Clinical trial NCT02547935
Conditions: Type 2 Diabetes Mellitus, CKD and Albuminuria
Sponsor: AstraZeneca
Start date: 2015-09-21; Completion date: 2018-05-18
Enrollment: 459 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical research study is to determine whether dapagliflozin alone or in combination with saxagliptin can decrease albuminuria and improve glycemic control in patients with Type 2 diabetes, albuminuria and renal impairment (CKD). The study is planned to randomize a total of 450 patients (150 patients per treatment arm)

Detailed description:

Arms: arm 1: Tablets administered orally once daily for 24 weeks arm 2: Tablets administered orally once daily for 24 weeks arm 3: Tablets administered orally once daily for 24 weeks
Interventions: intervention 1: Dapagliflozin 10 mg intervention 2: Saxagliptin 2.5 mg intervention 3: Matching Placebo for Dapagliflozin 10 mg and Saxagliptin 2.5mg
Intervention descriptions: intervention 1: Tablets administered orally once daily for 24 weeks. intervention 2: Tablets administered orally once daily for 24 weeks. intervention 3: Tablets administered orally once daily for 24 weeks.

Protocol documents:
Prot_000.pdf: 
 
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Clinical Study Protocol  
 
Drug Substance 
Dapagliflozin 
 
Study Code 
D1690C00023 
 
Edition Number 
6.0 
 
Date 
18-Sep-2017 
 
An exploratory Phase II/III, randomized, double-blind, placebo controlled, 
parallel design study to evaluate the efficacy, safety and pharmacodynamics 
of dapagliflozin and dapagliflozin in combination with saxagliptin in CKD 
patients with type 2 diabetes mellitus and albuminuria treated with ACEi or 
ARB 
 
Sponsor: AstraZeneca AB, 151 85 Södertälje, Sweden 
 
The following Amendment(s) and Administrative Changes have been made to this protocol since the date of 
preparation: 
Amendment No. 
 Date of Amendment 
Local Amendment No: 
Date of Local Amendment 
1 
 
16-Nov-2015 
2 
 
08-Jan-2016 
3 
 
01-Apr-2016 
4 
 
17-Nov-2016 
5 
 
18-Sep-2017 
Administrative Change 
No. 
 Date of Administrative 
Change 
Local Administrative 
Change No. 
Date of Local 
Administrative Change 
 
  
 
  
 
  
This submission document contains confidential commercial information, disclosure of which is prohibited 
without providing advance notice to AstraZeneca and opportunity to object. 
 
This Clinical Study Protocol has been subject to a peer review according to AstraZeneca 
Standard procedures.  The clinical study protocol is publicly registered and the results are 
disclosed and/or published according to the AstraZeneca Global Policy on Bioethics and in 
compliance with prevailing laws and regulations.


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VERSION HISTORY
 
 
 
 
 
 
 
 
 
  
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Drug Substance Dapagliflozin
Study Code D1690C00023
Edition Number 6.0
Date 18-Sep-2017
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Drug Substance Dapagliflozin
Study Code D1690C00023
Edition Number 6.0
Date 18-Sep-2017
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Drug Substance Dapagliflozin
Study Code D1690C00023
Edition Number 6.0
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Study Code D1690C00023
Edition Number 6.0
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Study Code D1690C00023
Edition Number 6.0
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Study Code D1690C00023
Edition Number 6.0
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Study Code D1690C00023
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Date 18-Sep-2017
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Study Code D1690C00023
Edition Number 6.0
Date 18-Sep-2017
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Study Code D1690C00023
Edition Number 6.0
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Study Code D1690C00023
Edition Number 6.0
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PROTOCOL SYNOPSIS
An exploratory Phase II/III, randomized, double-blind, placebo controlled, 
parallel design study to evaluate the efficacy, safety and pharmacodynamics 
of dapagliflozin and dapagliflozin in combination with saxagliptin in CKD 
patients with type 2 diabetes mellitus and albuminuria treated with ACEi or 
ARB
International Co-ordinating Investigator
Target subject population
The target patients include, female or male aged ≥18 years at visit 1:
x
With history of type 2 diabetes mellitus (T2DM) for more than 12 months with
1. Inadequate glycemic control, defined as HbA1c ≥7.0% and ≤11.0% before 
randomization 
AND
2. Stable anti-diabetic treatment during the last 12 weeks prior to 
randomization
x
With albuminuria (UACR 30 - 3500 mg/g)
x
With renal impairment, Estimated Glomerular Filtration Rate (eGFR) 25-75
mL/minute/1.73 m2 before randomization
x
With stable angiotensin converting enzyme (ACE) inhibitor or an angiotensin II 
receptor blocker (ARB) for at least 3 months prior to screening, where the dose of 
the ACE inhibitor or the ARB is considered appropriate for that patient and the 
patient has been stable and maintained on that dose for at least 4 weeks prior to 
study randomization.
Study site(s) and number of subjects planned
This study will be an international multi-centre study at approximately 100 clinical sites 
across North America, EU & ROW. It is planned to randomize a total of 450 patients (aim 150 
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Study Code D1690C00023
Edition Number 6.0
Date 18-Sep-2017
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patients per treatment). Each clinical site is expected to randomize at least 4 patients. 
Competitive enrolment will be applied.
Study period
Phase of development
Estimated date of first subject enrolled
Q3 2015
Phase II/III
Estimated date of last subject completed
Q2 2018
Study design
This is an exploratory, phase II/III, randomized, double-blind, 3-arms, parallel group, placebo 
controlled, multi-national, multi-centre study to evaluate the efficacy, safety and 
pharmacodynamics of dapagliflozin and dapagliflozin in combination with saxagliptin in 
CKD patients with type 2 diabetes mellitus and albuminuria treated with ACEi or ARB.
The study consists of a 2-week screening period followed by a 4-week single-blind placebo 
lead-in period, 24 week double-blind placebo-controlled treatment and a 3-week follow-up
period.  
Objectives
Primary Objectives:
Outcome Measure:
Primary objectives for the Saxagliptin/Dapagliflozin treatment 
arm
x
To compare the mean change from baseline in HbA1c between 
dapagliflozin 10 mg plus saxagliptin 2.5 mg and placebo, after 
24 weeks of oral administration of double-blind treatment in 
patients with type 2 diabetes and CKD.
x
To compare the mean percent change from baseline in urine 
albumin-to creatinine ratio (UACR) between dapagliflozin 10 
mg plus saxagliptin 2.5 mg and placebo, after 24 weeks of oral 
administration of double-blind treatment in patients with type 2 
diabetes and CKD.
x
Change from baseline in 
HbA1c at Week 24
x
Percent change from 
baseline in UACR at Week 
24
Primary objective for the Dapagliflozin treatment arm
x
To compare the mean percent change from baseline in urine 
albumin-to creatinine ratio (UACR) between dapagliflozin 10 
mg and placebo, after 24 weeks of oral administration of 
double-blind treatment in patients with type 2 diabetes and 
CKD .
x
Percent change from 
baseline in UACR at Week 
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Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
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Secondary Objectives: 
Outcome Measure : 
Secondary objectives for the Saxagliptin/Dapagliflozin 
treatment arm: 
x 
To compare the mean percent change from baseline in total 
body weight between dapagliflozin 10 mg plus saxagliptin 2.5 
mg and placebo, after 24 weeks of oral administration of 
double-blind treatment.  
x 
To compare the mean change from baseline in fasting plasma 
glucose (FPG) between dapagliflozin 10 mg plus saxagliptin 
2.5 mg and placebo, after 24 weeks of oral administration of 
double-blind treatment. 
x 
To compare the proportion of patients achieving a 30% 
reduction in UACR between dapagliflozin 10 mg plus 
saxagliptin 2.5 mg and placebo, after 24 weeks of oral 
administration of double-blind treatment. 
x 
To compare the proportion of patients achieving a reduction in 
HbA1c <7.0% between dapagliflozin 10 mg plus saxagliptin 2.5 
mg and placebo, after 24 weeks of oral administration of 
double-blind treatment. 
x 
To compare the mean change from baseline in seated systolic 
blood pressure (SBP) between dapagliflozin 10 mg plus 
saxagliptin 2.5 mg and placebo, after 24 weeks of oral 
administration of double-blind treatment. 
 
 
x 
Percent change from 
baseline in total body weight 
at Week 24 
 
x 
Change from baseline in 
FPG at Week 24 
 
x 
30% reduction in UACR at 
Week 24 
 
 
x 
HbA1c < 7.0 % at  Week 24 
 
 
x 
Change from baseline in 
seated SBP at Week 24 
Secondary objectives for the Dapagliflozin treatment arm: 
x 
To compare the mean percent change from baseline in total 
body weight between dapagliflozin 10 mg and placebo, after 24 
weeks of oral administration of double-blind treatment. 
x 
To compare the proportion of patients achieving a 30% 
reduction in UACR between dapagliflozin 10 mg and placebo, 
after 24 weeks of oral administration of double-blind treatment. 
x 
To compare the mean change from baseline in seated systolic 
blood pressure (SBP) between dapagliflozin 10 mg and 
placebo, after 24 weeks of oral administration of double-blind 
treatment. 
x 
To compare the mean change from baseline in HbA1c between 
dapagliflozin 10 mg and placebo, after 24 weeks of oral 
administration of double-blind treatment. 
x 
To compare the mean change from baseline in fasting plasma 
glucose (FPG) between dapagliflozin 10 mg and placebo, after 
24 weeks of oral administration of double-blind treatment. 
x 
To compare the proportion of patients achieving a reduction in 
HbA1c <7.0% between dapagliflozin 10 mg and placebo, after 
24 weeks of oral administration of double-blind treatment. 
 
x 
Percent change from 
baseline in total body weight 
at Week 24 
x 
30% reduction in UACR at 
Week 24 
 
x 
Change from baseline in 
seated SBP at Week 24 
 
x 
Change from baseline in 
HbA1c at Week 24 
 
x 
Change from baseline in 
FPG at Week 24 
 
x 
HbA1c < 7.0 % at Week 24 
 


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Study Code D1690C00023
Edition Number 6.0
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Safety Objectives:
Outcome Measure :
x
To assess the proportion of patients discontinued from 
the study due to sustained increase in serum creatinine 
by ≥1.5 times baseline level (AKI stage 1).
x
To evaluate the safety and tolerability of dapagliflozin 
10 mg once daily and dapagliflozin 10 mg plus 
saxagliptin 2.5 mg once daily in patients with type 2 
diabetes and CKD .
x
To assess the mean change from baseline in eGFR 
after 24 weeks of oral administration of double-blind 
treatment between dapagliflozin 10 mg and placebo 
and between dapagliflozin 10 mg plus saxagliptin 2.5 
mg and placebo.
x
To assess the mean change from baseline in eGFR at 
follow-up (3 weeks after treatment completion) 
between dapagliflozin 10 mg and placebo and 
between dapagliflozin 10 mg plus saxagliptin 2.5 mg 
and placebo.
 
x
Discontinuation from study due to 
sustained increase in serum creatinine 
≥1.5 times baseline level
x
AEs 
x
Vital Signs
x
Orthostatic Reactions
x
Physical Examination
x
Clinical Chemistry/Haematology 
Parameters
x
Change from baseline in renal 
function (eGFR) at Week 24
x
Change from baseline in renal 
function (eGFR) at Week 27 
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Study Code D1690C00023
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Study Code D1690C00023
Edition Number 6.0
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Study Code D1690C00023
Edition Number 6.0
Date 18-Sep-2017
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Duration of treatment
The study will start with a 2-week screening period. Eligible patients will enter a 4-week 
single-blind placebo lead-in period and then be randomized to double-blind treatment in a 
1:1:1 ratio to receive either:
a)
Dapagliflozin 10 mg tablet plus saxagliptin 2.5 mg tablet,
b)
Dapagliflozin 10 mg tablet plus saxagliptin 2.5 mg placebo tablet,
             or
c)
Dapagliflozin 10 mg placebo tablet plus saxagliptin 2.5 mg placebo tablet,
administered once daily for the 24-week double-blind treatment period and followed 
up for 3 weeks after the treatment period.
Investigational product, dosage and mode of administration
Dapagliflozin 10 mg alone or dapagliflozin 10 mg plus saxagliptin 2.5 mg will be 
administered orally once daily during the 24-week double-blind, treatment period.
Comparator, dosage and mode of administration
Placebo to match dapagliflozin 10mg and placebo to match saxagliptin 2.5mg will be 
administered orally once daily during the 4-week single blind placebo lead-in period and the 
24-week double-blind treatment period.
Other treatments
x
Insulin, antihypertensive drugs, lipid lowering drugs, and oral anti-diabetic drugs 
(except SGLT2 inhibitors, GLP-1 agonists and DPP4 inhibitors) are allowed during 
the study. The dose should be kept constant throughout the entire study from start of 
run-in to end of follow-up (week 27). 
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Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
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x 
Patients may receive open-label rescue medication added on to, but not as a 
replacement for their current study drug regimen. Rescue medication in this 
protocol refers to any approved, appropriate anti-diabetic agent, except SGLT2 
inhibitor, GLP1 agonist and DPP4 inhibitors, for which there is either initiation or 
upward titration, in accordance with the approved label and conventional standards 
of care. 
x 
The dose of any concomitant anti-hypertensive medication should be kept constant 
as far as possible throughout the entire study from start of run-in to the end of 
follow-up (week 27). However, in case of symptomatic hypotension or severe 
uncontrolled hypertension, anti-hypertensive treatment can be adjusted according to 
the Investigator’s judgement. 
Statistical methods 
Multiplicity due to the two active treatment groups will be controlled by a Bonferroni 
adjustment, such that statistical significance will be determined according to a two-sided alpha 
level of 0.025. Within the saxagliptin 2.5 mg + dapagliflozin 10 mg treatment group the 
control of the alpha level in the testing of both co-primary endpoints (the percent change in 
urine albumin-to creatinine ratio (UACR) from baseline to 24 weeks and the change in HbA1c 
from baseline to 24 weeks) will require that each achieves statistical significance at the 0.025 
level for a claim of superiority to placebo, and to proceed to a sequential comparison of 
secondary endpoints.  Within the dapagliflozin 10 mg treatment group the control of the alpha 
level for the primary endpoint (the percent change in urine albumin-to creatinine ratio (UACR) 
from baseline to 24 weeks) will require the achievement of statistical significance at the 0.025 
level for a claim of superiority to placebo, and to proceed to a sequential comparison of 
secondary endpoints. Parallel sequential testing strategies will be used for comparing each 
active treatment group to placebo for the secondary endpoints. 
The analysis of the change in HbA1C from baseline to Week 24 will be based on a repeated 
measures model (RMM) including all scheduled time points following randomization up to 
and including week 24. The analysis of percent change in UACR from baseline to Week 24 
will be conducted on the log-transformed UACR values using RMM.    


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Study Code D1690C00023 
Edition Number 6.0 
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TABLE OF CONTENTS 
PAGE 
 
TITLE PAGE ....................................................................................................... 1 
VERSION HISTORY .......................................................................................... 2 
PROTOCOL SYNOPSIS ................................................................................... 12 
TABLE OF CONTENTS ................................................................................... 21 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS ......................... 27 
1. 
INTRODUCTION ............................................................................................. 30 
1.1 
Background and rationale for conducting this study ........................................... 30 
1.2 
Benefit/risk and ethical assessment .................................................................... 33 
1.3 
Study Design...................................................................................................... 36 
1.4 
Study flowchart details ....................................................................................... 37 
2. 
STUDY OBJECTIVES ...................................................................................... 39 
2.1 
Primary objective ............................................................................................... 39 
2.2 
Secondary objectives .......................................................................................... 40 
2.3 
Safety objectives ................................................................................................ 42 
2.4 
Exploratory objectives ....................................................................................... 42 
3. 
SUBJECT SELECTION, ENROLMENT, RANDOMISATION, 
RESTRICTIONS, DISCONTINUATION AND WITHDRAWAL ..................... 46 
3.1 
Inclusion criteria ................................................................................................ 47 
3.2 
Exclusion criteria ............................................................................................... 47 
3.3 
Subject recruitment information ......................................................................... 50 
3.4 
Subject enrolment and randomization ................................................................. 50 
3.5 
Procedures for handling incorrectly enrolled or randomized subjects .................. 51 
3.6 
Methods for assigning treatment groups ............................................................. 51 
3.7 
Methods for ensuring blinding ........................................................................... 52 
3.8 
Methods for unblinding ...................................................................................... 53 
3.9 
Restrictions ........................................................................................................ 53 
3.10 
Discontinuation of investigational product ......................................................... 54 
3.10.1 
Discontinuation Guidelines due to Protocol-Defined Major Hypoglycemia 
Episode or Recurrent Non-Major Hypoglycemia Episodes ................................. 55 


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Study Code D1690C00023 
Edition Number 6.0 
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3.10.2 
Discontinuation Guidelines due to Acute Kidney Injury (AKI) ........................... 56 
3.10.3 
Rescue Due to Lack of Glycemic Control in the Treatment Period ..................... 56 
3.10.4 
Guidelines with regard to changes in insulin dose .............................................. 58 
3.10.5 
Procedures for discontinuation of a subject from investigational product ............ 58 
3.11 
Criteria for withdrawal ....................................................................................... 59 
3.11.1 
Screen failures ................................................................................................... 59 
3.11.2 
Withdrawal of the informed consent ................................................................... 59 
3.11.3 
Lost to follow-up ............................................................................................... 59 
3.12 
Discontinuation of the study ............................................................................... 59 
4. 
STUDY PLAN AND TIMING OF PROCEDURES........................................... 60 
4.1 
Study flowchart details ....................................................................................... 60 
4.2 
Assessments schedule ........................................................................................ 61 
4.3 
Enrolment/screening period................................................................................ 67 
4.4 
Single-blind placebo lead-in period (Visit 2) ...................................................... 67 
4.5 
Treatment period ................................................................................................ 69 
4.5.1 
Visit 3, Randomization ....................................................................................... 69 
4.5.2 
Visit 4, Treatment .............................................................................................. 70 
4.5.3 
Visit 5, Treatment .............................................................................................. 70 
4.5.4 
Visit 6, Treatment .............................................................................................. 71 
4.5.5 
Visit 7, Treatment .............................................................................................. 72 
4.5.6 
Visit 8, Treatment .............................................................................................. 73 
4.5.7 
Visit 9, End of Treatment/Discontinuation/Rescue ............................................. 73 
4.6 
Visit 10, Follow-up period ................................................................................. 75 
5. 
STUDY ASSESSMENTS .................................................................................. 75 
5.1 
Efficacy assessments .......................................................................................... 76 
5.1.1 
UACR ................................................................................................................ 76 
5.1.2 
HbA1c ............................................................................................................... 76 
5.1.3 
FPG ................................................................................................................... 76 
5.1.4 
Weight and height .............................................................................................. 77 
5.1.5 
BMI ................................................................................................................... 77 
5.1.6 
Seated blood pressure and pulse ......................................................................... 77 
5.1.7 
Waist circumference .......................................................................................... 77 
5.1.8 
24h urinary glucose excretion............................................................................. 77 
5.1.9 
Urine glucose to creatinine ratio ......................................................................... 77 
5.1.10 
Fractional urinary sodium excretion ................................................................... 77 
5.1.11 
Insulin dose ........................................................................................................ 78 
5.1.12 
Fasting serum lipids and cardiovascular biomarkers ........................................... 78 
5.1.13 
Glucose metabolism ........................................................................................... 78 
5.1.14 
Arterial Stiffness (for participants in selected sites only): ................................... 78 
5.2 
Safety assessments ............................................................................................. 78 


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Study Code D1690C00023 
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5.2.1 
eGFR ................................................................................................................. 78 
5.2.2 
Laboratory safety assessments ............................................................................ 79 
5.2.3 
Physical examination ......................................................................................... 80 
5.2.4 
ECG ................................................................................................................... 80 
5.2.5 
Vital signs .......................................................................................................... 80 
5.2.5.1 
Pulse and blood pressure .................................................................................... 80 
5.2.6 
Other safety assessments .................................................................................... 81 
5.2.6.1 
Self-monitored blood glucose and hypoglycemic events ..................................... 81 
5.2.6.2 
Hepatic events (Hepatic Adjudication Committee) ............................................. 82 
5.2.6.3 
Asymptomatic bacteriuria .................................................................................. 82 
5.2.6.4 
Microscopic Haematuria .................................................................................... 82 
5.2.6.5 
Volume Depletion .............................................................................................. 83 
5.3 
Other assessments---Not applicable .................................................................... 83 
5.4 
Pharmacokinetics ............................................................................................... 83 
5.4.1 
Blood sample collection ..................................................................................... 83 
5.4.2 
Determination of drug concentration .................................................................. 83 
5.4.3 
Storage and destruction of pharmacokinetic samples .......................................... 84 
5.5 
Pharmacodynamics ............................................................................................ 84 
5.6 
Pharmacogenetics (Not Applicable) ................................................................... 84 
5.7 
Biomarker analysis ............................................................................................. 84 
5.7.1 
Labelling and shipment of biological samples .................................................... 85 
5.7.2 
Chain of custody of biological samples .............................................................. 85 
5.7.3 
Withdrawal of Informed Consent for donated biological samples ....................... 85 
5.8 
Volume of blood ................................................................................................ 86 
6. 
SAFETY REPORTING AND MEDICAL MANAGEMENT ............................. 87 
6.1 
Definition of adverse events ............................................................................... 87 
6.2 
Definitions of serious adverse event ................................................................... 87 
6.3 
Recording of adverse events ............................................................................... 88 
6.3.1 
Time period for collection of adverse events ...................................................... 88 
6.3.2 
Follow-up of unresolved adverse events ............................................................. 88 
6.3.3 
Variables ............................................................................................................ 88 
6.3.4 
Causality collection ............................................................................................ 89 
6.3.5 
Adverse events based on signs and symptoms .................................................... 89 
6.3.6 
Adverse events based on examinations and tests ................................................ 90 
6.3.7 
Hy’s Law ........................................................................................................... 90 
6.3.8 
Hypoglycemic events ......................................................................................... 90 
6.3.9 
Potential events of diabetic ketoacidosis ............................................................. 90 
6.3.10 
Adverse events (AEs) leading to amputation and potential risk factor AEs 
for amputations affecting lower limbs (“preceding events”) ............................... 91 
6.4 
Reporting of serious adverse events ................................................................... 91 


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6.5 
Overdose ............................................................................................................ 92 
6.6 
Pregnancy .......................................................................................................... 92 
6.6.1 
Maternal exposure .............................................................................................. 92 
6.6.2 
Paternal exposure ............................................................................................... 93 
6.7 
Management of IP related toxicities ................................................................... 93 
6.8 
Study governance and oversight ......................................................................... 93 
6.8.1 
Steering Committee---Not Applicable ................................................................ 94 
6.8.2 
Data Monitoring Committee---Not Applicable ................................................... 94 
6.8.3 
Scientific Advisory Committee---Not Applicable ............................................... 94 
7. 
INVESTIGATIONAL PRODUCT AND OTHER TREATMENTS ................... 94 
7.1 
Identity of investigational product(s) .................................................................. 94 
7.2 
Dose and treatment regimens ............................................................................. 94 
7.3 
Labelling ............................................................................................................ 95 
7.4 
Storage ............................................................................................................... 95 
7.5 
Compliance ........................................................................................................ 95 
7.6 
Accountability.................................................................................................... 96 
7.7 
Concomitant and other treatments ...................................................................... 96 
7.7.1 
Other concomitant treatment .............................................................................. 98 
7.8 
Post Study Access to Study Treatment---Not Applicable .................................... 98 
8. 
STATISTICAL ANALYSES BY ASTRAZENECA .......................................... 98 
8.1 
Statistical considerations .................................................................................... 98 
8.2 
Sample size estimate .......................................................................................... 99 
8.3 
Other statistical considerations ........................................................................... 99 
8.4 
Definitions of analysis sets ............................................................................... 100 
8.4.1 
Enrolled Patients Data Set ................................................................................ 100 
8.4.2 
Lead-in Patients Data Set ................................................................................. 100 
8.4.3 
Full Analysis set............................................................................................... 100 
8.4.4 
Per protocol analysis set ................................................................................... 101 
8.4.5 
Safety analysis set ............................................................................................ 101 
8.4.6 
PD analysis set---Not Applicable ..................................................................... 101 
8.4.7 
PRO analysis set---Not Applicable ................................................................... 101 
8.5 
Outcome measures for analyses ........................................................................ 101 
8.5.1 
Primary outcome variables ............................................................................... 101 
8.5.2 
Secondary outcome variables ........................................................................... 101 
8.5.3 
Safety outcome variables.................................................................................. 102 
8.5.4 
Exploratory outcome variables ......................................................................... 102 
8.6 
Methods for statistical analyses ........................................................................ 104 


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Study Code D1690C00023 
Edition Number 6.0 
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8.6.1 
Analysis of the primary variable (s) .................................................................. 104 
8.6.2 
Analysis of the secondary variable(s) ............................................................... 105 
8.6.3 
Subgroup analysis (if applicable) ..................................................................... 106 
8.6.4 
Interim analysis ................................................................................................ 107 
8.6.5 
Exploratory analysis ......................................................................................... 107 
8.6.6 
Analysis for Japanese Subgroup ....................................................................... 107 
9. 
STUDY AND DATA MANAGEMENT BY ASTRAZENECA ....................... 107 
9.1 
Training of study site personnel ....................................................................... 107 
9.2 
Monitoring of the study .................................................................................... 108 
9.2.1 
Source data ...................................................................................................... 108 
9.2.2 
Direct access to source data in Japan ................................................................ 108 
9.2.3 
Study agreements ............................................................................................. 109 
9.2.4 
Archiving of study documents .......................................................................... 109 
9.3 
Study timetable and end of study ...................................................................... 110 
9.4 
Data management by Cognizant ....................................................................... 110 
10. 
ETHICAL AND REGULATORY REQUIREMENTS ..................................... 112 
10.1 
Ethical conduct of the study ............................................................................. 112 
10.2 
Subject data protection ..................................................................................... 112 
10.3 
Ethics and regulatory review ............................................................................ 112 
10.4 
Informed consent ............................................................................................. 114 
10.5 
Changes to the protocol and informed consent form ......................................... 115 
10.6 
Audits and inspections ..................................................................................... 115 
11. 
LIST OF REFERENCES ................................................................................. 116 
12. 
APPENDIX A ADDITIONAL SAFETY INFORMATION ............................. 119 
12.1 
Further Guidance on the Definition of a Serious Adverse Event (SAE) ............ 119 
12.2 
A Guide to Interpreting the Causality Question ................................................ 119 
13. 
APPENDIX B INTERNATIONAL AIRLINE TRANSPORTATION 
ASSOCIATION (IATA) 6.2 GUIDANCE DOCUMENT ................................ 121 
13.1 
Labelling and Shipment of Biohazard Samples................................................. 121 
14. 
APPENDIX C ALGORITHM ON MANAGEMENT OF SUSTAINED 
ELEVATED LIVER SAFETY ABNORMALITIES ........................................ 122 
14.1 
Algorithm on Management of Sustained Elevated Liver Safety 
Abnormalities .................................................................................................. 122 
14.2 
Patients must be Discontinued from the Study if an Initial and Repeat 
Confirmatory Laboratory Tests Meet any of the Following Criteria:................. 122 
14.3 
Guidance on Assessment of Hepatic Laboratory Abnormalities ........................ 123 


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14.4 
Specialized Liver Panel .................................................................................... 124 
14.5 
Liver Discontinuation Panel ............................................................................. 125 
15. 
APPENDIX D NEW YORK HEART ASSOCIATION (NYHA) 
CLASSIFICATION ......................................................................................... 127 
15.1 
New York Heart Association (NYHA) Classification ....................................... 127 
 
LIST OF TABLES 
Table 1 
Lack of Glycemic Control Criteria for Initiation of Open-Label 
Rescue Medication ................................................................................ 57 
Table 2 
Study Planning and details procedure .................................................... 61 
Table 3 
Laboratory Safety Variables .................................................................. 79 
Table 4 
Volume of blood to be withdrawn from each patient ............................. 86 
LIST OF FIGURES 
Figure 1 Study flow Chart .................................................................................................. 37 
LIST OF APPENDICES 
Appendix A 
Additional Safety Information  
Appendix B 
IATA 6.2 Guidance document 
Appendix C 
Algorithm on Management of Sustained Elevated Liver Safety 
Abnormalities 
Appendix D 
New York Heart Association (NYHA) Classification 


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LIST OF ABBREVIATIONS AND DEFINITION OF TERMS
The following abbreviations and special terms are used in this study Clinical Study Protocol.
Abbreviation or 
special term
Explanation
ACEi
Angiotensin-converting enzyme inhibitor
ARB
Angiotensin II receptor blocker
AE
Adverse event
ALK-P
Alkaline Phosphatase
ALT
Alanine Aminotransferase
AKI 
Acute Kidney Injury
AST
Aspartate Aminotransferase
AIx
Augmentation Index
BMI
Body Mass Index
BP
Blood Pressure
CABG
Coronary Artery Bypass Grafting
CPP
Central Pulse Pressure
CKD
Chronic Kidney Disease
CRF
Case Report Form (electronic/paper)
CRO
Contract Research Organization
CSA
Clinical Study Agreement
CSP
Clinical Study Protocol
CSR
Clinical Study Report
CV
Cardiovascular
DBP
Diastolic Blood Pressure
DKA
Diabetic Ketoacidosis
DM
Diabetes Mellitus
DNA
Deoxyribonucleic acid 
DPP4
Dipeptidyl peptidase-4
EC
Ethics Committee, synonymous to Institutional Review Board (IRB) and 
Independent Ethics Committee (IEC)
eGFR
Estimated Glomerular Filtration Rate
CCI


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Abbreviation or 
special term
Explanation
EU
European Union
GCP
Good Clinical Practice
GMP
Good Manufacturing Practice
GLP-1
Glucagon-like peptide-1
FFA
Free Fatty Acids
FPG
Fasting Plasma Glucose
FU
Follow-Up
Hb
Haemoglobin
HbA1C
Glycosylated Haemoglobin
HDL-C
High Density Lipoprotein Cholesterol
HF
Heart Failure
HIV
Human Immunodeficiency Virus
HN
High Normal
HOMA
Homeostatic Model Assessment
ICF
Informed Consent Form
ICH
International Conference on Harmonisation
International 
Co-ordinating 
investigator
If a study is conducted in several countries the International Co-ordinating 
Investigator is the Investigator co-ordinating the investigators and/or 
activities internationally. 
IRB
Institutional Review Board
IP
Investigational Product 
KG
Kilogram
LDL-C
Low Density Lipoprotein Cholesterol
LOCF
Last Observation Carried Forward
LSLV
Last Subject Last Visit
IVRS
Interactive Voice Response System
IWRS
Interactive Web Response System
MDRD
Modification of Diet in Renal Disease
MedDRA
Medical Dictionary for Regulatory Activities
MG
Milligram
CCI
CCI


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Abbreviation or 
special term
Explanation
NYHA
New York Heart Association
OD
Once Daily
OAE
Other Significant Adverse Event
PI
Principal Investigator
PK
Pharmacokinetic
PPG
Post-Prandial Glucose
PTCA
Percutaneous Transluminal Coronary Angioplasty
PTH
Parathyroid Hormone
RMM
Repeated Measures Model
ROW
Rest of the World
SAE
Serious adverse event 
SBP
Systolic Blood Pressure
SD
Standard Deviation
SGLT2
Sodium Glucose co-Transporter 2
SU
Sulfonylurea
T2DM
Type 2 Diabetes Mellitus
T2DN
Type 2 Diabetes Nephropathy
TB
Total Bilirubin
TG
Triglycerides
TIA
Transient Ischemic Attack
TZD
Thiazolidinedione
UACR
Urine albumin-to-creatinine ratio
UA
Uric Acid
ULN
Upper Limit of Normal
US
United States
UTI
Urinary Tract Infections
WBDC
Web Based Data Capture
WOCBP
Women of childbearing potential
CCI


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1. 
INTRODUCTION 
1.1 
Background and rationale for conducting this study 
Dapagliflozin (Forxiga®, Farxiga®) is a stable, 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 kidneys. 
Traditionally, the presence of glucose in the urine has been seen as a sign of poor glycemic 
control and, thus, something to be avoided. Familial renal glucosuria in humans, however, due 
to genetic mutations that reduce the function of SGLT2, is associated with life-long glucosuria 
that is generally asymptomatic. Results from nonclinical- and clinical studies have shown that 
dapagliflozin can be used to promote urinary excretion of glucose as a well-tolerated and 
effective method of reducing blood glucose levels. Thus, treatment with an SGLT2 inhibitor 
may affect hyperglycaemia directly by increasing glucose excretion in the urine as well as 
indirectly by ameliorating underlying defects in glucose homeostasis in patients with T2DM. 
Dapagliflozin’s mechanism of action reduces plasma glucose regardless of the patient’s 
insulin sensitivity and β-cell secretory function. Because this mechanism is independent of 
insulin secretion or insulin action, this approach to anti diabetic therapy provides an 
opportunity to achieve clinically important glycemic efficacy with a comparatively low risk of 
hypoglycemia. This insulin-independent mechanism is also potentially applicable to a broad 
spectrum of patients. In addition, the excretion of glucose may promote weight loss or prevent 
weight gain, as a consequence of calorie loss, a potential benefit for many patients with T2DM. 
The dapagliflozin clinical development program was designed to demonstrate the safety and 
efficacy of dapagliflozin in a wide range of patients with T2DM. The program included both 
placebo-controlled and active comparator studies in drug-naïve patients at an early stage of 
disease and patients who require additional therapy after failure to reach adequate glycemic 
control with their current regimen. Dapagliflozin’s pharmacodynamic effect of glucosuria is 
detected almost immediately (within 1 hour post-dose), is maintained through 2 years of 
treatment, and results in reductions in Fasting Plasma Glucose (FPG), Post-prandial Glucose 
(PPG), and HbA1c (glycosylated haemoglobin). Treatment with dapagliflozin, with its unique 
mechanism of action, results in a persistent loss of glucose with associated calories in the 
urine, resulting in a consistent and maintained reduction of the total body weight, in addition 
to the improved glycemic control. The weight loss is predominantly a result of a reduction in 
fat mass, visceral adipose tissue, and subcutaneous adipose tissue in T2DM. Dapagliflozin 
also has a mild diuretic effect, which in combination with weight loss, has the potential to 
reduce blood pressure.  
Saxagliptin (Onglyza®) is a highly potent, selective, reversible, and competitive dipeptidyl l 
peptidase 4 (DPP4) inhibitor. DPP4 is the enzyme responsible for the inactivation of 
Glucagon-like peptide-1 (GLP-1) and Gastric inhibitory polypeptide (GIP). By inhibiting the 
enzyme DPP4, saxagliptin potentiates active endogenous GLP-1 concentrations, augmenting 
the physiological mechanism of insulin secretion and decreasing glucagon release, thereby 
reducing postprandial and fasting glucose levels in patients with T2DM. 


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The results from the saxagliptin Phase IIb and III programs in over 
patients support the 
oral dose of saxagliptin 2.5 and 5 mg once daily in a wide range of patients with T2DM, as 
either monotherapy, add-on combination therapy with metformin, a thiazolidinedione (TZD), 
a sulfonylurea (SU), insulin or initial combination therapy with metformin and the results 
from the Phase III studies confirmed clinically meaningful benefits on HbA1c, as well as 
fasting plasma glucose (FPG), postprandial glucose (PPG), insulin, C-peptide, and glucagon 
levels. 
Diabetic subjects with renal impairment are of interest because diabetic nephropathy affects 
approximately 30% of patients with diabetes. In the United States, for instance, about 20% of 
individuals with diabetes have an estimated glomerular filtration rate (eGFR) lower than 60 
ml/min/1.73m2 (chronic kidney disease, CKD stage ≥3). As diabetic patients progress from 
normal to diminished renal function over the natural history of their disease, there is a medical 
need for safe and effective oral anti-diabetic therapy. Several existing anti-diabetic agents are 
contraindicated in this population, are associated with increased risk of hypoglycemia, or have 
not been adequately studied in these patients. Safety and efficacy data in subjects with normal, 
mildly, and moderately impaired renal function have been collected in previous studies in the 
dapagliflozin and saxagliptin development program.
While saxagliptin 2.5 mg daily has been shown to be well tolerated and improve glucose 
control even in individuals with CKD stage >3  (Nowicki et al 2011), dapagliflozin’s ability to 
inhibit renal glucose reabsorption declines with decreasing eGFR and in CKD3, urinary 
glucose excretion with dapagliflozin is about 50% lower than in patients with normal or 
mildly impaired renal function. In a previous study in CKD3, dapagliflozin 5 and 10 mg daily 
was well-tolerated but did not have a significant impact on glycemic control in patients with 
more advanced CKD, although there was a modest decrease in HbA1c and FPG in patients
with a GFR of 45–59 ml/min (Kohan et al 2014). However, that study suffered from several 
limitations. The use of insulin-based regimens in almost two-thirds of patients, often with 
sliding scale administration, made accurate capture of insulin dosing difficult. Differential 
adjustments of insulin between placebo and dapagliflozin could have blunted the apparent 
efficacy of dapagliflozin. A second limitation was the relatively small size of the study, which 
was powered for a 0.6% change in HbA1c, and therefore limited in its ability to demonstrate 
smaller glycemic effects and thus, the study may be considered underpowered and subject to 
type 2 error. Other limitations including, a very short placebo lead-in period, and a relatively 
large placebo effect in this study could potentially also have affected its generalizability and 
obscured the interpretation of the data. 
In other clinical studies, which did not suffer from the limitations described above, SGLT2-
inhibitors have been shown to be well-tolerated and effective in T2DM patients with reduced 
kidney function lending support to further studies in this population.  
There is a growing body of evidence indicating that SGLT2 inhibition might be beneficial 
from a nephroprotective standpoint. This effect is thought to be achieved partly by 
mechanisms independent of overall blood pressure and blood glucose reductions. Such other 
mechanisms are thought to be reduced intra-glomerular pressure through an enhanced 
CCI


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tubuloglomerular feedback mechanism (De Nicola 2014 and Thomas 2014) as well as a 
reduced glucose and sodium transport over the proximal tubule cells (Pollock et al 1991 and 
Komala et al 2013) 
Preclinical data in a mouse model of type 2 diabetes and obesity show similar reductions in 
renal inflammatory response after dapagliflozin treatment as has been seen with ARB 
treatment (Terami et al 2014 and Sato-Horiguchi et al 2012). Further, data from a type 2 
diabetic nephropathy model have indicated that a combination therapy with SGLT2i and 
ACEI is more effective in lowering blood pressure and more nephroprotective than 
administration of either agent alone (Kojima et al 2013). Of notice, treatment with a SGLT2i 
in a type 1 diabetic nephropathy (eNOS knockout) rat model did not have any 
nephroprotective effect.  
Preclinical data do also support nephroprotective effects of DPP4 inhibitors. Thus, in rodent 
models of T1 and T2DN, treatment with DPP4 inhibitors has been found to decrease renal 
injury markers such as albuminuria, fibrosis, inflammation and oxidative stress (Tanaka et al 
2014). Even clinical data suggest nephroprotective effect of SGLT2 and DPP4 inhibitors as 
reduced urinary albumin excretion have been observed in T2DN trials with both these agents. 
(Scirica et al 2013).  
Despite the glucose lowering effect of dapagliflozin is reduced in parallel with a declining 
renal function, reduced urinary albumin excretion has been found in patients with moderate 
renal impairment on top of RAAS blockade for up to 1 year (Sjöström et al 2015). 
Although a causal relationship is debated, changes in albuminuria over time predicts mortality 
and both cardiovascular and renal outcomes significantly better than glucose status and blood 
pressure control in patients at a high cardiovascular risk (Schmieder et al 2014). 
The combination of DPP-4 and SGLT2 inhibition has therefore been proposed as a promising 
future option for T2DM patients with CKD (Schernthaner et al 2014). 
Rationale for study design, doses and control groups  
This study will be performed as part of the clinical development program for dapagliflozin for 
treatment of T2DM. This study intends to evaluate the efficacy, safety and pharmacodynamics 
of dapagliflozin and dapagliflozin in combination with saxagliptin in CKD patients with type 
2 diabetes mellitus and albuminuria treated with ACEi or ARB who have inadequate glycemic 
control, defined as HbA1c ≥7.0% and ≤11.0%, and renal impairment (eGFR ≥25 to ≤75 
ml/min/1.73 m2).  
The pharmacodynamic effects of saxagliptin and dapagliflozin have previously been studied 
in patients with renal impairment. Saxagliptin 2.5mg once daily significantly reduced UACR 
and HbA1c (Mosenzon et al 2014, Nowicki et al 2011, Kohan et al 2014) and dapagliflozin 
reduced UACR and HbA1c albeit the effect on HbA1c was not statistically different from 
placebo (Kohan et al 2014). All these doses were well-tolerated in this population and the 
saxagliptin dose of 2.5 mg is currently in the approved label for treatment of subjects with 
moderate or severe renal impairment. Dapagliflozin 10mg once daily was chosen because the 


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overall safety has not been different from 5mg once daily and the long term albuminuria 
lowering effects are thought to be more robust. Because the anti-glycemic effect of 
dapagliflozin vanes with decreasing GFR, HbA1c is the primary endpoint in the dapagliflozin 
+ saxagliptin arm and secondary in the dapagliflozin arm. 
Patients will be randomized to 24 weeks treatment with dapagliflozin 10 mg, dapagliflozin 10 
mg plus saxagliptin 2.5 mg or matching placebo. The study will be an international multi-
centre study at approximately 100 centres in North America, EU & ROW. It is planned to 
randomize a total of 450 patients (150 patients per treatment arm). The study is powered to 
detect a difference of 0.42% in mean HbA1c and 35% difference in UACR between active 
treatment and placebo following 24 weeks of treatment. 
Dapagliflozin 10 mg once daily, saxagliptin 2.5 mg once daily or matching placebo will be 
added to usual care of patients who have inadequate glycemic control on their existing 
therapies.  
This double-blind, randomized phase II/III study requires a placebo group to determine 
efficacy of dapagliflozin and dapagliflozin plus saxagliptin in a specific patient segment in 
order to discriminate effects caused by the study treatment from effects caused by other 
factors. All patients in the study are protected from harm by rescue criteria, which call for 
withdrawal from the study if the patient shows evidence of inadequately controlled disease. 
Randomization will be stratified by pre-enrolment anti-hyperglycemic therapy 
(long/intermediate-acting and mixed insulin regimen, metformin-based regimen, sulfonylurea 
(SU)-based regimen, thiazolidinedione (TZD)-based regimen, and other regimen.  
Any patients on metformin treatment need to have a dose suitable according to local 
guidelines and investigator’s judgement for the targeted CKD segments (i.e., eGFR –25-75 
ml/min/1.73 m2, calculated using the MDRD formula or specific formulas for Japanese and 
Taiwanese see 5.2.1). The study consists of a 2-week screening period, a 4-week single-blind 
placebo lead-in period, a 24-week double-blind, placebo-controlled treatment period, and a 3-
week follow-up (FU) period. The study drugs are taken once daily in the morning. The main 
efficacy assessments will be performed at regular intervals and will include HbA1c, UACR, 
weight, waist circumference, FPG, seated BP and heart rate. During the double-blind 
treatment period, HbA1c and urinary glucose values will be blinded to the Investigator and to 
the Sponsor. These values will be provided to the Investigator after the study has been 
completed. FPG value will be reported as an un-blinded value throughout the study. The main 
safety assessments will be performed at regular intervals and will include physical 
examination, vital signs, orthostatic reaction, renal function (change in s-creatinine), safety 
laboratory test, and AE monitoring. 
1.2 
Benefit/risk and ethical assessment  
Risk category 
Dapagliflozin and saxagliptin have global market approval and have been administered to 
thousands of T2DM patients. Details regarding potential risks associated with administration 


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of dapagliflozin once daily and saxagliptin once daily are provided in respective Investigator’s 
Brochures. 
Considering dapagliflozin’s and saxagliptin's mechanism of action, the previous clinical 
experience with these compounds, the study’s design features (including the inclusion, 
exclusion, and discontinuation criteria), and the planned safety procedures, participation in 
this study presents a minimal, and thus acceptable, risk to the individual patients that will be 
included.  
Potential risks 
Details regarding potential risks associated with administration of saxagliptin and 
dapagliflozin are provided in the Investigator’s Brochure (IB) for each medication. 
Dapagliflozin:  
Inhibition of SGLT2 results in increased urinary glucose excretions, which is commonly 
believed to increase the risk of urinary tract infections (UTIs). In some of the global Phase III 
studies, events of UTI were reported in a slightly higher proportion of dapagliflozin-treated 
patients than the placebo group. Increased urinary glucose excretion may also lead to an 
increased risk of developing genital infections. In global Phase III studies, the proportions of 
patients treated with dapagliflozin who reported AEs that matched a predefined list of Medical 
dictionary for regulatory activities (MedDRA) preferred terms that were indicative of genital 
infection were higher than those seen for placebo. 
Based on the mechanism of action of dapagliflozin and results of animal and clinical studies, 
there may be a potential risk for this compound to cause hypovolaemia or electrolyte 
imbalance. Severe hypovolaemia can cause hypotension, reduced renal perfusion and, in worst 
cases, acute renal failure. As a precaution, patients who, in the judgment of the Investigator, 
may be at risk for dehydration or volume depletion due to co-existing conditions or 
concomitant medications, such as loop diuretics, should have careful monitoring of their 
volume status. In patients already receiving dapagliflozin who develop conditions that may 
cause hypovolaemia or electrolyte imbalance, decisions to interrupt or discontinue 
dapagliflozin therapy and management of patients should be based on clinical judgment. 
Higher proportions of patients with marked laboratory abnormalities of hyperphosphatemia 
were reported in dapagliflozin vs. placebo but the clinical meaning of this is unclear. 
Hepatic laboratory markers were assessed in all the clinical studies with dapagliflozin. In the 
pooled analyses, the proportion of patients with elevated liver function tests was similar in the 
dapagliflozin and comparator groups and no clinically meaningful or consistent mean changes 
from baseline in liver function tests were observed in the dapagliflozin and placebo groups 
across the Phase IIb and III clinical studies. One patient had a SAE reported as drug-induced 
acute hepatitis that was later diagnosed as most comparable with autoimmune hepatitis. 
There have been postmarketing reports of ketoacidosis, including diabetic ketoacidosis, in 
patients with type 1 and type 2 diabetes mellitus taking dapagliflozin and other SGLT2 


Clinical Study Protocol 
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Date 18-Sep-2017 
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inhibitors, although a causal relationship has not been established. Dapagliflozin is not 
indicated for the treatment of patients with type 1 diabetes mellitus. 
 
Patients treated with dapagliflozin who present with signs and symptoms consistent with 
ketoacidosis, including nausea, vomiting, abdominal pain, malaise, and shortness of breath, 
should be assessed for ketoacidosis, even if blood glucose levels are below 14 mmol/ (250 
mg/dL). If ketoacidosis is suspected, discontinuation or temporary interruption of 
dapagliflozin should be considered and the patient should be promptly evaluated. 
 
Predisposing factors to ketoacidosis include a low beta-cell function reserve resulting from 
pancreatic disorders (eg, type 1 diabetes, history of pancreatitis, or pancreatic surgery), insulin 
dose reduction, reduced caloric intake, or increased insulin requirements due to infections, 
illness or surgery and alcohol abuse. Dapagliflozin should be used with caution in these 
patients. 
 
No study procedure will put patients at a risk beyond those ordinarily encountered during the 
performance of routine medical examinations or routine tests. 
Saxagliptin:  
Prior to approval, saxagliptin was evaluated in 6 pivotal Phase III, randomized, double-blind 
controlled trials. The majority of adverse events (AEs) reported in clinical studies have been 
of mild intensity and few have required treatment discontinuation. Post approval, the 
cardiovascular safety of saxagliptin was evaluated in 8280 patients with T2DM with high CV 
risk. When added to the standard of care, saxagliptin neither reduced nor increased the risk of 
the primary composite endpoint of CV death, myocardial infarction (MI), or ischemic stroke 
(Scirica et al 2013). However, in subgroups analysis, increased risk for hospitalization for 
heart failure was found in patients treated with saxagliptin.  
Joint pain (arthralgia) was reported during post marketing use of saxagliptin, as well as other 
medicines from the same medicine group (DPP4 inhibitors). Patients experienced joint pain 
which could be severe in some cases. Some patients experienced relief of symptoms when the 
medication was discontinued.  Some patients experienced recurrence of symptoms when 
restarting the same or another DPP4 inhibitor medication. 
 
Protection against risks 
This study has been designed with appropriate measures in place so as to monitor and 
minimize any of the potential health risks to participating patients. In order to ensure the 
safety of all patients participating in this study, AstraZeneca will conduct a real-time review of 
all safety information from all ongoing clinical dapagliflozin studies as they become available. 
Safety signal detection will include the integration of all available sources of safety 
information, including clinical study data, AE reports, pre-clinical data, epidemiological 
studies and literature reports, to identify and characterize unrecognized safety risks or changes 


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Date 18-Sep-2017 
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in those which are currently expected Adverse Drug Reactions. Any information that may 
affect the benefit-risk profile of dapagliflozin will be immediately communicated to relevant 
Health Authorities and appropriate actions will be taken regarding the clinical program as 
needed. Thus real-time, active safety surveillance will be conducted during the entire duration 
of this study. In addition, all dapagliflozin studies are subject to a carefully designed patient 
risk management plan that includes the temporary and if necessary permanent discontinuation 
of investigational product (IP) in individual patients in whom a potential health risk or a 
laboratory abnormality of clinical concern has been identified. 
Potential benefits to patients 
All patients will receive counselling on dietary and life-style modifications. Global phase II 
and phase III studies have established the effect of dapagliflozin and saxagliptin therapy on 
glycemic control. This phase II/III study will evaluate these effects of dapagliflozin and 
dapagliflozin together with saxagliptin in T2DM patients with CKD. In addition, dapagliflozin 
is expected to help decrease body weight (or prevent weight gain) as well as help lower BP 
especially in patients with elevated baseline BP. Patients are also expected to receive some 
benefit in the form of increased medical care/attention when participating in study procedures, 
which includes at least 10 clinical visits. 
Informed consent and alternatives to participation 
All prospective participants will be fully informed of the possible risks and benefits associated 
with this study, and their consent will be obtained prior to performing any study-specific 
activity. Should a prospective participant elect to not participate in the study or to withdraw 
from the study, other medications are available to treat their diabetes, and the patient will not 
be disadvantaged in any way. 
Conclusion 
Considering the pre-clinical and clinical experience with dapagliflozin and saxagliptin and the 
precautions included in the study protocol, participation in this study presents a minimal and 
thus acceptable risk to patients who meet the inclusion and none of the exclusion criteria and 
consent to take part in the study.  
1.3 
Study Design  
This is an exploratory phase II/III study in patients with CKD (eGFR= 25-75 
mL/minute/1.73m2), type 2 diabetes mellitus with micro- or macroalbuminuria (urine 
albumin-to-creatinine ratio (UACR) 30-3500 mg/g). The study is randomized, double-blind, 
placebo controlled and parallel group designed, multi-national, multi-centre study to evaluate 
pharmacodynamics of dapagliflozin 10 mg once daily (od) and dapagliflozin 10 mg once daily 
in combination with saxagliptin 2.5 mg once daily on top of background ACEi or ARB 
treatment. The study consists of a 2-week screening period followed by a 4-week single-blind 
placebo lead-in period, 24-week double-blind placebo-controlled treatment, and a 3-week 
follow-up period. Patients will be screened within two weeks before the lead-in period. 


Clinical Study Protocol 
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Patients will be stratified according to background anti-diabetes medication. All patients must 
have had a stable anti-diabetic treatment during the previous 12 weeks.  
The study will be an international multi-centre study at approximately 100 clinical sites in 
North America, EU & ROW. It is planned to randomize a total of 450 patients (aim 150 
patients per treatment). Each clinical site is expected to enrol at least 4 patients. Competitive 
enrolment will be applied. The study is primarily designed to investigate the effect of 
dapagliflozin alone or in combination with saxagliptin on HbA1c and UACR. 
The main efficacy assessments will include HbA1c and morning spot urine albumin to 
creatinine ratio (UACR). 
Safety assessments will be performed at regular intervals and will include physical 
examination, vital signs (including measured orthostatic reactions), renal function, body 
weight, safety laboratory test, hypoglycaemia and AE monitoring. 
1.4 
Study flowchart details 
Figure 1 Study flow Chart 
 
At Visit 1, patients will be screened for an HbA1c (HbA1c ≥7.0% and ≤11.0%), eGFR level 
(eGFR 20-80 mL/minute/1.73m2) and micro or macroalbuminuria (UACR 30 – 3500 mg/g). 
Patients who meet these criteria will be enrolled and further examined for all inclusion and 
exclusion criteria. At Visit 2 (start of lead-in visit), patients will be examined for lab panel. If 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
38(127) 
the eGFR value (eGFR 25-75 mL/minute/1.73m2) meets the inclusion criteria at Visit 1 or 2 
and none of the exclusion criteria are met the patients will enter a 4-week single-blind placebo 
lead-in period. At Visit 3, patients who meet all of the inclusion criteria and none of the 
exclusion criteria at Visit 1 and 2 spaces will be randomized to the 24-week double-blind 
placebo-controlled treatment period. The prescription of anti-diabetic and anti-hypertensive 
drugs, (including diuretics) should be kept constant throughout the entire 4-week lead in 
period. At randomization, patients will be stratified according to the pre-enrolment anti-
hyperglycaemic therapy. 
After either completion of the treatment period or permanent premature discontinuation of 
study medication, patients will enter a 3-week safety and sustained efficacy follow-up period 
without study medication. The follow-up visit (Visit 10) provides the opportunity to further 
evaluate changes in physical signs, symptoms or laboratory parameters that may be related to 
dapagliflozin with/without co-administration of saxagliptin. The total planned study duration 
from Visit 1 to the safety follow-up (Visit 10) will be 33 weeks. 
Summary scheme for inclusion based on HbA1c, eGFR and UACR 
Visit 1: 
HbA1c 7.0%-11.0%, inclusive 
 
 
eGFR 20-80 mL/min/1.73 m2, inclusive 
 
 
Single morning spot UACR 30-3500 mg/g, inclusive 
 
Visit 2:  
eGFR 25-75 mL/min/1.73 m2, inclusive at Visit 1 or 2 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
39(127) 
2. 
STUDY OBJECTIVES 
2.1 
Primary objective 
Primary Objectives: 
Outcome Measure: 
Primary objectives for the Saxagliptin/Dapagliflozin 
treatment arm 
x To compare the mean change from baseline in HbA1c 
between dapagliflozin 10 mg plus saxagliptin 2.5 mg and 
placebo, after 24 weeks of oral administration of double-
blind treatment in patients with type 2 diabetes and CKD . 
x To compare the mean percent change from baseline in 
urine albumin-to creatinine ratio (UACR) between 
dapagliflozin 10 mg plus saxagliptin 2.5 mg and placebo, 
after 24 weeks of oral administration of double-blind 
treatment in patients with type 2 diabetes and CKD . 
 
 
x Change from baseline in 
HbA1c at Week 24 
 
x Percent change from 
baseline in UACR at 
Week 24 
 
Primary objective for the Dapagliflozin treatment arm 
x To compare the mean percent change from baseline in 
urine albumin-to creatinine ratio (UACR) between 
dapagliflozin 10 mg and placebo, after 24 weeks of oral 
administration of double-blind treatment in patients with 
type 2 diabetes and CKD . 
 
 
x Percent change from 
baseline in UACR at 
Week 24 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
40(127) 
2.2 
Secondary objectives 
Secondary Objectives: 
Outcome Measure : 
Secondary objectives for the Saxagliptin/Dapagliflozin 
treatment arm: 
x To compare the mean percent change from baseline in 
total body weight between dapagliflozin 10 mg plus 
saxagliptin 2.5 mg and placebo, after 24 weeks of oral 
administration of double-blind treatment.  
x To compare the mean change from baseline in fasting 
plasma glucose (FPG) between dapagliflozin 10 mg plus 
saxagliptin 2.5 mg and placebo, after 24 weeks of oral 
administration of double-blind treatment. 
x To compare the proportion of patients achieving a 30% 
reduction in UACR between dapagliflozin 10 mg plus 
saxagliptin 2.5 mg and placebo, after 24 weeks of oral 
administration of double-blind treatment. 
x To compare the proportion of patients achieving a 
reduction in HbA1c <7.0% between dapagliflozin 10 mg 
plus saxagliptin 2.5 mg and placebo, after 24 weeks of 
oral administration of double-blind treatment. 
x To compare the mean change from baseline in seated 
systolic blood pressure (SBP) between dapagliflozin 10 
mg plus saxagliptin 2.5 mg and placebo, after 24 weeks of 
oral administration of double-blind treatment. 
 
 
x Percent change from 
baseline in total body 
weight at Week 24 
 
x Change from baseline in 
FPG at Week 24 
 
 
x 30% reduction in UACR 
at Week 24 
 
x HbA1c < 7.0 % at  Week 
24 
 
 
x Change from baseline in 
seated SBP at Week 24 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
41(127) 
Secondary objectives for the Dapagliflozin treatment arm: 
x To compare the mean percent change from baseline in 
total body weight between dapagliflozin 10 mg and 
placebo, after 24 weeks of oral administration of double-
blind treatment. 
x To compare the proportion of patients achieving a 30% 
reduction in UACR between dapagliflozin 10 mg and 
placebo, after 24 weeks of oral administration of double-
blind treatment. 
x To compare the mean change from baseline in seated 
systolic blood pressure (SBP) between dapagliflozin 10 
mg and placebo, after 24 weeks of oral administration of 
double-blind treatment. 
x To compare the mean change from baseline in HbA1c 
between dapagliflozin 10 mg and placebo, after 24 weeks 
of oral administration of double-blind treatment. 
x To compare the mean change from baseline in fasting 
plasma glucose (FPG) between dapagliflozin 10 mg and 
placebo, after 24 weeks of oral administration of double-
blind treatment. 
x To compare the proportion of patients achieving a 
reduction in HbA1c <7.0% between dapagliflozin 10 mg 
and placebo, after 24 weeks of oral administration of 
double-blind treatment. 
 
x Percent change from 
baseline in total body 
weight at Week 24 
 
x 30% reduction in UACR 
at Week 24 
 
x Change from baseline in 
seated SBP at Week 24 
 
x Change from baseline in 
HbA1c at Week 24 
 
x Change from baseline in 
FPG at Week 24 
 
x HbA1c < 7.0 % at Week 
24 
 


Clinical Study Protocol
Drug Substance Dapagliflozin
Study Code D1690C00023
Edition Number 6.0
Date 18-Sep-2017
42(127)
2.3
Safety objectives
Safety Objectives:
Outcome Measure :
x
To assess the proportion of patients discontinued 
from the study due to sustained increase in serum 
creatinine by ≥1.5 times baseline level (AKI stage 
1). 
x
To evaluate the safety and tolerability of 
dapagliflozin 10 mg once daily and dapagliflozin 
10 mg plus saxagliptin 2.5 mg once daily in 
patients with type 2 diabetes and CKD .
x
To assess the mean change from baseline in 
eGFR after 24 weeks of oral administration of 
double-blind treatment between dapagliflozin 10 
mg and placebo and between dapagliflozin 10 mg 
plus saxagliptin 2.5 mg and placebo.
x
To assess the mean change from baseline in 
eGFR at follow-up (3 weeks after treatment 
completion) between dapagliflozin 10 mg and 
placebo and between dapagliflozin 10 mg plus 
saxagliptin 2.5 mg and placebo.
x
Discontinuation from study due to 
sustained increase in serum 
creatinine ≥1.5 times baseline level
x
AEs 
x
Vital Signs
x
Orthostatic Reactions
x
Physical Examination
x
Clinical Chemistry/Haematology 
Parameters
x
Change from baseline in renal 
function (eGFR) at Week 24
x
Change from baseline in renal 
function (eGFR) at Week 27 
2.4
Exploratory objectives
  
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Clinical Study Protocol
Drug Substance Dapagliflozin
Study Code D1690C00023
Edition Number 6.0
Date 18-Sep-2017
43(127)
 
 
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Clinical Study Protocol
Drug Substance Dapagliflozin
Study Code D1690C00023
Edition Number 6.0
Date 18-Sep-2017
44(127)
 
 
 
  
  
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Clinical Study Protocol
Drug Substance Dapagliflozin
Study Code D1690C00023
Edition Number 6.0
Date 18-Sep-2017
45(127)
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Clinical Study Protocol
Drug Substance Dapagliflozin
Study Code D1690C00023
Edition Number 6.0
Date 18-Sep-2017
46(127)
3.
SUBJECT SELECTION, ENROLMENT, RANDOMISATION, 
RESTRICTIONS, DISCONTINUATION AND WITHDRAWAL 
Investigator(s) should keep a record of patients who were considered for participation.
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Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
47(127) 
Each subject should meet all of the inclusion criteria and none of the exclusion criteria for this 
study.  Under no circumstances can there be exceptions to this rule. 
3.1 
Inclusion criteria 
For inclusion in the study subjects should fulfil the following criteria: 
1 
Provision of informed consent prior to any study specific procedures. 
2 
Female or male aged ≥18 years at Visit 1. 
<< (JP) The following should be added if applicable. For subjects aged <20 years and 
enrolled in Japan, a written informed consent should be obtained from the subject and his or 
her legally acceptable representative. >> (End JP) 
3 
History of type 2 diabetes mellitus for more than 12 months. 
4 
Inadequate glycemic control, defined as HbA1c ≥7.0% and ≤11.0% measured at Visit 
1.  
5 
Stable antidiabetic treatment during the last 12 weeks up to randomization. 
Stable anti-diabetic treatment regimen, defined as: Stable diet and exercise therapy 
alone or in combination with any or both of the two following alternatives. 
a. A regimen of any approved oral anti-diabetic medication (except SGLT2 inhibitors, 
GLP-1 receptor agonists and DPP4 inhibitors) where no dose-changes have 
occurred during the last 12 weeks up to randomization. 
b. Any insulin regimen is permitted as long as the dose is stable 12 weeks before 
randomization, changes ± 10% are allowed ((average daily number of units during 
the 12 weeks compared to the average during the last week before randomization).). 
6 
Renal impairment defined as eGFR 20-80 mL/minute/1.73m2at Visit 1 to enter the 
lead-in period,  25-75 mL/minute/1.73m2at Visit 1 or Visit 2 for randomization (for 
eGFR calculation, see section 5.2.1). 
7 
Micro or macroalbuminuria (UACR 30 – 3500 mg/g or 3.34- 395.85 mg/mmol, 
inclusive) at Visit 1.  
8 
Patient must be receiving an angiotensin converting enzyme (ACE) inhibitor or an 
angiotensin II receptor blocker (ARB) for at least 3 months prior to screening, where 
the dose of the ACE inhibitor or the ARB is considered appropriate for that patient, 
and has been stable and maintained on that dose for at least 4 weeks prior to study 
randomization. 
9 
Body mass index between 20 and 45 kg/m2 at visit 1. 
3.2 
Exclusion criteria 
Subjects should not enter the study if any of the following exclusion criteria are fulfilled: 
1 
Pregnant (confirmed with positive pregnancy test) or breast feeding at Visit 2. 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
48(127) 
2 
Women of childbearing potential (WOCBP) who are unwilling or unable to use an 
acceptable method to avoid pregnancy for the entire study period. 
3 
Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) > 3X ULN at 
Visit 2. 
4 
Total Bilirubin (TB) >2 mg/dL (35 μmol/L) at Visit 2.  
5 
Serum Potassium (K) > 5.5 meq/L (5.5 mmol/L) at Visit 2. 
6 
Serum Calcium (Ca) <8 mg/dL or > ULN (<1.99 mmol/L or > ULN) at Visit2. 
7 
Documented history of positive serologic evidence of current infectious liver disease 
including hepatitis B surface antigen or anti-hepatitis C virus antibody at Visit 2. 
Subjects how have isolated positive anti-hepatitis B antibodies (i.e. indicating 
immunity to hepatitis B infection or previous vaccination) may be included.   
8 
History of ≥2 major hypoglycaemic events in the 3 months prior to enrolment visit 
(Visit 1), defined as symptomatic events requiring external assistance due to severe 
impairment in consciousness or behaviour and prompt recovery after glucose or 
glucagon administration. 
9 
Haemoglobin <9.0 g/dL (90 g/L) at Visit 2. 
10 
Patients with Type 1 DM, history of pancreatitis or pancreatic surgery 
11 
History of diabetes insipidus, diabetic ketoacidosis or hyperosmolar nonketotic coma. 
12 
Severe uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 180 
mmHg and/or diastolic blood pressure (DBP) ≥ 110 mmHg at any visit up to 
randomization. 
13 
Any of the following CV/Vascular Diseases within 3 month prior to signing the 
consent at Visit 1: 
a. Myocardial infarction. 
b. Cardiac surgery or revascularization (CABG/PTCA). 
c. Unstable angina. 
d. Unstable heart failure (HF). 
e. HF New York Heart Association (NYHA) Class III-IV. 
f. Transient ischemic attack (TIA) or significant cerebrovascular disease. 
g. Unstable or previously undiagnosed arrhythmia. 
14 
Significant hepatic disease, including, but not limited to, chronic active hepatitis and/or 
severe hepatic insufficiency. 
15 
Documented history of severe hepatobiliary disease or hepatotoxicity with any 
medication. 
16 
History of haemoglobinopathy, or chronic or recurrent haemolysis.  


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
49(127) 
17 
History of acute kidney injury requiring renal replacement therapy (dialysis or 
ultrafiltration) or any biopsy or imaging verifying intercurrent kidney disease other 
than diabetic nephropathy or diabetic nephropathy with nephrosclerosis.  
18 
Donation of blood or blood products to a blood bank, blood transfusion, or 
participation in a clinical study requiring withdrawal of > 400 mL of blood during the 
6 weeks prior to signing the consent at Visit 1. 
19 
Malignancy within 5 years of the enrolment visit (Visit 1), with the exception of 
treated basal cell or treated squamous cell carcinoma. 
20 
Known immunocompromised status, including but not limited to, individuals who 
have undergone organ transplantation or who are positive for the human 
immunodeficiency virus. 
21 
History of unexplained microscopic or gross haematuria, or microscopic haematuria at 
Visit 2, confirmed by a follow-up sample at next scheduled visit.  
22 
Subjects who have contraindications to therapy as outlined in the saxagliptin and 
dapagliflozin Investigator Brochures or the local saxagliptin or dapagliflozin product 
label, including current treatment with potent cytochrome P4503A4/5 inhibitors (in 
countries where adjustment would be required by the local saxagliptin label). 
23 
Known allergies or contraindication to the contents of dapagliflozin, saxagliptin or 
placebo tablets. 
24 
History of drug-induced myopathy or drug-induced CK elevation. 
25 
Treatment with a SGLT2 inhibitor, GLP-1 agonist or DPP4 inhibitors at Visit 1 or 2. 
26 
Simultaneous treatment with both an ACEi and an ARB.  
27 
Long term treatment with glucocorticoids (two temporary periods of no longer than 10 
days each are allowed during the study); topical or inhaled corticosteroids are allowed.    
28 
A metformin dose which is outside the specified dose range for eGFR – 25-75 
mL/minute/1.73m2, according to local guidelines and/or investigator’s judgement. 
29 
Any condition which, in the judgment of the Investigator, may render the patient 
unable to complete the study or which may pose a significant risk to the patient or 
patient suspected or with confirmed poor protocol or medication compliance. 
30 
Patients at risk for volume depletion as judged by the investigator.   
31 
Employees of AstraZeneca, or their immediate relatives. Involvement in the planning 
and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study 
site). 
32 
Administration of any other investigational drug or participation in any interventional 
clinical studies 30 days prior of planned screening to this study. 
33 
Poorly controlled diabetes including but not limited to marked polyuria and polydipsia 
with greater than 10% weight loss during the 3 months prior to visit 1. 
34 
Administration of weight loss medication. 


Clinical Study Protocol
Drug Substance Dapagliflozin
Study Code D1690C00023
Edition Number 6.0
Date 18-Sep-2017
50(127)
3.3
Subject recruitment information 
3.4
Subject enrolment and randomization

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Clinical Study Protocol
Drug Substance Dapagliflozin
Study Code D1690C00023
Edition Number 6.0
Date 18-Sep-2017
51(127)
3.5
Procedures for handling incorrectly enrolled or randomized 
subjects
Subjects who fail to meet the eligibility criteria should not, under any circumstances, be 
enrolled or receive study medication.  There can be no exceptions to this rule.  Subjects who 
are enrolled, but subsequently found not to meet all the eligibility criteria must not be 
randomized or initiated on treatment, and must be withdrawn from the study.
Where a patient does not meet all the eligibility criteria but is randomized in error, or 
incorrectly started on treatment, the following steps need to be taken: 
x The Investigator or monitor should inform the AstraZeneca study physician immediately, 
ensuring patient safety must always be the number one priority.
x Study Treatment must be discontinued in all cases where continued treatment is deemed to 
pose a safety risk to the patient. A discussion should occur between the AstraZeneca study 
physician and the investigator, a decision may be reached that whether to continue or 
discontinue the patient from study treatment. The AstraZeneca study physician must ensure 
all decisions are appropriately documented.
x In those cases where continuation of study therapy is judged not to present a concern 
related to safety and disease management, the rationale for continuing study therapy must 
be clearly documented. The patient should continue follow up in accordance with defined 
study procedures. 
3.6
Methods for assigning treatment groups
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Clinical Study Protocol
Drug Substance Dapagliflozin
Study Code D1690C00023
Edition Number 6.0
Date 18-Sep-2017
52(127)
3.7
Methods for ensuring blinding
The study has a single blind placebo Lead-in period of 4 weeks from Visit 2, where patients 
will be blinded to treatment. Other, as members at AstraZeneca, investigational centres or any 
Contract Research Organization (CRO) handling data will be aware of the placebo treatment 
during this period.
The study will be conducted in a double-blind & double dummy fashion. The matching 
placebo are identical in size, colour, smell, taste, packaging and labelling to their respective 
active tablets of dapagliflozin 10 mg and saxagliptin 2.5 mg.
Until the completion of the 24-week randomised treatment period, no member of the study 
team at AstraZeneca, at the investigational centres or any CRO handling data will have access 
to the randomisation scheme, with the exception of AstraZeneca personnel generating the 
randomisation scheme as well as relevant persons at Pharmaceutical Development Supply 
Chain at AstraZeneca or their designee, where the information is needed to package study 
medication, the Patient Safety data entry site and the CRO companies providing the 
IVRS/IWRS and carrying out the packaging and labelling of investigational products. Patients 
and investigators will remain blinded past the 24-week randomised treatment period. The 
treatment codes and results will be kept strictly within AstraZeneca to safeguard the integrity 
of the blind of the investigators and patients, and hence to minimize any possible bias in data 
handling. 
The exception is for those personnel analyzing the PK data.  The randomisation code will be 
provided to ensure that only samples from patients who were on the relevant active study 
treatment are analysed.  The randomization list will be kept in a secure location until the end 
of the study
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Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
53(127) 
3.8 
Methods for unblinding  
Individual treatment codes, indicating the treatment randomisation for each randomised 
subject, will be available to the Investigator(s) or pharmacists from the IVRS/IWRS. Routines 
for this will be described in the IVRS/IWRS user manual that will be provided to each centre. 
<<(JP) Replace the above paragraph with: Individual treatment codes, indicating the 
treatment randomisation for each randomised subject, will be available to the Investigator(s) 
or pharmacists, and the personnel who are independent to the study evaluation at the Patient 
Safety Department, AstraZeneca from the IVRS/IWRS.>> (End JP) 
The treatment code should not be broken except in medical emergencies when the appropriate 
management of the subject requires knowledge of the treatment randomisation. The 
Investigator documents and reports the action to AstraZeneca, without revealing the treatment 
given to subject to the AstraZeneca staff. 
AstraZeneca retains the right to break the code for SAEs that are unexpected and are 
suspected to be causally related to an investigational product and that potentially require 
expedited reporting to regulatory authorities. Treatment codes will not be broken for the 
planned analyses of data until all decisions on the evaluability of the data from each individual 
subject have been made and documented. 
3.9 
Restrictions 
x 
All patients will visit the clinic fasting in the morning, between 6 a.m. to 10 a.m. 
Patients will be instructed to abstain from all food and beverages for 8 hours prior 
to each clinic visit (except for Visit 1). Drinking water is allowed. 
x 
Patients should not drink alcohol within 24 hours prior to each visit and should not 
use tobacco/nicotine within 12 hours prior to each visit. 
x 
Patients should bring all their medications and IP to the site. 
x 
Anti-hypertensive medication can be taken with a glass of water after completion of 
BP and body weight measurements. 
x 
Medications including IP should be taken after visit samples and examinations have 
been performed. Anti-hyperglycemic drugs should be taken in connection with a 
meal. 
x 
Antiepileptic drugs and antibiotics shall be taken as prescribed. 
x 
Women must immediately contact the Investigator if they suspect they might be 
pregnant and if they have changed or plan to change their birth control method. 
If a patient arrives for a visit without having followed the above instructions, the entire visit 
should be rescheduled (within the allowed time-window, if possible). 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
54(127) 
Donation of blood or blood products to a blood bank is not allowed during participation in the 
study. Prohibited and restricted concomitant medications are listed in Section 7.7
3.10 
Discontinuation of investigational product 
Patients may be discontinued from IP in the following situations: 
x 
Patient decision. The patient may, at any time, discontinue study treatment, without 
prejudice to further treatment. Patients who choose to discontinue study treatment 
are expected to continue in the study until the closing of the study. 
x 
Safety reasons as judged by the Investigator, by or an AZ representative. 
x 
Severe non-compliance to protocol as judged by the investigator and/or AZ 
Subjects MUST discontinue study treatment (investigational or non-investigational treatment) 
for any of the following reasons: 
x 
Any clinical AE, laboratory abnormality or inter current illness which, in the 
opinion of the Investigator, indicates that continued participation in the study is not 
in the best interest of the subject. 
x 
Pregnancy 
x 
Termination of the study by AstraZeneca. 
x 
Loss of ability to freely provide consent through imprisonment or involuntarily 
incarceration for treatment of either a psychiatric or physical (e.g., infectious 
disease) illness. 
x 
Protocol-defined major hypoglycemia episodes. 
x 
Liver criteria: 
ALT and/or AST >3 times the upper limit of normal (ULN) and concomitant TB >2 
times ULN confirmed at a repeated measurement at the central laboratory (which 
should be obtained within 3 days, whenever possible, following receipt of the initial 
laboratory results) 
ALT and/or AST >8 times ULN confirmed at a repeated measurement at the central 
laboratory (which should be obtained within 3 days, whenever possible, following 
receipt of the initial laboratory results)  
ALT and/or AST >5 times ULN confirmed at the central laboratory and sustained 
over a period of 14 days or more 
(See Appendix D Algorithm on Management of Sustained Elevated Liver Safety 
Abnormalities for further details) 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
55(127) 
x 
Acute renal insufficiency or worsened chronic renal insufficiency based on 
sustained ≥1.5 times increase in baseline s-creatinine (see page 56 Discontinuation 
Guidelines due to Acute Kidney Injury). 
Clinical indications for discontinuation because of hypoglycemia may include the following: 
x 
Multiple occasions of episodes outlined below that, in the opinion of the 
Investigator, indicate that continued treatment with study therapy is not in the best 
interest of the patient.  This includes, but is not limited to: 
- 
Symptoms suggestive of hypoglycemia (e.g, sweating, shakiness, increased 
heart rate, confusion, dizziness, light-headedness, or hunger) in the absence of 
environmental factors known to contribute to hypoglycemia (ie, excess physical 
activity, concurrent illness, or missed or delayed meal) 
and/or 
- 
Documented finger stick glucose values <54 mg/dL (<3.0 mmol/L).  
3.10.1 
Discontinuation Guidelines due to Protocol-Defined Major Hypoglycemia 
Episode or Recurrent Non-Major Hypoglycemia Episodes 
Subjects will be discontinued from study medication if they experience severe and/or frequent 
hypoglycemia episodes, defined as more than one major episode or recurring non-major 
episodes in the event where the possibility of down-titration of insulin and/or oral anti-diabetic 
medication(s), (other than blinded study medication) and/or other contributing factors (e.g., 
excessive physical activity) have been evaluated and corrected. NOTE: Dose titration of 
blinded study medication is not permitted at any time during the study. 
x 
A Major Hypoglycemia Episode is defined as a symptomatic episode which meets 
all of the following criteria: 
- 
External (the 3rd party) assistance due to severe impairment in consciousness or 
behaviour. 
- 
Capillary or plasma glucose value of < 3 mmol/L (< 54 mg/dL) 
- 
Prompt recovery after glucose or glucagon administration 
x 
Recurring Non-Major Episodes are defined as any recurrent hypoglycemia episodes, 
as determined by the Investigator, not meeting the definition of Major Episodes. 
It is the Investigator’s clinical assessment whether subjects who experience non-recurrent and 
non-major episodes of hypoglycemia should be discontinued from study medication. 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
56(127) 
3.10.2 
Discontinuation Guidelines due to Acute Kidney Injury (AKI) 
For patients with signs of deterioration in renal function, additional monitoring needs to be 
conducted. Any patients with >1.5 x baseline serum creatinine increase needs to be scheduled 
for a new serum creatinine test within 4 days whenever possible.  
x 
If the new serum creatinine value is >1.5 x basal level, the patient should be 
evaluated for any suspected new, temporary and reversible cause of renal 
dysfunction, e.g. concurrent use of NSAIDs, antibiotics, or other medications 
known to affect creatinine clearance; volume depletion; urinary tract infection, and 
obstructive uropathy. 
 If there is no suspected cause of the acute drop in renal function, the subject 
must permanently discontinue study medication and the Sponsor is notified. 
The investigator will follow the subject until the event has resolved or 
stabilized. 
 If there is a suspect reversible cause, the following actions should be taken: 
- 
Study medication should be withheld.  
- 
The suspected cause of renal dysfunction should be identified and corrected. 
- 
Serum creatinine should be checked again after approximately one week: 
 If serum creatinine is still >1.5 x baseline level: 
¾  The subject must permanently discontinue study medication and the 
Sponsor is notified. The Investigator will follow the subject until the 
event has resolved or stabilized 
 If serum creatinine is <1.5 x baseline level: 
¾  Study medication can be resumed. 
¾  Serum creatinine should be checked after approximately one week 
¾  The subject may continue in the study and will be followed according 
to the protocol. Additional monitoring of serum creatinine may be 
performed according to the local practice or Investigator’s judgment. 
3.10.3 
Rescue Due to Lack of Glycemic Control in the Treatment Period 
Rescue Medication  
Patients with lack of glycemic control during the 24 week treatment period may be eligible to 
receive open-label rescue medication in addition to their blinded treatment in order to treat 
ongoing hyperglycemia. Patients may receive open-label rescue medication added on to, but 
not as a replacement for, their current study medication regimen. Rescue medication in this 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
57(127) 
protocol refers to any approved, appropriate anti-diabetic agent, except SGLT2-inhibitors, 
GLP-1 agonists or DPP4 inhibitors, in accordance with the approved label and conventional 
standards of care. Open-label rescue medication is to be titrated as needed to obtain adequate 
glycemic control.  
During the treatment period, all rescue decisions will be based on central laboratory FPG and 
confirmatory FPG results. If patients meet the protocol-specified glycemic criteria based on 
FPG, they will be recommended for open-label rescue medication. 
Patients in the follow-up phase will not need to adhere to the protocol defined rescue criteria, 
and may have their anti-diabetic regimen adjusted at the Investigator’s discretion, except to 
start treatment with a SGLT2 inhibitor, a GLP1 agonist or a DPP4 inhibitor. 
 
The sections and tables listed below define the lack of glycemic control criteria for initiation 
of open-label rescue medication. 
Protocol-Defined Lack of Glycemic Control Criteria for Initiation of Open-Label Rescue 
Medication 
Pre-specified glycemic criteria (see Table 1 below), based upon central laboratory FPG and 
confirmatory, repeat FPG, have been established during the 24 week treatment period, starting 
at Week 4 and up to Week 24 visits, to determine eligibility for open-label rescue medication 
initiation/titration. 
Table 1 
Lack of Glycemic Control Criteria for Initiation of Open-Label Rescue 
Medication 
Visit Label 
Central Laboratory FPG 
From Week 4 to Week 12 (excluding week 12)  
FPG > 240 mg/dL (13.3 mmol/L) 
From Week 12 to Week 24 (excluding Week 24) 
FPG > 200 mg/dL (11.1 mmol/L) 
 
Patients with a central laboratory FPG value meeting the lack of glycemic control criterion at 
a pre-specified visit will be scheduled for a follow-up visit (within 3 - 5 days) to obtain a 
second central laboratory FPG value and review the patient’s glucose meter readings. If the 
repeat central laboratory FPG value still meets the criterion, the patient will receive rescue 
medication. 
Irrespective of study visit number, patients who meet rescue criteria in the treatment period 
must first complete the Week 24 visit procedures (within 5 days whenever possible) before 
being rescued to ensure that important trial endpoint measurements are collected. 
Following completion of the Week 24 “Rescue” visit, rescued patients will be administered 
open-label rescue medication in addition to their blinded study medication. Rescued patients 
will then continue in the treatment period according to their original visit schedule. Patients 
who received a first rescue medication, who subsequently fulfil lack of glycemic control 
criteria, may have other rescue medications added or substituted, according to Investigator 
judgment, without repetition of rescue visits. 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
58(127) 
3.10.4 
Guidelines with regard to changes in insulin dose 
Each subject’s baseline insulin therapy should remain unchanged wherever possible 
throughout the double-blind treatment period. The stable insulin regimen aims to continue 
insulin as it was being used by the subject at enrollment and lead-in, with no changes to 
insulin type and with as few changes in insulin dosage as possible. A stable insulin regimen is 
pivotal, because it makes it possible for the study to measure any differences in glycaemic 
control between the active treatment arms and the placebo arm. During the double-blind 
treatment period, a few subjects will experience poor glycaemic control, as measured by 
increased fasting plasma glucose measurements from the central laboratory during study visits. 
When glucose measurements exceed certain limits (as specified), the subject will be 
‘‘rescued’’.  
Up-titration in insulin dose is not allowed, unless fasting blood glucose rescue criteria is 
fulfilled or if insulin requirement has increased only temporarily, e.g., due to an infection and 
the increase in insulin dose is ≤10 percent of the baseline level after 1 week. If lasting increase 
in insulin dose is made i.e. the insulin dose is still >10 percent higher than the baseline level 1 
week after up-titration, the subject shall be handled as administration of anti-diabetic rescue 
medication and be treated as “rescued” (i.e., the patient must complete the Week 24 visit 
procedures, as outlined in section 4.5.7 and the patient will continue in the treatment period 
according to their original visit schedule.  
Down-titration of insulin is allowed only as necessary to prevent low blood glucose or 
hypoglycemia.  
3.10.5 
Procedures for discontinuation of a subject from investigational product  
If a subject was withdrawn before completing the study, the reason for withdrawal must be 
entered on the appropriate case report form (CRF) page. 
At any time, subjects are free to discontinue investigational product or withdraw from the 
study (i.e., investigational product and assessments – see Section 3.11), without prejudice to 
further treatment.  A subject that decides to discontinue investigational will always be asked 
about the reason(s) and the presence of any adverse events.  If possible, they will be seen and 
assessed by an Investigator(s).  Adverse events will be followed up (See Section 6); <<diary 
cards, questionnaires (e.g., for patient reported outcomes)>> and all study drugs should be 
returned by the subject. 
All patients who discontinue study drug will be asked to remain in the study for FU and 
complete all scheduled study visits through Week 27. At the time of discontinuation the Week 
24 (Visit 9) procedures will be performed. Patients will then complete all scheduled study 
visits and procedures. Patients unable or unwilling to return for scheduled visits as part of 
follow-up will have the opportunity to receive follow-up via telephone calls placed by the site 
mainly to review safety and concomitant medications. The only exception to this procedure is 
when a patient 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).  


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
59(127) 
If a subject is withdrawn from study, see Section 3.11. 
3.11 
Criteria for withdrawal  
3.11.1 
Screen failures  
Screening failures are patients who do not fulfil the eligibility criteria for the study, and 
therefore must not be randomized.  These patients should have the reason for study 
withdrawal recorded as ‘Incorrect Enrolment’ (i.e., patient does not meet the required 
inclusion/exclusion criteria).  This reason for study withdrawal is only valid for screen failures 
(not randomized patients). Patients can be re-enrolled one single time, but they cannot be re-
randomized. 
3.11.2 
Withdrawal of the informed consent 
Patients are free to withdraw from the study at any time (investigational product and 
assessments), without prejudice to further treatment. 
A patient who withdraws consent will always be asked about the reason(s) and the presence of 
any adverse events (AE).  The Investigator will follow up AEs outside of the clinical study.  
If a subject withdraws from participation in the study, then his/her enrolment/randomisation 
code cannot be reused. Withdrawn subjects will not be replaced.  
3.11.3 
Lost to follow-up 
Patient fails to return for study visits and cannot be reached with reasonable, repeated attempts. 
To prevent patients being lost to follow-up, their contact details, including next of kin contacts 
should be collected initially and updated regularly by the site staff or representative. The 
Investigator should educate the patient on the importance of contact with the Investigator 
throughout the study. Every effort will be made to ensure that the patient continues to return to 
the clinic for study visits and to avoid “lost to follow-up” during the conduct of the study. The 
study staff should make diligent attempts to contact patients who fail to return for study visits 
by using institutional databases, patient’s health professionals, and any other means that 
comply with country and local laws and regulations. After the first missed visit, patients who 
are considered temporarily lost to follow-up will have 2 documented telephone contact 
attempts and 1 certified letter in an effort to contact patients. 
 
3.12 
Discontinuation of the study 
The study may be stopped if, in the judgment of AstraZeneca, trial subjects are placed at 
undue risk because of clinically significant findings that: 
x 
meet individual stopping criteria or are otherwise considered significant  
x 
are assessed as causally related to study drug  
x 
are not considered to be consistent with continuation of the study 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
60(127) 
Regardless of the reason for termination, all data available for the subject at the time of 
discontinuation of follow-up must be recorded in the CRF. All reasons for discontinuation of 
treatment must be documented. 
In terminating the study, the Sponsor will ensure that adequate consideration is given to the 
protection of the subjects’ interests. 
4. 
STUDY PLAN AND TIMING OF PROCEDURES  
4.1 
Study flowchart details 
At Visit 1 patients will be screened for an HbA1c (HbA1c ≥7.0% and ≤11.0%), eGFR level 
(eGFR 20-80 mL/minute/1.73m2,) and micro- or macroalbuminuria (UACR 30 – 3500 mg/g). 
Patients who meet these criteria will be enrolled and further examined for all inclusion and 
exclusion criteria. At Visit 2 (start of lead-in visit), patients will be examined for lab panel. If 
the eGFR value is 25-75 mL/minute/1.73m2 at Visit 1 or Visit 2 and all other inclusion and 
none of the exclusion criteria are met, the patients will enter a 4-week single-blind placebo 
lead-in period. At Visit 3, patients who meet all of the inclusion and none of the exclusion 
criteria at Visit 1 and 2 spaces will be randomized to the 24-week double-blind placebo-
controlled treatment period. The prescription of anti-diabetic and anti-hypertensive drugs, 
(including diuretics) should be kept constant throughout the entire 4-week lead in period. At 
randomization, patients will be stratified according to pre-enrolment anti-hyperglycaemic 
therapy. 
After either completion of the treatment period or permanent premature discontinuation of 
study medication, patients will enter a 3-week safety and sustained efficacy follow-up period 
without study medication. The follow-up visit (Visit 10 (FU)) provides the opportunity to 
further evaluate changes in physical signs, symptoms or laboratory parameters that may be 
related to dapagliflozin with/without co-administration of saxagliptin. The total planned study 
duration from Visit 1 to the safety follow-up (Visit 10) will be 33 weeks. 
Summary scheme for inclusion based on HbA1c, eGFR and UACR 
Visit 1:  
HbA1c 7.0%-11.0%, inclusive 
 
 
eGFR 20-80 mL/min/1.73 m2,inclusive 
 
 
Single morning spot UACR 30-3500 mg/g, inclusive 
 
Visit 2:  
eGFR 25-75 mL/min/1.73 m2, inclusive, at Visit 1 or Visit 2. 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
61(127) 
4.2 
Assessments schedule 
Table 2 
Study Planning and details procedure 
Study period 
Screening 
Period 
Lead-in 
period 
Randomi
zation 
Treatment period 
Follow-up 
period 
 
Visit number 
1a 
Non-fasting 
2b,c  
Fasting 
3c,d,e  
Fasting 
4 c,d,e  
Fasting 
5 c,d,e  
Fasting 
6 c,d,e  
Fasting 
7 c,d,e  
Fasting 
8 c,d,e  
Fasting 
9 c,d,e  
Fasting 
10 c,d  
Fasting 
For 
details 
see 
Protocol 
Section 
Week 
-6 
-4 
0 
1 
4 
8 
12 
16 
24 
27 
Day 
-42 to -
29 
-28 
1 
8 
29 
57 
85 
113 
169 
190 
Visit window 
 
f5 
±0 
±2 
±5 
±5 
±5 
±5 
±5 
±3 
 
 
 
 
 
 
 
 
 
 
 
 
Written informed 
consentf 
X 
 
 
 
 
 
 
 
 
 
10.4 
Demographics  
X 
 
 
 
 
 
 
 
 
 
4.3 
Brief physical 
examinationg  
X 
 
 
X 
X 
 
X 
 
 
X 
5.2.3 
Full physical 
examinationh 
 
 
X 
 
 
 
 
 
X 
 
5.2.3 
Weight and heighti 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
5.1.4 
Medical/surgical 
history 
X 
 
 
 
 
 
 
 
 
 
4.3 
Inclusion/exclusio
n criteria 
Xj 
Xk 
Xl 
 
 
 
 
 
 
 
3.1 & 
3.2 
12-lead ECGm 
 
X 
 
 
 
 
 
 
 
 
5.2.4 
Randomisation to 
study treatment 
 
 
X 
 
 
 
 
 
 
 
3.4 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
62(127) 
Study period 
Screening 
Period 
Lead-in 
period 
Randomi
zation 
Treatment period 
Follow-up 
period 
 
Visit number 
1a 
Non-fasting 
2b,c  
Fasting 
3c,d,e  
Fasting 
4 c,d,e  
Fasting 
5 c,d,e  
Fasting 
6 c,d,e  
Fasting 
7 c,d,e  
Fasting 
8 c,d,e  
Fasting 
9 c,d,e  
Fasting 
10 c,d  
Fasting 
For 
details 
see 
Protocol 
Section 
Week 
-6 
-4 
0 
1 
4 
8 
12 
16 
24 
27 
Day 
-42 to -
29 
-28 
1 
8 
29 
57 
85 
113 
169 
190 
Visit window 
 
f5 
±0 
±2 
±5 
±5 
±5 
±5 
±5 
±3 
 
 
 
 
 
 
 
 
 
 
 
 
Blood pressure and 
Heart Rate 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
5.1.6 
Orthostatic blood 
pressure 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
5.2.5.1 
Waist 
Circumference 
 
 
X 
 
 
 
 
 
X 
X 
5.1.7 
Concomitant 
medication 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
7.7 
Dietary and life-
style advice 
 
X 
X 
 
X 
 
X 
 
X 
 
4.4 
Dispense Glucose 
Meter and 
Supplies/Provide 
Instructions 
 
X 
X 
 
X 
 
X 
 
X 
 
5.1.11&
5.2.6.1 
Pregnancy test 
(WOCBP only) 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
5.2.2 
Dispensation of 
Study Medication 
 
X 
X 
 
 
 
X 
 
 
 
7 
Drug 
accountability 
 
 
X 
 
X 
 
X 
 
X 
 
7.6 


Clinical Study Protocol
Drug Substance Dapagliflozin
Study Code D1690C00023
Edition Number 6.0
Date 18-Sep-2017
63(127)
Study period
Screening
Period
Lead-in 
period
Randomi
zation
Treatment period
Follow-up
period
Visit number
1a
Non-fasting
2b,c
Fasting
3c,d,e
Fasting
4 c,d,e
Fasting
5 c,d,e
Fasting
6 c,d,e
Fasting
7 c,d,e
Fasting
8 c,d,e
Fasting
9 c,d,e
Fasting
10 c,d
Fasting
For 
details 
see 
Protocol 
Section
Week
-6
-4
0
1
4
8
12
16
24
27
Day
-42 to -
29
-28
1
8
29
57
85
113
169
190
Visit window
f5
±0
±2
±5
±5
±5
±5
±5
±3
Adverse event 
review (AEs and 
SAEs)
Xn
X
X
X
X
X
X
X
X
X
6
Hypoglycaemic 
events
X
X
X
X
X
X
X
X
X
5.2.6.1
&6.3.8
Blood samples for 
haematology and 
clinical chemistry
Xo
X
X
X
X
X
X
X
X
X
5.2.2
CCI


Clinical Study Protocol
Drug Substance Dapagliflozin
Study Code D1690C00023
Edition Number 6.0
Date 18-Sep-2017
64(127)
Study period
Screening
Period
Lead-in 
period
Randomi
zation
Treatment period
Follow-up
period
Visit number
1a
Non-fasting
2b,c
Fasting
3c,d,e
Fasting
4 c,d,e
Fasting
5 c,d,e
Fasting
6 c,d,e
Fasting
7 c,d,e
Fasting
8 c,d,e
Fasting
9 c,d,e
Fasting
10 c,d
Fasting
For 
details 
see 
Protocol 
Section
Week
-6
-4
0
1
4
8
12
16
24
27
Day
-42 to -
29
-28
1
8
29
57
85
113
169
190
Visit window
f5
±0
±2
±5
±5
±5
±5
±5
±3
Urinalysis, dipstick
X
X
X
X
X
X
X
X
X
5.2.2
UACR, spot uriner
X
X
X
X
X
X
X
X
5.1.1
HbA1c
X
X
X
X
X
X
X
X
5.1.2
S-creatinine for 
eGFR calculationt
X
X
X
X
X
5.2.1
FPG
X
X
X
X
X
X
X
X
X
5.1.3
Assess FPG for 
Rescue
X
X
X
X
X
3.10.3
Fasting Serum 
Lipids (Total-C, 
LDL-C, HDL-C, 
TG, FFA)
X
X
5.1.12
CCI


Clinical Study Protocol
Drug Substance Dapagliflozin
Study Code D1690C00023
Edition Number 6.0
Date 18-Sep-2017
65(127)
Study period
Screening
Period
Lead-in 
period
Randomi
zation
Treatment period
Follow-up
period
Visit number
1a
Non-fasting
2b,c
Fasting
3c,d,e
Fasting
4 c,d,e
Fasting
5 c,d,e
Fasting
6 c,d,e
Fasting
7 c,d,e
Fasting
8 c,d,e
Fasting
9 c,d,e
Fasting
10 c,d
Fasting
For 
details 
see 
Protocol 
Section
Week
-6
-4
0
1
4
8
12
16
24
27
Day
-42 to -
29
-28
1
8
29
57
85
113
169
190
Visit window
f5
±0
±2
±5
±5
±5
±5
±5
±3
Parathyroid 
hormone (PTH)
X
X
5.2.2
Hepatitis Screen 
Panel 
X
5.2.2
Assessment schedule footnotes
a)
Screening procedures, indicated under Visit 1, can be completed over multiple visits, provided all procedures have been completed, with the results reviewed, prior to Visit 2. 
b)
Visit 3 should occur İ 42 days from visit 1the period from visit 2 to visit 3 must be at least 28 ±5 days. Note: The single-blind Lead-in study medication and all the central laboratory results 
from Visit 1 must have been received at the site prior to completing the entry into Visit2.
c)
Central Laboratory samples must be collected in a fasting state (at least 8 hours fasting (drinking water is allowed) prior to the study visit) and subjects should be seen between 6 AM and 10 
AM. Subjects must refrain from tobacco, caffeine for 12 hours, and alcohol for 24 hours prior to study visits. Ensure to collect all fasting blood samples prior to the morning dose(s) of blinded 
study medication. Doses of study medication on the day of the visits must be taken upon completion of study visit procedures.
d)
Double-blind treatment period visits must be scheduled according to the randomization visit date (Day 1), with a protocol-allowed visit window of ± 5 days (except ±2 days for Visit 4). 
Subjects will bring their glucose meter and study supplies to the site at all visits. Once a patient is randomised, all visits should be scheduled relative to Visit 3. Any slippage in time from one 
visit must not accumulate to affect other visits.
CCI


Clinical Study Protocol
Drug Substance Dapagliflozin
Study Code D1690C00023
Edition Number 6.0
Date 18-Sep-2017
66(127)
e)
Randomized subjects discontinuing study medication or requiring rescue should have Week 24 procedures done at the time of rescue or study medication discontinuation. All subjects who 
discontinue study medication will be asked to continue ordinary visit schedule, unless they entirely withdraw consent from the study. In subjects discontinuing the study due to AE/SAE, the 
Investigator will follow the subjects until the event has resolved or stabilized. In addition, subjects who prematurely discontinue from the study may be contacted after discontinuation from the 
study, to collect vital status information.
f)
The start of enrolment is defined by the signature of the Protocol-Specific Informed Consent Form by the prospective subject. When only the Protocol-Specific Informed Consent is signed, 
and all other enrolment visit procedures are completed at a later time. The date on which the Informed Consent Form is signed will serve to determine the date and window for the entry into 
start lead-in /Day -28 visit (Visit 2).
g)
A brief physical examination should include cardiovascular, lungs, abdomen, and extremities; and any organ systems pertinent to the subject’s signs, symptoms, or adverse events.
h)
A full physical examination should include general appearance, head, eyes, ears, nose, throat, neck, cardiovascular, lungs, abdomen, lymph nodes, extremities, neurological, skin, and 
musculoskeletal.
i)
Height only at Visit 1.
j)
Only HbA1c and s-Cr for eGFR calculation as well as single spot urine UACR (values at Visit 1). 
k)
s-Cr for eGFR, standard lab and other IC/EC (values at Visit 2).
l)
Lab values from Visit 3 will only be used as baseline values for study entry and not for eligibility evaluating. 
m)
The 12-lead ECG must be performed at Visit 2. The results from this ECG must be available, assessed, and initialled and dated by the Investigator prior to Visit 3.
n)
SAE should be collected from the time when the informed consent form is obtained from a patient 
o)
For blood chemistry only HbA1c and s-Cr for eGFR calculation. The samples do not have to be collected in a fasting state.
r)
Urine Albumin-to-Creatinine ratio: At Visit 1, one spot urine sample from the first morning void portion around or on the visit day, but for all other visits one spot urine sample from each of 
three separate first morning void portions on days  around the visit with one of the samples collected in the morning on the visit day.
t)
Please see formulas for eGFR calculation in section 5.2.1. At Visit 1, a separate serum sample is collected for eGFR calculation but at all other visits, the serum creatinine value from the 
clinical chemistry panel is used. 
w)
For participants in selected sites only.
C
C
C
C
C


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
67(127) 
4.3 
Enrolment/screening period 
Procedures will be performed according to the Study Plan Table 2. 
At enrolment, obtain written informed consent prior to any study procedure or change in 
medical therapy required by the protocol. Consenting patients are assessed to ensure that they 
meet eligibility criteria. Patients who do not meet these criteria must not be enrolled in the 
study. 
The below assessments to be performed for all consented patients at Visit 1: 
x 
Contact IVRS/IWRS to obtain unique patient enrolment number 
x 
Review and confirm the patient’s eligibility for the study by assessing inclusion and 
exclusion criteria listed in Sections 3.1 and 3.2. 
x 
A standard patient medical, medication and surgical history will be obtained with 
the review of selection criteria 
x 
Record demography (including sex, age, race and ethnic group) 
x 
Perform brief physical examination 
x 
Obtain vital signs (seated BP and Heart Rate), body weight & height  
x 
Obtain specimen (blood) for HbA1c, creatinine for eGFR calculation 
x 
Obtain morning urine sample for UACR  
x 
Perform urine pregnancy test for women of child bearing potential. Serum 
pregnancy test (βhCG) is performed, if urine pregnancy test result is positive. 
x 
Review concomitant medications & Serious Adverse events 
x 
Schedule the entry into lead-in visit between 06.00 a.m. and 10.00 a.m. 
x 
Remind patient to be fasting and withhold anti-diabetic medications, insulin, 
antihypertensive drugs, lipid lowering drugs and anti-platelet drugs, the morning of 
their next visit and to refrain from tobacco/nicotine/ caffeine for 12 hours and 
alcohol for 24 hours, respectively prior to next visit 
4.4 
Single-blind placebo lead-in period (Visit 2) 
At visit 2,HbA1c and eGFR level from blood sample obtained from Visit 1 will be checked If 
the HbA1c is ≥7.0 and ≤11.0% and the eGFR value is within the range (20-80 mL/min/1.73 
m2 ), then patients will enter a 4-week single-blind placebo lead-in period. At the lead-in visit, 
the patient’s current dietary and life-style will be reviewed. 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
68(127) 
Patients will be instructed on diet and life-style in accordance with the local Diabetes 
guidelines or ADA guidelines by a qualified member of the study staff beginning with the 
lead-in visit. The below procedures will be performed during the visit for the eligible patients: 
x 
Review and confirm the patient’s eligibility for the study by assessing inclusion and 
exclusion criteria listed in Sections 3.1 and 3.2. 
x 
Perform 12-lead ECG. ECG must be obtained and reviewed with no significant 
abnormalities prior to Randomization 
x 
Obtain vital signs (seated BP and Heart Rate) 
x 
Obtain blood samples for haematology and clinical chemistry 
x 
Obtain specimens (blood) for creatinine for eGFR calculation, FPG and hepatitis 
screen panel 
x 
Perform urine pregnancy test for women of child bearing potential. Serum 
pregnancy test (βhCG) is performed, if urine pregnancy test result is positive 
x 
Have patient to take their first dose of lead-in period study drug 
x 
Provide instruction on diet and life-style 
x 
Dispense blood glucose meter and supplies, provide instruction on their use and 
selfmonitoring of blood glucose (see Section 5.2.6.1) 
x 
Provide instruction on recording daily insulin and glucose values in the patient           
diary 
x 
Dispense the study drug 
x 
Obtain specimen for urinalysis 
x 
Remind patient to bring study drug, diary and glucose meter to the next  
x 
Schedule next visit 
x 
Review concomitant medications and AEs including hypoglycaemic events 
x 
Remind patient to be fasting and withhold the study medication, anti-diabetic 
medications, insulin, antihypertensive drugs, lipid lowering drugs and anti-platelet 
drugs, the morning of their next visit and to refrain from tobacco/nicotine/ caffeine 
for 12 hours and alcohol for 24 hours, respectively prior to next visit 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
69(127) 
4.5 
Treatment period 
Descriptions of the procedures for this period are included in the Study Plan Table 2. The 
specific requirements for the treatment period are mentioned below: 
4.5.1 
Visit 3, Randomization 
At Visit 3, patients who meet all of the inclusion and none of the exclusion criteria, including 
HbA1c ≥7.0% and ≤11.0% measured at Visit 1, eGFR 25-75 mL/minute/1.73m2inclusive, at 
Visit 1 or Visit 2, and micro or macro-albuminuria (UACR 30–3500 mg/g, inclusive) at Visit 
1, will be randomized to the 24 weeks double-blind treatment period. 
x 
Perform complete physical examination. 
x 
Measure body weight & waist circumference. 
x 
Review and confirm the patient’s eligibility for the study by assessing inclusion    
and exclusion criteria listed in Sections 3.1 and 3.2. 
x 
Contact IVRS/IWRS to randomize patient and obtain study drug dispensing 
assignment number and dispense the study drug. 
x 
Obtain vital signs (seated BP, orthostatic BP and Heart Rate). 
x 
Perform arterial stiffness measurements (for participants in selected sites only). 
x 
Obtain blood samples for haematology and clinical chemistry. 
x 
Provide instruction on diet and life-style. 
x 
Dispense blood glucose meter and supplies, provide instruction on their use and 
self-monitoring of blood glucose. 
x 
Perform urine pregnancy test for women of child bearing potential. Serum 
pregnancy test (βhCG) is performed, if urine pregnancy test result is positive. 
x 
Collect and assess compliance with study drug based on tablet count. 
x 
Review concomitant medications and Adverse events (AEs & SAEs) and 
hypoglycaemic events.  
x 
Obtain specimen (blood) for PTH and creatinine for eGFR calculation. 
x 
Obtain plasma and serum specimens (blood) to freeze and store for future potential 
exploratory biomarker analysis. 


Clinical Study Protocol
Drug Substance Dapagliflozin
Study Code D1690C00023
Edition Number 6.0
Date 18-Sep-2017
70(127)
x
x
Obtain specimen for urinalysis, 
x
Obtain urine specimen for UACR (morning urine sample on 3 different days around 
the visit).
x
x
Remind patient to be fasting and withhold the study medication, anti-diabetic 
medications, insulin, antihypertensive drugs, lipid lowering drugs and anti-platelet 
drugs, the morning of their next visit and to refrain from tobacco/nicotine/ caffeine 
for 12 hours and alcohol for 24 hours, respectively prior to next visit.
4.5.2
Visit 4, Treatment
x
Perform brief physical examination
x
Measure body weight
x
Obtain vital signs (seated BP, Heart Rate and orthostatic BP)
x
Obtain blood samples for haematology and clinical chemistry
x
Review concomitant medications and adverse events including AEs, SAEs and 
hypoglycaemic events.
x
Obtain specimen for urinalysis, 
x
Obtain specimen (blood) for FPG
x
Remind patient to be fasting and withhold the study medication, anti-diabetic 
medications, insulin, antihypertensive drugs, lipid lowering drugs and anti-platelet 
drugs, the morning of their next visit and to refrain from tobacco/nicotine/ caffeine 
for 12 hours and alcohol for 24 hours, respectively prior to next visit
4.5.3
Visit 5, Treatment
x
Perform brief physical examination
x
Measure body weight
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x
Obtain vital signs (seated BP, orthostatic BP and Heart Rate)
x
Review concomitant medications and adverse events (AEs & SAEs) and 
hypoglycaemic events.
x
Provide instruction on diet and life-style
x
Obtain blood samples for haematology and clinical chemistry
x
Obtain blood samples for PK
x
Dispense blood glucose meter and supplies, provide instruction on their use and 
self-monitoring of blood glucose.
x
Perform urine pregnancy test for women of child bearing potential. Serum 
pregnancy test (βhCG) is performed, if urine pregnancy test result is positive.
x
Collect and assess compliance with study drug based on tablet count.
x
Obtain specimen for urinalysis,
x
Obtain urine specimen for UACR (morning urine sample on 3 different days around 
the visit).
x
Obtain specimen (blood) for HbA1c & FPG
x
Assess FPG for Rescue
x
Remind patient to be fasting and withhold the study medication, anti-diabetic 
medications, insulin, antihypertensive drugs, lipid lowering drugs and anti-platelet 
drugs, the morning of their next visit and to refrain from tobacco/nicotine/ caffeine 
for 12 hours and alcohol for 24 hours, respectively prior to next visit
4.5.4
Visit 6, Treatment
x
Measure body weight
x
Obtain vital signs (seated BP, orthostatic BP and Heart Rate)
x
x
Obtain blood samples for haematology and clinical chemistry
x
Perform urine pregnancy test for women of child bearing potential. Serum   
pregnancy test (βhCG) is performed, if urine pregnancy test result is positive
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Drug Substance Dapagliflozin
Study Code D1690C00023
Edition Number 6.0
Date 18-Sep-2017
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x
Review concomitant medications and Adverse events (AEs & SAEs) and 
hypoglycaemic events 
x
Obtain specimen for urinalysis, 
x
Obtain urine specimen for UACR (morning urine sample on 3 different days around 
the visit)
x
Obtain specimen (blood) for HbA1c, FPG
x
Assess FPG for Rescue
x
Remind patient to be fasting and withhold the study medication, anti-diabetic 
medications, insulin, antihypertensive drugs, lipid lowering drugs and anti-platelet 
drugs, the morning of their next visit and to refrain from tobacco/nicotine/ caffeine 
for 12 hours and alcohol for 24 hours, respectively prior to next visit
4.5.5
Visit 7, Treatment
x
Perform brief physical examination
x
Measure body weight
x
Obtain vital signs (seated BP, orthostatic BP and Heart Rate)
x
Review concomitant medications and Adverse events (AEs & SAEs) and 
hypoglycaemic events 
x
Provide instruction on diet and life-style
x
Dispense blood glucose meter and supplies, provide instruction on their use and 
self-monitoring of blood glucose 
x
Perform urine pregnancy test for women of child bearing potential. Serum 
pregnancy test (βhCG) is performed, if urine pregnancy test result is positive
x
Dispense the study drug
x
Collect and assess compliance with study drug based on tablet count
x
Obtain specimen for urinalysis, 
x
Obtain urine specimen for UACR (morning urine sample on 3 different days around 
the visit)
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Clinical Study Protocol
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Edition Number 6.0
Date 18-Sep-2017
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x
Obtain specimen (blood) for haematology and clinical chemistry, HbA1c & FPG
x
x
Assess FPG for Rescue
x
Remind patient to be fasting and withhold the study medication, anti-diabetic 
medications, insulin, antihypertensive drugs, lipid lowering drugs and anti-platelet 
drugs, the morning of their next visit and to refrain from tobacco/nicotine/ caffeine 
for 12 hours and alcohol for 24 hours, respectively prior to next visit
4.5.6
Visit 8, Treatment
x
Measure body weight
x
Obtain vital signs (seated BP, orthostatic BP and Heart Rate)
x
Obtain blood samples for haematology and clinical chemistry
x
Perform urine pregnancy test for women of child bearing potential. Serum    
pregnancy test (βhCG) is performed, if urine pregnancy test result is positive;
x
Obtain specimen for urinalysis, 
x
Obtain urine specimen for UACR (morning urine sample on 3 different days around 
the visit)
x
Review concomitant medications and Adverse events (AEs & SAEs) and 
hypoglycaemic events 
x
Obtain specimen (blood) for HbA1c, FPG
x
Assess FPG for Rescue
x
Remind patient to be fasting and withhold the study medication, anti-diabetic 
medications, insulin, antihypertensive drugs, lipid lowering drugs and anti-platelet 
drugs, the morning of their next visit and to refrain from tobacco/nicotine/ caffeine 
for 12 hours and alcohol for 24 hours, respectively prior to next visit
4.5.7
Visit 9, End of Treatment/Discontinuation/Rescue
Randomized patients discontinuing study drug or requiring rescue should have Visit 9 (Week
24) procedures done at the time of rescue or study drug discontinuation. All patients who 
discontinue study drug will be asked to continue ordinary visit schedule, unless they entirely 
withdraw consent from the study.
x
Perform fully physical examination
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Clinical Study Protocol
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Study Code D1690C00023
Edition Number 6.0
Date 18-Sep-2017
74(127)
x
Measure body weight & waist circumference
x
Obtain vital signs (seated BP, orthostatic BP and Heart Rate)
x
At Visit 9/End of Treatment/Discontinuation: Perform arterial stiffness 
measurements (for participants in selected sites only). Not needed at Rescue Visit.
x
Obtain blood samples for haematology and clinical chemistry
x
Obtain blood samples for PK
x
Provide instruction on diet and life-style
x
Dispense blood glucose meter and supplies, provide instruction on their use and 
self-monitoring of blood glucose
x
Perform urine pregnancy test for women of child bearing potential. Serum 
pregnancy test (βhCG) is performed, if urine pregnancy test result is positive
x
Collect and assess compliance with study drug based on tablet count
x
Review concomitant medications and Adverse events (AEs & SAEs) and 
hypoglycaemic events 
x
Obtain specimen (blood) for PTH and creatinine for eGFR calculation.
x
Obtain plasma and serum specimens (blood) to freeze and store for future potential 
exploratory biomarker analysis. 
x
x
Obtain specimen for urinalysis, 
x
Obtain urine specimen for UACR (morning urine sample on 3 different days around 
the visit)
x
x
Assess FPG for Rescue
x
Remind patient to be fasting and withhold the study medication, anti-diabetic 
medications, insulin, antihypertensive drugs, lipid lowering drugs and anti-platelet 
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Study Code D1690C00023
Edition Number 6.0
Date 18-Sep-2017
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drugs, the morning of their next visit and to refrain from tobacco/nicotine/ caffeine 
for 12 hours and alcohol for 24 hours, respectively prior to next visit
4.6
Visit 10, Follow-up period
Descriptions of the procedures for this period are included in the Study Plan Table 2. The 
specific requirements for the follow-up period are mentioned below:
After completion of Week 24 visit, patients will enter a 3-week safety follow-up period 
without study drug. The follow-up visit (Visit 10) provides the opportunity to further evaluate 
changes in physical signs, renal function, symptoms or laboratory parameters that may be 
related to dapagliflozin or the combination of dapagliflozin and saxagliptin.
x
Perform brief physical examination
x
Measure body weight & waist circumference
x
Obtain vital signs (seated BP, orthostatic BP and Heart Rate)
x
Perform urine pregnancy test for women of child bearing potential. Serum   
pregnancy test (βhCG) is performed, if urine pregnancy test result is positive
x
Review concomitant medications and Adverse events (AEs & SAEs) and 
hypoglycaemic events 
x
Obtain specimen for urinalysis, 
x
Obtain urine specimen for UACR (morning urine sample on 3 different days around 
the visit)
x
Obtain specimen (blood) for haematology, and clinical chemistry, HbA1c, 
creatinine for eGFR calculation & FPG
5.
STUDY ASSESSMENTS  
will be used for data collection and 
query handling.  The investigator will ensure that data are recorded on the electronic Case 
Report Forms as specified in the study protocol and in accordance with the instructions 
provided.
The investigator ensures the accuracy, completeness and timeliness of the data recorded and 
of the provision of answers to data queries according to the Clinical Study Agreement.
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Study Code D1690C00023
Edition Number 6.0
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<< (JP) For Japan: replace Clinical Study Agreement with applicable information >> (End
JP) The investigator will sign the completed electronic Case Report Forms. A copy of the 
completed electronic Case Report Forms will be archived at the study site.
<< (JP):  The Principal Investigator/Investigator will record data on the observations, tests 
and assessments specified in the protocol on the <<paper/electronic>> CRFs provided by 
AstraZeneca. The CRF will be accompanied with ‘Instructions for the Investigator’, which 
should be followed. These instructions provide guidance for the recording of study data in the 
CRF including how to change data incorrectly recorded. >> (End JP)
5.1
Efficacy assessments
Blood and urine samples will be obtained at specified time points for laboratory evaluations.
The central laboratory for this study will perform the analysis of all scheduled laboratory tests 
and will provide reference ranges for these tests. The detailed methods for specimen collection, 
handling, processing, shipping, and storage will be supplied in the Investigator’s Laboratory 
Manual provided by the Central Laboratory. All clinical laboratory tests will be performed by 
the Central Laboratory or designated reference laboratory.
During the double-blind treatment and follow-up period, HbA1c and spot urinary glucose
values will be blinded to the Investigator and to the Sponsor. These values will be provided to 
the Investigator after the study has been completed. FPG value will be reported as an un-
blinded value throughout the study. During the whole study, 
 will be blinded to Investigator and to the Sponsor.
All glycemic efficacy objectives will be based on values measured by central laboratory. Any 
self-monitored plasma glucose measured by the patient and FPG measured by the site using 
glucose meter will be used only for safety purposes. [Note: The patients will be asked to check 
their blood glucose only if they develop symptoms suggestive of hypoglycemia or 
hyperglycemia and to record hypoglycemia symptoms in the patient diary.]
5.1.1
UACR
Urinary albumin to creatinine ratio is the primary assessment for the determination of the anti-
proteinuric efficacy. Morning spot urine sample (first morning void) will be collected for each 
study visit (except Visit 2 and 4) and analysed according to the procedures described in the 
Laboratory Manual. Note that three samples are needed for each visit, except Visit 1 (one 
sample).
5.1.2
HbA1c
HbA1c is the primary assessment for the determination of glycemic efficacy and will be 
analysed by a central laboratory according to the procedures described in the Laboratory
5.1.3
FPG
FPG is a well-established measure of glycemic efficacy and will be analysed by a central 
laboratory according to the procedures described in the Laboratory Manual. 
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Edition Number 6.0
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5.1.4
Weight and height
The patient’s weight will be recorded in kilogram (kg) to one decimal place, with light 
clothing and no shoes. All readings should be recorded as accurately as possible and the same 
scale should be used for all assessments for a given patient. The patient’s height (only at Visit 
1) will be recorded in centimetres, with no shoes.
5.1.5
BMI
BMI is a calculated ratio between weight and height (weight / height2, where weight is 
measured in kg, and height in metres) and will be computed by AstraZeneca.
5.1.6
Seated blood pressure and pulse
Pulse and BP measurements must be taken consistently throughout the study. Pulse and BP 
should be recorded using the same equipment at each visit. Use only the right or the left arm 
when measuring these parameters. Document which arm was used, along with the observer’s 
initials. The same arm should be used at all visits for each position. At each study visit, BP 
and pulse measurements should be obtained prior to blinded study drug administration. Pulse 
and BP will be measured thrice (1 minute apart) before any blood sampling is done after the 
patient has been sitting and resting for least 5 minutes. BP readings should be taken while the 
patient is in a comfortable seated position with the arm supported at the level of the heart. All 
three readings must be recorded in eCRF. For study analyses, the average of the three BP and 
pulse readings will be used.
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5.2
Safety assessments
Safety assessments will be performed at regular intervals and will include physical
examination, vital signs (including measured orthostatic reactions), renal function (change in 
eGFR), body weight, safety laboratory test (clinical chemistry, haematology, blood ketones 
and UA), hypoglycaemia and AE monitoring.
5.2.1
eGFR
eGFR is calculated according to the following formulas:
x
The general MDRD formula: 
eGFR (ml/min/1.73m2) = 175 x (standardized sCr)-1.154 x (Age)-0.203 x (0.742 if 
female) x (1.212 if Black) [Note: sCr reported in mg/dL]
x
The MDRD formula adapted for Japanese: 
eGFR (ml/min/1.73m2) = 194 x (standardized sCr)-1.094 x (Age)-0.287 x (0.739 if 
female) [Note: sCr reported in mg/dL]
To be considered Japanese, both parents and both sets of grandparents must be Japanese. The 
patient must be born in Japan, and must not have lived outside Japan for more than 5 years.
x
The MDRD formula adapted for Taiwanese: 
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Clinical Study Protocol 
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Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
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eGFR (ml/min/1.73m2) =  1.309 x the general MDRD0.912 
To be considered Taiwanese, both parents and both sets of grandparents must be Taiwanese. 
The patient must be born in Taiwan, and must not have lived outside Taiwan for more than 5 
years. 
5.2.2 
Laboratory safety assessments 
Blood and urine samples for determination of clinical chemistry, haematology, and urinalysis 
will be taken at the times indicated in the Study Plan (see Section 4). Additional safety 
samples may be collected for analysis at local laboratory, if clinically indicated at the 
discretion of the investigator. 
The detailed methods for specimen collection, handling, processing, shipping, and storage will 
be supplied in the Investigator’s Laboratory Manual provided by the Central Laboratory. 
The following laboratory variables will be measured:  
 
 
 
Table 3 
Laboratory Safety Variables 
Haematology (whole blood) 
Clinical Chemistry (serum or plasma) 
B-Haemoglobin (Hb) 
S-Aspartate transaminase (AST) 
B-Haematocrit 
S-Alanine transaminase (ALT) 
B-Red blood cell count 
S-Alkaline phosphatase (ALK-P) 
B-White blood cell count  
S-Bilirubin, total 
B-Platelet count 
S-Blood Urea Nitrogen 
 
S-Creatinine 
Urinalysis (dipstick)
S-Albumin 
Urine blood (dipstick for haematuria screening and 
microscopy if dipstick is positive) 
S-Total protein 
Pregnancy test (Urine HCG pregnancy test for 
WOCBP (HCG minimum sensitivity of 25 IU/L), 
dipstick analysed at the study centre)  
S-Uric acid 
 
S-Potassium 
 
S-Calcium, total 
 
S-Sodium 
 
S- Bicarbonate 
 
S- Chloride 
 
S- Magnesium 
 
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Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
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S- βHCG, if urine pregnancy test result is 
positive 
 
P- Parathyroid Hormone (PTH) 
 
P- 3-hydroxybutyrate 
 
Hepatitis Screen Panel (Includes Hepatitis 
Bviral antibody IgM, Hepatitis B surface 
antigen and Hepatitis C virus antibody). 
The Investigator should make an assessment of the available results with regard to clinically 
relevant abnormalities.  The laboratory results should be signed and dated and retained at 
centre as source data for laboratory variables.  For information on how AEs based on 
laboratory tests should be recorded and reported, see Section 6.3. 
NB. In case a subject shows an AST or ALT >3xULN or total Bilirubin > 2xULN please refer 
to Appendix D ‘Algorithm on Management of Sustained Elevated Liver Safety Abnormalities’, 
for further instructions. 
5.2.3 
Physical examination 
A brief physical examination should include the CV system, lungs, abdomen, and extremities, 
and any organ system pertinent to the patient’s signs, symptoms, or AEs. The patient should 
always be evaluated for the presence of oedema. A complete physical examination should 
include general appearance, head, eyes, ears, nose, throat, neck, CV system, lungs, abdomen, 
lymph nodes, extremities, neurological system, skin, and musculoskeletal system. The patient 
should always be evaluated for the presence of oedema. 
5.2.4 
ECG 
A 12-lead ECG will be taken after the patient has been lying down resting for at least 5 
minutes. The ECG will be evaluated by the investigator and entered as ‘Normal’ or 
‘Abnormal’ in the eCRF. If the ECG is evaluated as “Abnormal” the investigator should 
document the specific abnormality. 
5.2.5 
Vital signs 
5.2.5.1 
Pulse and blood pressure 
As BP is both efficacy and safety variable in this study, measurement of seated BP is 
described in Sections 5.1.6 
Orthostatic BP: At selected visits where orthostatic BP and pulse are collected, supine and 
standing measurements should be made after the seated BP and pulse measurements have 
been made, using the same arm that was used for the seated BP measurements. All readings 
should be recorded in eCRF. Ideally, BP should be measured with the same equipment, at the 
same time of day, and by the same personnel at each visit. 
The supine BP and pulse must be measured prior to the standing BP and pulse. After the 
patient rests in the supine position for at least 5 minutes, supine BP and pulse will be 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
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determined from three replicate measurements obtained at least 1 minute apart. All three 
readings must be recorded in eCRF. For study analyses, the average of the three BP and pulse 
readings will be used. 
After the supine BP and pulse measurements are obtained, the patient will stand for 2 to 3 
minutes. After this time, the BP will be measured with the arm supported at the level of the 
heart. Standing BP and pulse will be determined from three replicate measurements obtained 
at least 1 minute apart. All 3 readings must be recorded in eCRF. For study analyses, the 
average of the three BP and pulse readings will be used. 
5.2.6 
Other safety assessments 
5.2.6.1 
Self-monitored blood glucose and hypoglycemic events 
The patients will be asked to check their blood glucose when they develop symptoms 
suggestive of hypoglycemia and to record specific symptoms in a hypoglycemia/blood 
glucose diary. Any results collected in the diary will be reviewed by the investigator at each 
visit. The investigator is responsible for questioning the patient about all symptoms reported 
in the diary and for determining if they meet the clinical definition of hypoglycemia. Only 
symptoms and/or blood glucose values that meet the definition of hypoglycemia should be 
reported on the hypoglycemia eCRF pages see Section 6.3.8. Glucometers will be provided by 
AstraZeneca. 
Patients will be instructed to contact the investigator anytime they experience a hypoglycemic 
event. Hypoglycemic events must be recorded in the diary anytime a patient experiences 
either of the following: 
x 
Signs and symptoms of hypoglycemia (regardless of blood glucose value by finger 
stick) 
x 
Blood glucose value by finger stick <63 mg/dL (3.5 mmol/L) (regardless of 
symptoms). 
x 
Data to be collected for each hypoglycemic event: 
x 
Date and time of episode (start and stop) 
x 
Whether symptoms were present, and list of symptoms 
x 
Possible contributing factors 
x 
Whether a finger stick value was obtained, and if so, the plasma glucose value 
x 
Whether intervention was needed for recovery 
x 
How the episode was treated 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
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x 
Whether recovery was prompt after treatment 
x 
Time of last anti-diabetic agents administration 
x 
Time of last meal and its contents 
The patient diary will be reviewed and added to the patient’s source record. A new diary for 
the next period will be handed over to the patient if needed 
5.2.6.2 
Hepatic events (Hepatic Adjudication Committee) 
An independent Hepatic Adjudication Committee, blinded to the treatment of the patients, will 
determine the probability that drug-induced liver injury (DILI) is the cause of liver-related 
abnormalities, including, but not limited to: 
x 
Hepatic events timely related to death (within 30 days before death) 
x 
AST and/or ALT >3x ULN and TB >2x ULN (within 14 days of the AST and/or 
ALT elevation);  
x 
AST and/or ALT >10x ULN 
A separate Adjudication Manual will define and describe the procedure for the handling, 
reporting and classification of these cases. 
5.2.6.3 
Asymptomatic bacteriuria 
The following is presented to assist in the classification and management of asymptomatic 
bacteriuria in studies with dapagliflozin. It is not intended to supplant investigators clinical 
judgement. 
During enrolment, treatment and follow up of patients in this study, the investigator may 
discover a patient with asymptomatic bacteriuria. Asymptomatic bacteriuria is defined as the 
presence of ≥105 colony forming units/mL of bacteria, in a properly collected voided urine 
specimen, without signs or symptoms typically attributed to urinary tract infection (UTI). 
Asymptomatic bacteriuria is prevalent among diabetic women, and is associated with pyuria 
in 70% of cases. Neither guidelines from the US (Nicolle et al 2005, US Preventative Services 
Taskforce 2008 (USPSTF 2008)) nor 
Europe (European Association of Urology 2014 (EAU 2014)) recommend screening for, or 
treatment of, asymptomatic bacteriuria in non-pregnant diabetic patients. In this study, the 
central laboratory will report urinary dipstick test results for haemoglobin but will not 
routinely report the results of urinary dipstick tests for leukocyte esterase as a screening test 
for pyuria in surveillance urine examinations. 
5.2.6.4 
Microscopic Haematuria 
In the event that haematuria is observed during a patient’s participation, the sponsors 
recommend standard of care in diagnosing the cause of the haematuria. This section presents 


Clinical Study Protocol
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Edition Number 6.0
Date 18-Sep-2017
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references and an example of standard of care evaluation of microscopic haematuria. Local
standards of care should be followed.
Patients with repeated reports of microscopic haematuria in 2 or more properly collected urine 
samples need to have follow-up for this result according to standard of care. The American
Urological Association defines microscopic haematuria as three or more red blood cells per 
high-power microscopic field in urinary sediment from two or more properly collected 
urinalysis specimens (Grossfeld et al 2001). These Best Practice guidelines have been 
evaluated by Jung in a study of 772000 patients (Jung et al 2011).
Patients who show microscopic haematuria that is accompanied by significant proteinuria, red 
blood cell casts, or dysmorphic red blood cells in the sediment should be evaluated for the 
presence of primary renal disease and need to be referred to a nephrologist (AUA, Grossfeld 
et al 2001).
Patients who lack other explanation for their haematuria, or who have risk factors for 
significant urologic disease, will need a urological evaluation and should be referred to an 
urologist. Risk factors for significant urological disease include unexplained microscopic
haematuria as well as smoking history, occupational exposure to dyes or chemicals (such as 
benzenes or aromatic amines), visible haematuria, age >40 years, previous urologic history, 
history of irritative voiding symptoms, history of UTI, analgesics or phenacetin abuse, history 
of pelvic irradiation, or cyclophosphamide use (Greenwood M 1926). Results from any 
procedure or investigations should be reported on the eCRF.
5.2.6.5
Volume Depletion
The risk of electrolyte abnormalities, volume depletion, and impaired renal function is 
enhanced when two diuretics are used in combination. For this reason, caution should be 
exercised when administering dapagliflozin, which has a modest diuretic effect, to patients 
who are taking loop diuretics. These patients should have careful monitoring of electrolytes, 
volume status, and renal function. Loop diuretic dose adjustments should be made if clinically 
indicated.
5.3
Other assessments---Not applicable
5.4
Pharmacokinetics
5.4.1
Blood sample collection 
5.4.2
Determination of drug concentration
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5.4.3
Storage and destruction of pharmacokinetic samples
5.5
Pharmacodynamics
5.6
Pharmacogenetics (Not Applicable)
5.7
Biomarker analysis 
Collection of additional blood and urine biological samples for potential future analysis are 
performed at visit 3 and visit 9 (Rescue and Discontinue visit, if applicable). The donation of 
these extra samples is optional and the subject needs separately informed consent. After 
collection, the samples are stored for potential future analysis for exploratory biomarkers to 
assess correlations with disease activity, effects of study drug, clinical outcomes and toxicity. 
Storage, re-use and destruction of biological samples
Samples will be stored for a maximum of 15 years from the date of the Last Subject’s Last 
Visit, after which they will be destroyed.  The results of this biomarker research will be 
reported either in the Clinical Study Report itself or as an addendum, or separately in a 
scientific report or publication. The results of this biomarker research may be pooled with 
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Edition Number 6.0 
Date 18-Sep-2017 
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biomarker data from other studies with the study drug to generate hypotheses to be tested in 
future research. 
5.7.1 
Labelling and shipment of biological samples 
The Principal Investigator ensures that samples are labelled and shipped in accordance with 
the Laboratory Manual and the Biological Substance, Category B Regulations (materials 
containing or suspected to contain infectious substances that do not meet Category A criteria), 
see Appendix C ‘IATA 6.2 Guidance Document’. 
Any samples identified as Infectious Category A materials are not shipped and no further 
samples will be taken from the subject unless agreed with AstraZeneca and appropriate 
labelling, shipment and containment provisions are approved. 
5.7.2 
Chain of custody of biological samples 
A full chain of custody is maintained for all samples throughout their lifecycle. 
The Principal Investigator <<at each centre>> keeps full traceability of collected biological 
samples from the subjects while in storage at the centre until shipment or disposal (where 
appropriate) and keeps documentation of receipt of arrival. 
The sample receiver keeps full traceability of the samples while in storage and during use until 
used or disposed of or until further shipment and keeps documentation of receipt of arrival. 
AstraZeneca keeps oversight of the entire life cycle through internal procedures, monitoring of 
study sites and auditing of external laboratory providers. 
Samples retained for further use are registered in the AstraZeneca Biobank during the entire 
life cycle. 
5.7.3 
Withdrawal of Informed Consent for donated biological samples  
If a subject withdraws consent to the use of donated biological samples, the samples will be 
disposed of/destroyed, and the action documented.  If samples are already analysed, 
AstraZeneca is not obliged to destroy the results of this research. 
The Principal Investigator: 
x 
Ensures subjects’ withdrawal of informed consent to the use of donated samples is 
notified immediately to AstraZeneca 
x 
Ensures that biological samples from that subject, if stored at the study site, are 
immediately identified, disposed of /destroyed, and the action documented 
x 
Ensures the laboratory(ies) holding the samples is/are informed about the 
withdrawn consent immediately and that samples are disposed of/destroyed, the 
action documented and the signed document returned to the study site 


Clinical Study Protocol
Drug Substance Dapagliflozin
Study Code D1690C00023
Edition Number 6.0
Date 18-Sep-2017
86(127)
x
Ensures that the subject and AstraZeneca are informed about the sample disposal.
AstraZeneca ensures the central laboratory(ies) holding the samples is/are informed about the 
withdrawn consent immediately and that samples are disposed of/destroyed and the action 
documented and returned to the study site.
5.8
Volume of blood
The total volume of blood that will be drawn for each patient in this study is listed in the Table 
4 below. The collection of additional samples is performed locally at the discretion of the 
investigator and recorded appropriately, thus requiring additional sample volumes.
Table 4
Volume of blood to be withdrawn from each patient
Assessment
Sample Volume (ml)
No. of sample
Total Volume (ml)
Haematology HbA1c
2
10
20 (approx.)
PK
6
3
18 (approx.)
Clinical chemistry, 
Electrolyte Panel , 
eGFR By MDRD,
Lipid Panel, 
 
a
2.5 or 3.5 or 5 a
10
36 (approx.)
FPG
2
9
18 (approx.)
Parathyroid hormone 
2
2
4 (approx.)
CCI
CCI


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
87(127) 
(PTH) 
Hepatitis Screen 
Panel 
3.5 
1 
3.5 (approx.) 
Total 
 
 
161.5c (approx.) 
a. Request a part of these tests on each visit based on the assessment schedule.  
b. Exploratory biomarkers samples are optional and the subject needs separately informed 
consent. 
c. Refer to the central laboratory manual for the detailed sample collection volume.  
6. 
SAFETY REPORTING AND MEDICAL MANAGEMENT 
The Principal Investigator is responsible for ensuring that all staff involved in the study are 
familiar with the content of this section. 
6.1 
Definition of adverse events 
An adverse event is the development of an undesirable medical condition or the deterioration 
of a pre-existing medical condition following or during exposure to a pharmaceutical product, 
whether or not considered causally related to the product.  An undesirable medical condition 
can be symptoms (e.g., nausea, chest pain), signs (e.g., tachycardia, enlarged liver) or the 
abnormal results of an investigation (e.g., laboratory findings, electrocardiogram).  In clinical 
studies, an AE can include an undesirable medical condition occurring at any time, including 
run-in or washout periods, even if no study treatment has been administered. 
The term AE is used to include both serious and non-serious AEs. 
6.2 
Definitions of serious adverse event 
A serious adverse event is an AE occurring during any study phase (i.e., run-in, treatment, 
washout,follow-up), that fulfils one or more of the following criteria: 
x 
Results in death 
x 
Is immediately life-threatening 
x 
Requires in-patient hospitalisation or prolongation of existing hospitalisation. 
x 
Results in persistent or significant disability/incapacity or substantial disruption of 
the ability to conduct normal life functions. 
x 
Is a congenital abnormality or birth defect 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
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x 
Is an important medical event that may jeopardise the subject or may require 
medical intervention to prevent one of the outcomes listed above. 
For further guidance on the definition of a SAE, see Appendix B to the Clinical Study 
Protocol. 
6.3 
Recording of adverse events 
6.3.1 
Time period for collection of adverse events 
AEs will be collected from the start of the placebo lead-in period throughout the treatment 
period (Visit 2 to 9) and including the follow-up period (Visit 10). 
SAEs will be recorded from the time of informed consent is obtained until the end of the study 
(Visit 10) 
6.3.2 
Follow-up of unresolved adverse events 
Any AEs that are unresolved at the patient’s last AE assessment visit in the study are followed 
up by the Investigator for as long as medically indicated, but without further recording in the 
CRF. AstraZeneca retains the right to request additional information for any subject with 
ongoing AE(s)/SAE(s) at the end of the study, if judged necessary. 
6.3.3 
Variables  
The following variables will be collect for each AE; 
x 
AE (verbatim) 
x 
The date when the AE started and stopped 
x 
Maximum intensity 
x 
Whether the AE is serious or not 
x 
Investigator causality rating against the IP (yes or no) 
x 
Action taken with regard to investigational product 
x 
Outcome.  
In addition, the following variables will be collected for SAEs: 
x 
Date AE met criteria for serious AE 
x 
Date Investigator became aware of serious AE 
x 
AE is serious due to 
x 
Date of hospitalisation 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
89(127) 
x 
Date of discharge 
x 
Probable cause of death 
x 
Date of death 
x 
Autopsy performed 
x 
Causality assessment in relation to Study procedure(s) 
x 
Description of AE. 
Maximum intensity will be graded according to the following rating scale: 
x 
Mild (awareness of sign or symptom, but easily tolerated) 
x 
Moderate (discomfort sufficient to cause interference with normal activities) 
x 
Severe (incapacitating, with inability to perform normal activities) 
It is important to distinguish between serious and severe AEs.  Severity is a measure of 
intensity whereas seriousness is defined by the criteria in Section 6.2. An AE of severe 
intensity need not necessarily be considered serious.  For example, nausea that persists for 
several hours may be considered severe nausea, but not a SAE unless it meets the criteria 
shown in Section 6.2. On the other hand, a stroke that results in only a limited degree of 
disability may be considered a mild stroke but would be a SAE when it satisfies the criteria 
shown in Section 6.2. 
6.3.4 
Causality collection 
The Investigator will assess causal relationship between Investigational Product and each 
Adverse Event, and answer ‘yes’ or ‘no’ to the question ‘Do you consider that there is a 
reasonable possibility that the event may have been caused by the investigational product?’ 
For SAEs causal relationship will also be assessed for other medication and study procedures. 
Note that for SAEs that could be associated with any study procedure the causal relationship is 
implied as ‘yes’. 
A guide to the interpretation of the causality question is found in Appendix B to the CSP. 
6.3.5 
Adverse events based on signs and symptoms 
All AEs spontaneously reported by the patient or care provider or reported in response to the 
open question from the study personnel: “Have you had any health problems since the 
previous visit/you were last asked?”, or revealed by observation will be collected and recorded 
in the CRF. When collecting AEs, the recording of diagnoses is preferred (when possible) to 
recording a list of signs and symptoms. However, if a diagnosis is known and there are other 
signs or symptoms that are not generally part of the diagnosis, the diagnosis and each sign or 
symptom will be recorded separately. 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
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6.3.6 
Adverse events based on examinations and tests 
The results from protocol mandated laboratory tests and vital signs will be summarized in the 
CSR. Deterioration as compared to baseline in protocol-mandated laboratory values, vital 
signs, and other safety variables should therefore only be reported as AEs if they are clinically 
significant, fulfil any of the SAE criteria or are the reason for discontinuation of treatment 
with the investigational product. 
If deterioration in a laboratory value/vital sign is associated with clinical signs and symptoms, 
the sign or symptom will be reported as an AE and the associated laboratory result/vital sign 
will be considered as additional information. Wherever possible the reporting Investigator 
uses the clinical, rather than the laboratory term (e.g., anaemia versus low Hb value). In the 
absence of clinical signs or symptoms, clinically relevant deteriorations in non-mandated 
parameters should be reported as AE(s). 
Any new or aggravated clinically relevant abnormal medical finding at a physical examination 
as compared with the baseline assessment will be reported as an AE. 
6.3.7 
Hy’s Law 
Pre-defined liver enzyme elevations will undergo adjudication. The definitions of the events to 
be adjudicated are provided in the Hepatic Adjudication Manual. 
For all events identified for adjudication, the Investigator will complete the appropriate eCRF 
pages and provide source documentation as detailed in the Hepatic Adjudication Manual. See 
also Section 5.2.6.2 
6.3.8 
Hypoglycemic events 
A separate section in the eCRF will be used to document all reported episodes of 
hypoglycaemia (see Section 5.2.6.1). Hypoglycemic episodes should also be reported on the 
AE eCRF page if the event fulfils protocol criteria for a SAE (see Section 6.2). 
x 
Major hypoglycemic events, defined as symptomatic events requiring external 
assistance due to severe impairment in consciousness or behaviour, with a capillary 
or plasma glucose value <54 mg/dL (<3.0 mmol/L), and prompt recovery after 
glucose or glucagon administration. 
x 
Minor hypoglycemic event, defined as either a symptomatic episode with a 
capillary or plasma glucose measurement <63 mg/dL (<3.5 mmol/L) regardless of 
need for external assistance or an asymptomatic capillary or plasma glucose 
measurement below 63 mg/dL (3.5 mmol/L), that does not qualify as a major 
episode. 
6.3.9 
Potential events of diabetic ketoacidosis 
All potential events of DKA will be recorded in the eCRF and submitted to an independent 
DKA Adjudication Committee. The DKA Adjudication Committee T2DM will assess 


Clinical Study Protocol 
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Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
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available information on each potential DKA event and will classify the event in accordance 
with the definitions in the DKA Adjudication Charter T2DM.  
The DKA Adjudication Committee will be kept blinded to the study drug treatment received 
by each patient 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. 
6.3.10 
Adverse events (AEs) leading to amputation and potential risk factor AEs for 
amputations affecting lower limbs (“preceding events”) 
To ensure that data on amputations is systematically collected, amputations and underlying 
conditions relevant to amputation will be recorded on a specific eCRF page. 
If any of these relevant events have occurred, relevant information must be provided (this will 
be collected on a dedicated eCRF page). 
 
6.4 
Reporting of serious adverse events 
All SAEs have to be reported, whether or not considered causally related to the investigational 
product, or to the study procedure(s). All SAEs will be recorded in the CRF. 
If any SAE occurs in the course of the study, then Investigators or other site personnel inform 
the appropriate AstraZeneca representatives within one day i.e., immediately but no later 
than 24 hours  of when he or she becomes aware of it. 
The designated AstraZeneca representative works with the Investigator to ensure that all the 
necessary information is provided to the AstraZeneca Patient Safety data entry site within 1 
calendar day of initial receipt for fatal and life threatening events and within 5 calendar 
days of initial receipt for all other SAEs. 
For fatal or life-threatening adverse events where important or relevant information is missing, 
active follow-up is undertaken immediately.  Investigators or other site personnel inform 
AstraZeneca representatives of any follow-up information on a previously reported SAE 
within one calendar day i.e., immediately but no later than 24 hours of when he or she 
becomes aware of it. 
AstraZeneca representatives of any follow-up information on a previously reported SAE 
within one calendar day i.e., immediately but no later than 24 hours of when he or she 
becomes aware of it. 
Once the Investigators or other site personnel indicate an AE is serious in the WBDC system, 
an automated email alert is sent to the designated AstraZeneca representative. 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
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If the WBDC system is not available, then the Investigator or other study site personnel 
reports a SAE to the appropriate AstraZeneca representative by designated back-up 
procedures. 
The AstraZeneca representative will advise the Investigator/study site personnel how to 
proceed. 
The reference document for definition of expectedness is the IB for the AstraZeneca drug. 
 
6.5 
Overdose 
Overdose is defined as >100 mg for dapagliflozin or >40 mg for saxagliptin per day. 
Dapagliflozin has been well tolerated at doses of up to 500 mg per day in single dose testing 
in healthy volunteers and up to 100 mg per day in repeat dose testing for 14 days in healthy 
volunteers and patients with T2DM. If an overdose is suspected, monitoring of vital functions 
as well as treatment as appropriate should be performed 
x 
An overdose with associated AEs is recorded as the AE diagnosis/symptoms on the 
relevant AE modules in the CRF and on the Overdose CRF module. 
x 
An overdose without associated symptoms is only reported on the Overdose CRF 
module. 
If an overdose on an AstraZeneca study drug occurs in the course of the study, then the 
Investigator or other site personnel inform appropriate AstraZeneca representatives 
immediately, or no later than 24 hours of when he or she becomes aware of it. 
The designated AstraZeneca representative works with the Investigator to ensure that all 
relevant information is provided to the AstraZeneca Patient Safety data entry site. 
For overdoses associated with a SAE, the standard reporting timelines apply, see Section 6.4. 
For other overdoses, reporting must occur within 30 days. 
6.6 
Pregnancy 
All pregnancies and outcomes of pregnancy should be reported to AstraZeneca. 
6.6.1 
Maternal exposure 
If a patient becomes pregnant during the course of the study IP should be discontinued 
immediately. 
Pregnancy itself is not regarded as an AE unless there is a suspicion that the IP under study 
may have interfered with the effectiveness of a contraceptive medication. Congenital 
abnormalities/birth defects and spontaneous miscarriages should be reported and handled as 
SAEs. Elective abortions without complications should not be handled as AEs. The outcome 
of all pregnancies (spontaneous miscarriage, elective termination, ectopic pregnancy, normal 


Clinical Study Protocol 
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Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
93(127) 
birth or congenital abnormality) should be followed up and documented even if the patient 
was discontinued from the study. 
If any pregnancy occurs in the course of the study, then the Investigator or other site personnel 
informs the appropriate AstraZeneca representatives within 1day i.e., immediately but no 
later than 24 hours of when he or she becomes aware of it. 
The designated AstraZeneca representative works with the Investigator to ensure that all 
relevant information is provided to the AstraZeneca Patient Safety data entry site within 1 or 5 
calendar days for SAEs (see Section 6.4) and within 30 days for all other pregnancies. 
The same timelines apply when outcome information is available. 
The PREGREP module in the CRF is used to report the pregnancy and the PREGOUT is used 
to report the outcome of the pregnancy.  
6.6.2 
Paternal exposure  
There is no restriction on fathering children or donating sperm during the study. 
6.7 
Management of IP related toxicities  
Dose reductions of IP are not permitted in the study
6.8 
Study governance and oversight 
The safety of all AstraZeneca clinical studies is closely monitored on an on-going basis by 
AstraZeneca representatives in consultation with Patient Safety. Issues identified will be 
addressed; for instance this could involve amendments to the study protocol and letters to 
Investigators. 


Clinical Study Protocol
Drug Substance Dapagliflozin
Study Code D1690C00023
Edition Number 6.0
Date 18-Sep-2017
94(127)
6.8.1
Steering Committee---Not Applicable
6.8.2
Data Monitoring Committee---Not Applicable
6.8.3
Scientific Advisory Committee---Not Applicable
7.
INVESTIGATIONAL PRODUCT AND OTHER TREATMENTS
7.1
Identity of investigational product(s)
Name
Manufacturer
IMP/NIMP
Role
Type
Mandatory 
or guidance?
Route of 
administration
Formulatio
n
Comment
Dapagliflozin 
10 mg 
IMP
Drug 
Mandatory
Oral 
Film 
Coated 
Tablet
Green, 
plain, 
diamond 
shaped 
Dapagliflozin 
10 mg placebo 
IMP
Placebo 
Mandatory
Oral
Film 
Coated 
Tablet
Green, 
plain, 
diamond 
shaped
Saxagliptin 2.5 
mg
IMP
Drug 
Mandatory
Oral
Film 
Coated 
Tablet
Plain, 
yellow, 
biconvex, 
round 
Saxagliptin 2.5 
mg placebo
IMP
Placebo
Mandatory
Oral
Film 
Coated 
Tablet
Plain, 
yellow, 
biconvex, 
round
The tablets contain lactose, which may cause discomfort in lactose-intolerant individuals.
7.2
Dose and treatment regimens
The study consists of a 2-week screening period followed by a 4-week single-blind placebo 
lead-in period, a 24-week double-blind & double dummy placebo-controlled treatment, and a 
3-week follow-up period. Doses of study drug on the day of the visits must be taken after 
completion of study visit procedures. 
Treatment arm
Description
Investigational drugs/ treatments used in 
arm
Subject ratio
Main 
Treatment 
Arm Screening
Single blind placebo lead-
in (4w)
Dapagliflozin 10 mg placebo + saxagliptin 2.5 
mg placebo
100%
Randomized 
treatment arm 
1
Dapagliflozin 10 mg 
group
Dapagliflozin 10 mg + saxagliptin 2.5 mg 
placebo
33%
Randomized 
treatment arm 
2
Saxagliptin 2.5 mg + 
dapagliflozin 10 mg group
Dapagliflozin 10 mg + saxagliptin 2.5 mg 
33%
Randomized 
treatment arm 
3
Placebo group
Dapagliflozin 10 mg placebo + saxagliptin 2.5 
mg placebo
33%
CCI
CCI
CCI
CCI


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
95(127) 
Treatment during single-blind lead-in period 
During the 4-week (Visit 2-3) single-blind lead-in period eligible patient will be dispensed 1 
bottle of placebo to match saxagliptin 2.5mg along with 1 bottle of placebo to match 
dapagliflozin 10mg. First dose of lead-in period study drug will be administered at the clinic 
by site staff. Subsequent doses should be taken once daily in the morning. 
Treatment during double-blind & double dummy randomization period 
At Visit 3, eligible patients will be randomized to double-blind, double dummy treatment of 
dapagliflozin 10mg, saxagliptin 2.5mg or placebos to match both active products. The study 
drug should be taken once daily in the morning and at approximately the same time of the day 
during the study period. Nevertheless prior to each clinical visit patients should be instructed 
not to take any medication at morning and to abstain from any food and beverages for 8 hours; 
however, drinking water is allowed. On the day of study visit, study drug and other 
concomitant medications will be taken, after completion of study visit procedures. Except 
anti-hypertensive medication (see Section 3.9 First dose of study drug will be administered at 
the clinic by site staff. 
7.3 
Labelling 
Single Panel Labels or Booklet Labels will be prepared in accordance with Good 
Manufacturing Practice (GMP) and local regulatory guidelines. The labels will fulfil GMP 
Annex 13 requirements for labelling. Label text will be translated into local language. 
<<(JP) Replace the above paragraph with the paragraph below: Details are specified in the 
document explaining the reconstitution procedures and other handling procedures for the 
investigational products.>>(End JP) 
7.4 
Storage 
All study drugs should be kept in a secure place under appropriate storage conditions. The IP 
label on the bottle specifies the appropriate storage.  
<<(JP) Replace the second sentence of the paragraph above with: A description of the 
appropriate storage conditions is specified in the document explaining the reconstitution 
procedures and other handling procedures for the investigational products.>>(End JP) 
7.5 
Compliance 
The administration of all study drugs (including investigational products) should be recorded 
in the appropriate sections of the CRF. 
Each time study drug is dispensed, compliance will be reinforced. When study drug is 
returned, compliance will be assessed based on returned tablet counts. Tablet counts will be 
recorded in the eCRF. Patients should demonstrate good compliance with the administration 
of study drug (≥70% and ≤130%) during the lead-in period. For patients with compliance 
between ≥70% and < 80% or > 120% and ≤130%, the Investigator should ensure that there are 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
96(127) 
no systematic factors which may result in unacceptable compliance with study drug during the 
treatment period of the study. Such cases should be discussed with the study physician prior to 
randomization. During double-blind treatment period, patients judged to be non-compliant 
(defined as taking less than 80% or more than 120% of the prescribed dose of study drug) may 
continue in the study, but should be counselled on the importance of taking their study 
medication and applicable concomitant medications as prescribed. 
7.6 
Accountability 
The study drug provided for this study will be used only as directed in the study protocol. 
The study personnel will account for all study drugs dispensed to and returned from the 
patient. 
The investigator is responsible for making sure: 
x 
That the IP is handled and stored safely and properly. 
x 
That the IP is only dispensed to study patients in accordance with this protocol. 
Patients should return all unused IP and empty containers to the investigator. 
At the termination of the Clinical Study or at the request of AstraZeneca, the investigator will 
either return any unused IP to AstraZeneca or its designate, or destroy IP at the site depending 
on local regulations. If the IP is destroyed at site, the site personnel will account for all unused 
IP and for appropriate destruction. If the IP is returned to AstraZeneca or its designate, the 
study site personnel or the AstraZeneca monitor will account for all received IP received at the 
site, unused IP and for appropriate destruction. Certificates of delivery, destruction and return 
should be signed and archived.  
<< (JP) Replace content in this section with: Study drug will not be distributed to the study 
site until the contract is concluded between the study site and AstraZeneca. The 
Investigational Product Storage Manager is responsible for managing the study drug from 
receipt by the study site until the return of all unused study drug to AstraZeneca.  AstraZeneca 
will provide the study documents ‘Procedures for drug accountability’ and ‘Procedures for 
drug storage’ which describes the specific requirements.  The Investigator(s) is responsible for 
ensuring that the subject has returned all unused study drug.>> (End JP) 
7.7 
Concomitant and other treatments  
Changes in concomitant medication should be avoided during study participation, with the 
exception of situations defined in this protocol, but medication, which is considered necessary 
for the patient’s safety and well-being, may be given at the discretion of the investigators, who 
must decide if the patient should remain in study or need to be dismissed from study due to 
patient’s safety or interference with study objectives. 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
97(127) 
The administration of all medication must be recorded in the appropriate sections of the 
electronic CRF. The specific type of medication (trade or generic name), the indication for use, 
dosages, and the dates of usage should be reported. 
After having completed or discontinued the study, patients will receive usual care and 
antidiabetic agents according to the investigator's judgment and according to local medical 
practice. 
Restricted Medication/Class of drug: 
Usage: 
Metformin 
A metformin dose which is outside the specified 
dose range for  renal impairment (eGFR 
25-75mL/minute/1.73m2)according to local 
guidelines and/or investigator’s judgement is not 
allowed. 
Teriparatide, bisphosphonates and/or 
calcitonin 
Treatment with teriparatide, bisphosphonates 
and/or calcitonin are allowed provided the dose 
has not changed within 30 days prior to 
enrolment. 
Anemia treatment 
Use of erythropoiesis stimulating agents 
including, but not limited to, erythropoietin 
epoetin alfa, epoetin beta, darbepoetin alfa, or 
methoxy-polyethylene-glycol-epoetin beta, are 
allowed provided the treatment has been ongoing 
for at least 6 months and the dose is unchanged 
from 3 months prior to Visit 1 and throughout the 
study.   
 
Prohibited Medication/Class of drug: 
Usage: 
Antiviral drugs 
Treatment for HIV and/or use of antiviral drugs 
(delavirdine, indinavir, nelfinavir, ritonavir, 
saquinavir) is not allowed. 
Glucocorticoids (long term treatment) 
Long term treatment with glucocorticoids 
(equivalent to oral prednisolone ≥10 mg 
(betamethasone ≥1.2 mg, dexamethasone ≥1.5 
mg, hydrocortisone ≥40 mg) is not allowed, (two 
temporary periods of no longer than 10 days each 
are allowed during the study); topical or inhaled 
corticosteroids are allowed. 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
98(127) 
Weight loss medication 
Use of weight loss medication, including but not 
limited to sibutramine, phentermine, orlistat, 
rimonabant, benzphetamine, diethylpropion, 
methamphetamine, Victoza (liraglutide) 
indicated for anti-obesity treatment, and/or 
phendimetrazine from 30 days prior to Visit 1 to 
end of study is not allowed. 
Guidelines with regard to standard of care and other therapy 
During the duration of the study period, standard of care for each patient should be kept 
unchanged to the largest extent as possible, according to the judgment of the Investigator. 
Specifically, the dose of OADs, insulin, anti-hypertensive drugs, lipid lowering drugs and 
anti-platelet drugs should be kept constant throughout the entire study from start of run-in to 
end of follow-up (week 27). 
However, in case of hypotension, the dose of any anti-hypertensive medication can be reduced 
according to the Investigator’s judgement. 
7.7.1 
Other concomitant treatment 
Other medication other than that described above, which is considered necessary for the 
patient’s safety and well-being, may be given at the discretion of the Investigator and recorded 
in the appropriate sections of the CRF. 
7.8 
Post Study Access to Study Treatment---Not Applicable 
8. 
STATISTICAL ANALYSES BY ASTRAZENECA 
8.1 
Statistical considerations 
Multiplicity due to the two active treatment groups will be controlled by a Bonferroni 
adjustment, such that statistical significance will be determined according to a two-sided alpha 
level of 0.025. Within the saxagliptin 2.5 mg + dapagliflozin 10 mg treatment group the 
control of the alpha level in the testing of both co-primary endpoints (the percent change in 
urine albumin-to creatinine ratio (UACR) from baseline to 24 weeks and the change in HbA1c 
from baseline to 24 weeks) will require that each achieves statistical significance at the 0.025 
level for a claim of superiority to placebo, and to proceed to a sequential comparison of 
secondary endpoints.  Within the dapagliflozin 10 mg treatment group the control of the alpha 
level for the primary endpoint (the percent change in urine albumin-to creatinine ratio (UACR) 
from baseline to 24 weeks) will require the achievement of statistical significance at the 0.025 
level for a claim of superiority to placebo, and to proceed to a sequential comparison of 
secondary endpoints. Parallel sequential testing strategies will be used for comparing each 
active treatment group to placebo for the secondary endpoints. 


Clinical Study Protocol
Drug Substance Dapagliflozin
Study Code D1690C00023
Edition Number 6.0
Date 18-Sep-2017
99(127)
8.2
Sample size estimate
With 142 subjects per treatment group with post-baseline measurements, there is 90% power 
to detect a difference of 0.42% in mean change from baseline in HbA1c between 
saxagliptin/dapagliflozin treatment group and placebo and, separately dapagliflozin treatment 
group and placebo at significance level of 0.025, using a two sided alpha and assuming a 
standard deviation (SD) of 1.0%. Assuming 5% of the subjects do not have a post-baseline 
assessment, a total of 450 subjects (150 subjects per treatment group) need to be randomized.  
The estimated sample size of 142 subjects per group will also yield 92% power to detect a 
35% difference in UACR for each comparison at an alpha level of 0.025, assuming a SD = 
80%.  Based upon existing pooled data for dapagliflozin in treating patients with eGFR <60 
ml/min/1.73 m2 on ACEi/ARB the minimal detectable difference for this study is 0.27% for 
HbA1c and 21% for UACR
The significance level used to infer statistical significance for comparisons of primary and 
secondary endpoints will be 0.025, representing a two sided alpha level. Within the 
saxagliptin 2.5 mg + dapagliflozin 10 mg treatment group the control of the alpha level in the 
testing of both co-primary endpoints (the percent change in urine albumin-to creatinine ratio 
(UACR) from baseline to 24 weeks and the change in HbA1c from baseline to 24 weeks) will 
require that each achieves statistical significance at the 0.025 level for a claim of superiority to 
placebo, and to proceed to a sequential comparison of secondary endpoints.  Within the 
dapagliflozin 10 mg treatment group the control of the alpha level for the primary endpoint 
(the percent change in urine albumin-to creatinine ratio (UACR) from baseline to 24 weeks) 
will require the achievement of statistical significance at the 0.025 level for a claim of 
superiority to placebo, and to proceed to a sequential comparison of secondary endpoints.   
Parallel sequential testing strategies will be used for comparing each active treatment group to 
placebo for the secondary endpoints.  In all analyses p-values will be represent two-sided tests, 
and will not be adjusted for multiplicity. 
8.3
Other statistical considerations
If superiority of is demonstrated within the saxagliptin 2.5 mg + dapagliflozin 10 mg 
treatment group the for each of the two primary endpoints (HbA1c and percent change from 
baseline UACR) at the 0.025 level and/or within the dapagliflozin 10 mg treatment group the 
for the primary endpoints (percent change from baseline UACR) at the 0.025 level then 
secondary endpoints will be compared separately between that treatment group and placebo at 
an alpha level of 0.025.  Comparisons of secondary endpoints will be performed sequentially 
in the order prescribed in Section 2.2, and will cease for a given treatment group at the first 
instance a secondary endpoint dose not statistical significance in a secondary endpoint, or at 
the last comparisons, whichever occurs first.  Superiority of a treatment to placebo will be 
inferred if statistical significance is demonstrated and greater improvement occurred with that 
treatment than placebo.  
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.   
Continuous secondary and exploratory endpoints that are statistically compared and are 
measured at multiple instances during the 24 week double-blind treatment period will be 
evaluated using repeated measures models (RMM) which will include measurements from all 
scheduled time points following randomization up to and including week 24.  Primary, 
secondary, exploratory, and eGFR safety parameters within or at the end of 24 weeks double-
blind treatment analysed in the model will exclude all post-treatment results subsequent to 
glycemic rescue.  However, the effect of exclusion on estimates and differences will be 
evaluated in sensitivity analyses. Continuous secondary and exploratory endpoints that are 
statistically compared and are only measured at baseline and at the end of the 24 week double-
blind treatment period will be evaluated using analysis of variance models (ANOVA). 
Analyses of secondary, safety, and exploratory categorical endpoints that represent 
proportions of subjects will be performed using a logistic regression model. The endpoints 
within or at the end of 24 weeks double-blind treatment analyzed in the model will exclude all 
post-treatment results subsequent to glycemic rescue. Details will be provided in the Statistical 
Analysis Plan.  
8.4
Definitions of analysis sets
8.4.1
Enrolled Patients Data Set
The Enrolled Patients Data Set includes data collected from all patients who signed informed 
consent.
8.4.2
Lead-in Patients Data Set
The Lead-in Patients Data Set includes data collected from all patients who took at least one 
dose of lead-in medication.
8.4.3
Full Analysis set
The Full Analysis Set which will consist of all randomized patients who take at least one dose 
of double-blind study drug during the short term double-blind period and have a non-missing 
baseline value and at least one post-baseline efficacy value.
When the Full Analysis Set is used, patients 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).
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8.4.4 
Per protocol analysis set 
The per-protocol analysis set is a subset of the Full Analysis Set consisting of patients who do 
not violate the terms of the protocol which may affect the primary efficacy endpoint 
significantly. All decisions to exclude patients from the primary data set will be made prior to 
the un-blinding of the study. 
Relevant Protocol Deviations (RPDs), used to determine complete or partial data exclusion for 
the short term double-blind treatment period due to prohibited concomitant treatment, are 
listed in section 7.7. Any further protocol deviations for a particular study will be specified in 
the study-specific SAP. 
8.4.5 
Safety analysis set 
The Safety Analysis Data Set will consist of all patients who received at least one dose of 
double-blind study drug during the short term double-blind treatment period. The Safety 
Analysis Data Set will include any patient who accidentally received double-blind study drug 
but was not randomized in the study. 
All analyses using the Safety Analysis Data Set will be presented by randomized treatment 
group, except in cases where information was available which indicated that a patient received 
a different treatment for the entire course of their participation in the double-blind  treatment 
period of the study. In this case, the safety data for those patients will be presented by the 
treatment actually received. In case a patient never received the treatment as assigned by 
randomization, then the safety data for that patient will be presented by the first treatment 
received. No formal statistics analysis will be made for the safety variables, only descriptive 
summaries. 
8.4.6 
PD analysis set---Not Applicable 
8.4.7 
PRO analysis set---Not Applicable 
8.5 
Outcome measures for analyses 
8.5.1 
Primary outcome variables 
x 
The primary outcome variable will be the change from baseline in HbA1c (% 
saxagliptin/dapagliflozin versus placebo only) at Week 24. 
x 
Percent change from baseline in UACR at Week 24. 
8.5.2 
Secondary outcome variables 
Secondary outcome variables for the Saxagliptin/Dapagliflozin treatment comparisons: 
x 
Percent change from baseline in body weight (kg) at Week 24. 
x 
Change from baseline in FPG (mg/dL) at Week 24. 
x 
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x
HbA1c < 7.0 % at Week 24.
x
Change from baseline in seated SBP (mmHg) at Week 24.
Secondary outcome variables for the Dapagliflozin treatment comparisons:
x
Percent change from baseline in body weight (kg) at Week 24.
x
30% reduction in UACR at Week 24.
x
Change from baseline in seated SBP (mmHg) at Week 24.
x
Change from baseline in HbA1c (%) at Week 24.
x
Change from baseline in FPG (mg/dL) at Week 24.
x
HbA1c < 7.0 % at Week 24.
8.5.3
Safety outcome variables
Safety outcome variables will be:
x
Discontinuation for a sustained increase in serum creatinine by ≥1.5 times baseline 
level (AKI stage 1).
x
AEs.
x
Changes from baseline in SBP (mmHg), DBP (mmHg), and heart rate (bpm).
x
Changes from baseline in clinical chemistry/haematology parameters.
x
Changes from baseline in the findings from physical examination.
x
Changes from baseline in clinical laboratory test results.
x
Change from baseline in eGFR at Week 24.
x
Change from baseline in eGFR at Week 27.
8.5.4
Exploratory outcome variables
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8.6
Methods for statistical analyses
Analyses on the variables shown below will only include measurements obtained prior to or 
on the date of rescue medication for some analyses.  For other efficacy variables and 
exploratory variables, measurements after rescue medication will not be excluded from the 
analyses.
-
Change from baseline in HbA1c (%)
-
Change from baseline in FPG (mg/dL)
-
Proportion of patients with HbA1c < 7%
Further details will be specified in the Statistical Analysis Plan (SAP).
8.6.1
Analysis of the primary variable (s)
The analysis of the change in HbA1C from baseline to Week 24 will be based on a repeated 
measures model (RMM) including all scheduled time points following randomization up to 
and including week 24. The analysis of percent change from baseline in UACR from baseline 
to Week 24 will be conducted on the log-transformed UACR values using RMM.  Separate 
RMM models will be used to compare saxagliptin/dapagliflozin with placebo, and to compare 
dapagliflozin 10 mg alone with placebo.  RMM represent a longitudinal repeated measures 
analysis using ‘direct likelihood’, and include patients in the Full Analysis Set who have a
baseline measurement and at least one post-baseline measurement. Analyses on HbA1c will 
only include measurements prior to the administration of rescue medication. Measurements 
made following rescue administration will not be included in HbA1c analysis. 
The SAS procedure PROC MIXED will be used for primary analyses. The primary analysis 
models will each include the fixed categorical effects of treatment, week, randomization 
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stratification factor (i.e. anti-diabetic treatment strata) and treatment-by-week interaction as 
well as the continuous fixed covariates of baseline measurement and baseline measurement-
by-week interaction. (In UACR analyses the natural logarithmic transformation will be 
applied to baseline UACR values prior to analysis.)  An unstructured matrix for the within-
patient 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 will be 
defined in the statistical analysis plan in case of non-convergence of the preferred model or 
other issues.  
Point estimates and 95% confidence intervals for the mean change in HbA1c within each 
model for each treatment group as well as the difference in mean change between the 
saxagliptin/dapagliflozin treatment group and placebo will be calculated. P-value of the 
differences in Week 24 estimates between saxagliptin/ dapagliflozin and placebo will be 
calculated. For UACR, point estimates and 95% confidence intervals for the mean percent 
change in UACR within each treatment group will be obtained by exponention of model 
estimates, and differences in mean percent change will be similarly calculated. P-values of the 
differences in Week 24 percent change estimates between each treatment group 
(saxagliptin/dapagliflozin and, separately, dapagliflozin 10 mg only) and placebo from each 
model will be calculated. 
8.6.2 
Analysis of the secondary variable(s) 
Comparisons of the secondary efficacy endpoints between dapaglflozin 10 mg and placebo 
will be performed only if the test for the primary UACR endpoint is significant. Secondary 
efficacy endpoints will only be compared between saxagliplin/dapagliflozin and placebo will 
only be performed if each comparison of both co-primary endpoints is significant.  If 
statistical significance is achieved as prescribed above, then the secondary endpoints will be 
compared between that treatment (those treatments) and placebo in the order specified in 
Section 2.2. A sequential testing procedure will be employed for secondary comparisons in 
order to control the type I error rate at the 0.025 level.  Statistical comparisons between each 
treatment and placebo will be only performed for a given secondary endpoint if all previous 
sequential tests for that comparison are also significant. Otherwise, the testing procedure will 
stop at the secondary endpoint that does not reach statistical significance.    
The secondary endpoints percent change from baseline in total body weight at Week 24, 
change from baseline in FPG at Week 24, change from baseline in seated SBP at Week 24, 
and change from baseline in HbA1c at Week 24 (Dapagliflozin 10 mg) will be analyzed by 
RMM analyses, as described for the primary analyses.   
The secondary analyses of proportions for subjects with at least a 30 percent reduction in 
UACR from baseline to Week 24 and, separately, proportions for subjects with an HbA1c of 
less than 7 percent at Week 24 will be analyzed using a logistic regression model with 
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Analyses on HbA1c and FPG will only include measurements prior to the administration of 
rescue medication. Measurements made following rescue administration will not be included 
in HbA1c and FPG analysis
 
 
 
   
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8.6.4
Interim analysis
Not Applicable
8.6.5
Exploratory analysis 
  
9.
STUDY AND DATA MANAGEMENT BY ASTRAZENECA
9.1
Training of study site personnel
Before the first patient is entered into the study, an AstraZeneca representative will review and 
discuss the requirements of the CSP and related documents with the investigational staff and 
also train them in any study specific procedures and the WBDC system utilised. 
The PI will ensure that appropriate training relevant to the study is given to all of these staff, 
and that any new information relevant to the performance of this study is forwarded to the 
staff involved.
The PI will maintain a record of all individuals involved in the study (medical, nursing and 
other staff).
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9.2 
Monitoring of the study 
During the study, an AstraZeneca representative will have regular contacts with the study site, 
including visits to: 
x 
Provide information and support to the Investigator(s) 
x 
Confirm that facilities remain acceptable 
x 
Confirm that the investigational team is adhering to the protocol, that data are being 
accurately and timely recorded in the CRFs,that biological samples are handled in 
accordance with the Laboratory Manual and that study drug accountability checks 
are being performed 
x 
Perform source data verification (a comparison of the data in the CRFs with the 
subject’s medical records at the hospital or practice, and other records relevant to 
the study) including verification of informed consent of participating subjects. This 
will require direct access to all original records for each subject (e.g., clinic charts) 
x 
Ensure withdrawal of informed consent to the use of the subject’s biological 
samples is reported and biological samples are identified and disposed of/destroyed 
accordingly, and the action is documented, and reported to the subject, including 
verification of informed consent of participating subjects. In case of withdrawal of 
Informed Consent for the use of the biological sample (biomarkers) the monitor 
should verify that the sample disposal has been done and has been reported to the 
subject, and that the sample disposal is verified and documented at site. 
x 
Ensure site is compliant with study procedures to avoid “lost to follow-up” as listed 
in Section 3.10. 
The AstraZeneca representative will be available between visits if the Investigator(s) or other 
staff at the centre needs information and advice about the study conduct. 
9.2.1 
Source data 
Refer to the CSA for location of source data. 
<<(JP): Source data are any data generated as a result of the subject’s inclusion in the study 
(including run-in and/or follow up related to the study) and includes all related medical 
examinations and other records. <<Original data recorded on the CRFs and regarded as 
source data are as follows:>> (End JP) 
(JP) <<Add the following section: 
9.2.2 
Direct access to source data in Japan 
The Head of the study site and the Principal Investigator/ Investigator will cooperate for 
monitoring and audit by AstraZeneca, and accept inspection by the IRB or regulatory 


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authorities. All study documents such as raw data will be open for direct access to source data 
at the request of the monitor and the auditor of AstraZeneca, the IRB, or regulatory authorities. 
<<(JP) The monitor(s) will verify data from the CRFs against source data before the Principal 
Investigator signs the CRFs to ensure accuracy and completeness of documentation, and 
assure that the Principal Investigator has submitted the CRFs to AstraZeneca.  If the 
Investigator wishes to amend the collected CRFs, the monitor will ensure that the Principal 
Investigator has recorded the amendment with signature and date and provided this to 
AstraZeneca.>>(End JP) 
9.2.3 
Study agreements 
The Principal Investigator at each/the centre should comply with all the terms, conditions, and 
obligations of the Clinical Study Agreement, or equivalent, for this study.  In the event of any 
inconsistency between this Clinical Study Protocol and the Clinical Study Agreement, the 
terms of Clinical Study Protocol shall prevail with respect to the conduct of the study and the 
treatment of subjects and in all other respects, not relating to study conduct or treatment of 
subjects, the terms of the Clinical Study Agreement shall prevail. 
Agreements between AstraZeneca and the Principal Investigator should be in place before any 
study-related procedures can take place, or subjects are enrolled. 
<<(JP) Replace paragraphs above with paragraph below: The Principal Investigator at each 
centre should comply with all the terms, conditions, and obligations of the Study Agreement 
with the Principal Investigator, or equivalent, for this study.  In the event of any inconsistency 
between this CSP and the Study Agreement with Principal Investigator, the terms of CSP shall 
prevail with respect to the conduct of the study and the treatment of subjects and in all other 
respects, not relating to study conduct or treatment of subjects, the terms of the Study 
Agreement with Principal Investigator shall prevail. Agreements between AstraZeneca and the 
Principal Investigator should be in place before any study-related procedures can take place, 
or any subjects are enrolled.>>(End JP) 
9.2.4 
Archiving of study documents 
The Investigator follows the principles outlined in the Clinical Study Agreement (CSA). 
<<(JP) Replace the above paragraphs with the paragraphs below:  
Study files.  AstraZeneca will provide the Principal Investigator with a file in which to 
organise and retain all study-related documents.  All study documents (including letters from 
AstraZeneca) should be retained in this file by the Principal Investigator.  The monitor will 
regularly check the file to ensure that all relevant documents are retained.  The contents of the 
file may be audited/inspected by AstraZeneca’s auditor, regulatory authorities, or IRB. 
Period of record retention.  The study site (and the Principal Investigator) will retain the 
essential documents specified in the ICH GCP (e.g., source document such as medical records, 
contract, and signed consent form).  Essential documents should be retained at the study site 
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and thereafter destroyed only after agreement with AstraZeneca.  However this is not always 
applied to those that are not preservable such as blood samples. In the event of any 
inconsistency between the above-mentioned contents and the contract with the study site, the 
contract shall prevail.  These documents should be retained for a longer period however if 
needed by AstraZeneca, and the specific period and method of retention will be separately 
discussed between the study site and AstraZeneca.  AstraZeneca should notify the head of the 
study site in writing when the study related records are no longer needed.  The records should 
be managed by a responsible person appointed by the head of the study site.>>(End JP)
<<(JP) Add following section:
9.3
Study timetable and end of study
The end of the study is defined as ‘the last visit of the last subject undergoing the study’.
The study is expected to be started in Q3 2015 and to be ended by Q2 2018.
The study may be terminated at individual centres if the study procedures are not being 
performed according to GCP, or if recruitment is slow.  AstraZeneca may also terminate the 
entire study prematurely if concerns for safety arise within this study or in any other study 
with <<insert name of investigational product >>
<<(JP) Replace the above with: Planned duration of the study: Study period: <<Month, Year-
Month, Year>> (End JP)
<<(JP) Discontinuation or suspension of the whole study programme
If AstraZeneca decides to prematurely terminate or suspend the study, the Principal 
Investigator/Investigator, the head of the study site, and regulatory authorities should receive 
written notification of the reasons for the premature termination or suspension.
The Principal Investigator/Investigator will immediately notify the decision to the subjects, 
give appropriate medical treatment; take necessary measures, and record treatment or 
measures provided on the source documents.
Completion of the study
Upon terminating the study, the Principal Investigator/Investigator will report in writing the 
completion of the study as well as the summary of the results to the head of the study site in 
accordance with the study site’s rules.  The head of the study site, who is informed of the 
termination by the Investigator, will provide a written notification of the results to the IRB and 
AstraZeneca. >>(End JP)
9.4
Data management by 
Data management will be performed by 
, the AZ Data Management Centre, 
according to the Data Management Plan. 
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Data will be entered into the 
 the study site. Trained site staff will be 
entering the data as specified in the protocol and according to the eCRF instructions. Data 
entered into the WBDC system will be immediately saved to a central database and changes 
tracked to provide an audit trail. The data will then be Source Data Verified, reviewed, 
queried and updated as needed.
AEs and medical/surgical history will be classified according to the terminology of the latest 
version the MedDRA. Medications will be classified according to the AstraZeneca Drug 
Dictionary. All coding will be performed by the Medical Coding Team at the Data 
Management Centre.
The PI is responsible for signing the eCRF and this may be delegated to a trained Investigator.
The data will be validated as defined in the Data Management Plan. Quality control 
procedures will be applied to each stage of data handling to ensure that all data are reliable 
and have been processed correctly. The Data Management Plan will also clarify the roles and 
responsibilities of the various functions and personnel involved in the data management 
process.
When all data have been coded, validated, signed and locked, clean file will be declared. Any 
treatment revealing data may thereafter be added and the final database will be locked. A copy 
of the eCRF will be archived at the study site when the study is completed.
Serious Adverse Event (SAE) Reconciliation
SAE reconciliation reports are produced and reconciled with the Patient Safety database 
and/or the investigational site. 
Data Management of genotype data
Not Applicable
Data associated with human biological samples
Data associated with biological samples will be transferred from laboratory (ies) internal or 
external to AstraZeneca.
Management of external data
Data Management determines the format of the data to be received from external vendors and 
coordinates the flow of data to the clinical database. Data Management will assure that the 
data collection tool for IVRS are tested and validated. External data reconciliation will be 
done with the clinical database as defined in the Data Management Plan.
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10. 
ETHICAL AND REGULATORY REQUIREMENTS 
10.1 
Ethical conduct of the study 
The study will be performed in accordance with ethical principles that have their origin in the 
Declaration of Helsinki and are consistent with ICH/Good Clinical Practice, applicable 
regulatory requirements and the AstraZeneca policy on Bioethics and Human Biological 
Samples. 
<<(JP) Add the following: The applicable regulatory requirements in Japan are ‘Good Clinical 
Practice for Trials on Drugs (MHLW Ordinance No. 28, 27 March 1997, partially revised by 
MHLW Ordinance and their related notifications>>(End JP) 
10.2 
Subject data protection 
The Informed Consent Form will incorporate (or, in some cases, be accompanied by a 
separate document incorporating) wording that complies with relevant data protection and 
privacy legislation. 
<<(JP) Replace the above paragraph with this text: 
The Master Informed Consent Form will explain that:  
x 
Study data will be stored in a computer database, maintaining confidentiality in 
accordance with national data legislation 
x 
Patient data will be maintaining confidentiality in accordance with national data 
legislation 
x 
For data verification purposes, authorised representatives of AstraZeneca, a 
regulatory authority, an IRB may require direct access to parts of the hospital or 
practice source records relevant to the study, including subjects’ medical history 
All data computer processed by AstraZeneca will be identified by study code and enrolment 
code (E-code) (End JP) 
10.3 
Ethics and regulatory review 
An Ethics Committee should approve the final study protocol, including the final version of 
the Informed Consent Form and any other written information and/or materials to be provided 
to the subjects.  The Investigator will ensure the distribution of these documents to the 
applicable Ethics Committee, and to the study site staff. 
The opinion of the Ethics Committee should be given in writing. The Investigator should 
submit the written approval to AstraZeneca before enrolment of any subject into the study.  
The Ethics Committee should approve all advertising used to recruit subjects for the study. 


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AstraZeneca should approve any modifications to the Informed Consent Form that are needed 
to meet local requirements. 
If required by local regulations, the protocol should be re-approved by the Ethics Committee 
annually. 
Before enrolment of any subject into the study, the final study protocol, including the final 
version of the Informed Consent Form, is approved by the national regulatory authority or a 
notification to the national regulatory authority is done, according to local regulations. 
AstraZeneca will handle the distribution of any of these documents to the national regulatory 
authorities. 
AstraZeneca will provide Regulatory Authorities, Ethics Committees and Principal 
Investigators with safety updates/reports according to local requirements. 
Each Principal Investigator is responsible for providing the Ethics Committees/IRB with 
reports of any serious and unexpected adverse drug reactions from any other study conducted 
with the investigational product.  AstraZeneca will provide this information to the Principal 
Investigator so that he/she can meet these reporting requirements. 
<<(JP) Replace the above paragraphs with: 
An IRB should approve the final study protocol, including the final version of the Informed 
Consent Form and any other written information and/or materials to be provided to the 
subjects.  The head of the study site will ensure the distribution of these documents to the 
applicable IRB, and the Principal Investigator to the Investigator and study site staff. 
The opinion of the IRB should be given in writing.  The head of the study site should submit a 
notification of direction/determination as well as a copy of the IRB written approval to 
AstraZeneca and the Principal Investigator before enrolment of any subject should into the 
study. 
The IRB should approve all advertising used to recruit subjects for the study. 
AstraZeneca should approve any modifications to the Informed Consent Form that are needed 
to meet local requirements. 
A valid contract between the study site and AstraZeneca should be signed before the 
Investigator can enrol any subject into the study.  The protocol should be re-approved by the 
IRB annually.   
The head of the study site should seek the opinion of the IRB with respect to the 
appropriateness of continuing the study at the study site at least once a year when the duration 
of the study exceeds one year. The Principal Investigator should submit progress reports to the 
IRB via the head of the study site at the time of the protocol re-approval. 


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Before enrolment of any subject into the study, the final study protocol, including the final 
version of the ICF, should be approved by the national regulatory authority with notification 
provided, according to local regulations.  AstraZeneca will handle the distribution of any of 
these documents to the national regulatory authorities. 
AstraZeneca will provide Regulatory Authorities, IRB, the head of the study site and the 
Principal Investigator with safety updates/reports according to local requirements. 
The head of the study site should submit a written report to the IRB providing the details of all 
safety relative information reported by AstraZeneca. >>(End JP) 
10.4 
Informed consent 
The Principal Investigator(s) at each centre will: 
x 
Ensure each subject is given full and adequate oral and written information about 
the nature, purpose, possible risk and benefit of the study 
x 
Ensure each subject is notified that they are free to discontinue from the study at 
any time 
x 
Ensure that each subject is given the opportunity to ask questions and allowed time 
to consider the information provided 
x 
Ensure each subject provides signed and dated informed consent before conducting 
any procedure specifically for the study 
x 
Ensure the original, signed Informed Consent Form(s) is/are stored in the 
Investigator’s Study File 
x 
Ensure a copy of the signed Informed Consent Form is given to the subject 
x 
Ensure that any incentives for subjects who participate in the study as well as any 
provisions for subjects harmed as a consequence of study participation are 
described in the informed consent form that is approved by an Ethics Committee. 
<<(JP) Japan only: 
x 
If any new information on the study medication becomes available which may 
influence the decision of the subject to continue the study, the Investigator(s) should 
inform the subject of such information immediately, record this in a written form, 
and confirm with the subject if he or she wishes to continue the participation in the 
study.  In addition, if the Investigator(s) deem it necessary to revise the Informed 
Consent Form, they should revise it immediately (Refer to Section 10.5).  The 
Investigator(s) should re-explain the subjects using updated Informed Consent Form 
even if although the subjects have already been informed of the new information 


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verbally.  Written informed consent to continue participation in the study should be 
provided separately.>>(End JP) 
10.5 
Changes to the protocol and informed consent form 
Study procedures will not be changed without the mutual agreement of the <<International 
co-ordinating Investigator, National Co-ordinating Investigator, and the Principal 
Investigator >>and AstraZeneca. 
If there are any substantial changes to the study protocol, then these changes will be 
documented in a study protocol amendment and where required in a new version of the study 
protocol (Revised Clinical Study Protocol). 
The amendment is to be approved by the relevant Ethics Committee and if applicable, also the 
national regulatory authority approval, before implementation.  Local requirements are to be 
followed for revised protocols. 
AstraZeneca will distribute any subsequent amendments and new versions of the protocol to 
each Principal Investigator(s). For distribution to Ethics Committee see Section 10.3. 
If a protocol amendment requires a change to a centre’s Informed Consent Form, AstraZeneca 
and the centre’s Ethics Committee are to approve the revised Informed Consent Form before 
the revised form is used.  
If local regulations require, any administrative change will be communicated to or approved 
by each Ethics Committee. 
<<(JP) Replace the above paragraphs with:  
Study procedures will not be changed without the mutual agreement of the Principal 
Investigator and AstraZeneca.  If it is necessary for the study protocol to be amended, the 
amendment should be submitted to the Head of the Study Site and be approved by its IRB.  If 
applicable, AstraZeneca should submit a notification to the regulatory authority before it is 
implemented.  If a protocol amendment requires a change to a particular centre's Informed 
Consent Form, then AstraZeneca and the centre's IRB should be notified.  Approval of the 
revised Informed Consent Form by AstraZeneca and by the IRB is required before the revised 
form is used.  If an administrative change is required, such a change should be notified to or 
approved by each IRB according to local requirements >> (End JP) 
10.6 
Audits and inspections 
Authorised representatives of AstraZeneca, a regulatory authority, or an Ethics Committee 
may perform audits or inspections at the centre, including source data verification.  The 
purpose of an audit or inspection is to systematically and independently examine all study-
related activities and documents, to determine whether these activities were conducted, and 
data were recorded, analysed, and accurately reported according to the protocol, Good Clinical 
Practice (GCP), guidelines of the International Conference on Harmonisation (ICH), and any 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
116(127) 
applicable regulatory requirements.  The Investigator will contact AstraZeneca immediately if 
contacted by a regulatory agency about an inspection at the centre. 
<<(JP) All study data may undergo a reliability review and onsite-GCP inspection by the 
regulatory authorities. >>(End JP) 
11. 
LIST OF REFERENCES 
European Association of Urology 2014 (EAU 2014) 
European Association of Urology. Guidelines on the management of urinary and male genital 
tract infections 2014. Available from: URL: http://www.uroweb.org/ 
Grossfeld et al 2001 
Grossfeld GD, Wolf JS Jr, Litwin MS, Hricak H, Shuler C, Agerter DC, et al. Asymptomatic 
Microscopic Hematuria in Adults: Summary of the AUA Best Practice Policy 
Recommendations. Am Fam Physician. 2001;63:1145-1154. 
Greenwood M 1926 
Greenwood M. The natural duration of cancer. Reports on public health and medical subjects. 
1926;33:1-26. 
Jung et al 2011 
Jung H, Gleason JM, Loo RK, Patel HS, Slezak JM, Jacobsen SJ. Association of hematuria on 
microscopic urinalysis and risk or urinary tract cancer. The Journal of Urology 2011; 
185:1698-703. 
Kohan et al 2014 
Kohan DE, Fioretto P, Tang W, List JF. Long-term study of patients with type 2 diabetes and 
moderate renal impairment shows that dapagliflozin reduces weight and blood pressure but 
does not improve glycemic control. Kidney Int. 2014;85:962-71. 
De Nicola 2014 
De Nicola L. Sodium/glucose cotransporter 2 inhibitors and prevention of diabetic 
nephropathy: targeting the renal tubule in diabetes. Am J Kidney Dis 2014; 64(1):16-24. 
Kojima et al 2013 
Kojima N, Williams JM, Takahashi T, Miyata N, and Roman R J. Effects of a new SGLT2 
inhibitor, luseogliflozin, on diabetic nephropathy in T2DN rats. J Pharmacol Exp Ther 2013; 
345:464-72. 
Komala et al 2013 
Komala MG, Panchapakesan U, Pollock C, Mather A. Sodium glucose cotransporter 2 and the 
diabetic kidney. Curr Opin Nephrol Hypertens 2013; 22(1):113-19. 


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Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
117(127) 
Mosenzon et al 2014 
Mosenzon O, Bhatt DL, Litwak L, Shestakova M, Ray K, Leibowitz G, Hirshberg B, Wei C,  
Parker A, Iqbal N, Scirica B, Ma RC, Raz I. On behalf of the SAVOR-TIMI 53 Steering 
Committee and Investigators. Effect of Saxagliptin on Renal Outcomes. 
Presentation at the European Association for the Study of Diabetes Vienna – September 2014. 
Nicolle et al 2005 
Nicolle LE, Bradley S, Colgan R, Rice JC, Schaeffer A, Hooton TM. Infectious Diseases 
Society of America guidelines for the diagnosis and treatment of asymptomatic bacteriuria in 
adults. Clin Infect Dis 2005;40:643-54. 
Nowicki et al 2011 
Nowicki M, Rychlik I, Haller H, Warren M L, Suchower L, Gause-Nilsson I. Saxagliptin 
improves glycaemic control and is well tolerated in patients with type 2 diabetes mellitus and 
renal impairment. Diabetes, Obesity and Metabolism 2011; 13(6): 523-532. 
Pollock et al 1991 
Pollock CA, Field MJ, Bostrom TE, Dyne M, Gyory AZ and Cockyane DJH.  Proximal 
tubular cell sodium concentration in early diabetic nephropathy assessed by electron 
microprobe analysis. Pflügers Archiv 1991; 418 (1-2):14-17. 
Sato-Horiguchi et al 2012 
Sato-Horiguchi C, Ogawa D,  Wada J, Tachibana H,  Kodera R,  Eguchi J,  Nakatsuka A, 
Terami N, Shikata K,  Makino H.  Telmisartan attenuates diabetic nephropathy by suppressing 
oxidative stress in db/db mice. Nephron Exp Nephrol 2012; 121:e97–e108  
Schernthaner et al 2014 
Schernthaner G, Mogensen CE, Schernthaner G-H. The effects of GLP-1 analogues, DPP-4 
inhibitors and SGLT2 inhibitors on the renal system. Diabetes & Vascular Disease Research 
2014; 11(5): 306–323. 
Schmieder et al 2014 
Roland E. Schmieder & Rudolph Schutte & Helmut Schumacher & Michael Böhm & 
Giuseppe Mancia & Michael A.Weber & Matthew McQueen & Koon Teo & Salim Yusuf & 
on behalf of theONTARGET/TRANSCEND investigators. Mortality and morbidity in relation 
to changes in albuminuria glucose status and systolic blood pressure: an analysis of the 
ONTARGET and TRANSCEND studies. Diabetologia 2014;57:2019–2029. 
Sjöström et al 2015 
Sjostrom CD, Johansson P, Sugg J, Johnsson E. Dapagliflozin reduces albuminuria on top of 
renin angiotensin system blockade in diabetic patients with moderate renal impairment.  Abstr. 
SAT-461 ISN World Congress of Nephrology, March 2015, Cape Town. 
Scirica et al 2013 
Scirica BM, Bhatt DL, Braunwald E, Steg PG, Davidson J, Hirshberg B, Ohman P, Frederich 
R, Wiviott SD, Hoffman EB, Cavender MA, Udell JA, Desai NR, Mosenzon O, McGuire DK, 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
118(127) 
Ray KK, Leiter LA, Raz I; SAVOR-TIMI 53 Steering Committee and Investigators. 
Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus.N Engl J 
Med. 2013 Oct 3;369(14):1317-26. 
Terami et al 2014 
Terami N, Ogawa D, Tachibana H, Hatanaka T, Wada J, Nakatsuka A, Eguchi J, Horiguchi 
CS, Nishii N, Yamada H, Takei K, Makino H. Long-term treatment with the sodium glucose 
cotransporter 2 inhibitor, dapagliflozin, ameliorates glucose homeostasis and diabetic 
nephropathy in db/db mice. PLoS One. 2014 Jun 24;9(6). 
Tanaka et al 2014 
Tanaka T, Higashijima Y, Wada T, Nangaku M. 
The potential for renoprotection with incretin-based drugs. Kidney Int. 2014 Oct;86(4):701-11.  
Thomas 2014 
Thomas MC. Renal effects of dapagliflozin in patients with type 2 diabetes.  Ther Adv 
Endocrinol Metab 2014; 5(3):53-61. 
US Preventative Services Taskforce 2008 (USPSTF 2008) 
US Preventative Services Taskforce. Recommendation Statement Screening or Asymptomatic 
Bacteriuria. Revised 2008. Available from: URL: 
http://www.ahrq.gov/clinic/uspstf/uspsbact.htm 
 
 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
119(127) 
12. 
APPENDIX A ADDITIONAL SAFETY INFORMATION 
12.1 
Further Guidance on the Definition of a Serious Adverse Event 
(SAE) 
Life threatening 
‘Life-threatening’ means that the patient was at immediate risk of death from the AE as it 
occurred or it is suspected that use or continued use of the product would result in the patient’s 
death. ‘Life-threatening’ does not mean that had an AE occurred in a more severe form it 
might have caused death (eg, hepatitis that resolved without hepatic failure). 
Hospitalisation 
Outpatient treatment in an emergency room is not in itself a serious AE, although the reasons 
for it may be (eg, bronchospasm, laryngeal oedema). Hospital admissions and/or surgical 
operations planned before or during a study are not considered AEs if the illness or disease 
existed before the patient was enrolled in the study, provided that it did not deteriorate in an 
unexpected way during the study. 
Important medical event or medical intervention 
Medical and scientific judgement should be exercised in deciding whether a case is serious in 
situations where important medical events may not be immediately life threatening or result in 
death, hospitalisation, disability or incapacity but may jeopardize the patient or may require 
medical intervention to prevent one or more outcomes listed in the definition of serious.  
These should usually be considered as serious. 
Simply stopping the suspect drug does not mean that it is an important medical event; medical 
judgement must be used. 
x 
Angioedema not severe enough to require intubation but requiring iv hydrocortisone 
treatment 
x 
Hepatotoxicity caused by paracetamol (acetaminophen) overdose requiring 
treatment with N-acetylcysteine 
x 
Intensive treatment in an emergency room or at home for allergic bronchospasm
x 
Blood dyscrasias (eg, neutropenia or anaemia requiring blood transfusion, etc) or 
convulsions that do not result in hospitalisation 
Development of drug dependency or drug abuse 
12.2 
A Guide to Interpreting the Causality Question 
When making an assessment of causality consider the following factors when deciding if there 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
120(127) 
is a ‘reasonable possibility’ that an AE may have been caused by the drug. 
x 
Time Course. Exposure to suspect drug. Has the patient actually received the 
suspect drug? Did the AE occur in a reasonable temporal relationship to the 
administration of the suspect drug? 
x 
Consistency with known drug profile. Was the AE consistent with the previous 
knowledge of the suspect drug (pharmacology and toxicology) or drugs of the same 
pharmacological class? Or could the AE be anticipated from its pharmacological 
properties? 
x 
De-challenge experience. Did the AE resolve or improve on stopping or reducing 
the dose of the suspect drug? 
x 
No alternative cause. The AE cannot be reasonably explained by another aetiology 
such as the underlying disease, other drugs, other host or environmental factors. 
x 
Re-challenge experience. Did the AE reoccur if the suspected drug was 
reintroduced after having been stopped? AstraZeneca would not normally 
recommend or support a re-challenge. 
x 
Laboratory tests. A specific laboratory investigation (if performed) has confirmed 
the relationship. 
In difficult cases, other factors could be considered such as: 
x 
Is this a recognized feature of overdose of the drug? 
x 
Is there a known mechanism? 
Causality of ‘related’ is made if following a review of the relevant data, there is evidence for a 
‘reasonable possibility’ of a causal relationship for the individual case. The expression 
‘reasonable possibility’ of a causal relationship is meant to convey, in general, that there are 
facts (evidence) or arguments to suggest a causal relationship. 
The causality assessment is performed based on the available data including enough 
information to make an informed judgment. With limited or insufficient information in the 
case, it is likely that the event(s) will be assessed as ‘not related’. 
Causal relationship in cases where the disease under study has deteriorated due to lack of 
effect should be classified as no reasonable possibility. 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
121(127) 
13. 
APPENDIX B INTERNATIONAL AIRLINE 
TRANSPORTATION ASSOCIATION (IATA) 6.2 GUIDANCE 
DOCUMENT 
13.1 
Labelling and Shipment of Biohazard Samples 
International Airline Transportation Association (IATA) classifies biohazardous agents into 3 
categories.  For transport purposes the classification of infectious substances according to risk 
groups was removed from the Dangerous Goods Regulations (DGR) in the 46th edition (2005).  
Infectious substances are now classified either as Category A, Category B or Exempt.  There 
is no direct relationship between Risk Groups and categories A and B. 
Category A Infectious Substances are infectious substances in a form that, when exposure to 
it occurs, is capable of causing permanent disability, life-threatening or fatal disease in 
otherwise healthy humans or animals.  Category A pathogens are eg, Ebola, Lassa fever virus: 
x 
Are to be packed and shipped in accordance with IATA Instruction 602. 
Category B Infectious Substances are infectious Substances that do not meet the criteria for 
inclusion in Category A.  Category B pathogens are eg, Hepatitis A, B, C, D, and E viruses, 
Human immunodeficiency virus (HIV) types 1 and 2.  They are assigned the following UN 
number and proper shipping name: 
x 
UN 3373 – Biological Substance, Category B 
x 
are to be packed in accordance with UN3373 and IATA 650 
Exempt - all other materials with minimal risk of containing pathogens 
x 
Clinical trial samples will fall into Category B or exempt under IATA regulations 
x 
Clinical trial samples will routinely be packed and transported at ambient 
temperature in IATA 650 compliant packaging  
x 
Biological samples transported in dry ice require additional dangerous goods 
specification for the dry-ice content 
x 
IATA compliant courier and packaging materials should be used for packing and 
transportation and packing should be done by an IATA certified person, as 
applicable 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
122(127) 
x 
Samples routinely transported by road or rail are subject to local regulations which 
require that they are also packed and transported in a safe and appropriate way to 
contain any risk of infection or contamination by using approved couriers and 
packaging / containment materials at all times.  The IATA 650 biological sample 
containment standards are encouraged wherever possible when road or rail transport 
is used. 
14. 
APPENDIX C ALGORITHM ON MANAGEMENT OF 
SUSTAINED ELEVATED LIVER SAFETY ABNORMALITIES 
14.1 
Algorithm on Management of Sustained Elevated Liver Safety 
Abnormalities 
The monitoring for liver safety will be performed using the serum levels of AST, ALT and TB 
(see Figure 1 Sustained elevated liver safety abnormalities flow chart). 
Patients with a central laboratory ALT and/or AST >3 X ULN will be scheduled for a 
follow-up visit within 3 days following receipt of the initial laboratory results, to obtain repeat 
central laboratory ALT, AST, TB and Alkaline Phosphatase (ALK-P). In the event that the 
repeat laboratory assessments cannot be obtained within 3 days, the Investigator is encouraged 
to discuss possible alternatives with the Sponsor. Patients should remain on study medication 
until confirmatory results are obtained, unless otherwise contraindicated. 
x 
If the repeat ALT and AST are ≤ 3X ULN, patient should continue study 
treatment according to their original visit schedule unless otherwise contraindicated. 
x 
If the repeat ALT and/or AST are >3X ULN but ≤ 8X ULN and TB≤ 2X ULN, 
the patient’s medical history, including details of risk factors for liver diseases, 
should be evaluated for potential underlying aetiologies. In addition, specialized 
blood sampling will be performed to evaluate liver function as well as identify 
potential causes of laboratory elevation(s). The Investigator should continue to 
monitor the patient’s liver tests every 3 days following receipt of the prior 
laboratory results until the ALT and AST are ≤ 2X ULN or until ALT and AST are 
at or below baseline levels. The frequency of retesting can decrease to once a week 
or less if abnormalities stabilize and the patient is asymptomatic. Patients should 
remain on study medication unless confirmatory results indicate that a criterion for 
discontinuation has been met or continuing study medication would be otherwise 
contraindicated. 
14.2 
Patients must be Discontinued from the Study if an Initial and 
Repeat Confirmatory Laboratory Tests Meet any of the Following 
Criteria: 
x 
ALT and/or AST are > 3 x ULN and TB > 2 x ULN 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
123(127) 
x 
ALT and/or AST are >5 x ULN for > 14 consecutive days, at any time after initial 
confirmatory results 
x 
ALT and/or AST are >8 x ULN 
In each of these situations, study medication will be discontinued, the Sponsor notified and the 
End of Treatment Visit performed within 3 days of the confirmed laboratory results (see 
Section 3.10in the CSP). 
At the End of Treatment Visit, medical history including details of risk factors for liver 
diseases (if not previously assessed) will be requested and additional blood sampling 
performed (Specialized Liver Panel and Liver Discontinuation Panel, see detailed below). 
Patient should also be scheduled for a Follow-up Visit (ie, procedures of Visit 10) 3 weeks 
after discontinuation of investigational product. A referral consultation to a hepatologist or 
gastroenterologist (specializing in liver abnormalities) should be obtained. 
Any additional tests and/or examinations should be carried out at the discretion of the 
Investigator. Any further investigations and laboratory results for patients with abnormal 
laboratory values at the Follow-up Visit should be made available to the Sponsor upon request. 
Additional information, including but not limited to completion of supplemental eCRFs may 
be requested for certain adverse events and/or laboratory abnormalities which are 
reported/identified as part of the hepatic safety surveillance. 
Following the End of Treatment Visit, the Investigator should continue to monitor the 
patient’s liver tests every 3 days following receipt of the prior laboratory results until the ALT 
and AST are ≤2 x ULN or until ALT and AST are at or below baseline levels. The frequency 
of retesting can decrease to once a week or less if abnormalities stabilize and the patient is 
asymptomatic. 
14.3 
Guidance on Assessment of Hepatic Laboratory Abnormalities 
The following is presented to assist in the evaluation and management of hepatic laboratory 
values. It is not intended to supplant Investigators’ clinical judgment. 
Patients who experience ALT and/or AST values >3 x ULN confirmed with a repeated test 
will have the following performed within 3 days of the confirmed laboratory results: 
x 
AE assessment 
x 
Physical Examination for jaundice and other signs of liver diseases 
x 
Review of relevant risk factors and current history focusing on possible causes of 
the increased ALT and/or AST and/or TB, including: 
 
Use of suspect concomitant medication [including over-the-counter (ie, 
acetaminophen/paracetamol), herbal and vitamin preparations] 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
124(127) 
 
Recent alcohol consumption or recreational drug/narcotic use 
 
Recent unaccustomed physical exertion 
 
Occupational or environmental exposure to hepatotoxins 
 
Other conditions which may cause liver diseases or which may cause abnormal 
test results 
x 
Specialized Liver Laboratory Panel (see below) 
14.4 
Specialized Liver Panel 
For patients who are being monitored frequently as a result of confirmed AST and/or 
ALT >3X ULN, additional central laboratory tests will be performed within 3 days of receipt 
of confirmatory results. These laboratory tests will study the possible causes of the increased 
ALT and/or AST and/or TB, and may include, but are not limited to, the following tests: 
Hepatitis A IgM 
x 
Hepatitis BsAg 
x 
Hepatitis B Core Ab IgM 
x 
Hepatitis C virus RNA 
x 
Hepatitis C Ab 
x 
Hepatitis E IgM 
x 
Epstein-Barr Virus (EBV) IgM Ab 
x 
Lactate Dehydrogenase (LDH) 
x 
Gamma-glutamyl-transpeptidase (GGT) 
x 
Carbohydrate deficient transferrin (CDT) 
x 
Prothrombin time (PT/INR) 
x 
Iron Panel - iron, ferritin, total iron binding capacity (TIBC) 
x 
Immunology Panel including Antinuclear Antibody (ANA), Anti-Smooth Muscle 
Antibody (SMA) and Anti-Liver/Kidney Microsomal Antibody (Anti-LKM) 
x 
Anti-tissue Transglutaminase Antibody 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
125(127) 
14.5 
Liver Discontinuation Panel 
For patients who are discontinued from the study as a result of sustained elevated liver safety 
abnormalities, additional central laboratory tests will be performed at the time of End of 
Treatment Visit. Similar to the Specialized Liver Panel, these laboratory tests will study the 
possible causes of the increased ALT and/or AST and/or TB, and may include, but are not 
limited to, the following tests: 
x 
Cytomegalovirus (CMV) IgM Ab 
x 
Herpes Simplex Virus (HSV) 1 and 2 
x 
Ceruloplasmin 
x 
Toxoplasmosis 
x 
Alpha-1 antitrypsin 
For specific details regarding the Specialized Liver Panel or the Liver Discontinuation Panel 
laboratory tests, refer to the Central Laboratory Manual for this study. 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
126(127) 

 


Clinical Study Protocol 
Drug Substance Dapagliflozin  
Study Code D1690C00023 
Edition Number 6.0 
Date 18-Sep-2017 
127(127) 
15. 
APPENDIX D NEW YORK HEART ASSOCIATION (NYHA) CLASSIFICATION 
15.1 
New York Heart Association (NYHA) Classification 
The NYHA classification will be based on the following definitions: 
Class I  
No limitation: 
Ordinary physical exercise does not cause undue fatigue, dyspnoea or palpitations. 
Class II 
Slight limitation of physical activity: 
Comfortable at rest but ordinary activity results in fatigue, palpitations, dyspnoea. 
Class III 
Marked limitation of physical activity: 
Comfortable at rest but less than ordinary activity results in symptoms. 
Class IV 
Unable to carry out any physical activity without discomfort: 
Symptoms of congestive heart failure are present even at rest with increased discomfort with any physical activity. 

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Statistical Analysis Plan  
Study Code D1690C00023 
Edition Number 3.0 
Date 05 June 2018 
83(100) 
addition, a summary of proportion of patients with elevated liver test and/or reported AE of 
hepatic disorder will also be provided for the double-blind treatment period. A  
All scheduled laboratory evaluations are performed by central laboratories. All laboratory 
evaluations performed by central laboratories will be included in summary tables.  
Laboratory parameters will be presented in international system units, except for those listed 
in Table 12, which will be presented in conventional units (C) and international system units 
(SI). 
Table 12 SI and C units 
Test name 
SI unit 
C unit 
FPG 
mmol/L 
mg/dL 
FFA 
mmol/L 
mg/dL 
Cholesterol (incl. LDL and HDL) 
mmol/L 
mg/dL 
Triglycerides 
mmol/L 
mg/dL 
Urate 
umol/L 
mg/dL 
Urine glucose excretion 
Arbitrary units 
Arbitrary units 
Total Bilirubin 
umol/L 
mg/dL 
Serum creatinine 
umol/L 
mg/dL 
Urine creatinine 
mmol/L 
mg/dL 
Urine albumin 
mg/L 
g/dL 
Phosphate 
mmol/L 
mg/dL 
Note: UACR will be presented as C and not SI 
 
4.4.7.5.1 
Marked laboratory abnormalities 
Laboratory abnormalities will be evaluated based on marked abnormality (MA) criteria. 
Appendix C (Laboratory Abnormality Criteria) lists the pre-defined criteria for MAs. If both 
the baseline and on-treatment values of a parameter are beyond the same MA limit for that 
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, 
and the on-treatment value is beyond the high MA limit (or vice-versa), then the on-treatment 
value will be considered a MA. If the baseline value is not beyond either MA limit, and the 
post-baseline value is beyond either MA limit, then the post-baseline value will be considered 
MA. 
Laboratory MAs occurring during the double-blind treatment period will be summarized by 
treatment group for primary and sensitivity safety analysis. The directions of changes (high or 
low) in MAs will be indicated in the tables. Separate summaries will be provided for marked 
laboratory abnormalities including and excluding data after the administration of rescue 
medication. 


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