Clinical trial NCT02419612
Conditions: Diabetes
Sponsor: AstraZeneca
Start date: 2015-08-14; Completion date: 2019-09-18
Enrollment: 444 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This clincial trial is evaluating if the co-administration of saxagliptin and dapagliflozin, in addition to metformin, results in better glycemic control, as measured by HbA1c, over a treatment period of 52 weeks, compared to the addition of glimepiride to metformin in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on Metformin Alone. We will compare the change from baseline in HbA1c achieved with saxagliptin, in co-administration with dapagliflozin, added to current background therapy with metformin compared to glimepiride added to current background therapy with metformin ≥1500 mg at Week 52.

Detailed description:

Arms: arm 1: Saxagliptin 5 mg /dapagliflozin 10 mg Placebo once a day orally arm 2: Glimepiride or placebo 1mg or 2mg or 3mg or 4mg or 6mg once a day orally
Interventions: intervention 1: Saxagliptin intervention 2: Dapagliflozin intervention 3: Glimepiride intervention 4: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
SAP_002.pdf: 
Statistical Analysis Plan
Study Code
D1689C00013
Edition Number
3.0
Date
8 October 2019
A 52-WEEK INTERNATIONAL, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, 
ACTIVE-CONTROLLED, PARALLEL GROUP, PHASE 3B TRIAL WITH A 
BLINDED 104-WEEK LONG -TERM EXTENSION PERIOD TO EVALUATE THE
EFFICACY AND SAFETY OF SAXAGLIPTIN CO-ADMINISTERED WITH 
DAPAGLIFLOZIN IN COMBINATION WITH METFORMIN COMPARED TO 
GLIMEPIRIDE IN COMBINATION WITH METFORMIN IN ADULT PATIENTS WITH 
TYPE 2 DIABETES WHO HAVE INADEQUATE GLYCEMIC CONTROL ON 
METFORMIN THERAPY ALONE


PPD


Statistical Anal_vsis Plan
tsMS-477 I I8 AND BMS-5 t2 148
cvt 8 I -365
saxagliptin-dapaglillozur
A s2.WEEK INTERNATIONAL, MULTICENTER, RANDOMIZED, DOUBLE.BLIND,
ACTIVE.CONTROLLED, PARALLEL GROUP, PHASE 3BTRIAL WITH A
BLINDED lO4.WEEK LONG .TERM EXTENSION PERIOD TO EVALUATE THE
EFFICACY AND SAFEry OF SAXAGLIPTIN CO-ADMINISTERED WITH
DAPAGLIFLOZIN IN COMBINATION WITH METFORMIN COMPARED TO
GLIMEPIRIDE IN COMBINATION WITH METFORMIN IN ADULT PATIENTS WITH
TYPE 2 DIABETES WHO HAVE INADEQUATE GLYCEMIC CONTROL ON
METFORMIN THERAPY ALONE
CRO Statistician
J'lmlna Mar
Date
Global Product Statisficran
fJrlaL7
Date
PPD


Statistical Analysis Plan
CV181-365
BMS-477118 AND BMS-512148
saxagliptin-dapagliflozin
3
TABLE OF CONTENTS
TABLE OF CONTENTS............................................................................................................3
1
BACKGROUND AND RATIONALE....................................................................10
2
STUDY DESCRIPTION ........................................................................................11
2.1
Study Design ..........................................................................................................11
2.2
Treatment Assignment............................................................................................14
2.3
Blinding and Unblinding.........................................................................................14
2.3.1
Blinding..................................................................................................................14
2.3.2
Unblinding .............................................................................................................15
2.4
Protocol Amendments.............................................................................................15
2.5
Cardiovascular Adjudication Committee.................................................................15
2.6
Hepatic Adjudication Committee............................................................................15
2.7
DKA Adjudication Committee................................................................................15
3
OBJECTIVES ........................................................................................................16
3.1
Primary...................................................................................................................16
3.2
Secondary...............................................................................................................16
3.3
Exploratory Objectives ...........................................................................................17
3.4
Safety objectives:....................................................................................................19
4
ENDPOINTS..........................................................................................................19
4.1
Primary Endpoint....................................................................................................19
4.2
Secondary Endpoints ..............................................................................................19
4.3
Exploratory Endpoints............................................................................................20
4.4
Safety Endpoints.....................................................................................................21
5
SAMPLE SIZE AND POWER...............................................................................21
6
STUDY PERIODS, TREATMENT REGIMENS AND POPULATIONS 
FOR ANALYSES ..................................................................................................22
6.1
Study Periods..........................................................................................................22
6.2
Treatment Regimens...............................................................................................22
6.3
Populations for Analyses ........................................................................................22
6.3.1
Enrolled Subjects Data Set .....................................................................................22
6.3.2
Lead-in Subjects Data Set.......................................................................................22
6.3.3
Randomized Subjects Data Set................................................................................23
6.3.4
Full Analysis Set.....................................................................................................23


Statistical Analysis Plan
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saxagliptin-dapagliflozin
4
6.3.5
Evaluable Subjects Data Set ...................................................................................23
6.3.6
Treated Subjects Data Set.......................................................................................23
6.3.7
Short-term Completers Data Set .............................................................................23
7
STATISTICAL ANALYSES..................................................................................24
7.1
General Methods ....................................................................................................24
7.1.1
Definitions..............................................................................................................24
7.1.1.1
Baseline Value........................................................................................................24
7.1.1.2
Change and Percent Change from Baseline............................................................24
7.1.1.3
Handling of Missing Data.......................................................................................24
7.1.2
Longitudinal Repeated Measures Analysis..............................................................25
7.1.3
Analysis of Covariance (ANCOVA).........................................................................27
7.1.4
Descriptive Summaries of Continuous Variables.....................................................28
7.1.5
Descriptive Summaries of Categorical Variables....................................................28
7.1.6
Descriptive Summaries of Change from Baseline in Categorical Variables.............28
7.1.7
Kaplan-Meier Curve and Estimates for Time-to-Event Analyses .............................29
7.1.8
Proportion of Subjects Achieving Pre-defined Characteristic..................................29
7.1.9
Mean Daily Glucose and Mean Post-prandial Glucose (Self-monitored) ................29
7.1.10
Mean Amplitude of Glucose Excursions (MAGE) of Continuous Glucose 
Monitoring System Readings...................................................................................30
7.2
Study Conduct........................................................................................................31
7.3
Study Population ....................................................................................................33
7.3.1
Subject Disposition.................................................................................................33
7.3.2
Demography and Other Baseline Characteristics ...................................................33
7.3.3
Specific and General Disease History.....................................................................35
7.4
Extent of Exposure .................................................................................................35
7.4.1
Study and Rescue Medication .................................................................................35
7.4.2
Concomitant Medications.......................................................................................36
7.4.3
Measurements of Treatment Compliance ................................................................36
7.5
Efficacy..................................................................................................................37
7.5.1
Overall Efficacy Summary ......................................................................................37
7.5.2
Primary Efficacy Analysis.......................................................................................38
7.5.3
Handling of Missing Efficacy Data.........................................................................39


Statistical Analysis Plan
CV181-365
BMS-477118 AND BMS-512148
saxagliptin-dapagliflozin
5
7.5.3.1
Model for Change from Baseline Based on Return-to-Baseline Multiple 
Imputation..............................................................................................................39
7.5.3.2
Tipping Point Analysis based on Model for Change from Baseline Using 
Multiple Imputation................................................................................................40
7.5.4
Secondary Efficacy Analyses...................................................................................41
7.5.5
Exploratory Efficacy Analyses ................................................................................42
7.5.5.1
Proportion of Subjects Achieving Composite Response Targets ..............................42
7.5.5.2
Mean Change from Baseline at Week t....................................................................43
7.5.5.3
Change from Baseline for Lipids.............................................................................43
7.5.5.4
Mean Change from baseline in endpoints for sub-study ..........................................43
7.5.6
Summary of Primary Efficacy Endpoint within Subgroups ......................................44
7.5.7
Pharmacokinetic Analyses ......................................................................................44
7.5.8
Biomarker Analyses................................................................................................44
7.5.9
Outcomes Research Analyses..................................................................................44
7.5.10
Other Analysis........................................................................................................44
7.5.11
Interim Analyses.....................................................................................................44
7.6
Safety.....................................................................................................................45
7.6.1
Adverse Events .......................................................................................................45
7.6.1.1
All Adverse Events..................................................................................................45
7.6.2
Deaths ....................................................................................................................47
7.6.3
Serious Adverse Events...........................................................................................47
7.6.4
Adverse Events Leading to Discontinuation of Study Medication ............................47
7.6.5
Adverse Events of Special Interest (AEOSI) ............................................................48
7.6.5.1
Hypoglycemia.........................................................................................................48
7.6.5.2
Confirmed Adjudicated Cardiovascular Adverse Events .........................................50
7.6.5.3
Confirmed Adjudicated Hepatic Adverse Events .....................................................50
7.6.5.4
Confirmed Adjudicated DKA Events .......................................................................51
7.6.5.5
Other AEOSIs.........................................................................................................51
7.6.6
Laboratory Evaluation............................................................................................51
7.6.6.1
Marked Laboratory Abnormalities..........................................................................52
7.6.6.2
Change from Baseline for Selected Laboratory Parameters Over Time...................52
7.6.7
Vital Signs ..............................................................................................................53
7.6.8
Electrocardiograms................................................................................................54


Statistical Analysis Plan
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BMS-477118 AND BMS-512148
saxagliptin-dapagliflozin
6
7.6.9
Pregnancy Test Results...........................................................................................54
8
CONVENTIONS....................................................................................................54
8.1
Duration of Type 2 Diabetes...................................................................................54
8.2
Missing and Multiple Measurements ......................................................................54
8.3
Laboratory Evaluations...........................................................................................55
8.3.1
Post-treatment Efficacy and Safety Evaluations......................................................55
8.4
Longitudinal Assessments.......................................................................................56
8.5
Post-Treatment Efficacy Observations ....................................................................60
8.6
Assignment of Doses to Adverse Events and Laboratory Assessments....................60
8.7
Concomitant Medications .......................................................................................62
8.8
Counting Rules for Adverse Events ........................................................................62
8.9
Fasting State...........................................................................................................63
8.10
Percent Compliance Calculation .............................................................................63
8.11
Strip Sign for Selected Laboratory Data..................................................................63
9
CONTENT OF REPORTS .....................................................................................63
10
CHANGES OF ANALYSIS FROM PROTOCOL..................................................63
11
REFERENCES.......................................................................................................64
12
SUMMARY OF CUTOFFS FOR ANALYSES WHICH EXCLUDE 
RESULTS AFTER TREATMENT DISCONTINUATION.....................................65


Statistical Analysis Plan
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saxagliptin-dapagliflozin
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AMENDMENT HISTORY
Date
Brief description of change
April 6, 2016
Initial Approved SAP
Version 2, 
September 27, 
2017
Inserted texts from the core SAP and removed the references to 
core SAP.
Definition of confirmed hypoglycemia was updated.
Start of long-term treatment period was clarified in Section 6.1.
Section 6.3.5 was added to include the definition of Full 
Analysis Set. Following subsections were renumbered.
In Section 6.3.6 the definition of Evaluable Subjects Data Set 
was updated.
Section 7.1.9 for analysis of 6-point self-monitored blood 
glucose data was updated.
Table 7.2.1 for list of relevant protocol deviations and their 
exclusion level was updated.
Section 7.3.2 for demographics and baseline characteristics was 
updated.
In Section 7.4.1 additional categories were added for duration of 
exposure 
Section 7.5.2 was updated by adding new sensitivity analyses for 
primary endpoint.
Section 0 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.
Section 8.3 for laboratory evaluations was updated to include 
only data from central laboratory in safety tables
Section 8.4 was updated by adding visit windows for HbA1c and 
weight.
Section 10 was added to list the changes in analysis from 
protocol. Following section was renumbered.


Statistical Analysis Plan
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saxagliptin-dapagliflozin
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Date
Brief description of change
Version 3, 1 
October 2019
During ST CSR appendices development, following discrepancies were 
identified in SAP:

Section 7.6.1, 2nd paragraph:
Reference to the section number of “Counting rules for AE”, 
updated to be Section 8.8

Section 7.1.10, Figure 7.1.3-1
Reference#7 mentioned in the foot note of this figure has been 
updated to #3, as listed in section 11

APPENDIX 2, Quality-of-Life Scaling
Protocol number corrected from CV181-369 to CV181-365
As per protocol version 5.0

Sections 4.3 and 7.5.5.3
the time point for obtaining last MRI image is W156, the time 
point to be changed to W122 +/- 4 weeks
As the ST+LT analysis was planned the following updates were made:

Sections 2.7, 7.5.8, 7.6.5.4, 12 were added

Clarification of, and details pertaining to, the ST analyses were 
added in order to reliably and robustly reproduce the results at 
the ST+LT timepoint, and for any future analysis. Confirmation 
was added throughout the document to identify which datasets 
and analyses were applicable to the short-term and/or short-term 
and long-term treatment periods.
Section 7.1.2 – removed stratum from the model, and confirmed 
the interaction term
Section 7.1.8 – removed integration of group's modelled 
probability of response over the observed distribution of baseline 
covariate
Section 7.1.1.3, 7.5.3 and 7.6.6.2 – details of handling missing 
data were clarified 
Section 7.1.4 – updated the list of summary stats to include Q1, 
Q3, geometric mean and CV
Table 7.2-1 - updated to make relevant protocol deviations 
(RPDs) applicable to the ST+LT period
Tables 7.3.2.x – categories in table A updated in light of data, 
and table D added for Hematuria at the ST+LT treatment period 


Statistical Analysis Plan
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saxagliptin-dapagliflozin
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Date
Brief description of change
Section 7.4.1 – clarification of how duplicate dosing data is 
handled at the ST+LT analysis
Section 7.4.2 – sub-categories removed for allowed concomitant 
medication summary table
Section 7.5.2 – the sensitivity analysis to be undertaken at the 
ST+LT treatment period were added
Section 7.5.4 – confirmation that the proportion of subjects 
achieving a therapeutic glycaemic response is adjusted by 
baseline Hb1Ac
Section 7.5.5 – clarification that no adjustments for multiplicity 
will be done - p-values are nominal only
Section 7.5.9 – clarification of the author of the PRO report 
Section 7.5.5.2 – confirmation that model assumptions will be 
checked
Section 7.5.5.3 – details of lipid summary added
Section 7.5.5.4 and 8.2 – Updates in line with the errata to the 
ST CSR
Section 7.5.8 – details of biomarker analysis added
Section 7.6.1 – additional information about handling surgical or 
spontaneous amputations was added
Section 7.6.3 – SAE listings added for ST+LT analysis
Section 7.6.7, 8.3.1 and 8.5 – parameters were explicitly listed
Section 7.6.5.1 – details were added to described how conflicting 
hypoglycaemia events were handled
Section 7.6.5.5 – other AESI were defined more clearly
Section 8.2 – handling of missing MRI data was added
Table 8.4 – tables were updated and added to describe the 
various windows applied.


Statistical Analysis Plan
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saxagliptin-dapagliflozin
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1
BACKGROUND AND RATIONALE
Type 2 diabetes mellitus (T2DM) is a chronic progressive disease, characterized by hyperglycemia 
and an increased risk of microvascular and macrovascular complications. Achieving and 
maintaining the glycemic treatment goal is challenging. Typically, the treatment paradigm consists 
of a step-wise addition of different classes of antihyperglycemic drugs, as most patients eventually 
require two or more agents to achieve or maintain glycemic targets. Among the medications 
approved for the treatment of T2DM, metformin is the recommended drug of choice for initiating 
oral therapy, while other classes of antidiabetic agents are typically added sequentially as second-
and third-line agents. Despite multiple drugs and classes being available, many patients are still 
inadequately controlled. An ideal add-on to metformin would provide strong HbA1c reduction 
through complementary mechanisms of action (MoA), with weight loss, and no hypoglycemia.
Saxagliptin (BMS-477118) is a highly potent, selective, reversible, and competitive dipeptidyl
peptidase 4 (DPP4) inhibitor. DPP4 is the enzyme responsible for the inactivation of glucagon-
like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). By inhibiting 
DPP4, saxagliptin potentiates active endogenous GLP-1 concentrations, augmenting the
physiological mechanism of insulin secretion and decreasing glucagon release, thereby reducing
post-prandial and fasting glucose levels in patients with T2DM.
Dapagliflozin is a stable, competitive, reversible, highly selective, and orally active inhibitor of
human renal sodium glucose co-transporter 2 (SGLT2), the major transporter responsible for renal 
glucose reabsorption in the kidney. Dapagliflozin’s mechanism of action results in the direct and 
insulin-independent elimination of glucose by the kidney.
This is a Phase 3b study performed as part of the development program for saxagliptin / 
dapagliflozin fixed-dose combination (FDC, BMS-986098) to improve glycemic control as an 
adjunct to diet, exercise, and metformin treatment when treatment with both saxagliptin and 
dapagliflozin is appropriate. The study is intended to compare effects of saxagliptin co-
administered with dapagliflozin in combination with metformin to glimepiride in combination with 
metformin. Saxagliptin and dapagliflozin have demonstrated, both individually and in combination 
with metformin, a favorable safety and tolerability profile. They have demonstrated a low 
propensity for hypoglycemia. Both drugs have either demonstrated weight neutrality (saxagliptin) 
or moderate weight reduction (dapagliflozin). Dapagliflozin and saxagliptin have also 
demonstrated persistent beneficial effects on HbA1c. Thus, a second-line oral dual add-on therapy 
with saxagliptin co-administered with dapagliflozin could be a new option, as part of a triple 
combination that includes drugs with complementary mechanisms of action, low risk of 
hypoglycemia, and the potential for moderate weight loss, providing a more effective and patient-
friendly approach to the treatment of T2DM.
The purpose of this Study-specific Statistical Analysis Plan (SAP) is to present a detailed plan of 
the analyses of the Phase 3b study CV181-365. 


Statistical Analysis Plan
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saxagliptin-dapagliflozin
11
Research Hypothesis:
Co-administration of saxagliptin and dapagliflozin, in addition to metformin, results in better 
glycemic control, as measured by HbA1c, over a treatment period of 52 weeks, compared to the 
addition of glimepiride to metformin in subjects with inadequately controlled T2DM.
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 double-blind 
period. All relevant queries must be resolved, and the database must be locked for this period 
before the blind is broken (for the sponsor) for 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 CV181-365 study is an international multicenter, randomized, double-blind, active-controlled, 
parallel-group Phase 3b study. The primary endpoint is the change from baseline in HbA1c with 
saxagliptin in combination with dapagliflozin on top of background therapy with metformin, 
compared to glimepiride. The primary endpoint of HbA1c will be assessed at 52 weeks, however, 
the trial will continue with a 104-week blinded extension. Subjects with documented T2DM 
treated with a stable dose of metformin will be enrolled. All subjects should be treated according 
to regional standards of care for diabetes. Subjects must be receiving metformin in accordance 
with the product label for their country. Approximately 440 subjects meeting all eligibility criteria 
will be randomized (1:1) to receive either saxagliptin co-administered with dapagliflozin or
glimepiride. Enrollment of subjects based on disease state, and geographic region will be 
monitored and may be capped to ensure adequate representation. All potentially eligible subjects 
will undergo a screening visit. Each subject will sign an Informed Consent Form (ICF) prior to 
having any screening evaluations performed. Subjects who fulfill all eligibility requirements will 
enter a 2-week screening period and a 2-week lead-in period, during which they will continue their 
background medication with at least 1500 mg metformin. Approximately 2 weeks after entering 
the lead-in period, subjects will be expected to undergo a randomization visit. Subjects may 
withdraw prior to the randomization visit, or be withdrawn by study staff for any reason. At this 
visit, subjects will be re-evaluated by study staff to determine if after testing performed at the 
screening visit, after assessment of compliance, and any clinical changes that may have occurred 
during the lead-in period, the subject remains eligible and committed to participation in the study. 
If for any reason, prior to or during the randomization visit the subject is no longer eligible or 
interested in participating in the trial, he or she will be considered a lead-in failure, will not be 
randomized, and will not have additional follow up. If a subject is committed to participation, 
completes the lead-in period, and continues to meet eligibility criteria at the randomization visit, 
he or she will be randomized and will receive either saxagliptin 5 mg co-administered with 
dapagliflozin 10 mg plus metformin and matching placebo or glipimeride plus metformin and 
matching placebo in a double-blind fashion. Subjects will return to the site every 3 weeks to enable 


Statistical Analysis Plan
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12
titration of glimepiride from Week 3 up to Week 12, and then approximately every 12 to 13 weeks 
until the last visit (up to Week 156) for assessment of events related to the objectives of the study, 
tolerability and safety. Assessment of treatment compliance and provision of investigational 
product (IP) will be done at these visits.
Saxagliptin 5 mg tablets or matching placebo tablets will be provided, administered orally once 
daily for the 52-week double-blind treatment period and the 104-week subject and site blinded 
extension period. Saxagliptin 5 mg is the maximum recommend daily dose. No up- or down-
titration of saxagliptin will be allowed. Dapagliflozin 10 mg tablets (also the maximum 
recommended daily dose) or matching placebo tablets will be provided, administered orally once 
daily for the 52-week double-blind treatment period and the 104-week subject and site blinded 
extension period. No up- or down-titration of dapagliflozin will be allowed.
Glimepiride 1-6 mg or matching placebo capsules, administered orally once daily, will be provided 
for the 156-week blinded treatment period. During the first 12 weeks, the glimepiride dose will be 
slowly titrated in a stepwise blinded fashion depending on glycemic control. For the duration of 
the study, FPG will be measured at the study center using a glucose analyzer provided by BMS. 
The investigator’s decision on dose titration (either upwards if no issues with hypoglycemia or 
downwards if recurrent hypoglycemia occurs) will take both the plasma glucose measurements 
(measured prior to the visit), and the investigator’s measurements at the titration visits, into 
account. The glimepiride dose will be titrated to optimal effect (FPG 110 mg/dL 
[6.1 mmol/L]) or the highest tolerable dose during the first 12 weeks. The starting dose for 
glimepiride is 1 mg per day (once daily), which can be further increased by increments of 1-2 mg 
at 3-week intervals to a maximum of 6 mg per day (maximum recommended dose in the Summary 
of Product Characteristics and thus the maximum dose to be used in this study). The titration steps 
will be 2 mg, 3 mg, 4 mg, and 6 mg once daily if needed. In subjects for whom titration is not 
medically indicated at Week 3, re-assessment for titration will occur at Week 6, Week 9, and 
Week 12.
During the randomized treatment period, diet and life-style modification will continue to be
reinforced. All randomized subjects who are rescued with insulin (or other oral anti-diabetes 
therapy) and taking randomized IP should continue scheduled study visits as planned in the 
Clinical Study Protocol (CSP). Subjects who decide to prematurely discontinue the investigational 
products will always be asked about the reason(s) and the presence of any AEs. Subject should 
return and complete the procedures described for End of Treatment Visit (EOT) as soon as possible 
but at the latest 7 days after discontinuation of investigational product. The subjects with 
unresolved AEs should also be followed-up if medically indicated as judged by investigator. All 
subjects who discontinue from treatment will follow the same visit schedule as subjects who 
remain on treatment. The only exception to this requirement is when a subject withdraws consent 
for all study procedures or loses the ability to consent freely (i.e., is imprisoned or involuntarily 
incarcerated for the treatment of either a psychiatric or physical illness). Subjects lost to follow-
up (as defined by; unable to reach the subject after 3 documented phone calls, fax, email, or 
attempts to contact him/her through subject locator agencies [if allowed per national regulation] 


Statistical Analysis Plan
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and having sent one letter by registered/certified mail; all should be documented in the subject’s 
medical records).
The study design schematic is presented in Figure 2.1-1.
Figure 2.1-1: Study Design Schematic
In addition, two exploratory sub-studies will be conducted along with the above main study.
The reduction in body weight consistently observed during treatment with dapagliflozin has been 
shown to result in total body fat reduction. A sub-study will investigate whether this reduction in 
body fat is equally distributed among subcutaneous and visceral adipose tissue or if there is a 
preferential loss of adipose tissue in the visceral compartment. Body composition measurements 
by magnetic resonance imaging (MRI) can separately quantify the subcutaneous and the visceral 
adipose tissue. Non-invasive quantification of liver lipid content by magnetic resonance 
imaging-estimated proton density fat fraction (MRI-PDFF) is an emerging biomarker for 
assessment of the beneficial effects of weight loss and improvement in glycemic control on liver 
lipid metabolism. In this protocol, a subpopulation of approximately 60 randomized subjects 
(30 subject/treatment arm) who agree to participate (separate informed consent) will undergo 
MRI-PDFF measurement of subcutaneous and visceral adipose tissue, together with liver lipid 
content at baseline, at Week 52, and at Week 156.
Continuous Glucose Monitoring (CGM) is a useful technology (in addition to HbA1C) to 
qualitatively, as well as quantitatively, monitor the quality of glycemic control in the form of time 
spent in the euglycemic/hyperglycemic/hypoglycemic (blood glucose 70 mg/dL) ranges and the 
mean amplitude of glucose excursions (MAGE). Co-administration of saxagliptin and 
dapagliflozin is expected to better demonstrate less variability in glycemic control and more time 
spent in the euglycemic range compared to treatment with glimepiride administration. In this 
protocol, a subpopulation of approximately 120 randomized subjects (60 subject/treatment arm) 
who agree to participate (separate informed consent) will have CGM performed for periods of 
7 days at baseline and at Week 52 of treatment.


Statistical Analysis Plan
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2.2
Treatment Assignment
 
 
 
 
Subjects entering the 52-week double-blinded 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) 
double-blind treatment arms in a 1:1 ratio: 

Blinded saxagliptin 5 mg and dapagliflozin 10 mg

Titrated to blinded glimepiride 1 mg, 2 mg, 3 mg, 4 mg, or 6 mg
Randomization schedules for both subject treatment and containers will be generated and kept by 
BMS.
Subjects entering the 104-week long-term subject- and site-blinded treatment period 
Following completion of the 52-week double-blinded treatment period, subjects eligible for the 
long-term subject- and site-blinded treatment period will be continued in their same randomization 
assignment based on their original randomization grouping. Subjects that were assigned to receive 
the blinded saxagliptin 5 mg and dapagliflozin 10 mg arm will continue to receive the blinded 
saxagliptin 5 mg and dapagliflozin 10 mg. Subjects that were assigned to receive the blinded 
glimepiride will continue to receive blinded glimepiride (at a dose of 1 mg, 2 mg, 3 mg, 4 mg, or 
6 mg). At all study visits when study drug is dispensed, each subject will be assigned multiple 
container numbers by the IVRS. Container numbers will be assigned non-sequentially and will 
correspond to the numbers printed on the containers and bottles containing study drug, and will be 
recorded on the appropriate eCRF. The IVRS will be available 24 hours per day, 7 days a week.
2.3
Blinding and Unblinding
2.3.1 Blinding
The investigator, AstraZeneca personnel, and subjects will remain blinded to treatment allocation 
throughout the short-term, double-blind treatment period. The database used for the analysis of the 
short-term double-blind data of the study will be locked after all subjects have terminated the 
short-term double-blind treatment period of the study. The locked database will be unblinded for 
reporting purposes. To protect the integrity of the long-term treatment period of the studies, the 
subjects and investigators will not have access to the individual treatment assignments until the 
long-term treatment period has been completed.
For the duration of the double-blind treatment period (Day 1 to Week 52), the HbA1c and the 
urinary glucose values, including the urinary glucose:creatinine ratio, will be masked to the 
CCI


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sponsor and will not be available to the investigator. During the site- and subject-blinded treatment 
period, (after Week 52 and through Week 156), the above measurements will be unmasked to the 
sponsor. However, they still will not be available to the investigator except HbA1c values until 
after the study completion. HbA1c values will be provided to the investigator during the site- and 
subject-blinded treatment period.
2.3.2 Unblinding
Blinding is critical to the integrity of this clinical trial. However, in the event of a medical 
emergency or pregnancy, during which knowledge of the identity of the investigational product is 
critical to the subject's management, procedures are in place to have the blind broken for an 
individual subject. A listing of all subjects whose treatment is unblinded during the study will be 
included in the Clinical Study Report (CSR). A separate procedure is in place for unblinding in 
case of expedited safety reporting to regulatory authorities.
2.4
Protocol Amendments
Five protocol amendments have been processed and are incorporated into this SAP.  This SAP is 
based on the Revised Protocol 04, which incorporates amendment 5; date 8 February 2018 
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:

Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)  > 3X upper limit 
of normal (ULN) and total bilirubin (TB) >2X ULN (within 14 days of the AST and/or ALT 
elevation)

Hepatic events timely related to death (within 30 days before death)

AST and/or ALT > 10X ULN

Hepatic disorders leading to discontinuation from study treatment and/or death

Liver laboratory abnormalities such as elevated AST and/or ALT with or without TB 
elevations
A separate Adjudication Charter will define and describe the procedure for the handling, reporting, 
and classification of these events.
2.7
DKA Adjudication Committee
The diabetic ketoacidosis (DKA) Adjudication Committee will assess available information on 
each potential DKA event and will classify the event in accordance with the definitions in the DKA 


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Adjudication Charter T2DM. All potential events of DKA will be recorded in the eCRF and 
submitted to an independent DKA Adjudication Committee. 
The DKA Adjudication Committee will be kept blinded to the study drug treatment received by 
each subject with a potential DKA event in the clinical study. A separate DKA Adjudication 
Manual will define and describe the procedures for the collection of DKA information, handling, 
adjudication criteria and reporting of these events/cases.
3
OBJECTIVES
The following sections list the primary, secondary, and exploratory objectives specified in the 
protocol.
3.1
Primary
To compare the mean change from baseline in HbA1c achieved with saxagliptin, in 
co-administration with dapagliflozin, added to current background therapy with metformin, 
compared to glimepiride added to current background therapy with metformin at Week 52.
3.2
Secondary
Four secondary efficacy objectives for the short-term treatment period and two secondary efficacy 
objectives for the long-term treatment period are identified for consideration in this study, in 
addition to the primary objective.
Short-term:

To compare the mean change from baseline in total body weight achieved with saxagliptin, 
in co-administration with dapagliflozin, added to current background therapy with metformin, 
compared to glimepiride added to current background therapy with metformin at Week 52.

To compare the proportion of subjects achieving a therapeutic glycemic response, defined as 
HbA1c < 7.0%, at Week 52 with saxagliptin, in co-administration with dapagliflozin, added 
to current background therapy with metformin, compared to glimepiride added to current 
background therapy with metformin.

To compare the mean change from baseline in systolic blood pressure (SBP) achieved with 
saxagliptin, in co-administration with dapagliflozin, added to current background therapy 
with metformin, compared to glimepiride added to current background therapy with 
metformin at Week 52.

To compare the time to treatment intensification (addition of insulin or other glucose-lowering 
agent for rescue therapy or discontinuation for lack of glycemic control) achieved with 
saxagliptin, in co-administration with dapagliflozin, added to current background therapy 
with metformin, compared to glimepiride added to current background therapy with 
metformin during the 52-week double-blind treatment period.
Long-term:

To compare the time to treatment intensification (addition of insulin or other glucose-lowering 
agents for rescue therapy or discontinuation for lack of glycemic control) achieved with 
saxagliptin, in co-administration with dapagliflozin, added to current background therapy 


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with metformin, compared to glimepiride added to current background therapy with 
metformin during the 156-week treatment period.

To compare the proportion of subjects achieving therapeutic glycemic response, defined as 
HbA1c < 7.0%, at Week 156 with saxagliptin, in co-administration with dapagliflozin, added 
to current background therapy with metformin, compared to glimepiride added to current 
background therapy with metformin
3.3
Exploratory Objectives
Short-term:

To assess the proportion of subjects achieving therapeutic glycemic response, defined as 
HbA1c < 7.0%, without any hypoglycemia at Week 52 achieved with saxagliptin, in 
co-administration with dapagliflozin, added to current background therapy with metformin, 
compared to glimepiride added to current background therapy with metformin.

To assess the proportion of subjects achieving therapeutic glycemic response, defined as 
HbA1c < 7.0%, without any hypoglycemia and weight gain at Week 52 achieved with 
saxagliptin, in co-administration with dapagliflozin, added to current background therapy 
with metformin, compared to glimepiride added to current background therapy with 
metformin.

To assess mean change from baseline in fasting plasma glucose (FPG) achieved with 
saxagliptin, in co-administration with dapagliflozin, added to current background therapy 
with metformin, compared to glimepiride added to current background therapy with 
metformin at Week 52.  

To assess change from baseline of metabolic measures (glucagon, C-peptide, pro-insulin, 
insulin, iHOMA2) at Week 52 achieved with saxagliptin, in co-administration with 
dapagliflozin, added to current background therapy with metformin, compared to glimepiride 
added to current background therapy with metformin.

To assess change from baseline in average glucose values and post-prandial glucose values 
measured by 6-point self-monitored blood glucose (SMBG) profiles at Week 52 achieved 
with saxagliptin, in co-administration with dapagliflozin, added to current background 
therapy with metformin, compared to glimepiride added to current background therapy with 
metformin.

To assess change from baseline of urinary albumin to creatinine ratio at Week 52 achieved 
with saxagliptin, in co-administration with dapagliflozin, added to current background 
therapy with metformin, compared to glimepiride added to current background therapy with 
metformin. 

To assess change from baseline of biomarkers (high-sensitivity C-reactive protein [hsCRP], 
N-terminal pro-brain natriuretic peptide [NT Pro-BNP]) at Week 52 of double-blind treatment 
achieved with saxagliptin, in co-administration with dapagliflozin, added to current 
background therapy with metformin, compared to glimepiride added to current background 
therapy with metformin.

To assess changes in patient-reported treatment satisfaction, quality of life, and barriers to 
medication adherence achieved with saxagliptin, in co-administration with dapagliflozin, 


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added to current background therapy with metformin, compared to glimepiride added to 
current background therapy with metformin at Week 52.

To assess change from baseline in glycemic variability, as defined by mean amplitude of 
glycemic excursions (MAGE), in a sub-group using CGM achieved with saxagliptin, in 
co-administration with dapagliflozin, added to current background therapy with metformin, 
compared to glimepiride added to current background therapy with metformin at Week 52 in 
the subpopulation of subjects who undergo CGM.

To assess changes from baseline to Week 52 in visceral and subcutaneous adipose tissue 
volume and percent hepatic lipid content achieved with saxagliptin, in co-administration with 
dapagliflozin, added to current background therapy with metformin, compared to glimepiride 
added to current background therapy with metformin in the subpopulation of subjects who 
undergo MRI-PDFF.
Long-term:

To assess the mean change from baseline in HbA1c achieved with saxagliptin, in 
co-administration with dapagliflozin, added to current background therapy with metformin, 
compared to glimepiride added to current background therapy with metformin at Week 156.

To assess the time spent at or below HbA1c target (HbA1c < 7.0%) achieved with saxagliptin, 
in co-administration with dapagliflozin, added to current background therapy with metformin, 
compared to glimepiride added to current background therapy with metformin during 156 
weeks.

To assess the proportion of patients achieving therapeutic glycemic response, defined as 
HbA1c < 7.0%, without any hypoglycemia at Week 156 achieved with saxagliptin, in 
co-administration with dapagliflozin, added to current background therapy with metformin, 
compared to glimepiride added to current background therapy with metformin.

To assess the proportion of patients achieving therapeutic glycemic response, defined as 
HbA1c < 7.0%, without any hypoglycemia and weight gain at Week 156 achieved with 
saxagliptin, in co-administration with dapagliflozin, added to current background therapy 
with metformin, compared to glimepiride added to current background therapy with 
metformin.

To assess mean change from baseline in FPG achieved with saxagliptin, in co-administration 
with dapagliflozin, added to current background therapy with metformin, compared to 
glimepiride added to current background therapy with metformin at Week 156.

To assess change from baseline of metabolic measures (glucagon, C-peptide, pro-insulin, 
insulin, iHOMA2) at Week 156 achieved with saxagliptin, in co-administration with 
dapagliflozin, added to current background therapy with metformin, compared to glimepiride 
added to current background therapy with metformin. 

To assess change from baseline of urinary albumin to creatinine ratio at Week 156 achieved 
with saxagliptin, in co-administration with dapagliflozin, added to current background 
therapy with metformin, compared to glimepiride added to current background therapy with 
metformin.

To assess change from baseline of biomarkers (hsCRP, NT Pro-BNP) at Week 156 achieved 
with saxagliptin, in co-administration with dapagliflozin, added to current background 


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therapy with metformin, compared to glimepiride added to current background therapy with 
metformin.  

To compare the mean change from baseline in total body weight achieved with saxagliptin, 
in co-administration with dapagliflozin, added to current background therapy with metformin, 
compared to glimepiride added to current background therapy with metformin at Week 156.

To compare the mean change from baseline in systolic blood pressure achieved with 
saxagliptin, in co-administration with dapagliflozin, added to current background therapy 
with metformin, compared to glimepiride added to current background therapy with 
metformin at Week 156.

To assess changes in patient-reported treatment satisfaction, quality of life, and barriers to 
medication adherence achieved with saxagliptin, in co-administration with dapagliflozin, 
added to current background therapy with metformin, compared to glimepiride added to 
current background therapy with metformin at Week 156. 

To assess changes from baseline to Week 122 in visceral and subcutaneous adipose tissue 
volume and percent hepatic lipid content achieved with saxagliptin, in co-administration with 
dapagliflozin, added to current background therapy with metformin, compared to glimepiride 
added to current background therapy with metformin in the subpopulation of subjects who 
undergo MRI-PDFF.
3.4
Safety objectives:

Confirmed hypoglycemia defined as: blood glucose ≤70 mg/dL (3.9 mmol/L) recorded in 
the hypoglycemia module of the CRF for saxagliptin co-administered with dapagliflozin vs 
glimepiride at 52 and 156 weeks of therapy.

To evaluate the safety and tolerability of treatment achieved with saxagliptin, in 
co-administration with dapagliflozin, added to current background therapy with metformin, 
compared to glimepiride added to current background therapy with metformin at 52 and 
156 weeks of therapy.
4
ENDPOINTS
4.1
Primary Endpoint
The primary endpoint for analysis is mean change from baseline to Week 52 in HbA1c.
4.2
Secondary Endpoints
The secondary efficacy endpoints for the short-term treatment period include:

Mean change from baseline in total body weight at Week 52.

Proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c < 7.0%, 
at Week 52.

Mean change from baseline in SBP at Week 52.

Time to treatment intensification (addition of insulin or other glucose-lowering agent for 
rescue therapy or discontinuation for lack of glycemic control) during the 52-week double-
blind treatment period.
The secondary efficacy endpoints for the long-term treatment period include:


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
Time to treatment intensification (addition of insulin or other glucose-lowering agent for 
rescue therapy or discontinuation for lack of glycemic control) during the 156-week treatment 
period.

Proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c < 7.0%, 
at Week 156.
4.3
Exploratory Endpoints
The exploratory endpoints for the short-term treatment period include:

Proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c < 7.0%, 
without any hypoglycemia at Week 52.

Proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c < 7.0%, 
without any hypoglycemia and weight gain at Week 52.

Mean change from baseline in FPG at Week 52.

Mean change from baseline of metabolic measures (glucagon, C-peptide, pro-insulin, insulin, 
iHOMA2) at Week 52.

Mean change from baseline in average glucose values and post-prandial glucose values 
measured by 6-point SMBG profiles at Week 52. 

Mean change from baseline in urinary albumin to creatinine ratio at Week 52.

Mean change from baseline in biomarkers (hsCRP and NT Pro-BNP) at Week 52.

Mean change from baseline in patient-reported treatment satisfaction, quality of life, and
barriers to medication adherence at Week 52.

In a sub-study: Mean change from baseline in glucose variability, as defined by mean 
amplitude of glycemic excursions (MAGE), using CGM at Week 52.

In a sub-study:

Mean change from baseline in visceral and subcutaneous adipose tissue volume as assessed 
by MRI at Week 52 in the subpopulation of subjects who undergo MRI-PDFF. 

Mean change from baseline in percent hepatic lipid content as assessed by MRI at Week 
52 in the subpopulation of subjects who undergo MRI-PDFF.
The exploratory endpoints for the long-term treatment period include:

Mean change from baseline in HbA1c at Week 156.

Mean time spent at or below HbA1c target (HbA1c 7.0%) during 156 weeks.

Proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c < 7.0%, 
without any hypoglycemia at Week 156.

Proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c < 7.0%, 
without any hypoglycemia and weight gain at Week 156.

Mean change from baseline in FPG at Week 156.

Mean change from baseline of metabolic measures (glucagon, C-peptide, pro-insulin, insulin, 
iHOMA2) at Week 156.

Mean change from baseline in urinary albumin to creatinine ratio at Week 156.

Mean change from baseline in biomarkers (hsCRP and NT Pro-BNP) at Week 156.


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
Mean change from baseline in total body weight at Week 156.

Mean change from baseline in SBP at Week 156.

Mean change from baseline in patient-reported treatment satisfaction, quality of life, and 
barriers to medication adherence at Week 156.

Mean change from baseline in visceral and subcutaneous adipose tissue volume and percent 
hepatic lipid content as assessed by MRI at Week 122 in the subpopulation of subjects who 
undergo MRI-PDFF.
4.4
Safety Endpoints
The safety endpoints include:

The proportion of subjects with hypoglycemia events and the frequency and severity of the 
hypoglycemia events at Weeks 52 and Week 156

The proportion of subjects experiencing adverse events (AE) and marked abnormalities in 
clinical laboratory tests at Week 52 and Week 156

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 
at Week 52 and Week 156
5
SAMPLE SIZE AND POWER
The mean change in baseline in HbA1c at Week 52 will be assessed by comparing saxagliptin, in 
co-administration with dapagliflozin, added to current background therapy with metformin, versus 
the active comparator treatment group (glimepiride added to current background therapy with 
metformin).
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 using last observation carried forward (ANCOVA with 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.
Assuming a mean change from baseline in HbA1c difference effect of 0.35% for saxagliptin in 
co-administration with dapagliflozin plus metformin vs glimepiride plus metformin, a common 
standard deviation of 1.1%, and using a 2-sided significance level of 0.05 for the comparison, and 
assuming a 5% non-evaluability rate, then a sample size of 220 patients per arm will yield 90% 
power for the comparison of saxagliptin in co-administration with dapagliflozin plus metformin 
against glimepiride plus metformin.


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6
STUDY PERIODS, TREATMENT REGIMENS AND POPULATIONS FOR 
ANALYSES
6.1
Study Periods
Study CV181-365 consists of 4 study periods:
1) Screening period (Period A). This period starts with enrollment and ends on the start of lead-
in period.
2) Lead-in period (Period B). During this period, subjects will continue their diabetes 
management with metformin, diet and exercise. No placebo or study medication will be 
provided during the lead-in period.
3) 52-week short-term double-blind treatment period (Period C). On the Day 1 visit, subjects 
who meet all the protocol-specific enrollment and randomization criteria will be randomized.
4) 104-week long-term site and subject blind treatment period (Period D). After completing 
the short-term period, subjects will enter the 104-week site and subject blinded 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 early will follow the same 
visit schedule as subjects who remain on treatment. 
6.2
Treatment Regimens
The “as randomized” treatment group is defined as the treatment group to which a subject was 
randomized at the start of the double-blind 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 and will be used for subject disposition and protocol 
deviation results for the ST analysis only .


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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 
double-blind 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.
A subset of the randomized subjects data set will be used in  the short-term, and short-term and 
long-term analysis, defined as randomized subjects who consented to take part in the MRI-PDFF 
sub-study.
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.
The Evaluable Subject Data Set will only be used in the main efficacy result at Week  52 and no 
evaluable population will be summarized in the ST+LT CSR, although RPDs will be summarized 
for the ST+LT treatment period.
6.3.6
Treated Subjects Data Set
The Treated Subjects Data Set for the short-term treatment period and the short- and long-term 
treatment period will consist of all subjects who receive at least one dose of double-blind study
medication during the short-term double-blind 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 short-term double-blind treatment and entered
the long-term 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 short-term double-blind treatment period 
(even if the treatment they received in the short- or long-term treatment period was different).


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7
STATISTICAL ANALYSES
7.1
General Methods
7.1.1
Definitions
7.1.1.1
Baseline Value
Unless otherwise stated, for the short-term, and short-term and long-term analyses, 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 short-term and long-term is
defined as follows:
CWeek t = MWeek t - Mbaseline,
where:
CWeek t is the change from baseline at Week t,
MWeek t is the measurement at Week t,
Mbaseline is the measurement at baseline.
Percent change from baseline to any Week t in short-term, or short-term and long-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. 
Safety analyses include either subjects’ data “prior to rescue medication”, or “regardless of rescue 
medication”.  For analyses based on “prior to rescue medication”, subjects’ data up to and on the
date of the first dose of rescue medication, subject to the prescribed cut off of the IP treatment 


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discontinuation (see Section 0), will be used. For analyses based on “regardless of rescue 
medication”, subjects’ data are excluded only after treatment discontinuation based on the 
prescribed cut off days (see Section 0).  
Efficacy tables are summarized for subjects “prior to rescue and treatment discontinuation” and 
“regardless of rescue and treatment discontinuation”.  For analyses based on “prior to rescue and 
treatment discontinuation” subjects’ data will be included up to the earliest of the start of rescue 
medication, or last dose of study medication  including the cuts off allowances described in Section 
0.  For analyses “regardless of rescue and treatment discontinuation” all subjects’ data will eligible 
for inclusion in the analyses. 
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 ANCOVA, for Hb1Ac analysis of change  from baseline, the 
measurement closest to the target date is assigned as the Week 52 measurement and will be used. 
If no Week 52 measurement is available (subject has discontinued before Week 52, or 
measurement not taken at Week 52, 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 52, their last post-baseline measurement taken prior to or on the date of 
the first dose of rescue medication will be used in the “prior to rescue medication” analyses.  
For safety analyses based on “regardless of rescue medication”, which exclude data after treatment 
discontinuation, all data will be eligible to be used until the prescribed cut off (see Section 0).  
For urinary albumin to creatinine ratio (uACR) shift tables, if no week 52 data are available for a 
subject, then last available observation prior to week 52 is used. 
Section 8 provides additional information regarding handling of missing or partial dates, inclusion 
of values, windowing, and values obtained post treatment.
The same methodology will be used in the ST+LT analyses at Week 156.
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.


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The following general model will be used:
Cijk = intercept + β 1 [Mbaseline,ij] + τi + αk+ (α τ)ik + (α Mbaseline)ijk + errorijk
(Model 7.1.2.1)
where:
Cijk is the change from baseline for subject j in treatment group i at time k,
β1 is the slope coefficient for the baseline measurement,
Mbaseline,ij is the baseline measurement of subject j in treatment group i,
τi is the mean effect of treatment group i,
αk is the mean effect at time k
(α τ)ik is the interaction term between treatment group i and time k.
(α Mbaseline) ijk is baseline measurement-by-week interaction term for subject j in treatment
group i at time k, and
errorijk is the error term for subject j in treatment group i at time k.
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 first backup model is the same as the preferred model, but the Kenward-Roger method
will be replaced by Satterthwaite approximation.

The second backup model is the same as the preferred model but without the term for baseline
measurement-by-week interaction.
The second back-up model will only be provided if the first back-up model does not converge
or has memory issues. 
If the models do not converge, then the spatial power covariance matrix will be used instead.
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.
Appropriate diagnostics will be performed to check model assumptions.


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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.
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 treatment-by-
baseline 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 for the primary efficacy endpoint will be assessed for subgroups, in the ST
analysis, based on age group, female age group, gender, race, region, baseline HbA1c categories, 
and baseline eGFR categories, 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. Tests of the treatment-by-subgroup 
interaction will be assessed using contrasts of the treatment effect by subgroups at Week 52. 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 52.
7.1.3
Analysis of Covariance (ANCOVA)
In summaries of efficacy endpoints examining changes from baseline at Week 52 in the short-
term analysis, and week 156 in the short-term and long-term analysis, 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 + β [Y0,ij]+ τi + errorij
(Model 7.1.3.1)


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where:
Dt,ij = Y24,ij - Y0,ij = the Week 52 change from baseline of subject j in treatment group i (as
defined in Section 7.1.1.2 and Section 8 on conventions),
Y0,ij is the baseline measurement of subject j in treatment group i,
Y24,ij is the Week 52 measurement of subject j in treatment group i,
β is the slope of Dt,ij regressing on the baseline measurement and,
τi is the mean effect of treatment group i.
Intercept, β, and τi are unknown parameters to be estimated from the data.
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.
Model assumptions will be checked.
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 n, mean, median, first quartile (Q1) and third quartile 
(Q3) and standard error (SE). Geometric mean and coefficient of variation (CV) will be also be 
provided for lipid panel results. 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 double-blind treatment period, or during the short-term and long-
term treatment period. Treatment group differences will not be assessed in summaries of shifts.


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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. 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 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. 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) 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). For each treatment group, the probability of response is first 
modeled using a logistic regression model with baseline (e.g., baseline HbA1c) as a covariate. 
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. 
For composite response endpoints (glycemic control without hypoglycemia or weight gain), the 
proportion of subjects achieving targets will be summarized by treatment group without 
adjustment for baseline.
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 prior to Day 1 visit 
(between Week -1 and Day 1) and within a week of Week 52/Study Termination and Rescue or 
Early Treatment Termination. 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 post-prandial averages. The pre-prandial and post-prandial 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 pre-prandial and post-prandial 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”1. 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.
Figure 7.1.3-1 is an example of calculation as described in the original publication of MAGE 3.
Figure 7.1.3-1:
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 that despite that this 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:

Segment: the ascending or descending part between a nadir and a peak.

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 excursion during the 24 hours.
Phase V® is collecting the data for CGM in this study. More details on the collection and analysis 
is provided in Appendix 1.
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 7.2-1. 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 ≥ 7.5% 
and ≤ 10.5% 
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 
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 
double-blind/ ST + LT 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 double-blind/ST + LT 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
Randomized subjects who took no dose of 
metformin or dose of metformin outside dose 
range for ≥ 2 consecutive weeks in the 
short-term double-blind/ST + LT treatment 
period
Partial /Complete
Exclusion will start from the 
14th consecutive day that 
metformin was either not taken or 
outside range of ≥ 1500. Subjects 
who were on treatment < 14 days 
and did not take metformin 
according to protocol will be 
excluded 
8
Randomized subjects who receive no study 
medication or dosing for ≥ 2 consecutive 
weeks in the short-term double-blind/ST + 
LT 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 double-blind study 
medication will be excluded


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Table 7.2-1:
List of Relevant Protocol Deviations
RPD #
RPD Criteria
Exclusion Type
Exclusion Level
9
Randomized subjects who received incorrect 
study medication or dosing for 
≥2 consecutive weeks in the short-term 
double-blind/ST + LT treatment period
Partial/Complete
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 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 
double-blind/ST + LT treatment period.
Complete
7.3
Study Population
7.3.1
Subject Disposition
The disposition of subjects for the screening period, lead-in period, and the 52-week short-term
double-blind 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 double-blind treatment period
will be tabulated and listed. The summary will be presented by randomized treatment group and 
overall. 
The summary of status in the long-term treatment period 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, at the 
ST analysis.  At the ST+LT analysis, the demographic and baseline characteristics will be 
summarized for the Randomized subjects in MRI-PDFF sub-study.
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, and hematuria (other disease characteristics, for ST+LT 
only) is listed in Table 7.3.2.D.


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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 - <75
≥75 yrs
Female Age 
Categorical
≤ 50 yrs
> 50 yrs
Race 
Categorical
White, Black or African American,  
American Indian or Alaska Native, 
Native Hawaiian or other Pacific 
Islander, 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/1.73m2
≥ 60-< 90 mL/min/1.73m2
≥ 90 mL/min/1.73m2


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Table 7.3.2D: Hematuria (Other disease characteristics) (ST+LT only)
Characteristic 
Summarized as
Categories
Hematuria n (%)
Categorical
Female (Yes, No)
Male (Yes, No)
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 double-blind treatment period, at the ST analysis.  At the ST+LT analysis the 
demographic and baseline characteristics will be summarized for the Randomized subjects in MRI-
PDFF sub-study.
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 
double-blind treatment period.
7.4
Extent of Exposure
7.4.1
Study and Rescue Medication
The extent of exposure to study medication during the 52-week short-term double-blind treatment 
period is defined as the difference between the last and the first dose of study medication of the 
short-term double-blind 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 double-blind treatment 
period and the short-term double-blind treatment period prior to rescue as well as regardless of 
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, 169-252, 253-336, 337-371, ≥ 372 
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). All rescue medication use during the 52-week short-term double-blind treatment 
period will be summarized and listed by treatment group.
The extent of exposure to study medication during the combined short- and long-term treatment 
periods is defined as the difference between the last dose of short-term double-blind or long-term 
treatment and the first dose of double-blind study medication plus 1 day. For a subject, when there 
are duplicate records of study medication exposure data within one of the study treatments 
dispensed (saxagliptin, dapagliflozin, or glimepiride) that have identical start and stop dates and 
number of pills taken, but different bottle/lot numbers, the average of the pill counts across that 
date range in the duplicate records will be used to count the number of pills taken for that study 


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treatment during that date range.  The extent of exposure to study medication will be summarized 
using the Treated Subjects data set for the combined short- and long-term treatment period prior 
to rescue as well as regardless of rescue. The number and percent of subjects with an extent of 
exposure within pre-specified day ranges (1-90, 91-180, 181-360, 361-540, 541-720, 721-900, 
901-1100 and > 1100 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 used during the combined short- and long-term 
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 the 
short-term and combined short- and long-term treatment periods.
7.4.2
Concomitant Medications
Concomitant medications for the short-term double-blind treatment period will be any medication 
taken from start of the short-term double-blind treatment period up to the end of the short-term 
double-blind treatment period.
Concomitant  medications for combined short-term plus long-term treatment periods will be any 
medication taken from the start of the short-term double-blind treatment period up to the end of 
the combined short- and long-term treatment periods.
Concomitant medications for both the short-term and combined short- and long-term treatment 
periods will be summarized using the Treated Subjects dataset by drug class and (generic) drug 
name. Summary tables, for allowed, as well as disallowed concomitant medications, by drug class 
and generic drug name will be generated.  
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 the short-term and the combined short- and 
long-term treatment period for each treatment group. For each subject, percent compliance is 
defined as the total number of tablets taken divided by the total number of tablets that should have 
been taken, 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 double-blind treatment period dose recorded in the “Record of Study 
Medication” to the last short-term double-blind 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 


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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 double-blind treatment dose.
For the combined short- and long-term:
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 (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 treatment dose (following any adjustments for 
duplicate records as described in Section 7.4.1)..
7.5
Efficacy
7.5.1
Overall Efficacy Summary
All efficacy analyses will be performed using the Randomized Subjects data set. In addition, at the 
ST analysis, the primary efficacy analysis will be performed using the Evaluable Subjects data set 
if > 10% of subjects in any treatment group have relevant protocol deviations.
Unless otherwise specified, all analyses will be done using values prior to rescue/intensification of 
treatment or treatment discontinuation (plus a tolerance window after last dose as detailed in 
Section 0). For the endpoint of the proportion of subjects achieving a therapeutic glycemic 
response at Week 52/Week 156, all available data will be used, but subjects rescued prior to 
Week 52/Week 156 will be treated as non-responders. 
The comparator (glimepiride plus metformin) will be tested against saxagliptin, in 
co-administration with dapagliflozin plus metformin, for the primary efficacy endpoint at the 
alpha = 0.05 level (two-sided). The secondary efficacy endpoints will then be tested sequentially, 
each comparison tested at the alpha = 0.05 level (two-sided). The following testing hierarchy 
(shown in order of the step-wise testing sequence) for treatment comparisons will be used:  

Mean change from baseline in HbA1c at Week 52 (primary endpoint).

Mean change from baseline in total body weight at Week 52.

Percent of subjects achieving a therapeutic glycemic response, defined as HbA1c < 7.0%, at 
Week 52. 

Mean change from baseline in systolic blood pressure (SBP) at Week 52.

Time to treatment intensification (addition of insulin or other glucose-lowering agent for 
rescue therapy or discontinuation for lack of glycemic control) during the 52-week double-
blind treatment period.
If all the above five comparisons performed for the short-term analysis are statistically significant, 
the following two comparisons will be tested sequentially for the short-term plus long-term 
analysis:


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
Time to treatment intensification (addition of insulin or other glucose-lowering agent for 
rescue therapy or discontinuation for lack of glycemic control) during the 156-week treatment 
period.

Proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c < 7.0%, 
at Week 156
Analyses of exploratory endpoints specifically designed for sub-studies (CGM and MRI-PDFF) 
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 52 visit. The primary analysis 
of the change in HbA1c from baseline at Week 52 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 double-blind treatment period assessment. 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 (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 Section 7.1.2 in case of non-convergence of the preferred model or 
other issues. Data collected after the initiation of rescue medication will be excluded. Data 
collected outside the analysis window (defined in Section 8 of this SAP) after subjects 
discontinued double-blind 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 glimepiride 
will be calculated. 
Sensitivity Analyses 
The following sensitivity analyses will be carried out for the primary end point for the ST data/at 
week 52:

Primary analysis will be repeated using Evaluable Subjects data set.

Primary analysis will be repeated using all available values regardless of rescue or treatment 
discontinuation

An ANCOVA analysis using values prior to rescue or treatment discontinuation (LOCF will 
be used if the week 52 value is not available)

Analyses to address missing values (described below in Section 7.5.4)

Analysis using multiple imputation return-to-baseline 

Tipping point analysis
The following sensitivity analyses will be carried out for the ST+LT data/at Week 156 are: .

Change from baseline in HbA1c at week 156, ANCOVA (LOCF)  using the Randomized 
subject data set - completers not requiring glycemic rescue therapy, (defined as subjects who 


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took at least one dose of randomized study medication, completed the LT phase, and did not 
take any glycemic rescue therapy during the ST or LT treatment period)

Change from baseline in HbA1c at week 156, regardless of rescue and treatment 
discontinuation, repeated measures analysis  using the Randomized subject data set
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 mixed model repeated measures (MMRM) efficacy analyses, which assumes that data are 
missing at random (MAR), missing observations will not be imputed.
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. 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 return to its baseline value and 
not derive any benefit from treatment. 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.
Last observation carried forward (LOCF) will also be used to handle missing data as described in 
Section 7.1.1.3 for analyses such as sensitivity analyses of Hb1Ac (ANCOVA) at week 52 and 
156. 
7.5.3.1
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 52, 
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 52. 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:


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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  as a fixed factor 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.
In this study, the primary analysis is comparing Dapagliflozin + Saxagliptin + Metformin group 
to control group Glimipiride + Metformin. The above approach will be conducted using the 
Glimipiride + Metformin as the control group.
7.5.3.2
Tipping Point Analysis based on 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 to be 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 significant 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:
()
(
)
= (
)
(
)
+ 


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where -
−
(
)
{
)
are values imputed using a MAR-based imputation model in the mth
imputed dataset, m=1,…,M (number of imputations)
−
 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. 
Step 1: Use the common Step 1 in Section 4.1.5.1 for partial imputation to get monotone missing 
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 (Dapagliflozin + Saxagliptin + Metformin). The variables used as explanatory 
variables for imputation include Treatment, 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 is no longer rejected. 
Step 3: At each level of delta, analyze each of multiple imputed datasets using the same MMRM 
model as used for the primary analysis. Combine estimates obtained from multiple imputed 
datasets based on Rubin’s combination rules.
Step 4: Using a 2-sided Type I error level of 0.05, find the tipping point, i.e., the value of delta 
parameter for which the primary hypothesis is no longer rejected. In this study, we will 
compare Dapagliflozin + Saxagliptin + Metformin vs. Glimepiride + Metformin for each delta 
value. We will find the delta value at which the test of hypothesis is no longer rejected. A clinical 
interpretation about the plausibility of the assumptions underlying the tipping point will be 
provided.
7.5.4
Secondary Efficacy Analyses
In order to protect the overall type I error rate, the interpretation of the statistical significance of 
treatment comparisons for each secondary efficacy endpoint will be done using a step-wise 
procedure as outlined in Section 7.5.1
The ordered list of secondary endpoints for the sequential testing procedure is:

Mean change from baseline in total body weight at Week 52.

Percent of subjects achieving a therapeutic glycemic response, defined as HbA1c < 7.0%, at 
Week 52. 

Mean change from baseline in SBP at Week 52.


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
Time to treatment intensification (addition of insulin or other glucose-lowering agent for 
rescue therapy or discontinuation for lack of glycemic control) during the 52-week 
double-blind treatment period.

Time to treatment intensification (addition of insulin or other glucose-lowering agent for 
rescue therapy or discontinuation for lack of glycemic control) during the 156-week treatment 
period.

Proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c < 7.0%, 
at Week 156
The analysis of change from baseline for total body weight and SBP will be performed using the 
same longitudinal repeated measures model as for the primary efficacy endpoint.
The proportion of subjects achieving a therapeutic glycemic response (defined as HbA1c < 7.0%) 
at Week 52 and Week 156 will be summarized by treatment group and compared between 
treatment groups using logistic regression, adjusting for baseline Hb1Ac. The 95% confidence 
intervals for the response rate within each treatment group, as well as for the difference in response 
rates between treatment groups, will be calculated with adjustment for baseline HbA1c. Subjects 
who are rescued, discontinued or have missed measurements at Week t (t = 52 and 156, 
respectively) will be considered as not achieving glycemic response.
Time to treatment intensification will be analyzed using a Cox proportional hazards model. 
Estimates of the hazard ratio and 95% confidence intervals will be provided. This analysis will be 
performed only when there are at least 10 events in each treatment group. Kaplan-Meier estimates 
will be calculated and plotted by treatment group. For the analysis during 52 / 156 weeks, all 
subjects will be censored at 52 / 156 week short-term / long-term treatment period if treatment 
intensification has not occurred by then. Subjects rescued at Week 52 / 156 visit will be counted 
as having an event for the analysis.
7.5.5
Exploratory Efficacy Analyses
No adjustments for multiplicity will be done for exploratory endpoints; only nominal p-values will 
be presented.
7.5.5.1
Proportion of Subjects Achieving Composite Response Targets
The proportion of subjects achieving composite response targets will be summarized by treatment 
group without adjustment for baseline for the following composite response endpoints:

Proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c < 7.0%, 
without any hypoglycemia at Week 52.

Proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c < 7.0%, 
without any hypoglycemia and weight gain at Week 52.

Proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c < 7.0%, 
without any hypoglycemia at Week 156.

Proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c < 7.0%, 
without any hypoglycemia and weight gain at Week 156.


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7.5.5.2
Mean Change from Baseline at Week t
The analyses of change from baseline in exploratory endpoints including HbA1c, FPG, uACR, 
fasting plasma glucose, body weight, and SBP at Week 52 and Week 156 (if applicable) will be 
performed using the longitudinal repeated measures model as described in Section 7.1.2. The 
analysis of change from baseline for metabolic measures (glucagon, C-peptide, pro-insulin, 
insulin, iHOMA2), average glucose values and post-prandial glucose values measured by 6-point 
SMBG profiles (ST analysis only) will be performed using ANCOVA model as described in 
Section 7.1.3.  The statistical model assumptions will be checked, especially because uACR results 
are often skewed.
7.5.5.3
Change from Baseline for Lipids
The change from baseline in Triglycerides, Total Cholesterol, LDL and HDL parameters during 
the short-term and long-term treatment periods will be summarized for each treatment group at 
visits 52 and 156 only.  The data will be summarized by arithmetic mean, SD,  geometric means 
and coefficient of variation (CV), minimum, maximum, Q1, Median and Q3 values.
7.5.5.4
Mean Change from baseline in endpoints for sub-study
In the CGM sub-study, CGM will be performed for periods of 7 days at baseline and at Week 52 
of treatment. Mean amplitude of glucose excursions (MAGE) for a 24-hr period is calculated in 
the way defined in Section 7.1.3. The average of the 7 MAGE values at baseline or at Week 52 
will be used for analyses. Analyses of the mean change from baseline in MAGE at Week 52 will 
be performed using the ANCOVA model based on LOCF data. 
In the MRI-PDFF sub-study, the mean change from baseline in visceral and subcutaneous adipose 
tissue volume and percent hepatic lipid content as assessed by MRI at Week 52 will be performed 
using the ANCOVA model based on LOCF data.
The analysis of the mean change from baseline in visceral and subcutaneous adipose tissue volume 
and percent hepatic lipid content as assessed by MRI at the Week 122 CRF visit will be performed 
using the same longitudinal repeated measures model as described in Section 7.1.2.
MRI values from an earlier visit are used instead of values at Week 52/122 for patients who are 
rescued or prematurely discontinue prior to Week 52/122. MRIs from week 52/122 could have 
been scheduled up to 4 weeks after the Rescue or Premature Treatment Discontinuation Date.
The analysis of percent hepatic lipid content will be adjusted for baseline weight.
Liver fat fraction (%) will also be summarized in a shift tables from baseline to week 52 (in the 
ST summary), and weeks 52 and 122 (in the ST+LT summary), using categories of >=5.5% and 
<5.5%.
For MRI laboratory data (visceral adipose tissue, subcutaneous adipose tissue and liver fat 
function) obtained from day 2, up to  and including the last short-term double-blind dosing date + 
27 days (see Table8.4M) will be considered as obtained during the short-term double-blind 
treatment period. MRI laboratory data obtained from the day after the last study medication up to 
the last visit date of the follow-up period will be considered as obtained during the follow-up 


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period. MRI laboratory data obtained from the first day of long-term treatment up to including the 
last day of long-term medication (excluding assessments that were within 27 days from last day of 
ST double-blind treatment and were assigned to Week 52 analysis visit) will be considered as 
obtained during the combined short- and long-term treatment periods.    
7.5.6
Summary of Primary Efficacy Endpoint within Subgroups
Treatment effects will be assessed for subgroups based on age group, female age group, gender, 
race, region, baseline HbA1c categories, and baseline eGFR categories 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. 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. Adjusted mean change from baseline 
and its difference from the control group will be given for each subgroup at week 52.
7.5.7
Pharmacokinetic Analyses
Not applicable
7.5.8
Biomarker Analyses
The change from baseline in C-Reactive protein and N-Terminal ProB-type Natriuretic Peptide 
parameters during the short-term and long-term treatment period will be summarized descriptively 
for each treatment group at  week 52 and 156 only.
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, 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.  The outcomes research 
analyses will be summarized as a separate report by Phase V®.
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.


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7.6
Safety
The assessment of safety will be based on the analyses of AEs, vital signs, physical examinations, 
ECGs, hypoglycemia, 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 52-week double-blind period (at the time of 
the primary endpoint analysis) and then again at the final database lock (156 weeks) on the 
combined short- and long-term treatment periods.
Additional sensitivity analyses for adverse events and laboratory marked abnormalities will be 
performed excluding data after rescue for the short-term double-blind treatment period. The 
primary analyses of events of hypoglycemia will be performed excluding data after rescue.
7.6.1
Adverse Events
Adverse events analyses will be performed for the short-term and combined short- and long-term 
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 8.8.
In summaries by SOC and PT, AEs will be sorted by international order for system organ class 
(SOC) and by decreasing frequency of preferred term within each SOC for Dapagliflozin + 
Saxagliptin + Metformin group. In summaries by PT, AEs will be sorted by decreasing frequency 
within PT for Dapagliflozin + Saxagliptin + Metformin group.
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.
Extra details of surgical or spontaneous amputation are captured on CRF pages separate to the AE 
pages. Amputation AE/SAE will be included in the summaries of AE/SAEs.  In addition, separate
summaries will be provided including AEs leading to surgical or spontaneous amputation, an 
overview of adverse events leading to surgical or spontaneous/non-surgical amputations, and 
contributing factors and conditions that triggered any surgical or spontaneous/non-surgical 
amputations.
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 double-blind treatment period. All adverse events 


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(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 double-blind treatment 
period. For the analyses of the short-term double-blind treatment period, the summary of AEs and 
analyses by SOC and PT will be performed using the data prior to rescue as well as the data 
regardless of rescue. 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 double-blind treatment up to and including 
4 days and 30 days respectively, after the last dose date in the short-term double-blind 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 double-blind treatment period.
In addition, the following summaries will be provided for the short-term double-blind treatment 
period (excluding hypoglycemic events that are not reported as SAEs):

Most common adverse events by preferred term and treatment group (i.e., reported by ≥2% of
subjects in any treatment group),

Adverse events by system organ class, preferred term, intensity, and treatment group,

Adverse events related to study medication by system organ class, preferred term, and 
treatment group.

Proportion of subjects with adverse events by SOC and PT in subgroups of subjects 
defined by age category (< 65, ≥65, and ≥75 yrs), gender, race, and female age category (≤
50 and > 50 yrs).
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 the combined short- and long-term 
treatment period. AEs and SAEs with an onset from Day 1 of short-term double-blind treatment 
up to and including 4 days and 30 days respectively, after the last dose date in the short- or 


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long-term treatment period will be included in summaries of the combined short- and long-term 
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 used to identify deaths for 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 the short-term treatment period and listing of all deaths that occur during the study 
will be produced for the combined short- and long-term treatment period.
7.6.3
Serious Adverse Events
All SAEs (including hypoglycemic events) will be described in narratives, regardless of 
investigator assessment of causality. 
SAEs with an onset from Day 1 of short-term double-blind treatment up to and including 30 days 
after the last dose date in the short-term double-blind 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 double-blind treatment period.
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- or long-term treatment period will be considered as occurring during the 
combined short- and long-term treatment periods.
SAEs occurring during the short-term or combined short- and long-term treatment periods 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. 
At the time of the ST+LT analysis two SAE listings will be produced:  A listing of all SAEs for 
the short-term treatment period will be produced, displaying all SAEs (including pre-treatment 
events) that occurred prior to or on the start date of long-term treatment period,  as well as listing 
of all SAEs for the combined short- and long-term treatment period 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 double-blind 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 during the 
short-term double-blind treatment period 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.


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AEs with an onset during the combined short- and long-term 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 the combined short- and 
long-term treatment period, no upper cutoff day windows (i.e., 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 other 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 double-blind treatment 
up to and including 4 days and 30 days, respectively, after the last dose date in the short-term 
double-blind 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 double-blind treatment period.
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- or long-term 
treatment period will be considered as occurring during the combined short- and long-term 
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 double-blind treatment up to and 
including 4 (30 days in case of SAEs) days after the last dose date in the short-term double-blind 
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 double-blind treatment period. 
Hypoglycemic events with an onset from Day 1 of the short-term double-blind treatment up to and 
including 4 (30 days in case of SAEs) 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 recommendations2 :
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.”2


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Documented symptomatic hypoglycemia: 
“An event during which typical symptoms of 
hypoglycemia are accompanied by a measured plasma glucose concentration 70mg/dl 
(3.9mmol/l).”2
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.”2
It is not medically possible for an event to be considered to be both asymptomatic hypoglycemia 
as well as severe hypoglycemia.  In the ST+LT analysis, if an event is classified as both severe 
and asymptomatic, it will be considered only to be severe hypoglycemia in the summary tables.  If 
an event is classified as both severe and as documented symptomatic hypoglycemia, even if 
unlikely but not deemed medically implausible, the event will be included in the summary tables 
under both classifications.
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.”2
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 
patients 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.”2
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 


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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. 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 double-blind 
treatment period, and the short-term and long-term treatment period.  . For short-term double-blind 
period analyses, the only upper cutoff date is 4 days (30 days in case of SAEs) following the date 
of the last dose of short-term double-blind study medication or the start of the long-term treatment 
period, whichever comes first.  For the short-term and long-term treatment period, the upper cutoff 
date is 4 (30 days in case of SAEs) days following the date of the last dose of study medication.
Hypoglycemic events with an onset during the short-term double-blind treatment period and 
leading to discontinuation of study medication will be summarized by treatment group.  A similar 
summary will be produced for the short-term and long-term treatment period.  When summarizing 
hypoglycemic events leading to discontinuation, no upper cutoff day windows are applied.
A summary of the incidence of confirmed hypoglycemia, defined as blood glucose ≤70mg/dL 
(3.9 mmol/L) recorded in the hypoglycemia module of the CRF, will be provided. Additionally, a 
summary will be provided for subjects who have at least one episode of confirmed hypoglycemia.
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 double-blind treatment period up to the start date 
of the long-term treatment period, and separately for the short-term and long-term treatment 
period.
7.6.5.2
Confirmed Adjudicated Cardiovascular Adverse Events
The number and percentage of subjects with confirmed cardiovascular events (i.e., hospitalization 
for heart failure as determined by the adjudication committee) will be summarized by preferred 
term and treatment group.
In this study, only events of heart failure requiring hospitalization will be adjudicated. 
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 this study, the following hepatic events will be adjudicated:

AST and/or ALT >3X ULN and TB >2X ULN (within 14 days of the AST and/or ALT 
elevation)


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
AST and/or ALT >10X ULN

Hepatic event AE/SAE occurring within 30 days before subject death
In addition, a listing of all adjudicated hepatic adverse events by subjects will be provided. 
7.6.5.4
Confirmed Adjudicated DKA Events
The number and percentage of subjects with confirmed DKA events (as determined by the 
adjudication committee) will be summarized by preferred term (as listed in Appendix B of the 
DKA Adjudication Charter v3.0 dated 17 July 2018) and treatment group.  
7.6.5.5
Other AEOSIs
Other 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 listing of AEOSI will include all data regardless of use of rescue 
medication:

AEs of genital infection by recurrence 

AEs of genital infection by gender

AEs of Urinary Tract Infection (UTI) by recurrence

AEs of UTI by gender

AEs of severe cutaneous adverse reactions (SCAR)

AEs of renal impairment/failure

AEs of volume depletion

AEs of fracture

AEs of liver injury

AEs of hypersensitivity reactions

AEs of decreased lymphocyte count

AEs of pancreatitis

AEs of Breast, bladder, prostate and pancreatic cancer 

AEs of cardiac failure

AEs of decreased thrombocyte count
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 short-
and long-term 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 (Glucagon, proinsulin, hematology and chemistry 
assessments, UACR,  C-Reactive Protein (biomarker), N Terminal ProB Type Natriuretic Peptide 


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(biomarker) 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 double-blind 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 double-blind treatment period. Laboratory data obtained from the 
day after the last study medication + 4 days (30 days for liver function laboratory 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 short-term treatment up to and including 4 days (30 days 
for liver function laboratory tests) after the last dose of short- or long-term medication will be 
considered as obtained during the combined short- and long-term 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 3 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.
Because the mechanism of action of dapagliflozin is known to impact urine glucose levels, 
urinalysis results of glucose will not be summarized. All laboratory evaluations performed by 
central laboratories will be included in summary tables,. All laboratory tables for the CSRs will be 
produced in both conventional 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 double-blind treatment period and the 
combined short- and long-term treatment periods will be summarized by treatment group. In the 
short-term double-blind 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 short-term treatment period and the combined short- and long-term 
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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
hematocrit

hemoglobin

platelet count

white blood cell (WBC) count

total bilirubin

alanine aminotransferase (ALT)

alkaline phosphatase

aspartate aminotransferase (AST)

Estimated GFR using MDRD equation:
eGFR (mL/min/1.73m2) =175 x (Scr)-1.154 x(Age)-0.203 x (0.742 if female) x (1.210 if 
African-American)

creatinine kinase (creatine phosphokinase) (CK)

creatinine, serum (Scr)

electrolytes - sodium, potassium, chloride, magnesium and calcium

total protein, serum

inorganic phosphorus

urinary albumin to creatinine ratio

creatinine clearance 
Change from baseline in categorical variables will be provided using shift tables.  For urinary 
albumin to creatinine ratio, the shift table will be derived from laboratory assessments after the 
date of first dose of short-term double-blind study medication up to and including 4 days following 
the date of last dose of short-term and long-term study medication, or up to the end date of the 
short-term and long-term treatment period, whichever comes first. Week 156 value in the shift 
table is chosen for Week 156 using the day range of 1003 to last day of long-term treatment as in 
SAP table8.4H, regardless of rescue medication, and up to and including 4 days following the date 
of last dose of short-term + long term study medication. If no week 156 value available then last 
available post-baseline observation prior to week 156 should be used (imputed) for Week 156 in 
the shift table (i.e., LOCF)
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 double-blind 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
double-blind treatment period.
Vital signs data obtained after the start of study medication dosing up to and including 4 days after 
the last short- or long-term dosing date will be considered as obtained during the combined short-
and long-term 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 


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by treatment group at each scheduled visit using descriptive statistics (using available data 
regardless of rescue for subjects in Treated Subjects Data Set) for BMI, waist circumference, 
sitting SBP, DBP and HR, only.
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 52 and at Week 156 by the ECG tracing at baseline.
7.6.9
Pregnancy Test Results
By-subject listings of pregnancy test results will be provided using Treated Subject Data Set for 
the short-term and the combined short- and long-term treatment periods.
8
CONVENTIONS
Data collected outside the analysis window (defined in Section 8.4) after subjects discontinued 
double-blinded 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:

Missing day, but month and year are present: the day will be imputed as the 15th day of the
month.

Missing day and month, but year is present: the day and month will be imputed as 30 June
of the year (provided that the imputed date is less than the consent date).

Missing year, but day and month are present: No imputations will occur, and the subject
will be excluded from all summaries related to duration of Type 2 diabetes.

Missing day, month and year: No imputations will occur, and the subject will be excluded
from all summaries related to duration of Type 2 diabetes.

If any such imputed date falls after the consent date, then the diagnosis date will be taken as 
equal to the consent date.
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.


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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:

If there are two or more observations within the same visit window, the non-missing 
observation closest to the target day will be used in the analysis 

If two observations are equidistant from the target day, the non-missing observation with the 
later collection date will be used in the analysis

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

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.

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.

For MRI visits, values from an earlier visit will be used instead of values at Week 52/122 for 
patients who were rescued or prematurely discontinue prior to Week 52/122. MRIs from week 
52/122 could have been scheduled up to 4 weeks after the Rescue or Premature Treatment 
Discontinuation Date.
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 
double-blind study drug, observations may not contribute to summaries/analyses if they are 
measured after the last dose of the double-blind study medication given during the treatment 
periods, as indicated below:
For efficacy parameters:

Lipids, glucagon, proinsulin, uACR, biomarkers (C-reactive protein, N-terminal ProB-type 
Natriuretic Peptide) and SBP will be summarized only if measured on or prior to the 4th day 
after the last study drug treatment date.

FPG, fasting C-peptide, fasting insulin, HOMA assessments 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.

HbA1c, BMI, waist circumference and body weight will be summarized/analyzed only if 
measured on or prior to the 8th day after the last study drug treatment date.


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For safety parameters:

SAEs, including hypoglycemia, reported as 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. 

All other safety events (non-serious AEs, non-serious 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.
8.4
Longitudinal Assessments
Day 1 for the short-term double-blind treatment period is the start date of short-term double-blind 
treatment medication. 
Visit windows are specified below.
Table 8.4 A:
Vital Signs and FPG Visit Windows for the Short-term Analyses
Visit
Treatment 
Period
Target Day
Day Range
Week 3
ST
22
2-35
Week 6 
ST
43
36-64
Week 12
ST
85
65-99
Week 16
ST
113
100-155
Week 28
ST
197
156-239
Week 40
ST
281
240-323
Week 52
ST
365
324 to last day of ST double-blind treatment
Table 8.4 B:
Vital Signs (except BMI and Waist Circumference), FPG Visit Windows 
for the Short and Long-term Analyses
Visit
Treatment 
Period
Target Day
Day Range
Week 3
ST
22
2-35
Week 6 
ST
43
36-64
Week 12
ST
85
65-99
Week 16
ST
113
100-155
Week 28
ST
197
156-239
Week 40
ST
281
240-323
Week 52
ST
365
324 to last day of ST double-blind treatment
Week 65
LT
456
First day of long-term treatment -501
Week 78
LT
547
502-592
Week 91
LT
638
593-683
Week 104
LT
729
684-774
Week 117
LT
820
775-865


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Table 8.4 B:
Vital Signs (except BMI and Waist Circumference), FPG Visit Windows 
for the Short and Long-term Analyses
Visit
Treatment 
Period
Target Day
Day Range
Week 130
LT
911
866-956
Week 143
LT
1002
957-1047
Week 156
LT
1093
1048 to last day of long-term treatment
Table 8.4 C:
BMI - Visit Windows for the Short and Long-term Analyses
Visit
Treatment 
Period
Target Day
Day Range
Week 28
ST
197
2-281
Week 52
ST
365
282 to last day of ST double-blind treatment
Week 65
LT
456
First day of long-term treatment -501
Week 78
LT
547
502-592
Week 91
LT
638
593-683
Week 104
LT
729
684-774
Week 117
LT
820
775-865
Week 130
LT
911
866-956
Week 143
LT
1002
957-1047
Week 156
LT
1093
1048 to last day of long-term treatment
Table 8.4 D:
Waist Circumference - Visit Windows for the Short and Long-term 
Analyses
Visit
Treatment 
Period
Target Day
Day Range
Week 28
ST
197
2-281
Week 52
ST
365
282 to last day of ST double-blind treatment
Week 65
LT
456
First day of long-term treatment -638
Week 117
LT
820
639-956
Week 156
LT
1093
957 to last day of long-term treatment
Table 8.4 E:
HbA1c- Visit Windows for the Short-term Analyses
Visit
Treatment 
Period
Target Day
Day Range
Week 12
ST
85
2-99
Week 16
ST
113
100-155
Week 28
ST
197
156-239


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Visit
Treatment 
Period
Target Day
Day Range
Week 40
ST
281
240-323
Week 52
ST
365
324 to last day of ST double-blind treatment
Table 8.4 F:
HbA1c-- Visit Windows for the Short- and Long-term Analyses
Visit
Treatment 
Period
Target Day
Day Range
Week 12
ST
85
2-99
Week 16
ST
113
100-155
Week 28
ST
197
156-239
Week 40
ST
281
240-323
Week 52
ST
365
324 to last day of ST double-blind treatment
Week 65
LT
456
First day of long-term treatment -501
Week 78
LT
547
502-592
Week 91
LT
638
593-683
Week 104
LT
729
684-774
Week 117
LT
820
775-865
Week 130
LT
911
866-956
Week 143
LT
1002
957-1047
Week 156
LT
1093
1048 to last of LT treatment
Table 8.4 G: Safety Lab and Lipid Panel (except HbA1c, FPG, Biomarkers and HOMA) 
and uACR - Visit Windows for the Short-term Analyses
Visit
Treatment 
Period
Target Day
Day Range
Week 6
ST
43
2-64
Week 12
ST
85
65-141
Week 28
ST
197
142-281
Week 52
ST
365
282 to last day of ST double-blind treatment
uACR data collected at Weeks 28 and 52 also used these visits, target days and day ranges for the MMRM analysis; 
lipid panel data collected at Week 52 also used these visits, target days and day ranges.
Table 8.4 H:
Safety Lab and Lipid Panel (except HbA1c, FPG, Biomarkers and 
HOMA) and uACR - Visit Windows for the Short and Long-term 
Analyses
Visit
Treatment 
Period
Target Day
Day Range
Week 6
ST
43
2-64


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Table 8.4 H:
Safety Lab and Lipid Panel (except HbA1c, FPG, Biomarkers and 
HOMA) and uACR - Visit Windows for the Short and Long-term 
Analyses
Visit
Treatment 
Period
Target Day
Day Range
Week 12
ST
85
65-141
Week 28
ST
197
142-281
Week 52
ST
365
282 to last day of ST double-blind treatment
Week 78
LT
547
First day of long-term treatment -638
Week 104
LT
729
639-820
Week 130
LT
911
821-1002
Week 156
LT
1093
1003 to last day of long-term treatment
uACR data collected at Weeks 28, 52, 117 and 156 also used these visits, target days and day ranges for the MMRM 
analysis; lipid panel data collected at Weeks 52 and 156 also used these visits, target days and day ranges.
Table 8.4 I:
HOMA, Biomarkers - Visit Windows for the Short-term Analyses
Visit
Treatment Period
Target Day
Day Range
Week 52
ST
365
Day 2 to last day of ST double-blind treatment
Table 8.4 J:
HOMA, Biomarkers – Visit Windows for the Short and Long-term Analyses
Visit
Treatment Period
Target Day
Day Range
Week 52
ST
365
Day 2 to last day of ST double-blind treatment
Week 156
LT
1093
First day of long-term treatment to last day of 
long-term treatment
Table 8.4 K: ECG - Visit Windows for the Short-term Analyses
Visit
Treatment Period
Target Day
Day Range
Week 52
ST
365
Day 2 to last day of ST double-blind treatment
Table 8.4 L:
ECG – Visit Windows for the Short and Long-term Analyses
Visit
Treatment Period
Target Day
Day Range
Week 52
ST
365
Day 2 to last day of ST double-blind treatment
Week 104
LT
729
First day of long-term treatment - 911
Week 156
LT
1093
912 - last day of long-term treatment


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Table 8.4 M: MRI - Visit Windows for the Short-term Analyses
Visit
Treatment Period
Target Day
Day Range
Week 52
ST
365
Day 2 to (last day of ST double-blind 
treatment + 27 days)
Table 8.4 N: MRI – Visit Windows for the Short and Long-term Analyses
Visit
Treatment Period
Target Day
Day Range
Week 52
ST
365
Day 2 to (last day of ST double-blind 
treatment + 27 days)
Week 122
LT
855
First day of long-term treatment to last day of 
long-term treatment (exclude assessments that 
were within 27 days from last day of ST 
double-blind treatment and were assigned to 
Week 52 analysis visit)
8.5
Post-Treatment Efficacy Observations
While short-term double-blind 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 double-blind study medication (up to and including
the start of long-term treatment period, where applicable) as indicated below:

Lipids, glucagon, proinsulin, uACR, biomarkers (C-reactive protein, N-terminal ProB-type 
Natriuretic Peptide) and SBP will be summarized only if measured on or prior to the 4th day
after the last study drug treatment date.

FPG, fasting C-peptide, fasting insulin, HOMA assessments 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.

HbA1c, body weight, BMI, and waist circumference will be summarized/analyzed only if
measured on or prior to the 8th day after the last study drug treatment date.
Similar rule applies for the combined short- and long-term 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:


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For AEs, a missing or incomplete onset date will be imputed according to the following 
conventions:

If the onset date for an AE is missing or incomplete, an imputed date will be derived to
slot the event to an appropriate analysis period. This derived date will not be reported in
summary tables or listings. Every effort will be made to determine the actual onset date for
the event or to obtain a reliable estimate for the onset date from the investigator.

If an onset date is missing, the derived onset date will be calculated 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 derived onset
date will be set to missing.

If an onset date is incomplete, the derived onset date will be calculated using the following
algorithm:

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:
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.


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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,

The date of the first dose of study medication is defined as the earliest start date with number
of tablets > 0 reported on the study medication page.

Date of the last dose of study medication is defined as the latest start or stop date with number
of tablets > 0 reported on the study medication page.
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:

If the reported start date is missing or invalid and the informed consent date is not missing or
invalid, then the imputed start date is set equal to the informed consent date. If the consent
date is missing or invalid and the birth date is not missing or invalid, then the imputed start
date is set equal to the birth date. If the start date, the consent date and the birth date are all
invalid or missing, then the imputed start date is set equal to missing.

If the reported start date is partially entered, then the imputed start date is set equal to the
earliest possible reported start date based on the partial entered reported start date.

If the reported end date is missing, continuing, unknown or invalid, then the imputed
end date is set equal to the most recent database extraction date.

If the reported end date of the medication is partial, then the imputed end date is set equal
to the last possible reported end date based on the partial entered reported end date.
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
select the event to be included in summary tables:

Relationship to study medication

Intensity of event

Onset date

Related events will take precedence over unrelated events in determining the event to include
in summary tables.


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
More intense events will take precedence over less intense events in determining the event
to include in summary tables.

Earlier onset date events will take precedence over late onset date events in determining the
onset to include in summary tables.
When reporting adverse events by intensity, in addition to providing a summary table based on
the event selection criteria detailed above, summary tables will also be provided based on the most
intense event during the analysis period - independent of relationship to study medication. For
these tables, the following criteria, in order of precedence, will be used to select the event to be
included in summary tables:

Intensity of event

Onset date
8.9
Fasting State
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.
8.10
Percent Compliance Calculation
See Section 7.4.3. 
8.11
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 (>, ε, <, or δ), 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 double-blind period will be included in the short-term CSR 
while all the analyses specified for the combined short- and long-term treatment period will be 
included in the Final CSR.
10
CHANGES OF ANALYSIS FROM PROTOCOL
Changes from Protocol prior to short-term data base lock are summarized in the following table:
Changes
Reason for changes
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 70 mg/dL (3.9 mmol/L) as recorded 
in the hypoglycemia module of the CRF 
To avoid error in summarizing data based on 
glucose values which were not collected using 
consistent methods.


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Changes
Reason for changes
irrespective of the method using which 
glucose data were collected.
MI sensitivity analyses for primary endpoint 
were added. 
To be consistent with other saxagliptin plus 
dapagliflozin studies.
11
REFERENCES

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. 

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.  

Service, F.J., Mean amplitude of glycemic excursions, a measure of diabetic instability. 
Diabètes.  1970, Sep ; 19, 644-55.

Kaplan EL, Meier P.  Nonparametric estimation from incomplete observations. Journal of 
American Statistical Association. 1958; 53:457-481.

Greenwood M. The natural duration of cancer. Reports on public health and medical subjects. 
1926; 33:1-26.

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.


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12
SUMMARY OF CUTOFFS FOR ANALYSES WHICH EXCLUDE RESULTS 
AFTER TREATMENT DISCONTINUATION  
Assessment collected more than x days after last dose in the ST+LT treatment period are 
excluded from analyses 
Number 
of days
Assessment/measurement
1
Efficacy
fasting plasma glucose
fasting C-peptide
fasting insulin
spot urinary glucose/creatinine ratio
HOMA assessments 
     Beta cell function for C-Peptide
     Beta cell function for insulin
     Insulin sensitivity for C-peptide
     Insulin sensitivity for insulin
     Insulin rstn for C-peptide 
     Insulin rstn for insulin 
4
Efficacy
SBP
glucagon
proinsulin
urinary albumin to creatinine ratio
biomarkers
     C-reactive protein
     N-terminal ProB-type Natriuretic Peptide
lipids (Total-C, LDL-C, HDL-C, TG) 
4
Safety
non-serious adverse events 
     including non-serious hypoglycemic events
vital signs 
hematology labs
clinical chemistry labs
8
Efficacy
HbA1c
body weight 
BMI
waist circumference
30
Safety
SAEs  (including hypoglycemic reported as SAEs)
liver function tests
  ALT
  AST
  alkaline phosphatase
  total bilirubin 


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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
1
CGMVIS
BGMEANALL
Mean of all sensor glucose values
recorded in CGMRULNM units during 
the visit’s active monitoring period (e.g. 
130 milligram/deciliter)
2
CGMVIS
MAGE_SC
Mean amplitude of glucose excursions 
(MAGE)  calculated using CGM sensor 
glucose data for a 24-hour period 
corresponding to 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 exceed the value of 
one standard deviation of the blood 
glucose for the same 24-hour period”
3
CGMVIS
WPWDSDDY
Mean of the daily (24-hour) sensor 
glucose standard deviations (Within-
patient and within-day standard deviation 
for glucose values) during the visit’s 


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active monitoring period* (e.g. 41.7 
mg/dL)
4
CGMVIS/CGMDAY
CGM_GE71_LE180_PCTTIME
Percent [0,100] of time spent within 
sensor glucose interval range [71mg/dL, 
180mg/dL] during the visit’s active 
monitoring period (e.g., 67.9%)
Percent [0,100] of time spent within 
sensor glucose interval range [71mg/dL, 
180mg/dL] during a single day of the 
active monitoring period (e.g., 67.9%)
5
CGMVIS/CGMDAY
CGM_HYPO_PCTTIME
Percent of time [0,100] spent with sensor 
glucose value less than or equal to 70 
mg/dL during a single day of the active 
monitoring period (e.g., 4.2%)
Percent of time [0,100] spent with sensor 
glucose value less than or equal to 70 
mg/dL during a single day of the active 
monitoring period (e.g., 4.2%)
6
GMVIS/CGMDAY
CGM NOC_HYPO_PCTTIME
Percent of time [0,100] spent with sensor 
glucose value less than or equal to 70 
mg/dL during military time interval 
[0000, 0600) during the visit’s active 
monitoring period* (e.g., 4.2%)
Percent of time [0,100] spent with sensor 
glucose value less than or equal to 70 
mg/dL during military time interval 
[0000, 0600) during a single day of the 
active monitoring period (e.g., 4.2%)


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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 CV181-365 include:
Quality-of-Life Scaling

analogue perceived health (10-point rating -- overall, physical, emotional, personal, and 
job/work);

functional health status (Duke activity index, diabetes-specific symptom interference index, 
general symptom interference index);

general health perceptions (vitality, general health, sleep);

mental and emotional health (psychological well-being and psychological distress);

cognitive function (acuity, disorientation and detachment, and performance);

symptom distress;

sexual dysfunction.

weight perception
A brief description of the quality-of-life scales and corresponding number of items available in the 
Phase VHealth Outcomes Evaluation System3 is given in Sections 2.1.1 – 2.1.3 below.  A double 
asterisk indicates those scales and subscales intentionally omitted from protocol CV181-365.
Phase VGeneric Core Modules
A) Mental and Emotional Health (24 items) **
B) General Health Perceptions (11 items) **
C) Work/Daily Role Performance (11 items)
D) Symptom Distress (53 items) 
E) Sexual Dysfunction (5 items) 


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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 CV181365:
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).
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).


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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 CV181-365 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:

Life Interference

Convenience

Burden

Acceptance of Negative Aspects (including side effects, stress, hassle)

Acceptance of Positive Aspects (including effectiveness, ease of use, comfort)

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. 


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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. 
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


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Hemoglobin males/females
g/dL
> 20 g/dL
Blood Chemistry
Albumin
g/dL
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 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
2.5 mEq/L
6.0 mEq/L
HCO3 (Bicarbonate)
mEq/L
13 mEq/L
BUN
mg/dL
60 mg/dL
Creatinine
mg/dL
1.5X PreRx CREAT
Creatinine
mg/dL
2.5 mg/dL
CK (Creatine Kinase)
U/L
> 5X ULN
CK (Creatine Kinase)
U/L
> 10X ULN
Calcium
mg/dL
< 7.5 mg/dL
1 mg/dL from ULN and 0.5 
mg/dL from PreRx CA
Magnesium
mEq/L
< 1 mEq/L
> 4 mEq/L
PO4 (Phosphate)
mg/dL
Age 17-65: 1.8 mg/dL 
Age 66: 2.1 mg/dL
Age 17-65: 5.6 mg/dL Age 66:
5.1 mg/dL
Urine
UACR (Urinary Albumin to
mg/g
> 1800 mg/g
Elevated AT (ALT and/or AST) and Total Bilirubin
The following three criteria will be summarized in examination of elevated AT (ALT and/or


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AST) and total bilirubin:

(AST or ALT > 3X ULN) and (Bilirubin > 1.5X ULN within 14 days on or after AT 
elevation)

(AST or ALT > 3X ULN) and (Bilirubin > 2X ULN within 14 days on or after AT 
elevation)

(AST or ALT > 3X ULN) and ([Bilirubin > 2X ULN and no ALP ≥2X ULN) within 14 days 
on or after AT elevation])
APPENDIX 4
GEOGRAPHIC REGIONS
Geographic Region
Countries
North America
United States
Latin America
Mexico 
Europe
Russian Federation, Poland,
Sweden, Germany
United Kingdom, Czech Republic, Hungary,
Romania

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PPD


 
 
 
 
Page: 1 
 
Protocol Number:
CV181365 
 
Site Number:
All 
 
IND Number
63,634 
 
EUDRACT Number
201-003721-18 
 
Date:
28-Jan-2015 
 
Protocol CV181365: A 52-week International, Multicenter, Randomized, Double-Blind, 
Active-Controlled, Parallel Group, Phase 3b Trial with a Blinded 104-week Long-term 
Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered with 
Dapagliflozin in combination with Metformin Compared to Glimepiride in Combination with 
Metformin in Adult Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on 
Metformin Therapy Alone. 
 
Pharmacogenetics Blood Sample Amendment 
Number 01 - Site Specific 
Site All 
 
Medical Monitor 
 
 
 
 
24-hr Emergency Telephone Number: 
 
 
Sponsor: AstraZeneca Research and Development 
Study being conducted by Bristol-Myers Squibb on behalf of AstraZeneca 
 
Bristol-Myers Squibb Research and Development 
Avenue de Finlande 4 
B-1420 Braine-l’Alleud, Belgium 
Route 206 & Province Line Road 
Lawrenceville, NJ 08543 
 
This protocol amendment contains information that is confidential and proprietary to 
Bristol-Myers Squibb (BMS) and AstraZeneca. 
This amendment must be maintained with the referenced protocol. 
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BMS-477118 and BMS-512148 
saxagliptin and dapagliflozin 
 
 
2 
TABLE OF CONTENTS 
TABLE OF CONTENTS .................................................................................................................2 
1 
AMENDMENT RATIONALE ....................................................................................3 
2 
OBJECTIVES ...............................................................................................................3 
3 
STUDY SITES .............................................................................................................3 
4 
SUBJECT SELECTION CRITERIA ...........................................................................3 
5 
PROCEDURES ............................................................................................................4 
6 
PHARMACOGENETIC STATISTICAL ANALYSIS ...............................................4 
7 
CODING AND STORAGE OF DNA SAMPLES .......................................................5 
8 
SUBJECT DATA PROTECTION ...............................................................................5 
9 
DATA MANAGEMENT .............................................................................................5 
10 
SUBJECT RIGHTS ......................................................................................................6 
11 
RECORD RETENTION ...............................................................................................6 
12 
WITHDRAWAL OF SUBJECTS FROM PHARMACOGENETIC 
RESEARCH .................................................................................................................7 
13 
DESTRUCTION OF BLOOD SAMPLE AND RELATED MATERIAL ..................7 
14 
FLOW CHART/TIME AND EVENTS SCHEDULE ..................................................8 
15 
PHARMACOGENETIC SAMPLE COLLECTION AND PROCESSING .................8 
16 
INFORMED CONSENT ..............................................................................................8 
16.1 
Informed Consent Procedures .......................................................................................8 
17 
INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS 
COMMITTEE (IRB/IEC) .............................................................................................9 
18 
REFERENCES .............................................................................................................9 
APPENDIX 1 
SAMPLE WITHDRAWAL PROCEDURES ............................................10 
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1 
AMENDMENT RATIONALE 
The information gained from Pharmacogenetic research studies is expected to result in safer and 
more effective therapies and to lead to the discovery of new diagnostics, prognostics and 
molecular targets and pathways. To learn more about the association between a subject’s genetic 
makeup and drug response, subjects will be asked to voluntarily give a blood sample so that 
scientists can perform exploratory pharmacogenetic research. 
This research will be limited to information recorded on the case report form or generated from 
the main clinical trial and results from the associated pharmacogenetic blood sample. Subjects 
will not be contacted in the future by the sponsor to provide any further information.  
Pharmacogenetics can be defined as the study of how variations in genes influence drug 
response. Genetic factors are considered to play an important role in the observed inter- 
individual differences in the metabolism, toxicity, and pharmacological response of drugs. The 
ability to determine which genes and their variants are associated with toxicity and efficacy for a 
specific drug will improve drug therapy and subsequently be beneficial to patients. 
2 
OBJECTIVES 
The objective of this Amendment is to permit the collection and storage of blood samples for use 
in future exploratory pharmacogenetic research. Bristol-Myers Squibb is conducting this study 
on behalf of AstraZeneca. AstraZeneca is the sponsor for the CV181365 study and they will be 
responsible for the pharmacogenetic portion of this study including the logistically aspects 
related to this amendment. 
AstraZeneca will use DNA obtained from the blood sample and health information collected 
from the main clinical trial, CV181365, to study the association between genetic variation and 
drug response. AstraZeneca may also use the DNA to study the causes and further progression of 
Type 2 Diabetes and other Metabolic Diseases. Samples from this study may also be used in 
conjunction with pharmacogenetic research results from other clinical studies to accomplish this 
objective. 
3 
STUDY SITES 
Pharmacogenetic sample collection will be performed at sites that permit pharmacogenetic 
studies to be conducted in compliance with all applicable laws, rules, and regulations.  
4 
SUBJECT SELECTION CRITERIA 
To participate in this Pharmacogenetic Sample Amendment, subjects must provide a signed 
Pharmacogenetic Blood DNA informed consent and must have consented to participate in the 
main clinical trial CV181365. 
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Inclusion criteria 
For inclusion in this Pharmacogenetic Sample Amendment: 
• Subjects must fulfill all of the inclusion criteria described in the main body of the Clinical 
Study Protocol and must have consented to participate in the main clinical trial CV181365 
• Provide informed consent for the genetic sampling and analyses 
 
Exclusion criteria 
Exclusion from this genetic research may be for any of the exclusion criteria specified in the 
main study or any of the following: 
• Previous bone marrow transplant 
• Whole blood transfusion within 120 days of genetic sample collection 
 
5 
PROCEDURES 
Subjects who have consented to participate in this study and who have voluntarily given written 
informed consent for pharmacogenetic sample collection will have a one-time blood sample 
collected at Day 1. If the pharmacogenetic blood sample is not collected at visit Day 1, it may be 
collected at any other subsequent scheduled sample collection. For each subject, approximately 
10mL of blood (less than 2 teaspoons) will be collected. The sample will be stored at 
AstraZeneca Sample Bank for pharmacogenetic research. 
No pre-determined number of study subjects is required, as participation for pharmacogenetic 
analysis is strictly voluntary. Subjects will be asked to read, understand, and sign an informed 
consent form designed for the purpose of collecting a one time sample for pharmacogenetic 
research. Subjects will be informed that they will not be excluded from the main clinical 
trial CV181365 if they do not wish to participate in the Pharmacogenetics Sample 
Amendment. 
6 
PHARMACOGENETIC STATISTICAL ANALYSIS 
Joint exploratory data analysis may be performed in the future to investigate if genetic variants 
(genotypes) are associated with clinical outcomes (phenotypes) such as, but not limited to, drug 
response, efficacy, safety, toxicity, and overall survival. The following potential analyses may be 
performed as appropriate: 
• Examine demographic factors such as race/ethnicity, age and gender to determine appropriate 
stratification or adjustment for the analysis. 
• Summarize allele and genotype frequencies from the sample with 95% confidence intervals.  
• Explore the relationship among genetic variation, expression of genes and proteins and 
clinical outcomes using methods such as, but not limited to, chi-squared tests, linear models, 
generalized linear models, non-parametric models, survival models or clustering algorithms.  
 
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7 
CODING AND STORAGE OF DNA SAMPLES 
The processes adopted for the coding and storage of samples for genetic analysis are important to 
maintain patient confidentiality. Samples will be stored for a maximum of 15 years, from the 
date of last subject last visit, after which they will be destroyed. DNA is a finite resource that is 
used up during analyses. Samples will be stored and used until no further analyses are possible or 
the maximum storage time has been reached. 
The samples and data for genetic analysis in this study will be de-identified. The sample and data 
will not be labeled with a personal identifier. The study number and patient number will be 
linked to a second unique identifier.   
Once DNA is extracted from the de-identified blood sample it is given another unique identifier. 
The DNA number will be used to identify the sample and corresponding data at the designated 
contract laboratory. No personal details identifying the individual donor will be available to any 
AstraZeneca or external provider working with the DNA. A link between the blood sample and 
the DNA extracted from the sample will be maintained in a confidential link file maintained by 
AstraZeneca DNA Biobank or contracted storage facility. 
All genetic samples will be stored under secure conditions with restricted access at AstraZeneca. 
The blood or data derived from the samples may be made available to groups or organizations 
working with AstraZeneca on this study or as part of the development drug project. However, the 
samples and any results will remain the property of AstraZeneca at all times. AstraZeneca will 
not give blood, DNA samples or data derived from the samples to any other parties, except as 
required by law. All samples and DNA will be destroyed maximum of 15 years from the date of 
last subject last visit after or according to local legislation. Samples may be destroyed prior to 
this timeframe if the patient has withdrawn consent 
8 
SUBJECT DATA PROTECTION 
AstraZeneca will not provide individual genotype results to subjects, any insurance company, 
any employer, their family members, general physician or any other third party, unless required 
to do so by law. 
Extra precautions are taken to preserve confidentiality and prevent genetic data being linked to 
the identity of the subject. In exceptional circumstances, however, certain individuals might see 
both the genetic data and the personal identifiers of a subject. For example, in the case of a 
medical emergency, an AstraZeneca Physician or an investigator might know a subject’s identity 
and also have access to his or her genetic data. Also Regulatory authorities may require access to 
the relevant files, though the subject’s medical information and the genetic files would remain 
physically separate. 
9 
DATA MANAGEMENT 
Any genotype data generated in this study will be in the secure system within AstraZeneca 
and/or third party contracted to work with AstraZeneca to analyze the samples.   
The results from this genetic research may be reported in the CSR for the main study, or in a 
separate report as appropriate. 
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Some or all of the clinical datasets from the main study may be merged with the genetic data in a 
suitable secure environment separate from the clinical database. 
10 
SUBJECT RIGHTS 
Study subjects can withdraw their consent to participate in the Pharmacogenetic Sample 
Amendment even after the sample has been shipped to the AstraZeneca Sample Bank. As long as 
the Investigator or Investigator’s designee retains the clinical trial records, a study subject will be 
able to contact his/her Investigator or the Investigator’s designee and ask for his/her sample to be 
withdrawn from the Sample Bank and destroyed.  
As the collection of the biological samples is an optional part of the study, the subject may 
continue in the main study even if they choose not to participate in this amendment. 
The Principal Investigator: 
• Ensures subjects’ withdrawal of informed consent to the use of the donated samples is timely 
communicated to AZ or its representative 
• Ensures that biological samples from that subject, if stored at the study site, are immediately 
identified, disposed of/destroyed, and the action documented in subject’s source documents 
• Ensures that the subject and AZ are informed about the sample disposal 
 
In the instance that the samples have been sent from the study site: 
• On receipt of the notification of withdrawal of consent, (Appendix 1), AZ or its 
representative ensure the relevant samples are located and sample disposal/destruction is 
requested and appropriately documented 
• A copy of the completed disposal/destruction documentation is returned to the study site 
 
11 
RECORD RETENTION 
The Investigator must retain essential documents for the maximum period required by applicable 
regulations and guidelines1 or Institutional procedures, or for the period specified by the sponsor, 
whichever is longer. The Investigator must contact Astra Zeneca or its representative prior to 
destroying any records associated with the study.  
Astra Zeneca will notify the Investigator when the trial records are no longer needed. 
If the Investigator withdraws from the study (eg, relocation, retirement), the records shall be 
transferred to a mutually agreed upon designee (eg, another Investigator, IRB). Notice of such a 
transfer will be given in writing to Astra Zeneca. 
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12 
WITHDRAWAL OF SUBJECTS FROM PHARMACOGENETIC RESEARCH 
Subjects have, at any time, the option to withdraw consent for participation from: 
1) Only the Pharmacogenetic Sample Amendment independent of the main clinical trial 
(CV181365); 
OR 
2) Only the main clinical trial (CV181365) independent of the Pharmacogenetic Sample 
Amendment; 
OR 
3) Both the main clinical trial (CV181365) and Pharmacogenetic Sample Amendment. 
 
Subjects who wish to withdraw their consent from the Pharmacogenetic Sample Amendment 
(ie, have their sample in the Sample Bank destroyed) should contact the Investigator. The 
Investigator will submit a Sample Withdrawal Form to the AstraZeneca Sample Bank 
(see Appendix 1). 
It is possible that subjects may decide to withdraw consent from the main clinical trial 
(CV181365) but continue with their consent for the Pharmacogenetic Sample Amendment. In 
such cases the Investigator should inform subjects that their sample would remain stored at the 
AstraZeneca Sample Bank and may be used for pharmacogenetic research. 
If a subject requests to withdraw consent for the Pharmacogenetic Sample Amendment after the 
time the Investigator is legally required to maintain the records linking the subject’s sample and 
coded health information to their identity, and the records have been destroyed, the sample will 
become anonymous and unable to be withdrawn.  
13 
DESTRUCTION OF BLOOD SAMPLE AND RELATED MATERIAL 
In the case of subjects who have withdrawn their consent for participation in the 
Pharmacogenetic Sample Amendment the Investigator will send a Sample Withdrawal Form to 
the AstraZeneca Sample Bank. Upon receipt of the Sample Withdrawal Form, AstraZeneca 
Sample Bank, will destroy any remaining blood sample and any material obtained from the 
sample in accordance with AstraZeneca procedure for Sample Destruction. A copy of the sample 
withdrawal form is provided in Appendix 1. After all samples have been destroyed AstraZeneca 
Sample Bank will provide the Investigator with verification of the sample destruction. In the case 
of samples that have been partially analyzed, the remaining sample will be destroyed but 
AstraZeneca shall be entitled to retain and use any research results obtained prior to the 
withdrawal of consent.  
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14 
FLOW CHART/TIME AND EVENTS SCHEDULE 
Time and Events Schedule:  
Procedure 
Visit Day Day 1 
Pharmacogenetic Sample Informed Consent 
Xa 
Pharmacogenetic Sample Collection 
Xb 
a Informed consent for pharmacogenetic testing may be obtained at any time during the trial PRIOR to the 
collection of the pharmacogenetic sample. 
b If the pharmacogenetic sample is not collected at visit Day Day 1, it may be collected at any other subsequent 
scheduled sample collection. 
 
15 
PHARMACOGENETIC SAMPLE COLLECTION AND PROCESSING 
The whole blood pharmacogenetic sample will be shipped at frozen temperature to the 
designated central laboratory Quintiles Central Laboratory. The samples will be stored frozen 
and transferred to the designated extraction lab and then to AstraZeneca Sample Bank for storage 
and future analysis. Details for collection, processing, storing and shipping these samples will be 
provided in a separate procedure manual.  
16 
INFORMED CONSENT 
Investigators must ensure that subjects, or, in those situations where consent cannot be given by 
subjects, their legally acceptable representative are clearly and fully informed about the purpose, 
potential risks and other critical issues regarding clinical studies in which they volunteer to 
participate. Freely given written informed consent must be obtained from every subject or, in 
those situations where consent cannot be given by subjects, their legally acceptable 
representative, prior to study participation. 
The rights, safety, well-being of the study subjects are the most important considerations and 
should prevail over interests of science and society. 
The following section contains Bristol-Myers Squibb procedures on obtaining informed consent 
from subjects or their legally acceptable representative prior to participating in a clinical trial. 
Procedures are described for all subjects including those who are unable to give informed 
consent. The relevant procedures must be used whenever they are applicable. 
A separate informed consent will be obtained from study subjects who voluntarily agree to 
participate in the Pharmacogenetic Sample Amendment. The informed consent form for 
pharmacogenetic sample collection reflecting this Amendment will be submitted for review and 
approval to the IRB/Ethics Committee charged with this responsibility. 
16.1 
Informed Consent Procedures 
Preparation of the consent form is the responsibility of the Investigator and must include all 
elements required by ICH, GCP and applicable regulatory requirements, and must adhere to GCP 
and to the ethical principles that have their origin in the Declaration of Helsinki. The consent 
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form must also include a statement that Bristol-Myers Squibb and regulatory authorities have 
direct access to subject records. Prior to the beginning of the study, the Investigator must have 
the IRB/IEC’s written approval/favorable opinion of the written informed consent form and any 
other information to be provided to the subjects. 
The Investigator must provide the subject or legally acceptable representative with a copy of the 
informed consent form and written information about the study in the language in which the 
subject is most proficient. The language must be non-technical and easily understood. The 
Investigator should allow time necessary for subject or subject’s legally acceptable 
representative to inquire about the details of the study, then informed consent must be signed and 
personally dated by the subject or the subject’s legally acceptable representative and by the 
person who conducted the informed consent discussion. The subject or legally acceptable 
representative should receive a copy of the signed informed consent and any other written 
information provided to study subjects prior to subject’s participation in the trial 
17 
INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE 
(IRB/IEC) 
This amendment, the informed consent form for pharmacogenetic sample collection and any 
advertisement for subject recruitment will be submitted for review and approval to the 
IRB/Ethics Committee charged with this responsibility. The investigator must have on file 
written and dated approval/favorable for this amendment from the IRB/Ethics Committee before 
this sample is collected. 
18 
REFERENCES 
1. 
Code of Federal Regulations, CFR 312.57, and International Conference on 
Harmonisation, ICH Guidelines. 
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APPENDIX 1 
SAMPLE WITHDRAWAL PROCEDURES 
AstraZeneca 
Research & Development 
 
FAX TRANSMITTAL SHEET 
 
FAX THIS COMPLETED PAGE TO: 
 
  
 
 
 
 
Email: 
 
 
 
 
WITHDRAWAL OF PERMISSION FOR USE OF SPECIMENS 
IN FUTURE PHARMACOGENETIC RESEARCH 
 
This section is to be completed by either the Investigator or the coordinator at the institution. 
The study subject indicated below (Only identify the study subject using the study subject number; DO NOT 
provide any other identifying information such as the study subject’s name or social security number) initially 
provided informed consent for his/her samples to be used for pharmacogenetic research by AstraZeneca. After 
discussion with a study staff member at our institution, he/she has now indicated that he/she wants to withdraw 
consent for future pharmacogenetic research by AstraZeneca and have his/her sample destroyed. 
PROTOCOL NUMBER:  
 
 
 
SITE NUMBER:  
 
 
 
STUDY SUBJECT NUMBER:   
 
 
 
INVESTIGATOR NAME:  
 
 
 
   INVESTIGATOR FAX:  
 
 
INVESTIGATOR SIGNATURE:  
 
 
 
 
 
 
 
 
DATE OF REQUEST:  ________________________________________ 
 
This section is to be completed by the AstraZeneca Sample Bank and faxed back to the Investigator. 
CONFIRMATION OF SAMPLE DESTRUCTION 
The pharmacogenetic sample and related material derived from the sample obtained from the study subject indicated 
above has been destroyed. Please notify the study subject that this has occurred. 
VERIFIED BY:   
 
 
 
 
 DATE:  
 
 
 
PRINT NAME: ______________________________ 
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Protocol Number:
CV181365
IND Number:
63,634
EUDRACT Number
2014-003721-18
Date:
11-Mar-2015
Protocol CV181365: A 52-week International, Multicenter, Randomized, Double-Blind, 
Active-Controlled, Parallel Group, Phase 3bTrial with a Blinded 104-week Long -term 
Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered with 
Dapagliflozin in combination with Metformin Compared to Glimepiride in Combination with 
Metformin in Adult Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on 
Metformin Therapy Alone.
Amendment Number 02
Site Number: All
Medical Monitor
24-hr Emergency Telephone Number:
Sponsor: AstraZeneca AB, 151 85 Södertälje, Sweden
Study being conducted by Bristol-Myers Squibb on behalf of AstraZeneca AB
Bristol-Myers Squibb Research and Development
Metabolics Clinical Research and Development
Avenue de Finlande 4
B-1420 Braine-l’Alleud, Belgium
Route 206 & Province Line Road
Lawrenceville, NJ 08543
This protocol amendment contains information that is confidential and proprietary to 
Bristol-Myers Squibb (BMS). 
This amendment must be maintained with the referenced protocol.
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Protocol Amendment 02
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BMS-477118 and BMS-512148
saxagliptin and dapagliflozin
2
Amendment Rationale:
The primary purpose of this amendment is to correct information in the Inclusion and Exclusion 
Criteria pertaining to the active comparator (glimepiride) and to align the current protocol to its 
sister study, CV181-363. As enrollment has not yet started, these changes will be applicable to 
future enrolled subjects and will not impact the overall study conduct or proposed data analyses.
x
In the Inclusion Criteria described in Section 3.3.1 sitagliptin was erroneously listed as the 
active comparator. Glimepiride is now correctly identified as the active comparator.
x
In the Exclusion Criteria described in Section 3.3.2, it is now specified that subjects who 
have contraindications to therapy as described in the glimepiride package insert should be 
excluded.
x
In the Exclusion Criteria described in Section 3.3.2; the word “enrollment” was removed as 
an exclusion because the study does permit the re-enrollment of a subject who has been 
discontinued from the study as a pre-treatment failure (eg, was not randomized). The 
criterion now excludes only previous randomization in the present study.
x
In the Exclusion Criteria described in Section 3.3.2; the number of days that a subject may 
not have taken any other investigational agent prior to screening has been changed from 90 to 
30 days to be consistent with CV181-363 and other studies in the saxagliptin/dapagliflozin 
clinical development program.
x
Two efficacy objectives seek to compare the time to treatment intensification (defined as the 
addition of insulin for rescue therapy or discontinuation for lack of glycemic control) 
between the saxagliptin/dapagliflozin and glimepiride arms.
Although insulin is 
recommended as the initial choice for rescue therapy (since these subjects are already taking 
dual or triple therapy), the protocol permits other options to be considered. The definition for 
treatment intensification was broadened to include the addition of insulin or other glucose-
lowering agents for rescue therapy or discontinuation for lack of glycemic control.
x
Hypersensitivity has been identified as a potential risk for dapagliflozin (and is already 
specified as a potential risk for saxagliptin). In the Overall Risk/Benefit Section (Section 
1.5), we have added hypersensitivity as a potential risk for dapagliflozin.
Changes to Protocol
1) Synopsis, Investigational Product(s), Dose and Mode of Administration, Duration of 
Treatment with Investigational Products, added: glimepiride 1-6 mg.
2) Synopsis, Secondary efficacy objectives, Short-term, 4th bullet, added: or other glucose-
lowering agent.
3) Synopsis, Secondary efficacy objectives, Long-term, 1st bullet: added: or other glucose-
lowering agent.
4) Synopsis Exploratory Objectives, Short-term, 9th bullet revised: to assess CGM.
5) Synopsis, Exploratory Objectives, Long-term, 2nd
bullet, removed: for saxagliptin/
dapagliflozin.
6) Synopsis, Exploratory Objectives, Long-term, 6th bullet, revised: double-blind treatment.
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7) Synopsis, Safety objectives, 1st bullet, added: for saxagliptin co-administered with 
dapagliflozin.
8) Synopsis, Study Schematic: removed: plus placebo.
9) Synopsis, Study Population: removed Asia
10) Synopsis, Study Drug: added: glimepiride
11) Synopsis, Dose and Treatment Regimens, added; Glimepiride 1-6mg or matching placebo 
capsules, administered orally once daily, will be provided for the 156-week blinded treatment 
period.
12) Synopsis, Concomitant and other treatments, added: other than IP.
13) Synopsis Sample Size Estimates: revised #Screened and #Enrolled
14) Synopsis, Secondary endpoints for analysis for the short-term treatment period include, 
added: or other glucose-lowering agents.
15) Synopsis, Secondary endpoints for analysis for the long-term treatment period include, 
added: or other glucose-lowering agents.
16) Section 1.3.2., Secondary objectives, Secondary efficacy objectives, Short-term, 4th bullet, 
add:  or other glucose-lowering agents.
17) Section 1.3.2., Secondary objectives, Secondary efficacy objectives, Long-term, 1st bullet, 
add:  or other glucose-lowering agents.
18) Section 
1.3.3, 
Exploratory 
Objectives, 
Long-term, 
2nd
bullet, 
removed:
for 
saxagliptin/dapagliflozin.
19) Section 1.3.3, Exploratory Objectives, Long term, 6th bullet revised: double-blind treatment.
20) Section 1.3.4, Exploratory Safety Objectives, 1st bullet, added: for saxagliptin co-
administered with dapagliflozin.
21) Section 1.5, Overall Risk/Benefit Assessment, Dapagliflozin, added section: Hypersensitivity 
reactions paragraph.
22) Section 3.1 Study Design added; Glimepiride 1-6mg or matching placebo capsules, 
administered orally once daily, will be provided for the 156-week blinded treatment period
23) Figure 3.1-1 Study Design Schematic: removed: plus placebo
24) Section 3.3.1 Inclusion Criteria; Number 1, added: or designee
25) Section 3.3.1 Inclusion Criteria; Number 3, Age and Reproductive Status; removed letter (d)
and (e) statements.
26) Section 3.3.1 Inclusion Criteria; Number 3, Age and Reproductive Status; revised letter (f)
and (g) statements.
27) Section 3.3.2 Exclusion Criteria; Number 4 Allergies and Adverse Drug Reaction; Letter a,
add: glimepiride
28) Section 3.3.2 Exclusion Criteria; Number 5, Other Exclusion Criteria; Letter m: remove 
enrollment.
29) Section 3.3.2 Exclusion Criteria; Number 5 Other Exclusion Criteria; Letter n: changed 
administration of any other investigational agent from within 90 days of the screening visit to 
30 days
30) Section 3.3.2 Exclusion Criteria; Number 5, Other Exclusion Criteria; Letter o” remove no
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31) Section 3.4.1 Prohibited and/or Restricted Treatments; 1stth bullet added; other than IP
32) Section 3.4.1 Prohibited and/or Restricted Treatments; 4th bullet changed administration of 
any other investigational agent from within 90 days of the screening visit to 30 days
33) Table 3.5.2-1, Lack of Glycemic Control Criteria for Initiation of Rescue Medication, 
provided additional clarification to recue time points.
34) Section 3.5.3 Discontinuation Guidelines due to Protocol-Defined Hypoglycemia Episodes, 
removed term placebo
35) Section 4.5 Selection and Timing of Dose for Each Subject; replaced the paragraph
36) Section 4.10 Retained Samples for Bioavailability/Bioequivalence removed associated 
subsequent text, added; Not applicable
37) Table 5.1-1 Flow Chart/Time and Event Schedule, Eligibility, added ‘sub-study’ text to 
Informed consent for MRI and CGM
38) Table 5.1-1 Flow Chart/Time and Event Schedule, Safety Assessment, amended scheduling 
of ‘Complete physical examination’ and ‘Brief physical examination’; Screening week -4 
and Lead-in week -2 respectively
39) Table 5.1-1 Flow Chart/Time and Event Schedule, Central Laboratory Tests, removed 
procedure, Blood & Urine Standard Safety Laboratory Panel 
40) Table 5.1-1 Flow Chart/Time and Event Schedule, Central Laboratory Tests, Clinical 
Chemistry, hematology, urinalysis (new wording added)
41) Table 5.1-2 Flow Chart/Time and Event Schedule, Safety Assessment, reworded text
‘Provide glucose meter supplies / instructions’
42) Table 5.1-2 Flow Chart/Time and Event Schedule, Central Laboratory, removed Blood & 
Urine Standard Safety Laboratory Panel; added Clinical chemistry, haematology, urinalysis 
(standard safety laboratory panel) 
43) Table 5.1-2 Flow Chart/Time and Event Schedule, Safety Assessment, removed procedure 
‘Height’.
44) Table 5.1-2 Flow Chart/Time and Event Schedule, Central Laboratory, removed procedure, 
B* Clinical chemistry haematology, urinalysis
45) Table 5.1-2 Flow Chart/Time and Event Schedule, Central Laboratory, MRI-PDFF, notes, 
provided added clarification
46) Table 5.1-2 Flow Chart/Time and Event Schedule, Study Drug, added text ‘or blinded 
placebo’ to study drug dispensations
47) Table 5.1-2 Flow Chart/Time and Event Schedule, Study Drug, removed text ‘placebo’ from: 
Register down-titration of glimepiride/placebo during maintenance period (if applicable in 
IVRS).
48) Table 5.1-3 Flow Chart/Time and Event Schedule, Safety Assessment, removed procedure 
‘Height’.
49) Table 5.1-3 Flow Chart/Time and Event Schedule, Safety Assessment, reworded ‘Provide 
glucose meter supplies / instructions’
50) Table 5.1-3 Flow Chart/Time and Event Schedule, Central Laboratory, removed Blood & 
Urine Standard Safety Laboratory Panel; added Clinical chemistry, haematology, urinalysis 
(standard safety laboratory panel) 
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51) Table 5.1-3 Flow Chart/Time and Event Schedule, Central Laboratory, removed procedure, 
B* Clinical chemistry haematology, urinalysis
52) Table 5.1-3 Flow Chart/Time and Event Schedule, Additional Assessment, MRI-PDFF,
notes, provided added clarification
53) Table 5.1-3 Flow Chart/Time and Event Schedule, Additional Assessment, amended to 
‘Assess HbA1c for rescue’.
54) Table 5.1-3 Flow Chart/Time and Event Schedule, Additional Assessment, removed
procedure, Contact IVR system
55) Table 5.1-3 Flow Chart/Time and Event Schedule, Study Drug, added schedule time-point 
wk 156
56) Table 5.1-3 Flow Chart/Time and Event Schedule, Study Drug, removed text ‘placebo’ from: 
Register down-titration of glimepiride/placebo during maintenance period (if applicable in 
IVRS).
57) Table 5.1-4 Flow Chart/Time and Event Schedule, Safety Assessment, amended terminology 
to Body weight and waist circumference.
58) Section 5.3.3 Guidance on Assessment of Cardiovascular Events; add Cardiovascular 
Adjudication Committee and delete Clinical Event Committee (CEC)
59) Section 5.3.7 Guidance on Volume Depletion, added dapagliflozin.
60) Section 5.8.7 Continuous Glucose Monitoring (CGM); second paragraph added term; on top 
of background metformin therapy
61) Section 5.9 Results of Central Assessments; update the language to clarify visits
62) Section 6.1.1 Revised segment to identify AstraZeneca (or designee) as point of contact for
SAE reporting.
63) Section 7.1 Cardiovascular Adjudication Committee; 2nd paragraph; replace manual with 
charter.
64) Section 8.3.2, Secondary Endpoint(s), short-term treatment & long-term treatment, added: or 
other glucose-lowering agent
65) Section 8.3.3 Exploratory Endpoint(s); add 5th bullet; Mean change from baseline in average 
glucose values and postprandial glucose values measured by 6-point SMBG profiles at 
Week 52
66) Section 8.3.3 Exploratory Endpoint(s); modify 9th bullet; add as defined by mean amplitude 
of glycemic excursions (MAGE)
67) Section 8.4.2, Efficacy Analyses(s), 5th & 6 th bullet, added: or other glucose-lowering agent
68) Section 11 List of abbreviations, removed BID, BUN, CYP, HCO3, K3EDTA, TID and 
WHO; added NMP 22 and SI
69) Appendix 4; step 2; replace total bilirubin (TB) d 1.5X upper limit of normal (ULN) with 
TB d 2X ULN in guidance for monitoring liver function
70) Appendix 5, Guidance on Contraception, removed: Any Single Method is Acceptable.
71) Addition of other minor clarifications and correction of typographical errors
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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.
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Page:
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Protocol Number:
CV181365
IND Number:
63,634
EUDRACT Number
2014-003721-18
Date:
12-Aug-2015
Protocol CV181365: A 52-week International, Multicenter, Randomized, Double-Blind, 
Active-Controlled, Parallel Group, Phase 3b Trial with a Blinded 104-week Long-term 
Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered with 
Dapagliflozin in Combination with Metformin Compared to Glimepiride in Combination with 
Metformin in Adult Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on 
Metformin Therapy Alone.
Amendment Number 03
Site Number: All
Medical Monitor
24-hr Emergency Telephone Number:
Bristol-Myers Squibb Research and Development
Cardiovascular Clinical Research and Development
Route 206 & Province Line Road
Lawrenceville, NJ 08543
Avenue de Finlande 4
B-1420 Braine-l’Alleud, Belgium
This protocol amendment contains information that is confidential and proprietary to 
Bristol-Myers Squibb (BMS). 
This amendment must be maintained with the referenced protocol.
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Protocol Amendment 03
CV181365
BMS-477118 AND BMS-512148
saxagliptin and dapagliflozin
2
Amendment Rationale:
The primary purpose of this amendment is to revise the CrCl discontinuation criteria. In addition 
the following changes were made to accommodate internal feedback and comments made by 
regulatory institutions.
x
Updated stability data that has been accumulated to allow the revision of the glimepiride 
storage conditions.
x
Emphasis and clarification to the overall ‘half-life’ of the treatments utilized in this study; 
denoting a computation of 30 days
x
Clarify the definition of abstinence throughout the protocol
x
Provide further details to define Adverse Event reporting.
Changes to the Protocol:
Secondary reasons for this amendment include:
1) Grammatical and spelling corrections throughout the document.
2) Synopsis (Safety Objectives): clarified ‘self monitored’ blood glucose.
3) In Section 1.3.4 (Exploratory Safety Objectives): clarified ‘self monitored’ blood glucose.
4) In Section 2.3 (Informed Consent) (1): removed ‘most’.
5) In Section 3.1 (Study Design and Duration/Dose and Treatment Regimens Blinded Study 
Medication): replace language for glimepiride IP dosing.
6) In Section 3.3.1 (Inclusion Criteria) (3) Age and Reproductive Status bullets (d) and (e): 
removed text.
7) In Section 3.3.1 (Inclusion Criteria) (3) Age and Reproductive Status bullets (f) and (g): 
replaced 33 day half-life to 30 days. Resulting in Total durations of 60 days and 123 days 
respectively.
8) In Section 3.3.1 (Inclusion Criteria) (3) Age and Reproductive, Highly Effective Methods of 
Contraception: Expanded language on Complete Abstinence.
9) In Section 3.4.1 (Prohibited and/or Restricted Treatments: removed 6th bullet 
(Acetaminophen (paracetamol) containing medications (such as Tylenol) while using the 
CGM device and 24 hours prior to insertion).
10) In Section 3.5 (Discontinuation of Subjects following any Treatment with Study Drug) 9th 
bullet: amended CrCl criteria for discontinuation.
11) Table 4.1 (Study Drug for CV181-365): updated storage conditions for glimepiride and 
placebo for glimepiride.
12) Section 4.5 (Selection and Timing of Dose for Each Subject) 3rd paragraph: replace language 
for glimepiride IP dosing.
13) Table 5.1-1 (Screening Procedural Outline Flow Chart for Protocol CV181-365) Procedure, 
FPG: amended < 270 mg/dL to d 270 mg/dL.
14) Table 5.1-1 (Screening Procedural Outline Flow Chart for Protocol CV181-365) footnote: 
amended lead-in to week-1.
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3
15) Table 5.1-2 (Short-term Procedural Outline Flow Chart for Protocol CV181-365) Procedure, 
MRI-PDFF: added additional note to reflect process when a subject has been rescued or 
undergone early termination
16) Table 5.1-2 (Short-term Procedural Outline Flow Chart for Protocol CV181-365) Procedure, 
Assess FPG for Rescue: removed Week 6 time-point visit.
17) Table 5.1-2 (Short-term Procedural Outline Flow Chart for Protocol CV181-365): amended 
procedure title to read “Dispense blinded glimepiride or blinded placebo and titrate during 
titration period (Weeks 3-12)”.
18) Table 5.1-2 (Short-term Procedural Outline Flow Chart for Protocol CV181-365) footnote: 
included MRI in Week 51 visit.
19) Table 5.1-3 (Long-term Procedural Outline Flow Chart for Protocol CV181-365) Procedure, 
Provide glucose meter supplies / instructions: removed Week 156 time-point visit.
20) Table 5.1-3 (Long-term Procedural Outline Flow Chart for Protocol CV181-365) Procedure, 
Provide logs / instructions: removed Week 156 time-point visit.
21) Table 5.1-4 footnote: amended to state Week 26
22) In Section 6.1.1 (Serious Adverse Event Collection and Reporting): added clarification of 
reporting including ‘Safety reporting to local regulatory authorities’ plus ‘Safety reporting to 
investigational review boards/ethics committees and investigators’ paragraphs
23) In Section 7.1 (Cardiovascular Adjudication Committee): removed ‘congestive’.
24) Appendix 5 (Guidance on Contraception) : Removed
25) Addition of other minor clarifications and correction of typographical errors.
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.
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Page:
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Protocol Number:
CV181365
IND Number:
63,634
EUDRACT Number
2014-003721-18
Date:
27-May-2016
Protocol CV181365: A 52-week International, Multicenter, Randomized, Double-Blind, 
Active-Controlled, Parallel Group, Phase 3bTrial with a Blinded 104-week Long -term 
Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered with 
Dapagliflozin in Combination with Metformin Compared to Glimepiride in Combination with 
Metformin in Adult Patients with Type 2 Diabetes Who Have Inadequate Glycemic Control on 
Metformin Therapy Alone.
Amendment Number 04
Site Number: All
Study Director / Central Medical Monitor
24-hr Emergency Telephone Number:
Sponsor: AstraZeneca AB, 151 85 Södertälje, Sweden
Study being conducted by Bristol-Myers Squibb on behalf of AstraZeneca AB
Bristol-Myers Squibb Research and Development
Metabolics Clinical Research and Development
Route 206 & Province Line Road
Lawrenceville, NJ 08543
Avenue de Finlande 4
B-1420 Braine-l’Alleud, Belgium
This protocol amendment contains information that is confidential and proprietary to 
Bristol-Myers Squibb (BMS). 
This amendment must be maintained with the referenced protocol.
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Protocol Amendment 04
CV181365
BMS-477118 and BMS-512148
saxagliptin and dapagliflozin
2
Amendment Rationale:
The purpose of this amendment is to provide an update of the safety language for the 
investigational product, contraceptive language changes, and a clarification regarding the 
evaluable data in the sub-study populations to include the following: 
x
Provided updated safety information and protocol guidance regarding ketoacidosis, 
urosepsis, and pyelonephritis.
x
Updated the contraceptive section. Removed condoms as a highly effective method and 
provided clarification of language for other highly effective methods of contraception.
x
Addressed sub-study language to allow sites to provide additional patients in the sub-studies 
if a subject has unevaluable data at baseline.
x
Additional administrative corrections (typos, etc.):
This amendment should be implemented upon receipt of IRB/IEC/HA approval.
This amendment applies to all subjects participating in this study.
Changes to the Protocol:
1. Updated Cover Page:  Updated the name and contact information for the person responsible 
for the medical and safety oversight of the study
2. Section 1.5: Overall Risk/Benefit - Dapagliflozin - Updated UTI language and added DKA 
language.
3. Section 3.3.1: Inclusion Criteria - 3. Age and Reproductive Status - Updated WOCBP 
language and contraception language: 
4. Section 3.5.4: Added section - Discontinuation Guidelines due to Ketoacidosis
5. Section 5.3.2.1: Guidance on Assessment of Urinary Tract Infections - Added urosepsis and 
pyelonephritis language
6. Section 5.3.4: Guidance on Assessment of Hepatic Laboratory Abnormalities - Clarification 
of discontinuation language.
7. Section 5.8.6: Magnetic Resonance Imaging (MRI) - Added clarification on evaluable data 
and continuation in base study.
8. Section 5.8.7: Continuous Glucose Monitoring (CGM) - Added clarification on evaluable 
data and continuation in base study.
9. Section 7.2: Hepatic Adjudication Committee - Clarification of discontinuation language.
10. Additional minor typo and administrative updates 
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.
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