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
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Sponsor: AstraZeneca

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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 
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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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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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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