: A 24-week International, Multicenter, Randomized, Open-Label, 
Active-Controlled, Parallel Group, Phase 3b Trial with a 28-week Extension to Evaluate the 
Efficacy and Safety of Saxagliptin Co-administered with Dapagliflozin to Insulin Glargine in 
Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin with or 
without Sulfonylurea Therapy 
Amendment Number 01
Site Number: All 
Medical Monitor
24-hr Emergency Telephone Number: 
Bristol-Myers Squibb Research and Development 
This protocol amendment contains information that is confidential and proprietary to 
Bristol-Myers Squibb (BMS).  
This amendment must be maintained with the referenced protocol. 
PPD
PPD
PPD


Protocol Amendment 01 
CV181369 
BMS-477118 AND BMS-512148 
saxagliptin and dapagliflozin 
 
 
2 
Amendment Rationale: 
x Added language to allow insulin titration to be initiated at 0.2 U/kg body weight in addition 
to the previous starting dose of 10U of glargine insulin. This change will only affect new 
subjects assigned to the insulin arm of the study. 
x Removal of the Week -2 (Lead-In) qualification requirement to have a central laboratory 
fasting plasma glucose (FPG) d 270 mg/dL (5.5 mmol/L) performed. This change will only 
affect new subjects enrolling in to the study. 
x Added section on assessment of ketoacidosis and urosepsis. This will affect all subjects. 
x Update criteria for highly effective methods of contraception.This will affect all subjects. 
x Added clarification of visit window to be +/- 5 days. This will affect all subjects. 
x  A number of typographical edits and addtional statistical clarifications to the protocol. 
 
Changes to the Protocol:  
1. Protocol, Section 1.1.3 Exploratory Objectives, Third bullet, First sentence: Added 
within-subject, within-day to definition. 
2. Protocol, Section 1.1.3 Exploratory Objectives, Fourth bullet, First sentence: Changed 
definition to: percentage of time spent within the euglycemic target range of  t 71 mg/dL 
(3.9 mmol/L) to definition, and as measured by CGM. 
3. Protocol, Section 1.1.3 Exploratory Objectives, Fifth bullet, First sentence: Changed 
definition to: percentage of time spent with glucose of d 70 mg/dL (3.9 mmol/L) as measured 
by CGM to definition. 
4. Protocol, Section 1.1.3 Exploratory Objectives, Sixth bullet, First sentence: Changed 
definition to: percentage of time spent with glucose of d 70 mg/dL (3.9 mmol/L) as measured 
by CGM between midnight 12:00 Aam and 6:00 am to definition. 
5. Protocol Section 1.2, Product Development Background, Fourth parapgraph, added: There 
have been post marketing reports of ketoacidosis, including diabetic ketoacidosis, in 
patientswith type 1 and type 2 diabetes mellitus taking dapagliflozin and other SGLT2 
inhibitors, although a causal relationship has not been established. 
6. Protocol Section 1.2, Product Development Background, Fifth parapgraph, Third sentence, 
added sentence: The saxagliptin/dapagliflozin combination has raised no new safety 
concerns. 
7. Protocol Section 1.3, Overall Risk/Benefit Assessment, Fifth paragraph: Potential benefits to 
subjects, Sixth sentence, added 52 week duration of the study. 
8. Protocol Section 2.3, Infromed Consent, Second paragraph, first sentence; must be. 
9. Protocol Section 3.1.1, Screening Period, First paragraph, Last sentence: which lasts for 
14 days. 
10. Protocol Section 3.1.1, Screening Period, Second paragraph, Second sentence,removed: and 
the requirements for entry into the Lead-In period have been met. 


Protocol Amendment 01 
CV181369 
BMS-477118 AND BMS-512148 
saxagliptin and dapagliflozin 
 
 
3 
11. Protocol Section 3.1.2, Lead-In Period, First paragraph, Last sentence, removed: as required 
per protocol (see Section 5.3.1.1) and added: and complete their subject diary as required per 
protocol (see Section 5.3.1.1). Visits should occur within +/- 5 day window of the protocol 
designated visit schedule, based on the screening date. Subjects should arrive at the site 
betwen 6:00 AM and 10:00 AM, should be in a fasting state (at least 8 hours) for all regularly 
scheduled visits and avoid alcohol, caffeine and tobacco prior to the visit(at least 8 hours). 
12. Protocol Section 3.1.2, Lead-In Period, Second paragraph, Second sentence, added: The 
initial pre-parandial glucose measurement on the 6-point SMBG day should be a fasting 
plasma glucose reading. 
13. Protocol Section 3.1.2, Lead-In Period, Fourth paragraph, change: Lead-In period r 5 days. 
14. Protocol Section 3.1.3, Short-term Treatment Period, Second paragragh, Second sentence, 
added: Visits should occur within +/- 5 day window of the protocol designated visit schedule, 
based on Day 1 visit date. Subjects should arrive at the site between 6:00 AM and 10:00 AM, 
should be in a fasting state (at least 8 hours) for all regularly scheduled visits and avoid 
alcohol, caffeine and tobacco prior to the visit (at least 8 hours). 
15. Protocol Section 3.1.3, Short-term Treatment Period, Fourth paragragh, Second sentence, 
added: The initial pre-prandial glucose measurement on the 6-point SMBG day should be a 
fasting plasma glucose reading. 
16. Protocol Section 3.1.3, Short-term Treatment Period, Fifth paragragh, Second sentence, 
added: have their dosage titrated to FPG target of d 100 mg /dL (5.5 mmol/L). 
17. Protocol Section 3.1.3, Short-term Treatment Period, Insulin Titration during the Short-term 
Treatment Period, First paragraph, First sentence, added: be recommended to start Day 1 
with an initial dose of 0.2U/kg bodyweight or at least 10 Units of insulin per day according to 
the discretion of the Investigator. 
18. Protocol Section 3.1.3, Short-term Treatment Period, Insulin Titration during the Short-term 
Treatment Period, First parapgraph, Sixth sentence, added: If there have been any 
unexplained hypoglycemic events (glucose d 70 mg/dL (3.9 mmol/L) during the last 3 days 
of SMBG readings, insulin glargine will not be uptitrated until  there are 3 days without 
hypoglycemia. The insulin titration will be checked at each site visit and the Investigator can 
provide recommendations of higher doses at his/her discretion between Weeks 8-12. The 
goal is to reach an acceptable  and stable dose by Week 12. 
19. Protocol Section 3.1.3, Short-term Treatment Period, Insulin Titration during the Short-term 
Treatment Period, Second parapgraph, First sentence, added:without an obvious explanation. 
20. Protocol Section 3.1.4, Long-term Treatment Period, First parapgraph, Third sentence, 
added: Visits should occur within +/- 5 day window of the protocol designated visit schedule, 
based on Day 1 visit date. Subjects should arrive at the site between 6:00 AM and 10:00 AM, 
should be in a fasting state (at least 8 hours) for all regularly scheduled visits and avoid 
alcohol, caffeine and tobacco prior to the visit (at least 8 hours). 
21. Protocol Section 3.1.4, Long-term Treatment Period, Third parapgraph, Second sentence, 
added: The initial pre-prandial glucose measurementr on the 6-point SMBG day should be a 
fasting plasma glucose reading. 
22. Protocol Section 3.1.5, Continuous Glucose monitoring (CGM) Sub-Study, Second 
parapgraph, added: with valid CGM data at the baseline assessment performed at the 
Week -2. 


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23. Protocol Section 3.2, Post Study Access to Therapy, First parapgraph, Second sentence, 
removed: to treat the condition under study and added: for T2DM thereafter. 
24. Protocol Section 3.3.1, Inclusion Criteria, 2) Target Population, a) deleted: Note: At Week -2 
(Lead-In), a central laboratory fasting plasma glucose (FPG) qualification check will be 
performed. Subjects will only be randomized on Day 1 if their FPG is d 270 mg/dL 
(15 mmol/L) at the Week -2 qualification check. A re-test will be permitted within 7 days if 
the Week -2 central lab result was > 270 mg/dL (15 mmol/L) but < 300 mg/dL 
(16.6 mmol/L). Subjects will be excluded if the central lab FPG value at Week -2 (Lead-In) 
is t 300 mg/dL (16.6 mmol/L) or if the central lab FPG value at Week -2 (Lead-In) and the 
re-test FPG value are both  > 270 mg/dL (15 mmol/L). 
25. Protocol Section 3.3.1, Inclusion Criteria, 2) Target Population, Section HIGHLY 
EFFECTIVE METHODS OF CONTRACEPTION: Removed first bullet: Male condoms 
with spermacide, added second bullet: Progestogen only hormonal contraception associated 
with inhibition of ovulation., third bullet, added: containinig a combination of estrogen + 
progesterone, added fourth bullet: Nonhormonal IUDs, added fifth bullet: Bilateral tubal 
occulsion, added sixth bullet: Vasectomized partner with documented azoospemia 90 days 
after procedure - Vasectomized partner is a highly effective birth control method provided 
that partner is the sole sexual partner of the WOCBP trial participant and that the 
vasectomized partner has recieived medical assessment of the surgical success., removed 
seventh bullet: IUDs, such as ParaGard®,removed eighth bullet: Tubal ligation, removed 
ninth bullet: Vasectomy, and added 10th buller: Inrauterine hormone-releasing system (IUS). 
26. Protocol Section 3.4.1 Prohibited and/or Restricted Treatments, First bullet, Second sentence 
added: Temporary insulin use is acceptable during hospitalizations if study medication is 
interrupted. 
x Protocol Section 3.5 Discontinuation of Subjects following any Treatment with Study Drug, 
Thirteenth bullet, added: If ketoacidosis is suspected, discontinuation or temporary 
interruption of dapagliflozin should be CONSIDERED and the patient promptly evaluated 
(see Section 3.5.6). 
27. Protocol Section 3.5 Discontinuation of Subjects following any Treatment with Study Drug, 
Third paragraph, Third sentence, added: and complete all study visits. 
28. Protocol Section 3.5.4 Rescue Guidlelines for Subjects with Protocol-Defined Lack of 
Glycemia Control, Table 3.5.4-1, Second sentence under Visit Label, removed: (including 
Week 52) and added under Central Laboratory FPG/HbA1c: (prior to Week 52). 
29. Protocol Section 3.5.6, Discontinuation Guidelines due to Ketoacidosis, new section and 
paragraph added: Patients treated with dapagliflozin who present with signs and symptoms 
consistent with ketoacidosis, including nausea, vomiting, abdominal pain, malaise, and 
shortness of breath, should be assessed for ketoacidosis, even if blood glucose levels are 
below 14 mmol/L (250 mg/dL). If ketoacidosis is suspected, discontinuation or temporary 
interruption of dapagliflozin should be considered and the patient should be promptly 
evaluated. Contact the medical monitor to discuss treatment options.  
30.  Protocol Section 4.5 Selection and Timing of Dose for Each Subject, Fourth bullet, First 
sentence, added: per local label. 


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31. Protocol Section 4.5 Selection and Timing of Dose for Each Subject, Fourth bullet, Second 
sentence, added: 0.2U/kg of body weight or at least and (per local label). Third and fourth 
sentence added: Investigators may modify the fixed dosing titration steps, scheduled in the 
first eight weeks, to optimize titration for individual patients in order to reach the target goal. 
Investigator has the discretion to modify insulin dose, based on his/her assessment, between 
Week 8 and Week 12, with the goal to reach an acceptable and stable insulin dose by 
Week 12 (see Appendix 6 for details). 
32. Section 5.1 Flow Chart/Time and Events Schedule, 5.1-1, Screening & Lead-In Visit Flow 
Chart for Protocol CV181369, Subscript section a) added: All visits should occur on the 
designated visit day +/- a 5 day window (based on the screening date) and Subscript section 
b), last sentence, added: The initial pre-prandial 6-point glucose measurement on the SMBG 
day should be a fasting plasma glucose reading.  
33. Section 5.1 Flow Chart/Time and Events Schedule, 5.1-1, Screening & Lead-In Visit Flow 
Chart for Protocol CV181369, Procedures, CGM Informed Consent procedure added to 
Screening Period (Week -4), FPG procedure removed for Lead-In (Week-2) along with 
notes,Vital Signs (seated BP & Heart Rate procedure), notes added: Note: Measurement must 
be taken prior to administration of study medication. 
34. Section 5.1 Flow Chart/Time and Events Schedule, 5.1-2, Short-term Visit Procedures Flow 
Chart for Protocol CV181369, Subscript section a) added: All visits should occur on the 
designated visit day +/- a 5 day window (based on the screening date), Subscript section b), 
last sentence, added: The initial pre-prandial 6-point glucose measurement on the SMBG day 
should be a fasting plasma glucose reading, Subscript section c) added third sentence: 
Investigator has the discretion to modify insulin doses during the fixed dosing schedule as 
well as during Week 8-Week 12  to achieve target daily FPG. 
35. Section 5.1 Flow Chart/Time and Events Schedule, 5.1-2, Short-term Visit Procedures Flow 
Chart for Protocol CV181369, Procedures, Contact IXRS-Oral Saxa/Dapa procedure at 
Day 1 with note added: Saxa/Dapa dispensed ONLY Day1 for ST period and Week 24 for 
LT period ONLY., Contact IXRS-Insulin procedure added at Week 4, Week 8 with note 
DGGHG,QVXOLQJODUJLQHLVGLVSHQVHGVXIILFHQWIRUZHHNVDVQHHGHGSHUVXEMHFW¶VLQGLYLGXDO
dosing regimen. refer to Protocol Secton 4, Vital Signs(Seated BP & Heart Rate) procedure, 
note added: Note: Measurements must be taken prior to administration of study medication, 
Dispense Study Medication(Oral medication or insulin) procedure, added note: Last dose of 
ST period Saxa/Dapa should be taken from their current bottle. 
36. Section 5.1 Flow Chart/Time and Events Schedule, 5.1-3, Long-Term Procedural Flow Chart 
for Protocol CV181369, Subscript section a) added: All visits should occur on the designated 
visit day +/- a 5 day window (based on the screening date) and Subscript section b), last 
sentence, added: The initial pre-prandial 6-point glucose measurement on the SMBG day 
should be a fasting plasma glucose reading. 


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37. Section 5.1 Flow Chart/Time and Events Schedule, 5.1-3, Long-Term Procedural Flow Chart 
for Protocol CV181369, Procedures, Contact IVRS procedure modified to Contact 
IXRS-Insulin with notes added: Insulin supplies should be sufficent for 8 weeks. *All 
patients should register Week 52/Rescue/EOT in IXRS, Vital Signs (Seated BP & Heart 
Rate) procedure, note added: Note: Measurement must be taken prior to administration of 
study medication, Dispense Study Medication (insulin glargine only) procedure, (insulin 
glargine only) was removed and note added: First dose of LT period Saxa/Dapa should be 
taken the day after the final ST visit, Collection of Study Medication procedure, note 
changed to Last dose of study medicationshould occur on the last day of the final visit 
foloowing completion of all visit procedures. 
38. Protocol Section 5.3.1.2, 6-point SMBG profiles, first sentense added: (within 15 minutes 
prior to the start of each meal) and (1.5-2 hours after the start of each meal), Second 
paragraph, sentence added: A minimum of 2 days of 6-point SMBGs is required to complete 
the 6-point SMBG profile for each period. 
39. Protocol Section 5.3.2.1, Guidance on Assessment of Urinary Tract Infections, Second 
paragraph added: Urosepsis and Pyelonephritis, There have been post-marketing reports of 
serious urinary tract infections, including urosepsis and pyelonephritis, requiring 
hospitalization in patients receiving dapagliflozin and other SGLT2 inhibitors. Treatment 
with SGLT2 inhibitors increases the risk for urinary tract infections. Evaluate patients for 
signs and symptoms of urinary tract infections and treat promptly. 
40. Protocol Section 5.38 added for Ketoacidosis with addtional paragraph text: There have been 
post-marketing reports of ketoacidosis, including diabetic ketoacidosis, in patients with 
type 1 and type 2 diabetes mellitus taking dapagliflozin and other SGLT2 inhibitors, although 
a causal relationship has not been established. Dapagliflozin is not indicated for the treatment 
of patients with type 1 diabetes mellitus. Patients treated with dapagliflozin who present with 
signs and symptoms consistent with ketoacidosis, including nausea, vomiting, abdominal 
pain, malaise, and shortness of breath, should be assessed for ketoacidosis, even if blood 
glucose levels are below 14 mmol/L (250 mg/dL). If ketoacidosis is suspected, 
discontinuation or temporary interruption of dapagliflozin should be considered and the 
patient should be promptly evaluated. Predisposing factors to ketoacidosis include a low 
beta-cell function reserve resulting from pancreatic disorders (e.g., type 1 diabetes, history of 
pancreatitis, or pancreatic surgery), insulin dose reduction, reduced caloric intake, or 
increased insulin requirements due to infections, illness or surgery and alcohol abuse. 
Dapagliflozin should be used with caution in these patients. Contact the medical monitor to 
discuss treatment options. 
41. Protocol Section 5.7.1 Patient reported outcomes (PRO), First prargraph, re-worded text to: 
The Phase V® health outcomes information system diabetes module will be used for the 
patient reported outcomes (PRO) assessments. The self-administered pro questionnaires 
consist of validated generic and diabetes-specific modules of treatment satisfaction, quality 
of life, and barriers to medication adherence and weight perception. 
42. Protocol Section 5.9, Continuous Glucose Monitoring (CGM) Sub-Study, Second paragraph, 
First sentence, added text: with valid CGM data at the baseline assessment at Week -2. 
43. Protocol Section 7.2 Hepatic Adjudication Committee, First sentence, removal of text: 
discontinuation from study treatment and/or. 
44. Protocol Section 8.3.3 Exploratory Endpoint(s), Bullet number 1) add text: mean. 


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7 
45. Protocol Section 8.3.3 Exploratory Endpoint(s), Bullet number 3) add text: within-subject, 
within-day as well as Week 2, Week 12. 
46. Protocol Section 8.3.3 Exploratory Endpoint(s), Bullet number 4) revised sentence to: In a 
sub-study, change from baseline in the percentage of time spent in the euglycemic target 
range of t 71 mg/dL (3.9 mmol/L) and d 180 mg/dL (10.0 mmol/L) as measured by CGM at 
Week 2, Week 12 and Week 24. 
47. Protocol Section 8.3.3 Exploratory Endpoint(s), Bullet number 5) revised sentence to: In a 
sub-study, change from baseline in the percentage of time spent with glucose d 70 mg/dL 
(3.9 mmol/L) as measured by CGM at Week 2, Week 12 and Week 24. 
48. Protocol Section 8.3.3 Exploratory Endpoint(s), Bullet number 6) revised sentence to: In a 
sub-study, change from baseline in the percentage of time spent with glucose d 70 mg/dL 
(3.9 mmol/L) as measured by CGM between midnight (12:00 AM) and 6:00 am at Week 2, 
Week 12 and Week 24. 
49. Protocol Section 8.3.3 Exploratory Endpoint(s), Bullet number 17) added text :Week 2, 
Week 24. 
50.  Protocol Section 8.4.5.1 Primary Efficacy Analyses, Sentence 12, added textor treatment 
discontinuation. Also added new paragraph after last sentence to read: Sensitivity analyses 
for the primary analysis of the change in HbA1c will include: Bullet 1-Repeat MMRM 
Analyses of the primary endpoint using values regardless of rescue. Bullet 2- Repeat MMRM 
Analyses of the primary endpoint using all available values (i.e., including values regardless 
of rescue or discontinuation). Bullet 3-ANCOVA analyses of the primary endpoint using 
values prior to rescue ( and within 8 days of treatment discontinuation) using last observation 
carried forward (LOCF) to impute missing values. Bullet 4- A pattern mixture model (which 
does not assume missing at random) will be fit to the data prior to rescue (and within 8 days 
of treatment discontinuation). 
51.  Protocol Section 8.4.5.2 Secondary Efficacy Analyses, Second paragraph, Second sentence, 
remove text: the methodology of Zhang, Tsiatis and Davidson and Tsiatis, Davidson, Zhang 
and Lu and replace with: logisitic regression. 
52. Protocol Section 8.4.5.3 Exploratory Efficacy Analyses, Sixth sentence, remove text: the 
methodology of Zhang, Tsiatis and Davidson and Tsiatis, Davidson, Zhang and Lu and 
replace with: logisitic regression. 
53. Protcol Section 8.4.9 Outcomes Research Analyses, Add sentence at the end of the 
paragraph: Phase V® is collecting the data for patient reported outcomes in this study. 
54. Protocol Section 8.4.10 Subgroup analysis, add text: baseline eGFR. 
55. Protocol Section 11, List of Abbreviations, Removed term PCTA-percutaneous transluminal 
coronary angioplasty and replaced it with PCI-percutanious coronary intervention. 
56. Protocol Section 12, References, remove reference numbers 5 & 6: 5) Kestelman P. et. al., 
Efficacy of the Simultaneous Use of Condoms and Spermicides Family Planning 
Perspectives.Vol 23 (5); October 1991 and 6) Gabbay MB, Thomas J, Gibbs A, Hold P. A 
Randomized Crossover Trial of The Impact of Additional Spermicide on Condom Failure 
Rates. Sex Transm Dis 2008; 35: 862-8. 


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8 
57. Protocol Section Appendix 2, Central Laboratory Assessments, Standrard Safety Laboratory 
Panels, Table Appendix 2, Urine Analyses, Urinalysis with microscopy, revised text: 
Hematuria urinalysis with microscopy, Bullet 1-Hematuria (completed only upon request) 
and Hematuria Dispstick analysis, Bullet 1-Postive result requires repeat microscopy. 
58. Protocol Section Appendix 5, Guidance on Contraception, Table Acceptable Highly 
Effective Methods of Contraception, table revised to text: Progestogen only hormonal 
contraception associated with inhibition of ovulationa. Non-hormonal IUDb. Vasectomyc. 
Bilateral tubal occlusion. Hormonal methods of contraception including oral contraceptive 
pills containing a combination of estrogen + progesterone, vaginal ring, injectable, and 
implants and intrauterine devices (IUDs). Intrauterine hormone-releasing system (IUS). 
Complete abstineneced. Footnotes include: a-A highly effective method of birth control with 
a failure rate of less than 1% per year. b- IUDs used shaould have a failure rate less than 1% 
(highly effective method) such as Mirena and ParaGard. c-Must be at least 90 days from the 
date of surgery with a semen analysis documenting azoospermia. d-Complete abstinence is 
defined as complete avoidance if heterosexual intercourse and is an acceptable form of 
contraception for all study drugs. Female subjects must continue to have pregnanct tests. 
Acceptable alternate methods of highly effective contraception must be discussed in the 
event that the subject chooses to forego complete abstinence. 
59. Protocol Section Appendix 7, Insulin Glargine Fixed Dose Titration Schedule, Second 
paragraph, Dosing should follow this fixed titration schedule, revised bullets 1-5, Bullet 1- 
Subjects will self-titrate their insulin dose in 2 Unit increments every 3 days (based on the 
FPG average from the previous 3 days) until Week 8 of the study. Note: Subjects must have 
at least 2 SMBG readings in order to titrate their insulin dose. Bullet 2- Subjects randomized 
to receive open-label insulin glargine will start on Day 1 with an initial dose of 0.2U/kg 
bodyweight or a 10 Unit dose (per local label directions), based on the discretion of the 
Investigator, administered subcutaneously once a day, at the same time every day, following 
Investigator instructions and training. Bullet 3-At Week 8 through Week 12, the Investigator 
has the discretion to increase or decrease the daily dose of insulin based on FPG and SMBG 
values, with the goal to reach an acceptable and stable insulin dose after 12 weeks of 
titration. Bullet 4-All attempts should be made to minimize changes after Week 12 to the 
daily insulin dose for the remainder of the study. 
60. Protocol Section Appendix 7, Insulin Glargine Fixed Dose Titration Schedule, For the first 
56 days of the study, First bullet, Second sentence added: A minimum of 2 daily FPG values 
are required before dose adjustment. Third bullet was deleted. 
 
Please maintain a copy of this amendment with your protocol. Please provide a copy to 
your Investigational Review Board / Ethics Committee, unless agreed otherwise with BMS. 


PPD

SAP_000.pdf: 
 
 
Statistical Analysis Plan 
 
Study Code 
D168BC00001 
 
Edition Number 
3.0 
 
Date 
21Sep2017 
 
 
 
 
 
A 24-WEEK INTERNATIONAL, MULTICENTER, RANDOMIZED, OPEN-LABEL, 
ACTIVE-CONTROLLED, PARALLEL GROUP, PHASE 3B TRIAL WITH A 28-
WEEK EXTENSION TO EVALUATE THE EFFICACY AND SAFETY OF 
SAXAGLIPTIN CO-ADMINISTERED WITH DAPAGLIFLOZIN COMPARED TO 
INSULIN GLARGINE IN SUBJECTS WITH TYPE 2 DIABETES WHO HAVE 
INADEQUATE GLYCEMIC CONTROL ON METFORMIN WITH OR WITHOUT 
SULFONYLUREA THERAPY  
 
 
 
 
 
 
 
 


PPD


PPD


TABLE OF CONTENTS 
TABLE OF CONTENTS .................................................................................................................4 
1 
BACKGROUND AND RATIONALE .........................................................................9 
2 
STUDY DESCRIPTION ............................................................................................10 
2.1 
Study Design ...............................................................................................................10 
2.2 
Treatment Assignment ................................................................................................11 
2.3 
Blinding and Unblinding ............................................................................................11 
2.4 
Protocol Amendments ................................................................................................12 
2.5 
Cardiovascular Adjudication Committee ...................................................................12 
2.6 
Hepatic Adjudication Committee ...............................................................................12 
3 
OBJECTIVES .............................................................................................................12 
3.1 
Primary Objective .......................................................................................................12 
3.2 
Secondary Objectives .................................................................................................12 
3.3 
Exploratory Objectives ...............................................................................................13 
3.4 
Safety ..........................................................................................................................14 
4 
ENDPOINTS ..............................................................................................................15 
4.1 
Primary Endpoint ........................................................................................................15 
4.2 
Secondary Endpoints ..................................................................................................15 
4.3 
Exploratory Endpoints ................................................................................................15 
4.4 
Safety Endpoints .........................................................................................................16 
5 
SAMPLE SIZE AND POWER ..................................................................................16 
6 
STUDY PERIODS, TREATMENT REGIMENS AND POPULATIONS FOR 
ANALYSES ...............................................................................................................17 
6.1 
Study Periods ..............................................................................................................17 
6.2 
Treatment Regimens ...................................................................................................17 
6.3 
Populations for Analyses ............................................................................................18 
6.3.1 
Enrolled Subjects Data Set .........................................................................................18 
6.3.2 
Lead-in Subjects Data Set ...........................................................................................18 
6.3.3 
Randomized Subjects Data Set ...................................................................................18 
6.3.4 
Full Analysis Set .........................................................................................................18 
6.3.5 
Evaluable Subjects Data Set .......................................................................................18 
6.3.6 
Treated Subjects Data Set ...........................................................................................18 
6.3.7 
Short-term Completers Data Set .................................................................................18 


7 
STATISTICAL ANALYSES .....................................................................................19 
7.1 
General Methods .........................................................................................................19 
7.1.1 
Definitions ...................................................................................................................19 
7.1.1.1 
Baseline Value ............................................................................................................19 
7.1.1.2 
Change and Percent Change from Baseline ...............................................................19 
7.1.1.3 
Handling of Missing Data ..........................................................................................19 
7.1.2 
Longitudinal Repeated Measures Analysis .................................................................20 
7.1.3 
Analysis of Covariance (ANCOVA) ............................................................................21 
7.1.4 
Descriptive Summaries of Continuous Variables .......................................................22 
7.1.5 
Descriptive Summaries of Categorical Variables ......................................................22 
7.1.6 
Descriptive Summaries of Change from Baseline in Categorical ..............................22 
7.1.7 
Kaplan-Meier Curve and Estimates for Time-to-Event Analyses ...............................22 
7.1.8 
Proportion of Subjects Achieving Pre-defined Characteristic ...................................23 
7.1.9 
Mean Daily Glucose and Mean Post-prandial Glucose (Self-monitored) .................23 
7.1.10 
Mean Amplitude of Glucose Excursions (MAGE) of continuous glucose 
monitoring system readings ........................................................................................24 
7.2 
Study Conduct ............................................................................................................25 
7.3 
Study Population .........................................................................................................27 
7.3.1 
Subject Disposition .....................................................................................................27 
7.3.2 
Demography and Other Baseline Characteristics ......................................................27 
7.3.3 
Specific and General Disease History ........................................................................28 
7.4 
Extent of Exposure .....................................................................................................30 
7.4.1 
Study and Rescue Medication .....................................................................................30 
7.4.2 
Concomitant Medications ...........................................................................................30 
7.4.3 
Measurements of Treatment Compliance ...................................................................31 
7.5 
Efficacy .......................................................................................................................31 
7.5.1 
Overall Efficacy Summary ..........................................................................................31 
7.5.2 
Primary Efficacy Analysis ..........................................................................................32 
7.5.3 
Handling of missing efficacy data ..............................................................................33 
7.5.3.1 
MMRM Model for Change from Baseline Based on Return-to-Baseline Multiple 
Imputation ...................................................................................................................34 
7.5.3.2 
Tipping Point Analysis based on ANCOVA Model for Change from Baseline 
Using Multiple Imputation ..........................................................................................35 


7.5.4 
Secondary Efficacy Analyses ......................................................................................36 
7.5.5 
Exploratory Efficacy Analyses ....................................................................................37 
7.5.5.1 
Mean change from baseline at Week t ........................................................................37 
7.5.5.2 
Glycemic Rescue or Discontinuation from Study treatment due to Lack of 
Efficacy .......................................................................................................................38 
7.5.5.3 
Summary of change from baseline for lipids ..............................................................38 
7.5.6 
Summary of Primary Efficacy Endpoint within Subgroups ........................................38 
7.5.7 
Pharmacokinetic Analyses ..........................................................................................39 
7.5.8 
Biomarker Analyses ....................................................................................................39 
7.5.9 
Outcomes Research Analyses .....................................................................................39 
7.5.10 
Other Analysis ............................................................................................................39 
7.5.11 
Interim Analyses .........................................................................................................39 
7.6 
Safety ..........................................................................................................................39 
7.6.1 
Adverse Events ............................................................................................................40 
7.6.1.1 
All Adverse Events ......................................................................................................40 
7.6.2 
Deaths .........................................................................................................................41 
7.6.3 
Serious Adverse Events ...............................................................................................41 
7.6.4 
Adverse Events Leading to Discontinuation of Study Medication ..............................42 
7.6.5 
Adverse Events of Special Interest (AEOSI) ...............................................................42 
7.6.5.1 
Hypoglycemia .............................................................................................................43 
7.6.5.2 
Confirmed Adjudicated Cardiovascular Adverse Events ...........................................44 
7.6.5.3 
Confirmed Adjudicated Hepatic Adverse Events ........................................................45 
7.6.5.4 
Other AEOSIs .............................................................................................................45 
7.6.6 
Laboratory Evaluation................................................................................................45 
7.6.6.1 
Marked Laboratory Abnormalities .............................................................................46 
7.6.6.2 
Change from Baseline for Selected Laboratory Parameters Over Time ....................46 
7.6.7 
Vital Signs ...................................................................................................................47 
7.6.8 
Electrocardiograms ....................................................................................................47 
7.6.9 
Pregnancy Test Results ...............................................................................................48 
8 
CONVENTIONS ........................................................................................................48 
8.1 
Duration of Type 2 Diabetes .......................................................................................48 
8.2 
Missing and Multiple Measurements..........................................................................48 
8.3 
Laboratory evaluations ...............................................................................................49 


8.3.1 
Post treatment efficacy and safety evaluations ...........................................................49 
8.4 
Longitudinal Assessments ..........................................................................................50 
8.5 
Post-Treatment Efficacy Observations .......................................................................51 
8.6 
Assignment of Doses to Adverse Events and Laboratory Assessments .....................52 
8.7 
Concomitant Medications ...........................................................................................53 
8.8 
Counting Rules for Adverse Events ...........................................................................54 
8.9 
Fasting State ................................................................................................................54 
8.10 
Percent Compliance Calculation .................................................................................55 
8.11 
Strip Sign for Selected Laboratory Data .....................................................................55 
9 
CONTENT OF REPORTS .........................................................................................55 
10 
CHANGES OF ANALYSIS FROM PROTOCOL ....................................................55 
11 
REFERENCES ...........................................................................................................56 
APPENDIX 1 
PHASE V INFORMATION FOR CONTINUOUS GLUCOSE 
MONITORING ..........................................................................................57 
APPENDIX 2 
PHASE V INFORMATION ON PATIENT-REPORTED 
OUTCOMES MEASUREMENT ..............................................................59 
APPENDIX 3 
MARKED ABNORMALITY CRITERIA ................................................64 
APPENDIX 4 
GEOGRAPHIC REGIONS .......................................................................65 


 AMENDMENT HISTORY 
Date 
Brief description of change 
April 6, 2017 
Initial Approved SAP 
September 8, 2017 
x Definition of confirmed hypoglycemia was updated. 
x In section 6.3.3 the definition of Randomized Subjects Data Set definition was 
updated by including all randomized subjects who receive at least one dose of 
study medication. 
x Section 6.3.4 is added to include the definition of Full Analysis Set. Following 
subsections were renumbered. 
x In section 6.3.5  the definition of Evaluable Subjects Data Set was updated. 
x Section 7.1.9 for analysis of 6-point self-monitored blood glucose data was 
updated. 
x Table 7.2-1 for list of relevant protocol deviations and their exclusion level was 
updated. 
x Section 7.3.2 for demographics and baseline characteristics was updated. 
x In section 7.4.1 additional categories were added for duration of exposure 
summary in the short term open-label treatment period. 
x In section 7.4.3 calculation for overall insulin compliance was added. 
x Section 7.5.2 was updated by adding new sensitivity analyses for primary 
endpoint. 
x Section 7.5.3 was added for handling missing efficacy data which includes 
additional MI based sensitivity analysis. Following sections were renumbered. 
Section 8.2 for selecting observations when there are multiple observations in a 
single visit window was updated. 
x Section 8.3 for laboratory evaluations was updated to include only data from 
central laboratory in safety tables 
x Section 8.4 was updated by adding visit windows for HbA1c and weight. 
x Section 10 was added to list the changes in analysis from protocol. Following 
section was renumbered. 
x Start of long-term treatment period was clarified in section 6.1. 
x Inserted texts from the core SAP and removed the references to core SAP. 
 


1 
BACKGROUND AND RATIONALE 
This Phase 3 study is part of a clinical program to support the development of a saxagliptin 5 mg -
dapagliflozin 10 mg fixed-dose combination (FDC) therapy for the treatment of T2DM. In subjects 
with T2DM who are inadequately controlled on metformin therapy with or without a sulfonylurea, 
this study will compare the efficacy and safety of the addition of saxagliptin-dapagliflozin versus the 
addition of insulin. The complementary mechanisms of action of saxagliptin and dapagliflozin, in 
combination with metformin, have been shown in previous studies to provide superior HbA1c 
lowering compared to either of the individual agents alone in subjects with inadequately controlled 
T2DM. 
As a FDC therapy, saxagliptin-dapagliflozin provides a new treatment option for T2DM patients. 
Dapagliflozin inhibits renal glucose reabsorption and acts independently of insulin, while saxagliptin 
enhances glucose-mediated insulin secretion by a glucose-dependent mechanism (via incretin effect).  
Saxagliptin and dapagliflozin have demonstrated, both individually, in combination and in 
combination with metformin with or without SU, a favorable safety and tolerability profile.  They have 
shown as single agents, as well as in combination with metformin, a low propensity for hypoglycemia 
consistent with their respective glucose dependent mechanism of action, therefore addressing a 
potential key concern when adding a glucose lowering agent. Both drugs have either demonstrated 
moderate weight reduction (dapagliflozin) or weight neutrality (saxagliptin) and do not require dose 
titration or injection, simplifying therapy compared to insulin. 
While insulin is an effective glycemic treatment for T2DM, insulin is associated with several 
undesirable side effects that can negatively affect patient compliance and limit its effectiveness.  These 
include increased risk of hypoglycemia and weight gain. Hypoglycemia is a clinically important 
barrier to optimizing treatment and there is emerging evidence that hypoglycemia is associated with 
negative cardiovascular outcomes. Over 85% of patients with T2DM are overweight or obese, and 
additional weight gain is undesirable and often results in reduced treatment compliance by the patients. 
In addition, not all patients are willing or able to inject insulin and keep up with the regular blood 
glucose monitoring required by insulin regimens. 
Research Hypothesis:   
In subjects with type 2 diabetes with inadequate glycemic control treated with metformin with or 
without SU, co-administration of saxagliptin and dapagliflozin over an open-label treatment period of 
24 weeks will result in glycemic control, measured by HbA1c that is non-inferior compared to the 
addition of insulin glargine. 
Schedule of Analyses: 
This analysis plan presents the objectives, endpoints, and analyses that will be conducted once all 
randomized subjects have either completed or been discontinued from the short-term open-label 
period.  All relevant queries must be resolved and the database must be locked for this period before 
the analyses.  Short-term plus long-term objectives, endpoints, and analyses performed at the time of 
the final database lock are also specified within this SAP. 


2 
STUDY DESCRIPTION 
2.1 
Study Design 
The CV181369 study is a randomized, open-label, two arm, parallel group, active-controlled, 
multicenter, Phase 3b study to evaluate the efficacy and safety of saxagliptin co-administered with 
dapagliflozin compared to insulin glargine. Subjects with documented T2DM and inadequate 
glycemic control (central laboratory HbA1c value t 8% and d 12% at screening) on a stable dose of 
metformin t 1500 mg/day for at least 8 weeks prior to screening visit with or without a stable dose of 
SU of at least 50% the maximal dose per local label for at least 8 weeks prior to screening visit will 
be enrolled. The primary endpoint of HbA1c will be assessed at 24 weeks; however, the trial will 
continue to 52 weeks as a long-term extension. 
The study design schematic is presented in Figure 2.1-1. 
Figure 2.1-1: 
Study Design Schematic 
 
 
Approximately 171 sites will randomize a combined total of approximately 598 subjects (299 subjects 
per treatment arm). Allowing approximately 12 months for patient recruitment, this study will be 
conducted over 24 months. 
Continuous Glucose Monitoring (CGM) is a useful technology (in addition to HbA1c) to qualitatively, 
as well as quantitatively, monitor glycemic control in the form of time spent in the 
euglycemic/hyperglycemic/hypoglycemic (blood glucose d 70 mg/dL) ranges and the mean amplitude 
of glucose excursions (MAGE).  In this protocol, a subpopulation of approximately 250 randomized 
subjects (a125 subject/treatment arm) who agree to participate (separate informed consent) will have 
CGM performed for periods of 7 days at 4 different timepoints throughout the study (Week -2 to -1 
(referred to as Baseline), Week 2 to 3 (referred to as Week 2), Week 11 to 12 (referred to as Week 
12), and Week 23 to 24 (referred to as Week 24)). 
Lead-In 
Period
Screening
Period
Wk
-4
Wk 
-1 *
Day 
1
Wk
24
Wk  
52
Short-Term 
Treatment Period
Long-Term 
Treatment Period
Wk 
1
Wk
2
Wk
4
Wk 
40
Wk
8
Wk
12
Wk
23*
Saxagliptin plus Dapagliflozin plus Metformin with or without  SU 
Glargine Insulin plus Metformin with or without  SU 
Glargine titration of 2U every 
3 days to daily glucose target
-Males/Females ш 18 years old
-HbA1c ш 8.0% and ч 12%
-Stable  dose of Met IR/XR
ш1500mg  for 8 Wks or 
Met with SU ш 50% Max dose
-CrCl ш 60 mL/min
-BMI ч 45 kg/m2
-CGM-
-CGM-
-CGM-
Wk
18
-CGM-
Wk
-2
Wk
3*
*Additional visits ONLY for subjects 
participating in CGM sub-study
Wk 
32
Wk
11*


2.2 
Treatment Assignment 
 
 
 
 
 
 
 
. 
Subjects entering the 24-week open-label short-term treatment period 
Following completion of the lead-in period, subjects who meet the criteria will be randomly assigned 
by the IVRS at the Day 1 Randomization visit, to one of the following two (2) open-label treatment 
arms in a 1:1 ratio:  
x saxagliptin 5 mg and dapagliflozin 10 mg 
x titrated insulin glargine  
Randomization will be stratified by current use of background medication (metformin alone vs. 
metformin plus SU) at baseline to ensure equal representation across all treatment groups and also 
within the sub-study.  Subjects will continue to receive their stable dose of metformin with or without 
SU throughout the study. 
During the first 12 weeks following randomization, there will be no protocol specified rescue criteria.  
During this time, subjects receiving open-label insulin glargine will be titrated to target, which is 
driven over an (8) week period, then at Investigator’s discretion with minimal adjustment 
recommended.  Titration of open-label saxagliptin and dapagliflozin will not be allowed at any time 
during the study. 
Subjects entering the 28-week open-label long-term treatment period  
Subjects who complete the Short-term Treatment Period will continue into the Long-term Period 
taking the same open-label study medication (saxagliptin 5 mg QD and dapagliflozin 10 mg QD or 
insulin glargine) that they were randomized to on study Day 1. Subjects will continue to receive their 
stable dose of metformin with or without SU throughout the study. 
2.3 
Blinding and Unblinding 
This is an open-label study.  The investigator, BMS and AstraZeneca personnel, and subjects will be 
unblinded to treatment allocation throughout the short-term and long-term treatment periods.  The 
database used for the analysis of the short-term treatment period of the study will be locked after all 
subjects have terminated the short-term treatment period of the study.  Analyses will not be performed 
by treatment arm until the Short-term database lock.  There will be one study report produced at the 
end of Short-term Period and a second study report produced at the end of Short-term plus Long-term 
period. 
CCI


For the short-term treatment period for each subject, the HbA1c values will be masked to the 
investigator.  After the short-term treatment period for each subject, the HbA1c values will no longer 
be masked.  All other laboratory values will be unmasked to both the investigator and the sponsor. 
2.4 
Protocol Amendments 
There has currently been one protocol amendment and the information has been incorporated into this 
document. 
2.5 
Cardiovascular Adjudication Committee 
A Clinical Event Committee (CEC) blinded to the treatment of the subjects, will independently 
adjudicate all events of heart failure with hospitalization. 
2.6 
Hepatic Adjudication Committee 
An Independent Hepatic Adjudication Committee, blinded to the treatment of the subjects, will 
determine the probability that drug-induced liver injury (DILI) is the cause of liver-related 
abnormalities, included but not limited to: 
x AST and/or ALT > 3X ULN and TB >2 X ULN (within 14 days of the AST and/or ALT elevation) 
x Hepatic events timely related to death (within 30 days before death) 
x AST and/or ALT > 10X ULN 
A separate Adjudication Charter will define and describe the procedure for the handling, reporting, 
and classification of these events. 
3 
OBJECTIVES 
3.1 
Primary Objective 
To examine whether the mean change from baseline in HbA1c with co-administered saxagliptin 5 mg 
and dapagliflozin 10 mg plus metformin with or without SU is non-inferior to titrated insulin glargine 
plus metformin with or without SU after 24 weeks of open-label treatment.  
3.2 
Secondary Objectives 
x To compare the mean change from baseline in total body weight with co-administered saxagliptin 
5 mg and dapagliflozin 10 mg plus metformin with or without SU versus titrated insulin glargine 
plus metformin with or without SU after 24 weeks of open-label treatment.   
x To compare the proportion of confirmed hypoglycemia [defined as: blood glucose 
 70mg/dL 
(3.9 mmol/L) recorded in the hypoglycemia module of the CRF] with co-administered saxagliptin 
5 mg and dapagliflozin 10 mg plus metformin with or without SU versus titrated insulin glargine 
plus metformin with or without SU during 24 weeks of open-label treatment.   
x To compare the proportion of subjects achieving a therapeutic glycemic response, defined as 
HbA1c < 7.0%, without any hypoglycemia, with co-administered saxagliptin 5 mg and 
dapagliflozin 10 mg plus metformin with or without SU versus titrated insulin glargine plus 
metformin with or without SU after 24 weeks of open-label treatment.   
x To examine whether the change from baseline in the mean value of 24-hour glucose readings 
measured by Continuous Glucose Monitoring (CGM) with co-administered saxagliptin 5 mg and 


dapagliflozin 10 mg plus metformin with or without SU is non-inferior to titrated insulin glargine 
plus metformin with or without SU after 2 weeks of open-label treatment.  
x To examine whether the proportion of subjects achieving a therapeutic glycemic response, defined 
as HbA1c < 7.0%, with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin 
with or without SU is non-inferior to titrated insulin glargine plus metformin with or without SU 
after 24 weeks of open-label treatment. 
3.3 
Exploratory Objectives 
x To assess the change from baseline in mean amplitude of glucose excursions (MAGE) of 24-hour 
glucose readings measured by CGM with co-administered saxagliptin 5 mg and dapagliflozin 10 
mg plus metformin with or without SU versus titrated insulin glargine plus metformin with or 
without SU after 2 weeks, 12 weeks and 24 weeks of open-label treatment. 
x To assess the change from baseline in the mean value of 24-hour glucose readings measured by 
CGM with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or 
without SU versus titrated insulin glargine plus metformin with or without SU after 12 weeks and 
24 weeks of open-label treatment.  
x To assess the change from baseline in within-subject, within-day standard deviation of 24 hour 
glucose readings measured by CGM with co-administered saxagliptin 5 mg and dapagliflozin 10 
mg plus metformin with or without SU versus titrated insulin glargine plus metformin with or 
without SU after 2 weeks, 12 weeks and 24 weeks of open-label treatment. 
x To assess the change from baseline in the percentage of time spent within the euglycemic target 
range of  71 mg/dL (3.9 mmol/L) and d 180 mg/dL (10.0 mmol/L) as measured by CGM with 
co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU 
versus titrated insulin glargine plus metformin with or without SU after 2 weeks, 12 weeks and 24 
weeks of open-label treatment.  
x To assess the change from baseline in the percentage of time spent with glucose d 70 mg/dL (3.9 
mmol/L) as measured by CGM with co-administered saxagliptin 5 mg and dapagliflozin 10 mg 
plus metformin with or without SU versus titrated insulin glargine plus metformin with or without 
SU after 2 weeks, 12 weeks and 24 weeks of open-label treatment. 
x To assess the change from baseline in the percentage of time spent with glucose d 70 mg/dL (3.9 
mmol/L) as measured by CGM between midnight (12am) and 6am with co-administered 
saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU versus titrated insulin 
glargine plus metformin with or without SU after 2 weeks, 12 weeks and 24 weeks of open-label 
treatment. 
x To assess the mean change from baseline in HbA1c with co-administered saxagliptin 5 mg and 
dapagliflozin 10 mg plus metformin with or without SU versus titrated insulin glargine plus 
metformin with or without SU after 52 weeks of open-label treatment.   
x To assess the mean change from baseline in total body weight with co-administered saxagliptin 5 
mg and dapagliflozin 10 mg plus metformin with or without SU versus titrated insulin glargine 
plus metformin with or without SU after 52 weeks of open-label treatment.   
x To assess the proportion of confirmed hypoglycemia [defined as: blood glucose d 70 mg/dL (3.9 
mmol/L) recorded in the hypoglycemia module of the CRF] with co-administered saxagliptin 5 
mg and dapagliflozin 10 mg plus metformin with or without SU versus titrated insulin glargine 
plus metformin with or without SU during 52 weeks of open-label treatment.   


x To assess the proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c 
< 7.0%, without any hypoglycemia, with co-administered saxagliptin 5 mg and dapagliflozin 10 
mg plus metformin with or without SU versus titrated insulin glargine plus metformin with or 
without SU after 52 weeks of open-label treatment.   
x To assess the proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c 
< 7.0%, with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or 
without SU versus titrated insulin glargine plus metformin with or without SU after 52 weeks of 
open-label treatment.  
x To assess the proportion of subjects requiring rescue or discontinuation for lack of glycemic 
control with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or 
without SU versus titrated insulin glargine plus metformin with or without SU during 24 weeks 
and 52 weeks of open-label treatment.  
x To assess the time to treatment intensification (addition of non study insulin or other anti-diabetic 
therapies for rescue therapy or discontinuation for lack of glycemic control) with co-administered 
saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU versus titrated insulin 
glargine plus metformin with or without SU during 24 weeks and 52 weeks of open-label 
treatment.  
x To assess the proportion of subjects achieving HbA1c d 6.5% with co-administered saxagliptin 5 
mg and dapagliflozin 10 mg plus metformin with or without SU versus titrated insulin glargine 
plus metformin with or without SU after 24 weeks and 52 weeks of open-label treatment.  
x To assess the proportion of subjects achieving HbA1c d 6.5% without any hypoglycemia with co-
administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU versus 
titrated insulin glargine plus metformin with or without SU after 24 weeks and 52 weeks of open-
label treatment.  
x To assess change from baseline in average glucose values and postprandial glucose values 
measured by 6-point self-monitored blood glucose (SMBG) profiles with co-administered 
saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU versus titrated insulin 
glargine plus metformin with or without SU after 12 weeks, 24 weeks and 52 weeks of open-label 
treatment. 
x To assess changes from baseline in subject-reported treatment satisfaction, quality of life, and 
barriers to medication adherence achieved with co-administered saxagliptin 5 mg and 
dapagliflozin 10 mg plus metformin with or without SU versus titrated insulin glargine plus 
metformin with or without SU after 12 weeks, 24 weeks and 52 weeks of open-label treatment. 
3.4 
Safety 
To assess the safety and tolerability of co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus 
metformin with or without SU versus titrated insulin glargine plus metformin with or without SU after 
24 weeks and 52 weeks of open-label treatment.  
 
 


4 
ENDPOINTS 
4.1 
Primary Endpoint 
Change from baseline in HbA1c at Week 24. 
4.2 
Secondary Endpoints 
The secondary efficacy endpoints for the Short-term treatment Period include: 
1) Change from baseline in total body weight at Week 24 
2) Proportion of subjects with confirmed hypoglycemia [defined as: blood glucose d 70 mg/dL (3.9 
mmol/L) recorded in the hypoglycemia module of the CRF] at Week 24 
3) Proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c < 7.0%, 
without any reported hypoglycemia (for the duration of the Short-term Period) at Week 24   
4) In a sub-study, change from baseline in the mean value of 24-hour glucose readings measured by 
Continuous Glucose Monitoring (CGM) at Week 2  
5) Proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c < 7.0% at 
Week 24  
4.3 
Exploratory Endpoints 
1) In a sub-study, change from baseline in mean amplitude of glucose excursions (MAGE) of 24 hour 
glucose readings measured by Continuous Glucose Monitoring (CGM) at Week 2, Week 12, and 
Week 24 (Phase V®  CGM Analytics variable name MAGE_SC see appendix 1). 
2) In a sub-study, change from baseline in the mean value of 24 hour glucose readings measured by 
Continuous Glucose Monitoring (CGM) at Week 12 and Week 24 (Phase V®  CGM Analytics 
variable name BGMEANALL see appendix 1). 
3) In a sub-study, change from baseline within-subject, within-day in the standard deviation of 24 
hour glucose readings measured by Continuous Glucose Monitoring (CGM) at Week 2, Week 12 
and Week 24 (Phase V®  CGM Analytics variable name WPWDSDDY see appendix 1). 
4) In a sub-study, change from baseline in the percentage of time spent in the euglycemic target range 
of  71 mg/dL (3.9 mmol/L) and d  180 mg/dL (10.0 mmol/L) as measured by CGM  at Week 2, 
Week 
12, 
and 
Week 
24 
(Phase 
V® 
CGM 
Analytics 
variable 
name 
CGM_GE71_LE180_PCTTIME see appendix 1). 
5) In a sub-study, change from baseline in the percentage of time spent with glucose d 70 mg/dL (3.9 
mmol/L) as measured by CGM at Week 2, Week 12, and Week 24 (Phase V®  CGM Analytics 
variable name CGM_HYPO_PCTTIME see appendix 1).  
6) In a sub-study, change from baseline in the percentage of time spent with glucose d 70 mg/dL (3.9 
mmol/L) as measured by CGM between midnight (12am) and 6am at Week 2, Week 12, and Week 
24 (Phase V®  CGM Analytics variable name CGM NOC_HYPO_PCTTIME see appendix 1). 
7) Change from baseline in HbA1c at Week 52. 
8) Change from baseline in total body weight at Week 52 
9) Proportion of subjects with confirmed hypoglycemia [defined as: blood glucose d 70 mg/dL (3.9 
mmol/L) recorded in the hypoglycemia module of the CRF] at Week 52 


10) Proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c < 7.0%, 
without any hypoglycemia, at Week 52   
11) Proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c < 7.0%, at 
Week 52   
12) Proportion of subjects requiring rescue or discontinuation for lack of glycemic control) at Week 
24 and Week 52  
13) Time to treatment intensification (addition of non study insulin or other anti-diabetic therapies for 
rescue therapy or discontinuation for lack of glycemic control) at Week 24 and Week 52 
14) Proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c d  6.5%, at 
Week 24 and Week 52   
15) Proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c d  6.5%, 
without any hypoglycemia at Week 24 and Week 52 
16) Change from baseline in average glucose values and postprandial glucose values measured by 6-
point SMBG profiles at Week 12, Week 24, and Week 52 
17) Change from baseline in patient-reported treatment satisfaction, quality of life, and barriers to 
medication adherence at Week 12, Week 24 and Week 52 
4.4 
Safety Endpoints 
The safety endpoints include: 
x The proportion of subjects with hypoglycemia events and the frequency and ADA 
classification of the hypoglycemia events during the Week 24 and Week 52 treatment periods 
x The proportion of subjects experiencing adverse events (AE) and marked abnormalities in 
clinical laboratory tests during the Week 24 and Week 52 treatment periods 
x The change from baseline at each post-baseline time point of assessment of selected safety 
clinical laboratory parameters, physical measurements, vital signs, and electrocardiogram 
data during the Week 24 and Week 52 treatment periods 
5 
SAMPLE SIZE AND POWER 
The change from baseline in HbA1c at Week 24 will be assessed comparing co-administered 
saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU versus titrated insulin 
glargine plus metformin with or without SU. 
Power calculations for longitudinal repeated measures analyses depend on many factors, including the 
pattern of drop-outs over time and correlations among the various time points included in the model. 
The choice of these parameters will affect any estimates of power, and their true values may not be 
known. Based on comparisons of results of longitudinal repeated measures analyses and analysis of 
covariance (ANCOVA) using last observation carried forward (LOCF) from previous diabetes trials, 
the estimated standard errors of the treatment differences were similar between analyses. Therefore, 
power calculations are based on ANCOVA with LOCF, with the expectation that this will provide a 
good estimate of the power for the primary analysis using a longitudinal repeated measures model. To 
demonstrate non-inferiority of saxagliptin plus dapagliflozin to insulin for changes from baseline to 
Week 24 in HbA1c within a non-inferiority margin of 0.30%, assuming a standard deviation 1.1%, 
and at a one-sided significance level of 0.025, 284 evaluable subjects will be needed in each treatment 
group to provide approximately 90% power (given a true difference of zero between the 2 treatment 


groups). Assuming that 5% of subjects do not have a post-baseline assessment, a total of approximately 
598 subjects (299 subjects per treatment arm) need to be randomized. Assuming that 50% of screened 
subjects will fail to meet screening criteria, a total of 1196 subjects need to be screened. 
 
6 
STUDY PERIODS, TREATMENT REGIMENS AND POPULATIONS FOR 
ANALYSES 
6.1 
Study Periods 
Study CV181-369 consists of 4 study periods: 
1) Screening period (Period A). This period starts with enrollment (i.e., signature of the protocol-
specific informed consent form constitutes the first procedure of the Screening period) and ends 
on the start of lead-in period.  Subjects should be on a stable dose of metformin  1500 mg/day for 
at least 8 weeks prior to screening visit with or without a stable dose of a SU of at least 50% the 
maximal dose per local label.  
2) Lead-in period (Period B). During this period, subjects will continue their diabetes management 
with stable dose of metformin 1500 mg/day with or without a stable dose of SU, diet and exercise.  
No placebo or study medication will be provided during the lead-in period. 
3) 24-week short-term open-label treatment period (Period C). On the Day 1 visit, subjects who 
meet all the protocol-specific enrollment and randomization criteria will be randomized. 
4) 28-week long-term open-label treatment period (Period D). After completing the short-term 
period, subjects will enter the 28-week open-label long-term treatment period. The start date of 
long-term treatment period is defined as the end date of short-term treatment period. This is the 
date when the subject entered the long-term treatment period and was dispensed long-term study 
medication. 
Follow-up non-treatment phase (Period X). Subjects who discontinue study treatment early will follow 
the same visit schedule as subjects who remain on treatment.  
6.2 
Treatment Regimens 
On the Day 1 visit, subjects who meet all protocol enrollment and randomization criteria will be 
randomized into one of the two open-label treatment arms, in a 1:1 ratio: 
x Saxagliptin 5 mg QD and Dapagliflozin 10 mg QD  
x Titrated insulin glargine 
Randomization will be stratified by current use of background medication (metformin alone vs. 
metformin plus SU) at baseline to ensure equal representation across all treatment groups and also 
within the sub-study. Subjects will continue to receive their stable dose of metformin with or without 
SU throughout the study. The “as randomized” treatment group is defined as the treatment group to 
which a subject was randomized at the start of the open-label treatment period (even if the treatment 
they received was different).  The primary efficacy analyses will be performed using the Randomized 
Subjects Data Set. 
The “as treated” treatment group is the same as the “as randomized” treatment group, except in cases 
where information was available which indicated that a subject received a different treatment for the 


entire course of their participation in the study (or period). In this case, the “as treated” treatment group 
is set to the treatment the subject actually received. In case a subject never received the treatment as 
assigned by randomization, then the “as treated” treatment group is the first treatment received. 
 
6.3 
Populations for Analyses 
6.3.1 
Enrolled Subjects Data Set 
This consists of all subjects who signed informed consent. 
6.3.2 
Lead-in Subjects Data Set 
The lead-in subject data set includes data collected from all subjects who have at least one vital sign 
measurement during Lead-in Period. 
6.3.3 
Randomized Subjects Data Set 
The randomized subject data set will consist of all randomized subjects who receive at least one dose 
of study medication.  Whenever using the randomized subject data set, subjects will be presented in 
the treatment group to which they were randomized at the start of the Short-term treatment Period 
(even if the treatment they received was different). This is also known as the Intent-to-Treat (ITT) 
population. This will be the primary efficacy data set. 
6.3.4 
Full Analysis Set 
The full analysis set (FAS) is defined as all randomized subjects who take at least one dose of the 
study medication and have a baseline value for HbA1c.  Analysis of the FAS will be based on the 
randomized treatment. 
6.3.5 
Evaluable Subjects Data Set 
The Evaluable Subjects Data Set will be a subset of the Randomized Subjects, with all data points 
collected after a relevant protocol deviation excluded from the data set. Relevant protocol deviations 
are defined as deviations that could potentially affect the interpretability of the study results. This is 
also known as the Per-protocol populationAll decisions to exclude patients and/or data from the 
Randomized Subjects Data Set will be made prior to un-blinding the study and agreed by the study 
team. 
6.3.6 
Treated Subjects Data Set 
The Treated Subjects Data Set for ST and ST+LT will consist of all subjects who receive at least one 
dose of study medication during the short-term treatment period. This will be the primary safety data 
set. Data in this data set will be analyzed based on randomized treatment, except in cases where a 
subject received a different treatment for the entire course of his/her participation in the treatment 
period. In this case, safety data for such a subject will be analyzed based on the first treatment the 
subject actually received. 
6.3.7 
Short-term Completers Data Set 
The short-term Completers Data Set will consist of all subjects in the Randomized Subjects Data 
Set  who  were  not  rescued,  and  completed  ST   treatment  and  entered  the  LT treatment 
period.  It is a subset of the Randomized Subjects Data Set. 


Whenever using the Short-term Completers Data Set, subjects will be presented in the treatment 
group to which they were randomized at the start of the ST treatment period (even if the treatment 
they received in the ST or LT was different. 
 
7 
STATISTICAL ANALYSES 
7.1 
General Methods 
7.1.1 
Definitions 
7.1.1.1 
Baseline Value 
Unless otherwise stated, for each subject, baseline value of a parameter (e.g., efficacy laboratory 
parameter, safety laboratory test, ECG or physical measurement endpoint) is defined as the last 
assessment on or prior to the date of the first dose of the study medication.  
7.1.1.2 
Change and Percent Change from Baseline 
Change from baseline to any Week t in short-term treatment period or ST +LT is defined as follows: 
 
CWeek t = MWeek t - Mbaseline , 
 
 
Percent change from baseline to any Week t in short-term treatment period is defined as follows: 
 
PWeek t =100×(MWeek t - Mbaseline) / Mbaseline . 
 
Where PWeek t is the percent change from baseline at Week t, and MWeek t  and Mbaseline are 
defined as above. 
 
The  “Week  t”  to  which  a  measurement  belongs  is  determined  using  the  conventions described 
in Section 8.2 and Section 8.4. 
7.1.1.3 
 Handling of Missing Data 
The main analysis for change from baseline specified for primary and secondary endpoints in 
following sections will use the repeated measures model.  For subjects who started rescue 
medication, measurements taken prior to the date of the first dose of rescue medication will be 
used. This model assumes that the time course of the endpoint values for subjects who discontinue 
treatment or are rescued at a specified time point is consistent with the time course for subjects who 
are ongoing at that time point. 
 
While utilizing models such as ANOVA, for example, in analysis of change (or percent change) 
from baseline as well as glycemic response endpoint at Week 24 LOCF, the measurement assigned 
as the Week 24 measurement will be used.  If no Week  4 measurement is available (subject has 


discontinued before Week 24, or measurement not taken at Week 24, though subject was not 
discontinued), then the last available earlier post- baseline measurement will be used (LOCF). For 
subjects who started rescue medication prior to Week 24, their last post-baseline measurement taken 
prior to the date of the first dose of rescue medication will be used. 
 
Section 8 provides additional information regarding handling of missing or partial dates, inclusion of 
values, windowing, and values obtained post treatment. 
7.1.2 
   Longitudinal Repeated Measures Analysis 
 
A longitudinal repeated measures analysis using ‘direct likelihood’ will be performed. The SAS 
procedure PROC MIXED will be used. The preferred model will include the fixed categorical effects 
of treatment, week and treatment-by-week interaction as well as the continuous fixed covariates of 
baseline measurement and baseline measurement-by-week interaction. 
 
The following model will be used: 
 
Cijk  = intercept + ß1  [Mbaseline,ij] + Ĳi  + Ȧm  + Į k+ (Į Ĳ)ik  + (Į Mbaseline)ijk  + errorijk 
(Model 7.1.2.1) 
 
where 
 

An unstructured matrix for the within-subject error variance-covariance will be used. The 
denominator degrees of freedom will be calculated according to the Kenward-Roger method. 
 
In case of non-convergence of the preferred model or memory space issues, the following back-
up models are defined: 
 
 
The second back-up model will only be provided if the first back-up model does not converge or 
has memory issues. 


The model will provide least-squares mean estimates, standard errors and 2-sided 95% 
confidence intervals for mean change at all time points within and between treatments. 
Pre-specified stratification factors other than site in the randomization (e.g. pre-enrollment factor) 
will be added as an additional fixed effect in the mixed model. 
 
Assessment of Treatment-by-Baseline Interaction: 
 
Treatment-by-baseline interaction will be assessed for the analyses of the primary efficacy 
endpoint. In the repeated measures model (7.1.2.1), the interaction will be tested by including the 
additional terms for the treatment-by-baseline interaction. 
 
The test for interaction will be performed at the 0.10 level of significance. If the treatment- by-
baseline interaction is not significant, the original model (7.1.2.1) will be used. Otherwise, the 
interaction will be assessed as qualitative or quantitative. Assessment of the interaction type will be 
based on regression lines plotted for each treatment group. The intercepts and slopes for these 
regression plots will be obtained from the analysis model including the interaction term. The 
intercepts will be estimated by the least squares treatment means. The abscissa of the plots will 
range from the minimum baseline value from all subjects included in the analysis to the maximum 
baseline value. 
 
If the regression lines do not cross, or the crossing is judged not severe (i.e., the crossing occurs 
near the boundary or beyond the range of baseline values), then the interaction will be considered 
quantitative and this does not compromise the validity of the treatment comparisons. In this case, 
the treatment comparisons will be made using the model without the interaction term. 
 
Otherwise, the interaction will be considered qualitative and treatment comparisons will not be 
presented as a result of the complete model. In this case, the impact of the baseline value on 
treatment effect will be investigated by summarizing the data in subsets defined by baseline 
categories. 
 
Subgroup Analyses and Assessment of Treatment-by-Subgroup Interaction: 
 
Treatment effects will be assessed for subgroups based on age group, gender, race, region, and 
baseline HbA1c, as defined in Table 7.3.2A and Table 7.3.2B.   The analyses will be based on 
model 7.1.2.1 with additional covariates of subgroups, treatment-by-subgroup, time-by-subgroup, 
and treatment-by-time-by-subgroup.  Additionally, the treatment-by-stratification will be assessed.    
Tests of the treatment by subgroup interaction will be assessed using contrasts of the treatment effect 
by subgroups at Week 24. The model to assess the treatment-by-baseline HbA1c interaction will 
include baseline HbA1c as a continuous variable.  Adjusted mean change from baseline and its 
difference from the control group will be given for each subgroup at week 24. 
7.1.3 
Analysis of Covariance (ANCOVA) 
 
In summaries of efficacy endpoints examining changes from baseline at Week 24, ANCOVA of 
the differences between post-baseline and baseline measurements will be performed, with treatment 
group as an effect and the baseline measurement as a covariate. 
The following ANCOVA model will be used: 
Dt,ij = intercept + ß [Y0,ij ]+ Ĳi  + Ȧ m + errorij 
Where  (Model 7.1.3.1)


 
 
The model will provide least squares mean estimates and 2-sided 95% confidence intervals for 
mean changes from baseline within and (when warranted) differences in mean change from 
baseline between treatments. Where applicable, t-statistics corresponding to the Type III sums 
of squares for the differences in the least squares means will be used to obtain p-values for 
treatment group comparisons. 
7.1.4 
Descriptive Summaries of Continuous Variables 
 
Descriptive summaries of continuous variables in terms of change or percent change from 
baseline values will be provided, including ns, means, medians, and standard error (SE). In 
addition, 95% confidence interval for the mean (percent) change from baseline will be calculated 
for continuous efficacy variables. They will be presented by treatment group and time point 
where applicable. 
 
7.1.5 
Descriptive Summaries of Categorical Variables 
 
Descriptive summaries of categorical variables will consist of frequencies and percentages 
for each treatment group and overall, where applicable. 
 
7.1.6 
Descriptive Summaries of Change from Baseline in Categorical 
Variables 
Descriptive summaries of change from baseline in categorical variables will be provided 
using shift tables. Frequencies and percentages of subjects within each treatment group will be 
generated for levels of cross-classifications of baseline and the on-treatment value of the 
parameter. The on-treatment value can either be the value at a certain time point, or e.g. for 
laboratory tests, the minimum/maximum value in the direction of toxicity, which has been 
observed during the short-term treatment period. Treatment group differences will not be 
assessed in summaries of shifts. 
7.1.7 
Kaplan-Meier Curve and Estimates for Time-to-Event Analyses 
Kaplan-Meier plots2 of time to event variables will be displayed by treatment group. Unless 
otherwise specified, the plot will be presented only when there are at least 5 events in one 
treatment group. Additionally, a table will accompany the plot and will display the Kaplan- 


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Meier estimates of the cumulative proportion (with 95% CI calculated based on Greenwood’s 
method3 when applicable) of subjects with event at specific time points by treatment group. 
If the estimated lower bound of 95% CI is below 0 or the estimated upper bound of 95% CI 
is over 1, then it will be restricted to 0 or 1 respectively. 
7.1.8 
Proportion of Subjects Achieving Pre-defined Characteristic 
Unless otherwise specified, the proportion of subjects with a pre-defined characteristic at Week t 
will be analyzed using logistic regression with adjustment for baseline HbA1c value and/or the 
stratification factor. Subjects in the randomized treatment group who do not demonstrate 
achieving therapeutic glycemic response at a specified timepoint or are rescued will count as 
treatment failures from that timepoint.  When proportion of responders (e.g., meeting HbA1c 
criteria; composite endpoints) is needed, the estimates, confidence intervals, and tests will be 
obtained using this methodology with adjustment for baseline variable (e.g., adjustment for 
baseline HbA1c) and stratification factor. For each treatment group, the probability of response 
is first modeled using a logistic regression model with baseline (e.g., baseline HbA1c) and 
stratification factor as the covariates.  Treatment group estimates of response rate are then 
obtained by integrating each group's modeled probability of response over the observed 
distribution of baseline covariate (combined across groups). For analysis of proportion of 
subjects achieving therapeutic glycemic response (HbA1c < 7%), the difference in response rate 
between the saxa-dapa arm and the insulin arm will be displayed along with standard error and 
95% confidence intervals using the methodology of Zhang, Tsiatis and Davidian and Tsiatis, 
Davidian, Zhang and Lu. Non-Inferiority will be demonstrated if the upper bound of the 95% 
confidence interval is less than 10%. 
When there are less than 5 responders in any treatment group, the unadjusted (and difference in) 
proportions, exact 95% confidence interval, and p-values from the Fisher’s exact test (when 
applicable) will be provided.  
7.1.9 
Mean Daily Glucose and Mean Post-prandial Glucose (Self-
monitored) 
All subjects will perform a 6 Point SMBG profile for any 3 days (to be included in the 
calculation of mean daily glucose, the measurements do not need to be recorded over 3 
consecutive days, nor do they need to have 3 complete days of measurements.). These are 
scheduled between Week (-2) to Week (-1), Week 11-12, Week 23-24 and Week 51-52. Blood 
glucose readings will consist of 3 pre-prandial measurements and 3 post-prandial measurements. 
Meals are considered to be breakfast, lunch and dinner. A minimum of 2 days of all 6-point 
SMBGs are required to complete the 6-point SMBG profile for each period. Similarly a 
minimum of 2 days of all post prandial SMBGs will be required for summary of postprandial 
averages. The pre-prandial and postprandial measurements collected at the nominal time points 
will be considered for analysis. 
Glucose concentrations at each of the 6 time points will be averaged over the 3 days to derive the 
mean glucose concentrations at each of the 6 time points. The mean daily glucose (MDG) will then 
be calculated as the average over the average glucose concentrations at the 6 time points. Only 
complete pairs of the average preprandial and postprandial blood glucose values will be used for 
the calculation.  For example, if the available average time point data for a subject at a visit are 


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pre-breakfast, post-breakfast, and pre-dinner, then the daily average will be calculated as (pre-
breakfast + post-breakfast)/2.  The average value for pre-dinner is excluded for the calculation 
since the average value for the post-dinner is missing.  The mean post-prandial glucose will be 
calculated as the average over the average glucose concentrations at the 3 post-prandial time 
points. 
7.1.10 
Mean Amplitude of Glucose Excursions (MAGE) of continuous 
glucose monitoring system readings 
Mean amplitude of glucose excursions (MAGE) is calculated using data from continuous glucose 
monitoring (CGM). MAGE for a 24-hour period equals “the arithmetic mean of the blood glucose 
increases or decreases (from blood glucose nadirs to peaks or vice versa) when both ascending 
and descending segments exceeded the value of one standard deviation of the blood glucose for 
the same 24-hour period”
. Therefore, it corresponds to the mean of absolute differences between 
consecutive maxima and minima, as long as these differences are greater than one standard 
deviation for the same 24-hour period. 
Here an example of calculation as described in the original publication of MAGE in 3.   
Figure 7.1.10-1: 
Blood glucose curve of a subject studied on intermediate-acting 
insulin regimen.  
 
Figure from Service, et al., 1970 3 


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As stated in 3, the calculation of MAGE for subject in Figure 7.1.3-1“is as follows: the first 
excursion, 333 to 208 mg./100 mL ., is 125 mg./100 mL., exceeding the value of one standard 
deviation; 62. The first blood glucose increase, from 208 to 322 mg./100 mL, is 114 mg/100 ml 
[...] and also exceeds one standard deviation; however, the subsequent blood glucose decrease of 
35 mg./100 mL (from 322 to 287 mg./100 mL) is less than one standard deviation and so this 
excursion is not counted. The next blood glucose increase, from 208 to 432 (224 mg./100 mL), and 
decrease, from 432 to 137 mg./100 mL (295 mg./100 mL), both exceed the value of one standard 
deviation; therefore this glycemic excursion is 295 because the first excursion is in a peak-to-nadir 
direction and the direction of calculation (peak-to-nadir or nadir-to-peak) is established, for that 
CBGA, by the direction of the first excursion.” Continuing, the next peak is 272 mg./100 mL which 
corresponds to an excursion of 135 mg./100 mL. The next excursion is 116 mg./100 mL to a nadir 
at 156 mg./100 mL, followed by an excursion of 160 mg./100 mL to a peak at 316 mg./100 mL. 
The next nadir is at 173 mg./100 mL corresponding to an excursion of 143 mg./100 mL and it is 
followed by a peak at 322 mg./100 mL and a respective excursion of 149 mg./100 mL and by a 
nadir at 196 mg./100 mL and a respective excursion of 126 mg./100 mL. The next excursion is 
178 mg./100 mL to a peak at 374 mg./100 mL, followed by one of 332 mg./100 mL to a nadir at 
42 mg./100 mL and one of 186 mg./100 mL to the subsequent peak of 228 mg./100 mL. Finally 
the last couple of excursions are 149 mg./100 mL to the next nadir at 79 mg./100 mL and 163 
mg./100 mL to the final peak point at 242 mg./100 mL. Therefore, MAGE for this subject profile 
corresponds to the arithmetic mean of all excursions and equals approximately 177 mg./100 mL. 
Note although the above example refers to glucose expressed in mg/dL, calculation of MAGE with 
glucose readings expressed in standard international units (i.e. mmol/L) will follow the same 
principle. 
For calculating MAGE the following definitions apply: 
x Segment: the ascending or descending part between a nadir and a peak. 
x Qualifying excursion: A change from nadir to peak (or from peak to nadir) where both 
the excursion and the following segment in the opposite direction exceed 1 standard 
deviation for the whole 24 hour period for the subject. 
MAGE is calculated as the arithmetic mean of all qualifying excursions during the 24 hours. 
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Ǥ
ͳǤ 
7.2 
Study Conduct 
Subjects who deviate from protocol conditions (e.g., important inclusion/exclusion criteria) will 
be reported as having significant protocol deviations. Significant protocol deviations that are 
determined to affect the primary efficacy results are deemed Relevant Protocol Deviations (RPDs). 
A list of relevant protocol deviation criteria, along with the consequent handling of data should 
those deviations occur, is given in Table 1.  There will be no data exclusion for significant protocol 
deviations only.  


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Table 7.2-1: 
List of Relevant Protocol Deviations 
RPD # 
RPD Criteria 
Exclusion 
Type 
Exclusion Level 
1 
Randomized subjects without type 2 diabetes or 
with central laboratory HbA1c more than 0.2% 
outside of specified limits of   8.0% and  12%  
Complete 
This will be assessed using the 
screening value or at an 
unscheduled visit prior to 
randomization. 
 
2 
Randomized subjects who did not receive stable 
dose of metformin with or without a stable dose of 
SU 
Complete 
Subjects not taking  1500 mg 
metformin for at least 8 weeks prior 
to enrollment  
3 
Randomized subjects with abnormal TSH and free 
T4 missing or abnormal at enrollment or at an 
unscheduled visit prior to randomization  
 
Complete 
Because the T4 test is collected 
reactively to TSH, this deviation 
would only occur if there were an 
abnormal TSH and free T4 value 
4 
Randomized subjects with history of 
hemoglobinopathy, (with the exception of sickle 
cell trait (SA) or thalassemia minor), and/or chronic 
or recurrent hemolysis. 
Complete 
 
5 
Randomized subjects who used antihyperglycemic 
medication (other than protocol required 
medications) for 14 or more consecutive days 
during the short-term open-label treatment period. 
Partial 
/Complete 
Exclusion will start from the 14th 
consecutive day that the medication 
was taken/ Subjects who were on 
treatment < 14 days and used 
prohibited  antihyperglycemic 
medication will be  excluded  
6 
Randomized subjects that were treated with any 
systemic corticosteroid therapy for  5 consecutive 
days initiated during the short-term open-label 
treatment period. 
 Partial 
/Complete 
Exclusion will start from the 5th day 
that the medication was taken. 
Subjects who were on treatment < 5 
days and used prohibited  
corticosteroid medication will be 
excluded 
7 
a. Randomized subjects who took no dose of 
metformin or dose of metformin outside dose range 
for  2 consecutive weeks in the short-term open-
label treatment period 
b. Randomized subjects who were on stable dose of 
SU at baseline but took  no dose of SU or different 
SU dose for  2 consecutive weeks in the short-term 
open-label treatment period 
Partial 
/Complete 
Exclusion will start from the 14th 
consecutive day that metformin was 
either not taken or outside range of 
 1500 or dose of SU was changed 
for subjects who were taking SU. 
Subjects who were on treatment < 
14 days and did not take 
metformin/SU according to protocol 
will be excluded  
8 
Randomized subjects who receive no study 
medication (saxagliptin, dapagliflozin, or insulin 
glargine) for  2 consecutive weeks in the short-
term open-label treatment period 
Partial 
/Complete 
Exclusion will start from the 14th 
consecutive day that the medication 
was not taken in an interruption. 
Subjects who were on treatment < 
14 days and did not receive study 
medication (saxagliptin, 


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Table 7.2-1: 
List of Relevant Protocol Deviations 
RPD # 
RPD Criteria 
Exclusion 
Type 
Exclusion Level 
dapagliflozin, or insulin glargine) 
will be excluded 
9 
Randomized subjects who received incorrect study 
medication (saxagliptin, dapagliflozin, or insulin 
glargine)  or dosing for  2 consecutive weeks in 
the short-term open-label treatment period 
Partial/Co
mplete 
 
Exclusion will start from the 14th 
consecutive day that the incorrect 
medication was taken. Subjects who 
were on treatment < 14 days and did 
not receive correct study medication 
(saxagliptin, dapagliflozin, or 
insulin glargine) or dosing will be 
excluded 
10 
Randomized subjects who are judged to be 
noncompliant in terms of overall compliance, i.e., 
who took less than 80% or more than 120% of their 
prescribed dose of study medication during the 
short-term open-label treatment period. 
Complete 
 
* If a patient has an unacceptable/missing value at screening visit but then has an unscheduled visit prior to 
randomization with an acceptable value, the patient will not be considered an RPD. 
 
7.3 
Study Population 
7.3.1 
Subject Disposition 
The disposition of subjects for the screening period, lead-in period, and the 24-week short-term 
treatment period will be summarized. The summary of status in the screening period will include 
all subjects in Enrolled Subjects Data Set. Reasons for discontinuation for subjects who 
discontinued from the lead-in period and from the short-term treatment period will be tabulated 
and listed. The summary will be presented by randomized treatment group and overall. 
 
The summary of status in the combined short-term plus long-term treatment periods will include 
all subjects in Randomized   Subjects Data Set and be presented by randomized treatment group. 
This summary will include subjects entering, completing and discontinuing the long-term 
treatment period with reasons for discontinuation.  
7.3.2 
Demography and Other Baseline Characteristics 
Demographic and other baseline characteristics, including diabetes-related characteristics and 
renal function characteristics will be summarized overall and by treatment group (where 
applicable) using the Randomized Subjects Data Set and/or the Evaluable Subjects Data Set  
Demographic and common baseline characteristics are listed in Table 7.3.2A. Common diabetes 
related baseline characteristics are listed in Table 7.3.2B. Common renal function baseline 
characteristics are listed in Table 7.3.2C. 
 


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Table 7.3.2A: Demographic and Common Baseline Characteristics  
Characteristic 
Summarized as 
Categories 
Gender  
Categorical 
Male, Female 
Age  
Categorical and Continuous 
< 65 yrs 
 65yrs 
65yryrs 
Female Age  
Categorical 
 50 yrs 
> 50 yrs 
Race  
 
Categorical 
White, Black or African American, 
Asian, Other 
 
Ethnicity  
Categorical 
Hispanic/Latino, 
Non Hispanic/Latino 
Body Weight  
Continuous  
- 
Height  
Continuous 
 
Body Mass Index 
Categorical and Continuous 
 
< 25 kg/m2 
 25 kg/m2 
 27 kg/m2 
 30 kg/m2 
Geographic Region 
Categorical 
As defined in Appendix 4  
 
Table 7.3.2B: Common Diabetes-Related Baseline Characteristics  

Characteristic 
Summarized as  
Categories 
Duration of Type 2 Diabetes 
Categorical and Continuous 
 
< 3 yrs 
 3 and  10 yrs 
> 10 yrs 
HbA1c  
Categorical and Continuous 
<8% 
 8 and < 9% 
 9% 
FPG  
Continuous  
- 

Table 7.3.2C: Common Renal Function Baseline Characteristics

Characteristic  
Summarized as 
Categories 
eGFR 
(MDRD) 
Categorical and Continuous 
<60 mL/min/1.73m^2 
 >=60-<90 mL/min/1.73m^2 
 >= 90 mL/min/1.73m^2 

All summaries of continuous characteristics will be based on non-missing observations. For 
categorical characteristics, percentages will be calculated out of the total number of subjects in the 
data set, overall and by treatment group, where applicable (i.e., each denominator includes the 
number of subjects with missing/unknown values for the characteristic). 
7.3.3 
Specific and General Disease History 
The number (percent) of subjects with diabetes, diabetes-related disease histories will be 
summarized by treatment group and overall using the Randomized Subjects Data Set for the 
short-term treatment period. 


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The number (percent) of subjects with general medical history findings will also be summarized 
by treatment group and overall using the Randomized Subjects Data Set for the short-term 
treatment period. 
 
 


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7.4 
Extent of Exposure 
7.4.1 
Study and Rescue Medication 
The extent of exposure to study medication during the 24-week short-term open-label treatment 
period is defined as the difference between the last and the first dose of study medication of the 
short-term open-label treatment period plus 1 day. The extent of exposure to study medication will 
be summarized using the Treated Subjects data set for the short-term open-label treatment period 
and the short-term open-label treatment period prior to rescue, where the number and percent of 
subjects with an extent of exposure within specified day ranges (1-6, 7-14, 15-28, 29-42, 43-56, 
57-70, 71-84, 85-168, 169-182, >= 183 days) will be presented by treatment group. The mean 
(SD), median and range of the number of days of exposure will also be presented. Summaries will 
be presented excluding and including periods of interruptions (defined by record of 0 tablets of 
study medications on the case report form (CRF). Total daily insulin dose at Week 12 and Week 
24 during the 24-week open-label treatment period will be summarized for the subjects taking 
Insulin. All rescue medication use during the 24-week short-term open-label treatment period will 
be summarized and listed by treatment group. 
The extent of exposure to study medication during the combined ST+LT treatment periods is 
defined as the difference between the last dose of ST or LT treatment and the first dose of study 
medication plus 1 day. The extent of exposure to study medication will be summarized using the 
Treated Subjects data set for the combined ST+LT treatment periods, regardless of and prior to 
rescue. The number and percent of subjects with an extent of exposure within pre-specified day 
ranges (1-90, 91-180, 181-270, and > 270 days) will be presented by treatment group. The mean 
(SD), median and range of the number of days of exposure will also be presented. Summaries will 
be presented including periods of interruptions (defined by record of 0 tablets of study medications 
on the case report form (CRF)). All rescue medication use during the combined ST+LT treatment 
periods will be summarized and listed by treatment group. 
A listing of subjects by batch number of study medication will also be generated for both ST and 
ST+LT treatment periods. 
7.4.2 
Concomitant Medications 
Concomitant medications for the short-term treatment period will be any medication taken from 
start of the short-term treatment period up to the end of the short-term treatment period. 
Concomitant  medications for combined short-term plus long-term treatment periods will be any 
medication  taken  from  start  of  the  ST  treatment  period  up  to  the  end  of  the combined 
ST+LT treatment periods. 
Concomitant medications for both the ST and ST+LT will be summarized using the Treated 
Subjects dataset by drug class and (generic) drug name. A summary table by drug class and generic 
drug name will be generated for each of the following: 
 


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In addition, a listing of all non-study medications taken during the study (including prior and 
concomitant) will be produced. 
Missing and partial date handling of start and stop dates of concomitant medications is described 
in Section 8.7. The WHO dictionary will be used to code the non-study medication. 
7.4.3 
Measurements of Treatment Compliance 
Percent treatment compliance will be calculated for ST and ST+LT treatment period for each 
treatment group. For each subject, percent compliance for saxagliptin plus dapagliflozin treatment 
group is defined as the total number of tablets taken divided by the total number of tablets that 
should have been taken, multiplied by 100.  Percent compliance for Insulin treatment group is 
calculated as number of days insulin dose was taken divided by the number of days insulin dose 
should have been taken (duration of exposure), multiplied by 100. A subject is considered 
compliant if percent compliance   is  80% and   120%. The number and percent of subjects 
considered compliant will be summarized for each treatment group using the Treated Subjects data 
set. 
For the Short-term: 
The number of tablets that should have been taken is calculated as 1 + the number of days from 
the first short-term treatment period dose recorded in the “Record of Study Medication” to the 
last short-term treatment dose, times the prescribed daily dose (i.e. 2 tablets per day, one from 
each bottle). The number of tablets taken is the total number of tablets recorded (sum of bottle 1 
and bottle 2) as taken based on the CRF, summed over the days counted when calculating the 
number of tablets that should have been taken, including the day of the last short-term treatment 
dose. 
For the combined ST and LT: 
The number of tablets that should  have  been taken  is calculated  as 1 + the number  of days  
from the  first  treatment period dose recorded in the “Record of Study Medication” to the last 
treatment dose, times the prescribed daily dose (ie, 2 tablets per day, one from each bottle). The 
number of tablets taken is the total number of tablets recorded (sum of bottle 1 and bottle 2) as 
taken based on the CRF, summed over the days counted when calculating the number of tablets 
that should have been taken, including the day of the last treatment dose. 
 
7.5 
Efficacy 
7.5.1 
Overall Efficacy Summary 
Efficacy analyses will be performed using the randomized subjects data set. For the non-inferiority 
endpoints, the analysis will also be performed in the evaluable subject data set. All analyses 
included in the hierarchical testing below, including the primary analysis, will use the randomized 


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subject data set. The analyses using the evaluable subject data set will not be included in the 
hierarchical testing. 
All the main analyses will be conducted using values prior to rescue/intensification of treatment 
or treatment discontinuation. Values collected after this time will be excluded from analyses. 
Sensitivity analysis using data regardless of rescue or treatment discontinuation will also be 
performed for the primary efficacy endpoint to assess the robustness of the primary efficacy 
results. 
The primary endpoint is the change in HbA1 from baseline at Week 24 visit. The primary endpoint 
will be tested for non-inferiority for saxagliptin plus dapagliflozin versus insulin at the alpha = 
0.025 level (one sided), within a non-inferiority margin of 0.30%.  If non-inferiority is 
demonstrated for the primary endpoint, the statistical tests for the secondary efficacy endpoints 
will be performed. The secondary endpoints then will be tested sequentially in the order that they 
appear below and in the objectives section of the protocol.  Each comparison will be tested at the 
alpha = 0.05 (two-sided) level.  Statistical tests between the dapagliflozin plus saxagliptin group 
and insulin group will be only performed for a given secondary endpoint if all previous sequential 
tests are statistically significant. Otherwise, the testing procedure will stop at the secondary 
endpoint that does not reach statistical significance.  These secondary endpoints are all testing 
superiority, with the exception of the fourth and fifth bullets below which are testing non-
inferiority. 
x Change from baseline in total body weight at Week 24 (tested for superiority) 
x Proportion of subjects with confirmed hypoglycemia [defined as: blood glucose d 70 
mg/dL (3.9 mmol/L) recorded in the hypoglycemia module of the CRF] at Week 24 (testing 
superiority) 
x Proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c < 
7.0%, without any reported hypoglycemia (for the duration of the Short-term Period) at 
Week 24   (testing superiority) 
x In a sub-study, change from baseline in the mean value of 24-hour glucose readings 
measured by Continuous Glucose Monitoring (CGM) at Week 2 (testing non-inferiority, 
using a non-inferiority margin of 12 mg/dL) 
x Proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c < 
7.0% at Week 24 (testing non-inferiority, using a non-inferiority margin of 10%) 
Analyses of secondary and exploratory endpoints specifically designed for sub-studies (CGM) will 
be performed using the subsets of the Randomized Subjects data set for the sub-studies. 
7.5.2 
Primary Efficacy Analysis 
The primary endpoint is the change in HbA1 from baseline at Week 24 visit.  The primary 
endpoint will be tested for non-inferiority for saxagliptin plus dapagliflozin versus insulin at the 
alpha = 0.025 level (one sided).  The primary analysis of the change in HbA1c from baseline at 
Week 24 visit will be based on a longitudinal repeated measures analysis using ‘direct 
likelihood’.  The model will use subjects in the primary efficacy data set (i.e., randomized 
subjects data set) who have a baseline assessment and at least one post-baseline open-label 


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treatment period assessment.  The SAS procedure PROC MIXED will be used.  The preferred 
model will include the fixed categorical effects of treatment, week, randomization stratification 
factor (background medication of metformin alone vs. metformin + SU) and treatment-by-week 
interaction as well as the continuous fixed covariates of baseline measurement and baseline 
measurement-by-week interaction (see Model 7.1.2.1 in Section 7.1.2).  An unstructured matrix 
for the within-subject error variance-covariance will be used. The denominator degrees of 
freedom will be calculated according to the Kenward-Roger method.  A number of back-up 
models are defined in the Core statistical analysis plan (Section 7.1.2) in case of non-
convergence of the preferred model or other issues.  Data collected outside the analysis window 
(defined in Section 8 of this SAP) after subjects discontinued study medication will also be 
excluded from the primary analysis.Point estimates and 95% confidence intervals for the mean 
change within each treatment group as well as the difference in mean change between the 
saxagliptin plus dapagliflozin versus insulin will be calculated.  If the upper limit of the 95% 
confidence interval of the difference is < 0.3%, then saxagliptin plus dapagliflozin as add-on 
therapy to metformin with or without SU will be considered non-inferior to insulin as add-on 
therapy to metformin with or without SU.  
Sensitivity Analyses  
The following sensitivity analyses will be carried out for the primary end point: 
x Primary analysis will be repeated using Evaluable Subjects data set. 
x Primary analysis will be repeated using all available values regardless of rescue or 
treatment discontinuation 
x An ANCOVA analysis using values prior to rescue or treatment discontinuation 
(LOCF will be used if the week 24 value is not available) 
x Analyses to address missing values (described below in section 7.5.3) 
- 
Analysis using multiple imputation return-to-baseline  
- 
Tipping point analysis 
 
7.5.3 
Handling of missing efficacy data  
Missing data in this study may result from patients discontinuing from the study prematurely or 
missing intermediate visits or selected assessments while remaining on study.  Every reasonable 
effort will be made to obtain the protocol-required data for all study assessments that are 
scheduled for all patients who have been enrolled.  For efficacy analyses, missing observations 
will not be imputed, except those inherited from the mixed model repeated measures (MMRM) 
which assumes that data are missing at random (MAR).   
MAR refers to missingness that is independent of missing responses, conditionally on observed 
responses and covariates.  As the imputation strategy should always consider the dropout 
patterns and the time-course of the efficacy measurements by treatment, the pre- and post- 
withdrawal values will be assessed to understand the impact of dropouts on the efficacy results.  


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The primary efficacy endpoint of HbA1c data will be visually examined to explore the 
missingness patterns by (1) plotting each individual patient’s HbA1c change trajectory in 
completers, side-by-side with those from the early study drug withdrawal, and by (2) plotting the 
early study drug withdrawal’s last HbA1c change data, overlaid with the box plot by visit from 
completer population. Two additional methods of sensitivity analyses will be performed to 
compare the results from an MAR-based analysis versus an MNAR–based analysis under several 
MNAR scenarios. The first method is the return-to-baseline using Multiple Imputation in which 
patients with missing data known or believed to have discontinued protocol therapy were 
assumed to have a washout (“return to baseline”) of any potential treatment effect. More 
specifically for each imputation of the multiple imputation, for those subject with missing Week 
24 measurements for HbA1c. The second method is the Tipping Point Analysis, which assumes 
that patients from the experimental treatment arm who discontinue treatment or initiate a rescue 
therapy would have values worse by some amount “delta” compared to efficacy values of similar 
patients who continue with study treatment and do not require rescue. The detailed analysis plan 
and implementation of these methods are described in section 7.5.3.1, and 7.5.3.2. 
The analysis for the treatment difference will be based on an ANCOVA model with change from 
baseline to week 24 as the dependent variable and covariate/factors of treatment group, 
randomization strata, and baseline HbA1c. 
 
7.5.3.1 
MMRM Model for Change from Baseline Based on Return-to-Baseline 
Multiple Imputation 
The return-to-baseline MI (Multiple Imputation) imputes the change from baseline to Week 24, 
and samples will be drawn from a Normal distribution with mean 0 and variance of pooled 
data. Let X = (Xobs, Xmiss) be the complete data at Week 24. X is consisted of observed 
measurements Xobs and the missing observations Xmiss.  In return-to-baseline imputation, when 
X is change from baseline (CHG), each missing observation Xmiss is imputed by a random draw 
from a Normal distribution with mean 0 and variance vimp: 
Xmis ~ N(0, vimp), 
The variance vimp is calculated from the observed changes: 
vimp = (1 + 1/Nc) vc, 
where vc is the variance of the change among completers across all treatment arms, and Nc is the 
number of completers. 
An ANCOVA model will be used to analyze the imputed datasets for change from baseline 
with treatment group and randomization strata as fixed factors and Baseline HbA1c as a 
covariate. The least square mean (LS mean) estimates will be combined using Rubin’s 
combination rules for statistical inference. All available measurements will be used including 
observations post-rescue and post-discontinuation of treatment. 


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In this study, the primary analysis is comparing Saxagliptin + Dapagliflozin + Metformin group 
to control group Insulin Glargine + Metformin. The above approach will be conducted using the 
Insulin Glargine + Metformin as the control group. 
 
7.5.3.2 
Tipping Point Analysis based on ANCOVA Model for Change from 
Baseline Using Multiple Imputation 
In order to address the impact of missing data due to initiation of rescue therapy, or premature 
treatment discontinuation on the primary efficacy analysis, a Tipping Point Analysis using 
multiple imputation will be performed to compare the results from analysis assuming a missing 
at random (MAR) mechanism versus analysis assuming a missing not at random (MNAR) 
mechanism. The specific MNAR assumption that will be considered in this framework is that 
patients from the experimental treatment arm who discontinue study treatment prematurely or 
who initiate a rescue therapy would have, on average, their efficacy values post rescue/post 
treatment discontinuation worse by some amount delta compared to efficacy values of similar 
patients who continue with the study treatment and do not require rescue therapy. Delta is 
considered a sensitivity parameter representing a degree of departure from the MAR assumption. 
The aim of the Tipping Point Analysis is to find a “tipping point” corresponding to a value of 
delta where the study conclusion of a non-inferior treatment effect would no longer hold. An 
interpretation of clinical plausibility of the assumption underlying the tipping point will be 
provided.    
The tipping point approach based on multiple imputation of values at time points after treatment 
discontinuation or initiation of rescue can be performed with a specified adjustment (referred to 
as delta adjustment or shift) applied to values imputed under an MAR-based imputation model 
for the appropriate subset of patients. In order to find a tipping point, a series of imputations will 
be performed with increasing values of delta.  
For the primary endpoint which is a continuous variable, we will use an additive delta adjustment 
(a shift) as follows: 
ܻ௝ሺ௔ௗ௝ሻ
ሺ௠ሻ
ൌܻ௝ሺ௜௠௣ሻ
ሺ௠ሻ
൅ߜ 
Where - 
 
í 
ܻ௝ሺ௜௠௣ሻ
ሼ௠ሻ
 are values imputed using a MAR-based imputation model in the mth 
imputed dataset, m=1,…,M (number of imputations) 
 
í 
ߜ is a mean shift (delta adjustment) parameter for adjusting imputed values  
 
The main steps in the implementation of the Tipping Point Analysis are described below.  


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Step 1: Investigate missing data patterns in the source data (containing observed values prior to 
initiation of rescue therapy or premature study treatment discontinuation).  If missing data have 
both monotone and non-monotone patterns, use a multivariate regression imputation model and 
the Markov chain Monte Carlo (MCMC) method to partially impute non-monotone data under 
the MAR assumption.  The variables used as explanatory variables for imputation include 
Randomization strata, HbA1c baseline, and post-baseline HbA1c at each time point. The 
imputations will be done separately within each treatment arm. If there are not enough 
observations to properly estimate covariance parameters, then stratification variables could be 
removed from the MCMC step, and/or the treatment arm can be included as an explanatory 
variable in the model. 
As a result, each imputed dataset will only have a monotone missing data pattern.  
Step 2: Impute remaining monotone missing data using an MAR-based regression imputation 
model for all patients who discontinued study treatment prematurely or initiated a rescue therapy. 
Apply a shift (an additive delta adjustment) to imputed values of patients in the experimental 
treatment arm (Saxagliptin + Dapagliflozin + Metformin). The variables used as explanatory 
variables for imputation include Treatment, Randomization strata, HbA1c baseline, and post-
baseline HbA1c at each time point.  
Imputations with delta adjustment described above will be performed with varying values of 
delta in order to perform a series of analyses with progressively larger values of delta until a 
tipping point is reached. A tipping point will correspond to the smallest value of delta for which 
the primary hypothesis (non-inferiority) is no longer held (the upper bound of 95% confidence 
interval of the difference is greater than 0.3).   
Step 3: At each level of delta, analyze each of multiple imputed datasets using the same 
ANCOVA model as used for the primary analysis. Combine estimates obtained from multiple 
imputed datasets based on Rubin’s combination rules. 
Step 4: Using 95% upper CI, find the tipping point, ie, the value of delta parameter for which the 
primary non-inferiority hypothesis is no longer held. In this study, we will compare the non-
inferiority of Saxagliptin + Dapagliflozin + Metformin vs. Insulin Glargine + Metformin for each 
Delta value. We will find the delta value at which the test of non-inferiority hypothesis is no 
longer held. A clinical interpretation about the plausibility of the assumptions underlying the 
tipping point will be provided.  
 
7.5.4 
Secondary Efficacy Analyses 
If non-inferiority is demonstrated for the primary endpoint, the statistical tests for the secondary 
efficacy endpoints will be performed.  The secondary endpoints then will be tested sequentially in 
the order that they appear in the objectives section of the protocol.  Each comparison will be tested 
at the alpha = 0.05 (two-sided) level for superiority.  Statistical tests between the dapagliflozin 


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plus saxagliptin group and insulin group will be only performed for a given secondary endpoint if 
all previous sequential tests are statistically significant.  Otherwise, the testing procedure will stop 
at the secondary endpoint that does not reach statistical significance.  
The continuous secondary endpoints (i.e., the change from baseline in total body weight, the 
change from baseline at Week 24 visit in the mean value of 24-hour glucose readings obtained 
from CGM) will be analyzed using a longitudinal repeated measures analysis, similarly to the 
one used for primary efficacy analysis.  The proportion of subjects achieving HbA1c < 7.0% will 
be analyzed using the methodology of Zhang, Tsiatis, and Davidian and Tsiatis, Davidian, 
Zhang, and Lu with adjustment for baseline HbA1c value and/or the stratification factor. The 
other binary endpoints (hypoglycemia endpoint and composite response endpoints of glycemic 
control with hypoglycemia) will be analyzed using logistic regression with adjustment for 
baseline HbA1c value and/or the stratification factor.   In addition to point estimates and 95% 
confidence intervals, p-values will be calculated for all secondary endpoints.  However, no claim 
will be based on endpoints for which the statistical testing is not performed for the endpoint as 
per the testing strategy as described above.  A clear distinction will be made between p-values 
whereby claims can and cannot be made.  All secondary efficacy analyses will use subjects in the 
primary efficacy data set (i.e., randomized subjects data set) who have a baseline assessment and 
any post-baseline open-label treatment period assessment.   
For the two secondary endpoints which are tested for non-inferiority, the analysis will be repeated 
using evaluable subjects data set to examine the robustness of the results.  The non-inferiority 
margins for the two secondary endpoints testing for non inferiority are specified in Table 7.5.4-1. 
Table 7.5.4-1: 
Non-inferiority margins specified for primary/secondary endpoints 
Secondary Endpoint 
Non-inferiority Margin 
Change from baseline in HbA1c at Week 24 
0.30% 
Change from baseline in mean 24-hour glucose readings measured by 
Continuous Glucose Monitoring (CGM) at Week 2 
12 mg/dL 
Proportion of subjects achieving a therapeutic glycemic response, defined as 
HbA1c < 7.0% at Week 24 
10% 
 
7.5.5 
Exploratory Efficacy Analyses 
None of the exploratory endpoints will be statistically tested. 
7.5.5.1 
Mean change from baseline at Week t 
The analyses of change from baseline in exploratory endpoints will be performed using the 
longitudinal repeated measures model (Model 7.1.2.1, including the stratification factor) as 
described in Section 7.1.2. 


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7.5.5.2 
Glycemic Rescue or Discontinuation from Study treatment due to Lack 
of Efficacy 
The proportion of subjects requiring treatment intensification (glycemic rescue or discontinue 
study treatment for lack of efficacy) up to Week 24 / 52 will be assessed by summarizing the 
difference in the percentages between treatment groups and by a time-to-event analysis using the 
Kaplan-Meier methodology. 
Time to treatment intensification will be analyzed using a Cox proportional hazards model.  
Estimates of hazard ratio and 95% confidence intervals will be provided.  Kaplan-Meier plots
 of 
time to intensification at Weeks 24 and 52 will be calculated and plotted by treatment group. 
Unless otherwise specified, the plot will be presented only when there are at least 10 events in one 
treatment group.  Additionally, a table will accompany the plot and will display the Kaplan-Meier 
estimates of the cumulative proportion (with 95% CI calculated based on Greenwood’s method
 
when applicable) of subjects with event at specific time points by treatment group. If the estimated 
lower bound of 95% CI is below 0 or the estimated upper bound of 95% CI is over 1, then it will 
be restricted to 0 or 1 respectively.  For the analysis during 24 / 52 weeks, all subjects will be 
censored at Week 24 / 52 visit (end of ST treatment/end of LT treatment) if treatment 
intensification has not occurred by then.  Subjects rescued at Week 24 / 52 will be counted as 
having an event for the analysis. 
Composite response endpoints (glycemic control without hypoglycemia), will be analyzed using 
logistic regression with adjustment for baseline HbA1c value and/or the stratification factor. None 
of the exploratory endpoints will be statistically tested 
In addition, an analysis of the proportion of subjects not rescued and achieving glycemic response 
(defined as HbA1c < 7%) in subjects from the Short-term Completers Data Set at time points 
during the LT period will be performed using the same methodology described above (with 
adjustment for end of ST HbA1c measurement). Subjects discontinued or missed measurements 
(regardless of the type of missing) at the specific time point will be considered as not achieving 
glycemic response. 
7.5.5.3 
Summary of change from baseline for lipids 
The change from baseline in lipids data during the short-term and long-term treatment periods 
will be summarized for each treatment group. 
 
7.5.6 Summary of Primary Efficacy Endpoint within Subgroups 
Treatment effects will be assessed for subgroups based on age group, gender, race, region, and 
baseline HbA1c, as defined in Table 7.3.2A and Table 7.3.2B. The analyses will be based on 
model 7.1.2.1 with additional covariates of subgroups, treatment-by-subgroup, visit-by-
subgroup, and treatment-by-visit-by-subgroup. Additionally the treatment-by-stratification 
interaction will be assessed. The nominal p-value for subgroup-by-treatment interaction will be 
presented. The p-value for the test of treatment by age, female age, baseline HbA1c, and baseline 
eGFR interaction will include corresponding continuous subgroup variables in the model. 


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Adjusted mean change from baseline and its difference from the control group will be given for 
each subgroup at week 24. 
 
7.5.7 
Pharmacokinetic Analyses 
Not applicable 
7.5.8 
Biomarker Analyses 
Not applicable. 
7.5.9 
Outcomes Research Analyses 
The Phase V® Health Outcomes Information System Diabetes Module will be used for the patient-
reported outcomes (PRO) assessments. The self-administered PRO questionnaires consist of 
validated generic and diabetes-specific modules of treatment satisfaction, quality of life, barriers 
to medication adherence and weight perception.  Mean change from baseline in these parameters 
will be analyzed using longitudinal repeated measures model with terms for treatment group, 
baseline value, randomization stratification factor (back ground medication of metformin alone vs. 
metformin + SU), time, the interaction of treatment and time, and the interaction of baseline value 
and time. Point estimates and 95% confidence intervals will be calculated for the adjusted mean 
changes within each treatment group as well as for the differences in adjusted mean changes 
between treatment groups. 
Phase V® is collecting the data and analyzing the data for patient reported outcomes in this study. 
More details on the collection and analysis is provided in Appendix 2. 
7.5.10 
Other Analysis 
Not applicable. 
7.5.11 
Interim Analyses 
There will be produced one study report at the end of Short-term Period and a second study report 
at the end of Short-term plus Long-term period. 
7.6 
Safety 
The assessment of safety will be based on the analyses of AEs, vital signs, physical examinations, 
ECGs, hypoglycaemia, and clinical laboratory evaluations.  All safety analyses will be performed 
using treated subjects data set. 
The Treated Subjects Data Set will be used for all safety analyses, including data after rescue.  
Safety analyses will be performed using data from the 24-week open label period (at the time of 
the primary endpoint analysis) and then again at the final database lock (52 weeks) on the 
combined ST+LT treatment period.  Sensitivity analyses on data collected prior to rescue will be 
performed for selected Adverse Events (AEs) as described in Section 7.6 of the ST Core SAP and 
Section 7.5 of the ST+LT Core SAP. 


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7.6.1 
Adverse Events 
.Adverse events analyses will be performed for the ST and ST+LT periods. 
 
Adverse  Events  (AEs)  will  be  classified  by  Primary  System  Organ  Class  (SOC)  and 
Preferred Term (PT) according to the Medical Dictionary for Regulatory Activities (MedDRA). 
Summaries of AEs will use the version of MedDRA that is current at the time of database lock 
for each study. Counting rules for adverse events are described in Section 8.7. 
 
In summaries by SOC and PT, AEs will be sorted by decreasing frequency within each SOC 
and PT. In summaries by PT, AEs will be sorted by decreasing frequency within PT according 
to the highest of either of the combinational dose group across the study. 
Separate pages to capture events of hypoglycemia are contained within the CRF. Hypoglycemia 
or discontinuation due to hypoglycemia would not be reported on an AE CRF page unless the 
event fulfilled criteria for a Serious AE (SAE) in which case an SAE form would be 
completed. Hypoglycemia events that are reported as SAEs will be included in all summaries of 
AEs or SAEs (see Section 7.6.1.1). Separate summaries will be provided including 
hypoglycemia events reported on that special CRF pages. 
 
7.6.1.1 
All Adverse Events 
An overall summary of adverse events at subject level, including AEs, SAEs, death, 
hypoglycemia, treatment-related events and events leading to the discontinuation of study 
medication will be performed for the short-term treatment periods. All adverse events 
(serious and non-serious, excluding hypoglycemic events that are not reported as SAEs) will be 
summarized by system organ class, preferred term for the short-term treatment periods.   For the 
analyses of the short-term treatment period, the summary of AEs and analyses by SOC and PT 
will be performed for the primary and sensitivity safety analyses.  In addition, a subject listing 
of all reported adverse events will be produced, displaying all events (including pre-treatment 
events) that occurred prior to the start date of long-term treatment period, if any. All adverse 
events (serious and non-serious) including all hypoglycemic events will also be summarized by 
treatment group, where applicable. 
 
 
AEs and SAEs with an onset from Day 1 of short-term treatment up to and including 4 days 
and 30 days respectively, after the last dose date in the short-term treatment period (or up and 
including to the start date of the long-term treatment period whichever comes first) will be 
considered as occurring during the short-term treatment period. 
 
In addition, the following summaries will be provided for the short-term treatment period 
(excluding hypoglycemic events that are not reported as SAEs): 
 
 


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In addition to analyses of event incidence at the subject level, recurrence analyses will be 
performed at the event level.   In order to prepare these summaries, the CRF data will be 
processed to categorize each line of patient data as a new occurrence or a continuation of an 
existing event. This determination will be based upon onset and resolution dates. Each line of 
patient data will represent the maximum severity observed at the time of occurrence as well 
as the last known assessed relationship to study medication by the investigator. 
 
The following summary information will be provided: 
 
Total number and rate (exposure adjusted) of occurrences for all AEs occurring in at least 5% of 
the subjects treated. 
 
Additionally, a listing will be provided displaying the unique instances of all AEs, i.e., after 
duplicates have been eliminated and overlapping and contiguous occurrences of the same event 
have been collapsed. Because of how hypoglycemic events are assessed and captured in the 
database, each reported event is assumed to be unique and multiple hypoglycemic events will 
not be collapsed. 
 
Similar analyses of adverse events will be performed for ST+LT treatment period.  AEs and 
SAEs with an onset from Day 1 of short-term treatment up to and including 4 days and 30 days 
respectively, after the last dose date in the ST or LT treatment period will be included in 
summaries of the combined ST+LT treatment periods. 
No formal comparisons will be made between treatments. No formal statistical testing will be 
performed, only summary statistics will be provided. 
7.6.2 
Deaths 
All deaths recorded on the status page, the AE page, or SAE page (with a death date, cause of 
death, outcome or SAE categorization present) of the CRF will be considered a death in the 
analyses. Any deaths that occur during the study will be described in depth as narrative in the 
CSR. A listing of all deaths that occur prior to the start date of long-term treatment period will 
be produced for ST and listing of all deaths that occur during the study will be produced for 
ST+LT. 
7.6.3 
Serious Adverse Events 
All SAEs (including hypoglycemic events) will be described in narratives, regardless of 
investigator assessment of causality.  


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SAEs with an onset from Day 1 of short-term treatment up to and including 30 days after the last 
dose date in the short-term treatment period (or up to the start date of the long-term treatment 
period whichever comes first) will be considered as occurring during the short-term treatment 
period. 
SAEs with an onset from Day 1 of ST treatment up to and including 30 days after the last dose 
date in the ST or LT treatment period will be considered as occurring during the combined 
ST+LT treatment periods. 
 
SAEs occurring during the ST/ST+LT treatment period will be summarized by system organ 
class, preferred term and treatment group for both the primary and sensitivity safety analyses. In 
addition, the proportion of subjects with related SAEs will be presented by system organ class, 
preferred term and treatment group.  
 
A listing of all SAEs for ST will be produced, displaying all SAEs (including pre-treatment 
events) that occurred prior to the start date of long-term treatment period. 
A listing of all SAEs for ST+LT will be produced, displaying all SAEs (including pre-treatment 
events) that occurred during the study. 
 
7.6.4 
Adverse Events Leading to Discontinuation of Study Medication  
AEs with an onset during the short-term treatment period reported with an action taken of 
discontinuation of study medication will be summarized by system organ class, preferred term 
and treatment group for both the primary and sensitivity safety analyses. This summary will 
include hypoglycemia events that reported as SAEs. AEs leading to discontinuation with an onset 
date on or prior to the start date of the long-term treatment period will be summarized. In 
addition, a subject listing of discontinuations due to AEs will be provided, displaying all events 
that led to discontinuation with an onset date prior to the start of long-term treatment period. 
AEs with an onset during the combined ST+LT treatment periods reported with an action taken 
of discontinuation of study medication will be summarized by SOC, PT, and treatment group for 
the primary  safety analysis.  This summary will include hypoglycemia events that reported as 
SAEs. When summarizing AEs leading to discontinuation for ST+LT, no upper cutoff day 
windows (ie, 4 days and 30 days from last dosing date for AEs and SAEs respectively) will be 
applied. In addition, a subject listing of discontinuations due to AEs will be provided, displaying 
all events that led to discontinuation. 
7.6.5 
Adverse Events of Special Interest (AEOSI) 
Separate summaries will be provided for the following adverse events of special interest 
(AEOSI). Except as otherwise noted, to identify each type of adverse event of special interest in 
this section, a list of PTs will be selected before database lock and unblinding of the database.  
AEs and SAEs of special interest with an onset from Day 1 of short-term treatment up to and 
including 4 days and 30 days respectively, after the last dose date in the short-term treatment 
period (or up to the start date of the long-term treatment period whichever comes first) will be 
considered as occurring during the short-term treatment period. 


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AEs and SAEs of special interest with an onset from Day 1 of ST treatment up to and including 
4 days and 30 days respectively, after the last dose date in the ST or LT treatment period will be 
considered as occurring during the combined ST+LT treatment periods. 
7.6.5.1 
Hypoglycemia 
Separate pages to capture events of hypoglycemia are contained within the CRF.  
 
Hypoglycemic events with an onset from Day 1 of the short-term open-label treatment up to and 
including 4 days after the last dose date in the short-term open-label treatment period (or up to 
and including the start date of the long-term treatment period, whichever comes first) will be 
considered as occurring during the Short-term open-label treatment period. Hypoglycemic 
events with an onset from Day 1 of the short-term open-label treatment up to and including 4 
days after the last dose date in the long-term treatment period will be considered as occurring 
during the Short-term plus long-term treatment period.  
Hypoglycemic events will be categorized using two methods.  One classification is based on the 
ADA recommendations
: 
 
Severe hypoglycemia: “An event requiring assistance of another person to actively administer 
carbohydrate, glucagons, or other resuscitative actions. These episodes may be associated with 
sufficient neuroglycopenia to induce seizure or coma. Plasma glucose measurements may not be 
available during such an event, but neurological recovery attributable to the restoration of plasma 
glucose to normal is considered sufficient evidence that the event was induced by a low plasma 
glucose concentration.” Error! Bookmark not defined.  
Documented symptomatic hypoglycemia:“An event during which typical symptoms of 
hypoglycemia are accompanied by a measured plasma glucose concentration  70mg/dl 
(3.9mmol/l).” Error! Bookmark not defined. 
Asymptomatic hypoglycemia: “An event not accompanied by typical symptoms of 
hypoglycemia but with a measured plasma glucose concentration  70mg/dl (3.9mmol/l). Since 
the glycemic threshold for activation of glucagon and epinephrine secretion as glucose levels 
decline is normally 65–70mg/dl (3.6–3.9mmol/l) (24–26) and since antecedent plasma glucose 
concentrations of  70mg/dl (3.9mmol/l) reduce sympathoadrenal responses to subsequent 
hypoglycemia (1,11,20), this criterion sets the lower limit for the variation in plasma glucose in 
nondiabetic, nonpregnant individuals as the conservative lower limit for individuals with 
diabetes.” Error! Bookmark not defined. 
Probable symptomatic hypoglycemia:  “An event during which symptoms of hypoglycemia are 
not accompanied by a plasma glucose determination (but that was presumably caused by a 
plasma glucose concentration  70mg/dl [3.9mmol/l]). Since many people with diabetes choose 
to treat symptoms with oral carbohydrate without a test of plasma glucose, it is important to 
recognize these events as “probable” hypoglycemia. Such self-reported episodes that are not 
confirmed by a contemporaneous low plasma glucose determination may not be suitable 
outcome measures for clinical studies that are aimed at evaluating therapy, but they should be 
reported.” Error! Bookmark not defined. 


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Relative hypoglycemia: “An event during which the person with diabetes reports any of the 
typical symptoms of hypoglycemia, and interprets those as indicative of hypoglycemia, but with 
a measured plasma glucose concentration > 70mg/dl (3.9mmol/l). This category reflects the fact 
that subjects with chronically poor glycemic control can experience symptoms of hypoglycemia 
at plasma glucose levels > 70mg/dl (3.9mmol/l) as plasma glucose concentrations decline toward 
that level (27,28). Though causing distress and interfering with the patient’s sense of well-being, 
and potentially limiting the achievement of optimal glycemic control, such episodes probably 
pose no direct harm and therefore may not be a suitable outcome measure for clinical studies that 
are aimed at evaluating therapy, but they should be reported.” Error! Bookmark not defined. 
The second classification of hypoglycemic events follows: 
Major episodes of hypoglycemia - defined as symptomatic episodes requiring external (3rd 
party) assistance due to severe impairment in consciousness or behavior with a capillary or 
plasma glucose value < 3 mmol/L (< 54 mg/dL) and prompt recovery after glucose or glucagon 
administration. 
Minor episodes of hypoglycemia - defined as either a symptomatic episode with a capillary or 
plasma glucose measurement below 3.5 mmol/L (63 mg/dL) regardless of need for third-party 
assistance or an asymptomatic capillary or plasma glucose measurement below 3.5 mmol/L (63 
mg/dL), that does not qualify as a major episode. 
Other episodes of hypoglycemia - defined as episodes reported by the investigator that are 
suggestive of hypoglycemia but do not meet the above criteria.  
All analyses of hypoglycemic events will be performed both overall and by each class of events 
both including and excluding rescue data, with the ADA classification system and excluding 
rescue data analysis serving as the primary analysis. Data collected in the hypoglycemia CRF 
modules of the CRF will be included in the analysis. All blood glucose measurements collected 
in the hypoglycemia module of CRF will be considered for classifying the hypoglycemia events 
irrespective of the method using which glucose data were collected. 
The total number of events by treatment group will be summarized for the short-term open-label 
treatment period.  Hypoglycemic events with an onset during the short-term open-label treatment 
period and leading to discontinuation of study medication will be summarized by treatment 
group. When summarizing hypoglycemic events leading to discontinuation no upper cutoff day 
windows are applied. For short-term open-label period analyses the only upper cutoff date is the 
start date of the long-term treatment period. 
A summary of the incidence of confirmed hypoglycemia, defined as blood glucose value  
70mg/dL as recorded in the hypoglycemia module of CRF will be provided.   
A listing of subjects will be produced and it will display all hypoglycemic events with an onset 
date/time from the start date/time of short-term open-label treatment period up to the start date 
of the long-term treatment period 
7.6.5.2 
Confirmed Adjudicated Cardiovascular Adverse Events 
The number and percentage of subjects with confirmed cardiovascular events (ie., heart failure 
as determined by the adjudication committee) will be summarized by preferred term and 
treatment group. 


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7.6.5.3 
Confirmed Adjudicated Hepatic Adverse Events 
The number and percentage of subjects with confirmed hepatic events (as determined by the 
adjudication committee) will be summarized by preferred term and treatment group.  In addition, 
a listing of all adjudicated hepatic adverse events by subjects will be provided. 
7.6.5.4 
Other AEOSIs 
Adverse events of special interest (AEOSI) will be defined based on lists of preferred 
terms.  These lists will be reviewed and finalized prior to database lock and unblinding of the 
database.   
The following summaries and listings of AEOSI will include all data regardless of use of rescue 
medication: 
 
x AEs of genital infection 
x AEs of genital infection by gender 
x AEs of Urinary Tract Infection (UTI) 
x AEs of UTI by gender 
x AEs of renal impairment/failure 
x AEs of volume depletion 
x AEs of fracture 
x AEs of hepatic disorder 
x AEs of hypersensitivity reactions 
x AEs of severe cutaneous adverse reactions 
x AEs of gastroenteritis and upper respiratory tract infections 
x AEs of decreased lymphocyte count 
x AEs of pancreatitis 
x AEs of all malignancies 
x AEs of cardiac failure 
x AEs of DKA 
 
The number and percentage of subjects with each of these events will be summarized by 
preferred term and treatment group in the short-term treatment period and in the combined 
ST+LT treatment periods. 
 
The number and percentage of subjects with events of urinary-tract infection will be summarized 
for the subgroups defined on the basis of categorized variables including incidence (1, 2, 3 or > 
3). A similar summary will be produced for events of genital infection. 
7.6.6 
Laboratory Evaluation 
Unless otherwise specified, laboratory data obtained after the start of study medication dosing 
up to and including 4 days (30 days for liver function laboratory tests) after the last short-term 
dosing date (or up to and including the start of the long- term treatment period, whichever comes 
first) will be considered as obtained during the short-term treatment period.   Laboratory data 
obtained from the day after the last study medication + 4 days (30 days for liver function laboratory 


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tests) up to the last visit date of the follow-up period will be considered as obtained during 
the follow-up period.  Laboratory data obtained after the start of ST treatment up to and including 
4 days (30 days for liver function laboratory tests) after the last dose of ST or LT medication will 
be considered as obtained during the combined ST+LT treatment periods.  
Listings for lab data will include everything in the database. 
 
For liver safety, a summary of proportion of subjects with elevated liver test including elevated 
AT (ALT and/or AST) and total bilirubin (see Appendix 1 for definition) will be provided. In 
addition, a summary of proportion of subjects with elevated liver test and/or reported AE of 
hepatic disorder will also be provided. 
All laboratory evaluations performed by central laboratories will be included in summary tables.  
All lab tables for the CSRs will be produced in both US and SI units whenever available. 
7.6.6.1 
Marked Laboratory Abnormalities 
Laboratory abnormalities will be evaluated based on marked abnormality values (MA). The pre-
defined criteria for marked abnormalities are detailed in Appendix 3. If both the baseline and on-
treatment values of a parameter are beyond the same MA limit for the parameter, then the on-
treatment value will be considered a MA only if it is more extreme (farther from the limit) than 
was the baseline value. If the baseline value is beyond the low MA limit, and the post-baseline 
value is beyond the high MA limit (or vice-versa), then the post-baseline value will be considered 
a MA. 
 
Laboratory abnormalities occurring during the short-term treatment period and the combined 
ST+LT treatment periods will be summarized by treatment group.  In the short-term treatment 
period the summaries will be presented for both the primary and sensitivity safety analyses. The 
direction of change (high or low) in MA will be indicated in the tables.  
 
For each subject with an MA for a parameter, all the subject’s values of that parameter will be 
listed. 
7.6.6.2 
Change from Baseline for Selected Laboratory Parameters Over Time 
All analyses of laboratory data will use observed data regardless of rescue. Visit windows are 
provided in Section 8.3 in order to link each laboratory test to a scheduled visit. Change from 
baseline during the ST treatment period and the combined ST+LT treatment periods for selected 
laboratory parameters will be summarized descriptively by treatment group using n’s, means, 
medians, SEs, and 95% Cis 
 


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7.6.7 
Vital Signs 
Vital signs data obtained after the start of study medication dosing up to and including 4 days after 
the last short-term dosing date (or up to and including the start of the long- term treatment period, 
whichever comes first) will be considered as obtained during the short-term treatment period. 
Vital  signs  data  obtained  after  the  start  of  study  medication  dosing  up  to  and including 
4 days after the last ST or LT dosing date will be considered as obtained during the combined 
ST+LT treatment period. 
 
Visit windows are provided in Section 8.3 in order to link each vital sign measurement to a 
scheduled visit. Values and changes from baseline for vital sign measurements will be summarized 
by treatment group at each scheduled visit using descriptive statistics (using available data 
regardless of rescue for subjects in Treated Subjects Data Set). 
7.6.8 
Electrocardiograms 
The normality/abnormality of the ECG tracing, as determined by the investigator, will be 
summarized using frequency tables on number of subjects who have a normal/abnormal ECG 
tracing at Week 24 and at Week 52 by the ECG tracing at baseline. 


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7.6.9 
Pregnancy Test Results 
By-subject listings of pregnancy test results will be provided using Treated Subject Data Set for 
the ST and the combined ST+LT treatment periods. 
8 
CONVENTIONS 
Data collected outside the analysis window (defined in Section 8.4) after subjects discontinued 
open-label study medication will be excluded from analyses. 
8.1 
Duration of Type 2 Diabetes 
Duration of Type 2 diabetes is calculated as the number of years from Type 2 diabetes diagnosis 
date to informed consent date: 
 
(1 + consent date - diagnosis date) / 365.25. 
 
The duration of diabetes will be included in the baseline diabetes characteristics listing. 
 
If the date Type 2 diabetes was diagnosed is partially missing, the following rules will take 
effect: 
 
 
These durations, even if partially imputed, will be listed. However, only the portion of the date 
of diagnosis actually observed, rather than imputed dates, will be displayed in listings. 
8.2 
Missing and Multiple Measurements 
For listings of efficacy and safety measures, missing values will be represented as not reported. 
 
If the blood pressure measurements are taken at a wrong position, e.g., sitting instead of standing, 
then these measurements will be excluded from the summary/analysis. 
Some laboratory samples may be inadvertently analyzed multiple times for the same test, 
producing multiple lab results on the same collection date and time for the same subject.  
In case of multiple observations within a single visit window, the following rules apply: 
x If there are two or more observations within the same visit window, the nonmissing 
observation closest to the target day will be used in the analysis  


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x If two observations are equidistant from the target day, the non-missing observation with 
the later collection date will be used in the analysis 
x If two or more observations are collected on the same day and have a collection time 
associated with them, the non-missing observation with the later collection time will be 
used in the analysis 
x If two or more observations are collected on the same day and time, all non-missing and 
the average of the observations will be used in the analysis. 
x If two or more observations are collected on the same day, all non-missing but with no 
collection time associated with at least one of them, the average of the observations will be 
used in the analysis. 
If a visit window does not contain any observations, the data will be missing for that visit. 
 
8.3 
Laboratory evaluations 
All laboratory evaluations performed by central laboratories and local laboratories that are 
included in the database will be listed but only the data from central lab will be included in 
summary tables. 
8.3.1 Post treatment efficacy and safety evaluations 
While efficacy and safety observations will be listed regardless of whether the subject was taking 
open-label study drug, observations may not contribute to summaries/analyses if they are measured 
after the last dose of the open-label study medication given during the treatment periods, as 
indicated below: 
For efficacy parameters: 
x Lipids and metabolic surrogate markers will be summarized only if measured on or prior 
to the 4th day after the last study drug treatment date. 
x FPG and spot urinary glucose to creatinine ratio will be summarized/analyzed only if 
measured on or prior to the first day after the last study drug treatment date. 
x HbA1c and body weight will be summarized/analyzed only if measured on or prior to the 
8th day after the last study drug treatment date.  
For safety parameters: 
x SAEs and the lab measurements for the liver function tests will be included in the 
summaries only if occurred/measured on or prior to the 30th day after the last study drug 
treatment date.  
x All other safety events (non-severe AEs, hypoglycemia, etc) and measurements (safety lab, 
vital signs, etc) will be included in the summaries only if occurred/measured on or prior to 
the 4th day after the last study drug treatment date. 
 
 


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8.4 
Longitudinal Assessments 
Day 1 for the short-term treatment period is the start date of short-term treatment medication.  
 
Visit windows are specified below.  
Table 8.4-1: 
Visit Windows for the Short-term Analyses 
 
Visit 
Treatment 
Period 
Target Day 
Day Range 
Week 1 
ST 
8 
2-10 
Week 2 
ST 
15 
11-22 
Week 4 
ST 
29 
23-43 
Week 8 
ST 
57 
44-71 
Week 12 
ST 
85 
72-106 
Week 18 
ST 
127 
107-148 
Week 24 
ST 
169 
149 to last day of short-term 
 
 
 
 
 
 
 
 
 
Table 8.4-2: 
Visit Windows for the Short-term + Long-term analyses 
 
Visit 
Treatment 
Period 
Target Day 
Day Range 
Week 1 
ST 
8 
2-10 
Week 2 
ST 
15 
11-22 
Week 4 
ST 
29 
23-43 
Week 8 
ST 
57 
44-71 
Week 12 
ST 
85 
72-106 
Week 18 
ST 
127 
107-148 
Week 24 
ST 
169 
149 - 197 
Week 32 
LT 
225 
198 - 252 
Week 40 
LT 
281 
253-324 
Week 52 
LT 
365 
325 to last day of long-term 
treatment 
 
 
 


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Table 8.4-3: 
HbA1c, Weight - Visit Windows for the Short-term analyses 
 
Visit 
Treatment 
Period 
Target Day 
Day Range 
Week 4 
ST 
29 
2-43 
Week 8 
ST 
57 
44-71 
Week 12 
ST 
85 
72-106 
Week 18 
ST 
127 
107-148 
Week 24 
ST 
169 
149 to last day of short-term 
 
Table 8.4-4: 
HbA1c, Weight - Visit Windows for the Short-term + long term 
analyses 
 
Visit 
Treatment 
Period 
Target Day 
Day Range 
Week 4 
ST 
29 
2-43 
Week 8 
ST 
57 
44-71 
Week 12 
ST 
85 
72-106 
Week 18 
ST 
127 
107-148 
Week 24 
ST 
169 
149 -197 
Week 32 
LT 
225 
198 - 253 
Week 40 
LT 
281 
254-324 
Week 52 
LT 
365 
325to last day of long-term 
treatment 
 
8.5 
Post-Treatment Efficacy Observations 
While short-term treatment period (up to and including the start of long-term treatment period, 
where applicable) efficacy observations will be listed regardless of whether the subject was taking 
study drug, observations may not contribute to summaries/analyses if they are measured after the 
last dose of short-term study medication (up to and including the start of long-term treatment 
period, where applicable) as indicated below: 
 
 


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Similar rule applies for the combined ST+LT treatment periods. 
 
8.6 
Assignment of Doses to Adverse Events and Laboratory Assessments  
In case of missing dates, prior to assigning the treatment that the subject received at the onset of 
an AE or at the time of a laboratory assessment, imputation rules will be applied as follows: 
 
For AEs, a missing or incomplete onset date will be imputed according to the following 
conventions: 
 

- Calculate a surrogate date as the first non-missing valid date from the following list 
(in order of precedence): 
 First active study medication date 
 
 Consent date 
 
 Visit date corresponding to the visit at which the event was reported 
 
 If a valid non-missing date is not available for any of these dates, the surrogate 
date will be set to missing. 
- Based on the information provided, set the derived date to the earliest possible 
date. If only a year is provided, set the derived date to January first of that year. If a 
year and month is provided, set the derived date to the first day of that month. 
- If the surrogate date is non-missing then: 


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 If the derived date is on or after the surrogate date use the derived date as 
calculated 
 If the derived date is prior to the surrogate date and the surrogate date is 
consistent with the partial data provided for the onset date, use the surrogate date 
as the derived date 
 If the derived date is prior to the surrogate date and the surrogate date is not 
consistent with the partial data provided for the onset date then set the derived 
onset date to be the latest possible date based on the partial onset date information 
provided. If only a year is provided, set the derived date to December 31st of that 
year. If a year and month is provided, set the derived date to the last day of that 
month. 
- If all three dates used to determine the surrogate date are missing, then based on 
the information provided, set the derived date to the earliest possible date. If only a 
year is provided, set the derived date to January first of that year. If a year and month 
is provided, set the derived date to the first day of that month. 
A drug treatment file will be created, containing any starting and stopping dose as well as 
intermediate dose changes within each study period, with dates as recorded on the CRF.  In 
this context, 
 
 
 
8.7 
Concomitant Medications 
Start and stop date of all concomitant medications are collected on the CRF. In order to 
classify medication as prior, current or concomitant, partial, missing or invalid start and stop dates 
will be imputed where possible as follows: 
 


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
Imputed dates will not appear on the listings of non-study medication. 
8.8 
Counting Rules for Adverse Events  
Where a subject has the same adverse event, based on preferred terminology, reported multiple 
times in a single analysis period, the subject will only be counted once at the preferred terminology 
level in adverse event frequency tables. 
Where a subject has multiple adverse events within the same system organ class in a single 
analysis period, the subject will only be counted once at the system organ class level in adverse 
event frequency tables. 
 
When a subject has the same adverse event, based on preferred terminology, reported multiple 
times in a single analysis period, the following criteria, in order of precedence, will be used to  
 
 
                        Fasting State 


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Lipids parameters listed in the protocol include Total -C, LDL-C, HDL-C and TG. For lipid 
parameters, only data collected in fasting state will be used for analysis.  For FPG, fasting 
insulin, and fasting C-peptide, only assessments documented with the subject in fasting state 
will be summarized and listed. 
8.9 
Percent Compliance Calculation 
See Section 7.4.3.  
8.10 
Strip Sign for Selected Laboratory Data 
For selected laboratory test values that have been received with an operator sign as a part of the 
result (>, H, <, or G), a process to strip the operator sign will be applied and the resulting numeric 
values will be used for data analysis. The raw value with operator will remain as such on the 
CRF (or in the electronic record) and in the database. 
9 
CONTENT OF REPORTS 
All analysis results for the short-term open-label period will be included in the ST CSR while all 
the analyses specified for the ST+LT will be included in the Final CSR. 
10 
CHANGES OF ANALYSIS FROM PROTOCOL 
Changes from Protocol prior to ST data base lock are summarized in the following table: 
 
Changes 
Reason for changes 
1 
Definition of Randomized Subjects Data Set 
was updated as follows: 
   
The randomized subject data set will consist of 
all randomized subjects who receive at least 
one dose of study medication.  Whenever using 
the randomized subject data set, subjects will 
be presented in the treatment group to which 
they were randomized at the start of the Short-
term treatment Period (even if the treatment 
they received was different). This is also 
known as the Intent-to-Treat (ITT) population. 
This will be the primary efficacy data set. 
To be consistent with other saxagliptin plus 
dapagliflozin studies. 
 Definition of Full Analysis Set was added. 
To be consistent with other saxagliptin plus 
dapagliflozin studies. 
Summary and analysis of SMBG data was 
updated. 
To be consistent with other saxagliptin plus 
dapagliflozin studies. 
Definition of Confirmed hypoglycemia was 
updated to consider all events with glucose 
values d 70 mg/dL (3.9 mmol/L) as recorded 
in the hypoglycemia module of the CRF 
irrespective of the method using which 
glucose data were collected. 
 To avoid error in summarizing data based on 
glucose values which were not collected using 
consistent methods. 
 
MI sensitivity analysis for primary endpoint 
were added.  
To be consistent with other saxagliptin plus 
dapagliflozin studies. 


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11 
REFERENCES 
1. Zhang M., Tsiatis A., Davidian M. Improving efficiency of inference in randomized 
clinical trials using auxiliary covariates. Biometrics. 2008; DOI: 10.1111/j.1541-
0420.2007.00976.x.  
2. Tsiatis A., Davidian M. Zhang M., Lu X. Covariate adjustment for two-sample 
treatment comparisons in randomized clinical trials: a principled yet flexible 
approach. Statistics in Medicine. 2007; DOI: 10.1002/sim.3113.   
3. Service, F.J., Mean amplitude of glycemic excursions, a measure of diabetic 
instability. Diabetes.  1970, Sep ; 19, 644-55. 
4. Kaplan EL, Meier P.  Nonparametric estimation from incomplete observations. 
Journal of American Statistical Association. 1958; 53:457-481. 
5. Greenwood M. The natural duration of cancer. Reports on public health and 
medical subjects. 1926; 33:1-26. 
6. Workgroup on Hypoglycemia, American Diabetes Association. Defining and 
reporting hypoglycemia in diabetes: a report from the American Diabetes 
Association Workgroup on Hypoglycemia. Diabetes Care. 2005 May;28(5):1245-
9. 


APPENDIX 1 
PHASE V INFORMATION FOR CONTINUOUS GLUCOSE 
MONITORING 
All CGM monitoring assessments were undertaken using the Phase V Health Outcomes 
Information System (PVOIS – CGM Module), Phase V Technologies, Inc. (Phase V), Wellesley 
Hills, MA.   This PVOIS-CGM Module, consisting of validated measurement, instrumentation, 
scoring, algorithms and statistical programs has been continuously updated and expanded since its 
inception in 2004. Within the PVOIS-CGM system the two general applications are referred to as: 
1) “PVOIS-CGM-Monitoring” which essentially includes the quality features that provide quality 
assurance and control over the CGM clinical trial tasks described above and 2) “PVOIS-CGM-
Analytics” which includes the statistical transformations and conversions of the raw CGM data 
into the set of 170 or more “data analytics” variables.    
A separate and distinct component which the PVOIS-CGM utilizes to gather physiological data 
directly from the patient, includes the devices, systems and software which govern the collection 
of the electronic source data in the study (PVOIS-CGM-Device).  The selection and approval of 
this separate component is typically chosen by the Sponsor in consultation with Phase V.  
The PVOIS is governed by a standardized set of Quality Operation Procedures (“QOP’s”), Work 
Instructions (“WI’s”) and Task Specifications (TS’s) which are part of the Phase V® ISO 
13485/9001 Quality Management System (“PVT QMS”).   
 
Table 1.  Phase V® CGM Analytics Cited in SAP 
 
͓
Data Panel 
Phase V® CGM 
Analytics Variable 
Description 
ͳ
CGMVIS 
BGMEANALL 


ǯ
ȋǤǤͳ͵Ͳ
ȀȌ
ʹ
CGMVIS 
MAGE_SC 

ȋ
Ȍ

ʹͶǦ

ȋ
Ȍ


ʹͶǦǳ
͵
CGMVIS 
WPWDSDDY 
ȋʹͶǦȌ
ȋǦ
Ǧ
Ȍǯ
ȗȋǤǤͶͳǤ͹ȀȌ


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͓
Data Panel 
Phase V® CGM 
Analytics Variable 
Description 
Ͷ
CGMVIS/CGMDAY 
CGM_GE71_LE180_PCTTIME 
ȏͲǡͳͲͲȐ
ȏ͹ͳȀǡͳͺͲȀȐ
ǯ
ȋǤǤǡ͸͹ǤͻΨȌ
ȏͲǡͳͲͲȐ
ȏ͹ͳȀǡͳͺͲȀȐ

ȋǤǤǡ͸͹ǤͻΨȌ
ͷ
CGMVIS/CGMDAY 
CGM_HYPO_PCTTIME 
ȏͲǡͳͲͲȐ
͹ͲȀ

ȋǤǤǡͶǤʹΨȌ
ȏͲǡͳͲͲȐ
͹ͲȀ

ȋǤǤǡͶǤʹΨȌ
͸
GMVIS/CGMDAY 
CGM NOC_HYPO_PCTTIME 
ȏͲǡͳͲͲȐ
͹ͲȀ
ȏͲͲͲͲǡͲ͸ͲͲȌ
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APPENDIX 2 
PHASE V INFORMATION ON PATIENT-REPORTED OUTCOMES 
MEASUREMENT  
All patient-reported outcomes (PRO) assessments were undertaken using the Phase V Health 
Outcomes Information System (PVOIS – PRO Module), Phase V Technologies, Inc., Wellesley 
Hills, MA.   This PVOIS, consisting of validated measurement, instrumentation, scoring, 
algorithms and statistical programs has been continuously updated and expanded since its 
inception in 1987.  It entails a modular approach which includes both core and disease-specific 
assessments for many chronic conditions such as diabetes, hypertension, cancer, HIV, obesity, 
lipodystrophy, migraine headache, allergic rhinitis, and dyslipidemia.  Each disease or condition 
is assessed by include a Core assessment component and a Disease or Condition-Specific sub-
module.  In addition, there may be target population-specific sub-modules.  The system consists 
of several components including patient questionnaires, data entry and management systems, 
database structures, scoring algorithms and statistical routines.  The statistical database is 
maintained in SPSS for Windows Version 23 and all analytical output is generated using SPSS.  A 
SAS statistical database and verification program may be generated using Phase V conversion 
routines. 
The Module described below is referred to as the PVOIS – PRO – Diabetes Module.  
The quality-of-life (QOL) scales and subscales used in Protocol CV181369 include: 
Quality-of-Life Scaling 
x analogue perceived health (10-point rating  -- overall, physical, emotional, personal, and 
job/work); 
x functional health status (Duke activity index, diabetes-specific symptom interference index, 
general symptom interference index); 
x general health perceptions (vitality, general health, sleep); 
x mental and emotional health (psychological well-being and psychological distress); 
x cognitive function (acuity, disorientation and detachment, and performance); 
x symptom distress; 
x sexual dysfunction. 
x weight perception 
A brief description of the quality-of-life scales and corresponding number of items available in the 
Phase V Health Outcomes Evaluation System7 is given in Sections 2.1.1 – 2.1.3 below.  A double 
asterisk indicates those scales and subscales intentionally omitted from protocol CV181369. 
Phase V Generic Core Modules 
A) Mental and Emotional Health (24 items) ** 
B) General Health Perceptions (11 items) ** 


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C) Work/Daily Role Performance (11 items) 
D) Symptom Distress (53 items)  
E) Sexual Dysfunction (5 items)  
F) Subjective Cognitive Functioning (25 items)**  
G) Objective Cognitive Functioning** (5 psychomotor, recall, and memory tests);  
H) Negative Life Events and Stress Indices;  
I) Perceived Health (Analogue = 5 items and Likert General Symptom Interference Scale = 7 
items) 
J) Work/Role Disability (3 items) and  
K) Health Care Utilization (5 items). 
L) General Symptom Inference Scale 
M) Duke Activity Scale 
Phase V Diabetes-Specific Modules 
A) Diabetes-Specific Satisfaction with Treatment scales 
B) Diabetes Symptom Interference scale (7 items) 
C) Diabetes-Specific Symptom Distress module (24 items)  
QOL Scale Summary Descriptions of Scales used in Protocol CV181369: 
Health Care Utilization (Patient Reported): Five questions concerning frequency of 
hospitalizations, clinic or physician visits, nurse or other health care provider home visits, general 
assistance with chores and activities of daily living, telephone calls and consults to a physician, 
nurse or other health care provider. 
Work/Disability Days (Patient Reported): 3 questions on bed days, missed days at work and 
reduction in the level of usual activities (non-paid, e.g. housework). 
Perceived Health (Global Analogue Scale): 5 questions: Feeling past month 1) overall or in 
general, 2) physically, 3) emotionally, 4) personal life and 5) about job or work? 
Functional Health Status: 12 functional levels of activities of daily living ranging from strenuous 
activity to basic activities such as dressing, bathing and eating.  (Derived from the Duke Activity 
Scale). 
Diabetes-Specific Symptom Interference: 7 questions concerning interference with 1) work, 2) 
social events, 3) recreational activities, 4) exercise and physical activities, 5) work effectiveness, 
6) enjoying life and 7) feeling your best due to symptoms of diabetes (such as low or high blood 
sugar, dizziness, vision problems or problems with circulation). 


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General Symptom Interference: 7 questions concerning interference with 1) work, 2) social 
events, 3) recreational activities, 4) exercise and physical activities, 5) work effectiveness, 6) 
enjoying life and 7) feeling your best due to other more general symptoms or health problems such 
as fatigue, pain and depression. 
Symptoms and Side-Effects Distress: 53 questions including diabetes-specific and general 
symptoms (prevalence, frequency and distress severity). 
Mental and Emotional Health: 24 questions encompassing anxiety, depression, and loss of 
behavioral and emotional control (Psychological Distress), life satisfaction, positive well being 
and emotional ties (Psychological Well Being). 
General Health Perceptions: 11 questions on sleep disturbance, vitality and general health status. 
Cognitive Function and Performance: 15 questions assessing self-reported cognitive acuity, 
memory, reasoning, disorientation and detachment and 6 questions on self-rated cognitive 
performance. 
Sexual Satisfaction and Dysfunction: 5 questions (separate questionnaires for males and 
females) concerning sexual interest and satisfaction and problems with sexual functioning. 
Weight Perceptions: Weight Evaluation/Assessment: 1 item assessing the subject’s perceptions 
of their weight ranging from very underweight to very overweight and Weight Concern: 1 item 
assessing the subject’s distress associated with his or her weight. 
Composite Psychosocial: Mean of the subscales of Mental Health and Health Perceptions. 
Composite QOL: Mean of the subscales of Mental Health (6 scales), Health Perceptions and 
Sexual Satisfaction and Dysfunction.   
Overall QOL (Item-wise): Mean of all items in the Mental Health and Health Perceptions scales. 
Diabetes Treatment Satisfaction 
The treatment satisfaction measures used in protocol CV181369 include those constructs that focus 
on the patient's expectations and experiences with the process and perceived outcomes of the 
therapeutic regimen.  
The Diabetes Treatment Satisfaction module8 was developed independently by Phase V 
Technologies using a compendium of existing diabetes satisfaction items and incorporating new 
items developed from a series of focus group studies with persons with type 1 and type 2 diabetes 
experienced with newer oral hypoglycemic agents, insulin formulations, and pump and inhaled 
insulin technology.  Item pool selection, psychometric analysis, and field-testing was conducted 
by Phase V Technologies. 
The following constructs were evaluated using the long-form diabetes treatment satisfaction 
module including: 
x Life Interference 
x Convenience 


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x Burden 
x Acceptance of Negative Aspects (including side effects, stress, hassle) 
x Acceptance of Positive Aspects (including effectiveness, ease of use, comfort) 
x Overall Patient Preference (compared to other treatments). 
The full diabetes treatment satisfaction battery comprises four sections dealing with diabetes 
treatment involving A) any form, B) insulin (regardless of delivery), C) insulin injections and D) 
insulin inhalers.  Scales used in this protocol are described in Sections 2.2.1.  
 
Overall Satisfaction with Treatment (Module A) 
This 72-item section assesses satisfaction with diabetes treatment in general and is not targeted 
towards any one kind of treatment or delivery system.  The subscales included: 
Advocacy:  2 items on recommending and advocating the treatment to other persons with 
diabetes, including family and friends. 
Burden: 14 items concerning multiple aspects of burden of the therapeutic regimen including 
adherence, diet, exercise, burden for performing daily activities, social activities and enjoying 
life. 
Convenience: 6 items relating to ability to remember taking medication, overall convenience, 
being pleased with convenience, amount of time required to manage diabetes. 
Efficacy:  3 items on the patient’s perception of the treatment’s ability to control blood sugar. 
Flexibility: 4 items on how flexible the treatment is for scheduling and allowing variability in 
meals and overall flexibility. 
General Satisfaction: 5 items on general satisfaction and being pleased with current medication. 
Hassle: 8 items specific to the amount of bother and hassle of the regimen including dosing, 
treatment supplies, carrying supplies, supply disposal, pain and discomfort, and worries about 
hypoglycemia and hyperglycemia. 
Interference: 11 items concerning how much the diabetes medication interferes with daily 
routine, meals, recreation, family life, sleep schedules, energy levels, making plans, traveling, 
having fun and overall quality of life. 
Pain: 3 items concerning pain and discomfort. 
Preference: 2 items rating how strong the desire to search out other regimens that might be 
better and to continue on current regimen.  
Side effects: 5 items concerning gaining weight, unpleasant feelings, distress with hypoglycemia 
and hyperglycemia.  


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Social: 9 items rating the treatment’s interference with social interactions with family and 
friends, travel, having fun, and problems in performing work and social roles. 
Overall Satisfaction: mean of the 12 individual general satisfaction scales. 
 
 


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APPENDIX 3 
MARKED ABNORMALITY CRITERIA 
The criteria for marked abnormality for each variable are listed in the following table. Note that a 
post-baseline lab value will be considered a MA only if it satisfies the specified criteria and is 
more extreme (farther from the limit) than is the baseline value. 
Clinical Laboratory variables 
 
 
Units 
Marked Abnormality Criteria 
Low 
High 
Hematology 
HCT males/females 
% 
< 20.0% 
> 55.0% 
HCT males/females 
% 
> 60.0% 
Hemoglobin males/females 
g/dL 
< 6 g/dL 
> 18 g/dL 
Hemoglobin males/females 
g/dL 
> 20 g/dL 
Blood Chemistry 
Albumin 
g/dL 
d 2 g/dL 
> 6 g/dL 
Total protein 
g/dL 
> 10 g/dL 
ALP 
U/L 
> 3X ULN 
ALT 
U/L 
> 3X ULN 
AST 
U/L 
> 3X ULN 
ALT 
U/L 
> 5X ULN 
AST 
U/L 
> 5X ULN 
ALT 
U/L 
> 10X ULN 
AST 
U/L 
> 10X ULN 
ALT 
U/L 
> 20X ULN 
AST 
U/L 
> 20X ULN 
Total Bilirubin 
mg/dL 
> 2X ULN if PreRx d ULN; 
> 3X ULN if PreRx > ULN 
Glucose, Plasma Unspecified 
mg/dL 
< 54 mg/dL 
> 350 mg/dL 
Na (Sodium) 
mEq/L 
< 130 mEq/L 
> 150 mEq/L 
Na (Sodium) 
mEq/L 
< 120 mEq/L 
K (Potassium) 
mEq/L 
d 2.5 mEq/L 
t 6.0 mEq/L 
HCO3 (Bicarbonate) 
mEq/L 
d 13 mEq/L 
BUN 
mg/dL 
t 60 mg/dL 
Creatinine 
mg/dL 
t 1.5X PreRx CREAT 
Creatinine 
mg/dL 
t 2.5 mg/dL 
CK (Creatine Kinase) 
U/L 
> 5X ULN 
CK (Creatine Kinase) 
U/L 
> 10X ULN 


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APPENDIX 4 
GEOGRAPHIC REGIONS 
Geographic Region 
Countries 
North America 
United States 
Latin America 
Mexico  
Europe 
South Africa, 
Germany, Poland,  
Spain, Sweden 
Czech Republic 
Hungary, Denmark, 
Romania