Clinical trial NCT01554618
Conditions: Children and Adolescent With Type 2 Diabetes
Keywords: exenatide type 2 diabetes GLP-1 receptor agonist
Sponsor: AstraZeneca
Start date: 2011-12-02; Completion date: 2021-05-05
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study examines the Safety and efficacy study of exenatide once weekly in children and adolescents with type 2 diabetes

Detailed description:
This Phase 3, double-blind (controlled assessment period), randomized, multicenter, placebo-controlled parallel study is designed to examine the efficacy and safety of EQW compared to placebo (PBO) in adolescents with type 2 diabetes for 24 weeks. This study will assess safety and efficacy of EQW (as monotherapy and adjunctive therapy to oral antidiabetic agents and/or insulin). At least 40% and not more than 60% of the randomized patients must be females. At least 40% of patients should be recruited from areas with similar ethnicity and lifestyle to those of the European Union member states. Long term safety and efficacy of EQW will subsequently be monitored for 28 weeks in the open-label, uncontrolled extension period (through Week 52). The study will be terminated at Visit 11 (Week 62/Study Termination) which will be a follow-up visit occurring 10 weeks after the last dose administration at Visit 10 (Week 52). This study will be conducted in 77 patients with type 2 diabetes treated with diet and exercise alone or in combination with a stable dose of oral antidiabetic agents and/or insulin for at least 2 months prior to screening. During the controlled assessment period, approximately 77 patients will be randomly assigned in a 5:2 ratio to either EQW 2 mg (Group A) or PBO (Group B), to yield at least 70 evaluable patients: at least 50 patients in the exenatide and at least 20 patients in the PBO group. Following the 24-week controlled assessment period, patients assigned to the EQW 2 mg treatment (Group A) will continue to be treated with EQW 2 mg during the extension period (through Week 52). Patients randomized to PBO (Group B) will receive EQW 2 mg beginning at the start of the extension period, Week 25 through Week 52. In addition to receiving study medications, all patients will participate in a lifestyle intervention program encompassing diet and physical activity modifications following the signing of the informed consent and assent forms (Visit 1 \[Week -2\]) through the end of the extension period (Week 52). Following Visit 11 (Week 62/Study Termination), patients whose height increase is at least 5 mm between Visit 8 (Week 28) and Visit 11 (Week 62/Study Termination) will participate in a long-term safety follow-up period. Patients who discontinue study medication prior to Visit 11 (Week 62/Study Termination) will also participate in the Extended Safety Follow-up Period, unless they have a height increase of less than 5 mm over a 6-month interval at study site visits prior to discontinuation of study medication. Patients who do not have height assessments at study-site visits over a 6-month interval prior to discontinuation of study medication will enter the Extended Safety Follow-up Period. The Extended Safety Follow Up Period will continue for up to 3 years or until the difference between two 6-month interval visits is less than a 5 mm increase (whichever comes first). No study medication will be administered during the Extended Safety Follow-up Period. Blood samples will be collected for calcitonin and carcinoembryonic antigen (CEA) laboratory measurements.

Arms: arm 1: Exenatide once weekly arm 2: Placebo once weekly
Interventions: intervention 1: Exenatide Once Weekly intervention 2: Placebo
Intervention descriptions: intervention 1: 2 mg exenatide once weekly intervention 2: Placebo

Protocol documents:
Prot_002.pdf: 
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55

SAP_003.pdf: 
Statistical Analysis Plan
Study Code
D5551C00002 
Edition Number
2.0
Date
21MAY2020
A Phase 3, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Assess 
the Safety and Efficacy of Exenatide Once Weekly in Adolescents with Type 2 Diabetes


Statistical Analysis Plan 
Study Code D5551C00002
Edition Number 2.0
Date 21MAY2020
2
TITLE PAGE.......................................................................................................1
LIST OF ABBREVIATIONS ..............................................................................5
AMENDMENT HISTORY..................................................................................7
1.
STUDY DETAILS.............................................................................................11
1.1
Study objectives................................................................................................. 11
1.1.1
Primary objective...............................................................................................11
1.1.2
Secondary objective ...........................................................................................11
1.2
Study design ...................................................................................................... 12
1.3
Number of patients.............................................................................................13
1.4
Mixed meal sub-study........................................................................................ 14
1.4.1
Sub-study objectives ..........................................................................................14
1.4.2
Sub-study design................................................................................................ 14
1.4.3
Number of patients in sub-study.........................................................................14
1.4.4
Pharmacodynamic assessments: Plasma Glucose, Serum Insulin, C-
Peptide, and Glucagon .......................................................................................15
1.4.5
Pharmacokinetic assessments.............................................................................15
2.
ANALYSIS SETS .............................................................................................15
2.1
Definition of analysis sets .................................................................................. 15
2.1.1
All patients analysis set......................................................................................15
2.1.2
Randomized analysis set ....................................................................................15
2.1.3
Intent-to-treat (ITT) analysis set.........................................................................15
2.1.4
Evaluable analysis set ........................................................................................15
2.1.5
Safety analysis set..............................................................................................15
2.1.6
Pharmacokinetic (PK) analysis set......................................................................16
2.1.7
Standardized mixed meal test evaluable analysis set...........................................16
2.2
Violations and deviations ................................................................................... 16
3.
PRIMARY AND SECONDARY VARIABLES.................................................17
3.1
Primary efficacy variable ...................................................................................17
3.2
Secondary efficacy variables..............................................................................17
3.3
Exploratory efficacy variables............................................................................ 18
3.4
Safety variables..................................................................................................18
3.5
Exploratory safety variables............................................................................... 19
3.6
Definition of study variables .............................................................................. 19
3.6.1
Study baseline....................................................................................................19
3.6.2
Change and percent change from baseline..........................................................19
3.6.3
Early Termination visit.......................................................................................20
3.6.4
Rescue therapy...................................................................................................20


Statistical Analysis Plan 
Study Code D5551C00002
Edition Number 2.0
Date 21MAY2020
3
3.6.5
Study periods ..................................................................................................... 20
3.6.5.1
Efficacy .............................................................................................................21
3.6.5.2
Safety and concomitant medications...................................................................21
3.6.5.3
Controlled assessment period treatment completion ...........................................22
3.6.5.4
Controlled assessment period completion...........................................................22
3.6.5.5
Extension period treatment completion ..............................................................22
3.6.5.6
Extension period completion..............................................................................22
3.6.6
Total daily insulin dose ......................................................................................22
3.6.7
Free testosterone ................................................................................................23
4.
ANALYSIS METHODS....................................................................................23
4.1
General principles.............................................................................................. 23
4.1.1
Statistical notations and presentations ................................................................24
4.1.2
Hypothesis testing significance level.................................................................. 24
4.1.3
Handling of missing data....................................................................................25
4.1.3.1
Missing efficacy data .........................................................................................25
4.1.3.2
Missing baseline and demographic data..............................................................25
4.1.3.3
Missing safety data ............................................................................................ 25
4.1.3.4
Premature discontinuation..................................................................................26
4.1.4
Handling of data post rescue medication ............................................................26
4.1.5
Statistical modelling...........................................................................................27
4.2
Analysis methods...............................................................................................27
4.2.1
Study disposition and baseline demographics.....................................................27
4.2.1.1
Patient disposition..............................................................................................27
4.2.1.2
Demographics and baseline characteristics.........................................................27
4.2.1.3
Medical/Surgical history ....................................................................................30
4.2.1.4
Concomitant medications...................................................................................31
4.2.2
Overall compliance and extent of exposure ........................................................32
4.2.3
Efficacy analysis................................................................................................34
4.2.3.1
Estimands ..........................................................................................................34
4.2.3.2
Hierarchical testing strategy...............................................................................39
4.2.3.3
Analysis of primary variable ..............................................................................39
4.2.3.4
Sensitivity and supplementary analyses for primary endpoint.............................40
4.2.3.5
Analysis of secondary variables ......................................................................... 42
4.2.3.6
Analysis of exploratory variables .......................................................................45
4.2.4
Safety and tolerability analysis...........................................................................46
4.2.4.1
Adverse event analysis.......................................................................................47
4.2.4.2
Injection-site reactions .......................................................................................49
4.2.4.3
Drug-induced liver injury...................................................................................49
4.2.4.4
Clinical laboratory .............................................................................................49
4.2.4.5
Vital signs.......................................................................................................... 51
4.2.4.6
Antibodies to exenatide......................................................................................51
4.2.4.7
Hypoglycemia....................................................................................................51
4.2.5
Mixed meal sub-study........................................................................................ 53
4.3
Conventions.......................................................................................................53


Statistical Analysis Plan 
Study Code D5551C00002
Edition Number 2.0
Date 21MAY2020
4
4.3.1
Visit assignments for efficacy variables..............................................................53
4.3.2
Duplicate efficacy assessments........................................................................... 55
4.3.3
Visit assignment for safety variables .................................................................. 55
4.3.4
Rules for safety observations..............................................................................58
4.3.4.1
Multiple safety assessments ............................................................................... 58
4.3.4.2
Adverse events at patient level ........................................................................... 58
4.3.4.3
Adverse event at event level...............................................................................58
5.
CHANGES OF ANALYSIS FROM PROTOCOL .............................................60
6.
REFERENCES ..................................................................................................62
7.
APPENDIX .......................................................................................................63
7.1
Appendix B1 Partial date conventions for AEs...................................................63
7.2
Appendix B2 Algorithm for prior /concomitant medications ..............................64
7.3
Appendix B3  Units and marked abnormality criteria for safety laboratory 
variables and vital sign parameters.....................................................................66
7.4
Appendix B4 Preferred terms for potentially immune-related adverse 
events.................................................................................................................67


Statistical Analysis Plan 
Study Code D5551C00002
Edition Number 2.0
Date 21MAY2020
5
LIST OF ABBREVIATIONS
Abbreviation or special term
Explanation
AE
Adverse event
ALT
Alanine aminotransferase
AST
Aspartate aminotransferase
ATC
Anatomical Therapeutic Chemical
AUC
Area under the curve
BMI
Body mass index
CAP
Controlled assessment period
CEA
Carcinoembryonic antigen
CMH 
Cochran-Mantel-Haenszel test
CSP
Clinical study protocol
CSR
Clinical Study Report
CV
Coefficient of variation
DAE
Adverse event leading to discontinuation
DBL
Database lock
DHEAS
Dehydroepiandrosterone
eCRF
Electronic case report form
EP
Extension period
EQW
Exenatide once weekly
FPG 
Fasting plasma glucose
Free T4
Thyroxine
FSH
Follicle-stimulating hormone
GCV
Geometric coefficient of variation
GSD
Geometric standard deviation factor
HbA1c
Glycated hemoglobin A1c
HDL
High-density lipoprotein
HOMA 
Homeostasis Model Assessment
HOMA-B
Homeostasis Model Assessment -Beta-cell function
HOMA-S
Homeostasis Model Assessment- Insulin sensitivity
ICH
International Conference on Harmonization
IE
Intercurrent events
IGF-1
Insulin-like growth factor 1
ITT 
Intent-to-treat
LDL
Low-density lipoprotein 
LH
Luteinizing hormone
LS
Least squares
MAR
Missing at random
MedDRA 
Medical Dictionary for Regulatory Activities
MMRM
Mixed Model Repeated Measures
MNAR
Missing not at random
PBO
Placebo


Statistical Analysis Plan 
Study Code D5551C00002
Edition Number 2.0
Date 21MAY2020
6
PD
Protocol Deviation
PK 
Pharmacokinetic
PP
Per-protocol
PT
Preferred term
SAE
Serious adverse event
SAP
Statistical analysis plan
SAS
Statistical analysis software
SC 
Subcutaneous
SD
Standard deviation
SE
Standard error
SI
Standardized international
SHBG
Sex hormone binding globulin
SMBG 
Self-monitored blood glucose
SOC
System Organ Class
SU 
Sulfonylurea
TB 
Total bilirubin
TSH
Thyroid-stimulating hormone
ULN 
Upper limit of normal
UN
Unstructured
US
United States
WHODD 
World Health Organization Drug Dictionary


Statistical Analysis Plan 
Study Code D5551C00002
Edition Number 2.0
Date 21MAY2020
7
AMENDMENT HISTORY
Date
Brief description of change
N/A first version
05MAR2020
Section 3.2: C-peptide secondary endpoint removed due to collection at study 
visits not aligning for analysis.
Section 3.6.3: Wording aligned for inclusion of data surrounding rescue 
medication.
Section 3.6.4.3: Definition of treatment completion added as per AZ request.
Section 3.6.4.4: Definition of controlled assessment period completion added 
to clarify difference from treatment completion.
Section 3.6.5: Total daily insulin dosing clarification added to define how to 
derive dosing occurring throughout study, records to be used and handling of 
missed doses. 
Section 3.6.6: Derivation added for calculating free testosterone using total 
testosterone.
Section 4.1.2: Number of decimal places clarified for presentation of p-value, 
in line with presentation guidelines for summary statistics.
Section 4.1.3.2: Display of missing data in baseline and demographic outputs 
updated to be presented as a count outside of total count.
Section 4.2.1: Removed text surrounding missing/unknown values for study 
disposition and baseline demographics to avoid inconsistency with Section 
4.1.3.2. 
Section 4.2.1.2: Removal of Evaluable analysis set presentations for baseline, 
patient and demographic outputs after request at BDR1.
Section 4.2.1.4: Details provided for summarizing background insulin therapy 
by visit and medication classification. Also, which data to be excluded from 
the summary.
Section 4.2.2: Overall compliance analysis set changed from ITT to Safety as 
per request and change from CSP.
Section 4.2.3.2: C-peptide removed from hierarchical testing due to removal 
from secondary endpoints.
Section 4.2.3.3: Wording updated to add clarity to analysis being performed 
and default procedures in SAS programming. Aligned wording for inclusion 
of data surrounding rescue medication and efficacy endpoints. Updated 
baseline BMI percentiles for consistency of parameter throughout.
Section 4.2.3.4: Revised wording for the sensitivity analysis to clarify the 
procedure to be used and the steps involved with implementing.


Statistical Analysis Plan 
Study Code D5551C00002
Edition Number 2.0
Date 21MAY2020
8
Date
Brief description of change
Section 4.2.3.5: Text surrounding addition of Kaplan-Meier output and
handling of censoring. Also reference for windowing rescue medication for
glycemic control added.
Section 4.2.4.1: Analysis for AEs off-treatment added by as per BDR1 request
to capture all AEs occurring during the study.
Section 4.2.4.4: Change from worst value for laboratory parameters to 
maximum or minimum value.
Section 4.2.4.7: Clarity added for patients to be considered using medication at 
baseline.
Table 3.1: Rescue medication added to the target windowing.
Sections 4.3.1 and 4.3.3: Update to visit window tables to add analysis visit 
associated with protocol visit and target day’s surrounding assessments close 
to the CAP (Week 24 and 28) and EP (Week 52). Visit windows for total daily 
insulin added.
Section 5: More information provided on changes from protocol to SAP.
Section 6: Reference for free testosterone added.
Updated derivation for rescue medication from data to be included or excluded 
‘on or after’ to ‘after’ first administration, throughout.


Statistical Analysis Plan 
Study Code D5551C00002
Edition Number 2.0
Date 21MAY2020
9
Date
Brief description of change
04MAY2020
Updated throughout the addition of the HbA1c goal <6.5% in line with other 
Exenatide projects.
Section 3.6.1: Study baseline derivation adapted to be ‘on or prior to’ first 
dose of study medication, to be consistent with programming.
Section 3.6.4.1: Addition of text surrounding the Extension Period to be 
consistent with the outlined approach in the protocol deviation plan.
Section 3.6.4.2: Window of 90 days after last dose of study medication for 
serious adverse events added to definition, in line with CSP.
Section 4.1.1: Removed wording for descriptive statistics not presented on the 
log-transformed outputs.
Section 4.1.4: Updated approach for handling of systolic blood pressure to 
exclude data collected after the first administration of rescue medication, in 
line with diastolic blood pressure and other secondary endpoints.
Section 4.2.1.2: Calculation for duration of diabetes to take the earliest date 
i.e. changed to use date of informed consent rather than screening.
Section 4.2.1.4: Prior medication definition updated for clarity and consistency 
with outputs.
Section 4.2.3.1: Removal of systolic blood pressure using a different approach 
to rescue medications than the other secondary endpoints, as outlined in 
update to Section 4.1.4.
Section 4.2.3.3: Addition of baseline HbA1c by visit interaction to MMRM 
model. Removal of text surrounding unscheduled and early termination visits 
since windowing in Section 4.3 already outlines how to handle the data.
Section 4.2.3.4: Aligned model fixed effects with primary analysis.
Sections 4.2.3.5 and 4.2.4.4: Aligned modelling approach with primary with 
the addition of baseline dependent variable by visit interaction.
Section 4.2.4: Noted for summary tables the 10-week follow-up will be 
included where applicable in safety outputs.
Section 4.2.4.1: Approach to off-treatment adverse events updated to separate 
those which occurred for patients completing treatment and those prematurely 
discontinuing treatment. 
Section 4.2.4.2: Addition of injection site reactions to be summarized by 
injection device type.
Section 4.2.4.6: Wording updated to align with outputs.
Section 4.2.4.7: Addition of text from the CSP outlining mild, moderate and 
severe hypoglycemic events.
Section 4.2.5: Text added surrounding new summary table for the mixed meal 
sub-study. 


Statistical Analysis Plan 
Study Code D5551C00002
Edition Number 2.0
Date 21MAY2020
10
Date
Brief description of change
20MAY2020
Section 3.6.1: Text added regarding handling of multiple measurements that 
could be used for study baseline.
Section 3.6.3: Information on the early termination visit added from the CSP.
Section 3.6.4: Time element clarified about handling of HbA1c data 
surrounding rescue therapy.
Section 3.6.5.2: Hypoglycemic events brought in line with handling within 
periods similar to AEs. Windows for capturing data in the controlled 
assessment and extension periods clarified so patients prematurely 
discontinuing IP and completing IP have consistent approaches.
Section 3.6.5.3-6: Additional text added to define completers in the controlled 
assessment and extension periods for completing treatment or the period itself.
Section 3.6.6: Wording revised to clearly state that 7 days are being used for 
average calculations.
Section 4.2.1.4: Windows for capturing data for new concomitant medications 
in the controlled assessment and extension periods clarified so patients 
prematurely discontinuing IP and completing IP have consistent approaches 
around last dose of study medication.
Section 4.2.3.1: The eGFR estimands were added to Table 2 to describe 
approach to handling intercurrent events.
Section 4.2.3.5: Change from baseline HbA1c to screening HbA1c strata to be 
used in the MMRM modelling of secondary endpoints.
Section 4.2.4.1: Windows for capturing treatment-emergent adverse events in 
the controlled assessment and extension periods, as well as off-treatment 
adverse events clarified so patients prematurely discontinuing IP and 
completing IP have consistent approaches around last dose of study 
medication. Text surrounding AEs to be considered as leading to study 
discontinuation added.
Section 4.2.4.2: Date of device dispensing change added.
Section 4.2.4.4: Change from baseline HbA1c to screening HbA1c strata to be 
used in the MMRM modelling of secondary endpoints. 
Section 4.3.3: Table 3.4, target day for Week 52 updated. Clarity also 
provided on how patients discontinuing study medication should be handled 
when deriving total daily insulin.
Section 4.3.4.2: Removed phrasing around handling of selecting adverse 
events by intensity.
Section 5: More information provided on changes from protocol to SAP.
Section 7 (Appendix B1): Text surrounding imputing of completely missing 
end dates added.


Statistical Analysis Plan 
Study Code D5551C00002
Edition Number 2.0
Date 21MAY2020
11
1.
STUDY DETAILS
The scope of this statistical analysis plan (SAP) is to describe the planned summaries and 
analyses of data collected during the double-blind controlled assessment period (Week 0 to 
Week 24), open-label extension period (Week 24 to Week 52), follow-up period (Week 52 to 
Week 62) and the mixed meal sub-study. The presentation of data collected during the long-
term safety extension period is not within the scope of this SAP.
1.1
Study objectives
1.1.1
Primary objective
The primary objectives of the study are:
!
To assess the effect on glycemic control, as measured by glycated hemoglobin A1c
(HbA1c), of exenatide once weekly (EQW) following 24 weeks of treatment compared 
to placebo (PBO) in children and adolescents with type 2 diabetes mellitus
!
To evaluate the safety and tolerability of EQW compared to PBO following 24 weeks 
of treatment in children and adolescents with type 2 diabetes mellitus 
1.1.2
Secondary objective
The secondary objectives are:
!
To compare the effects of EQW following 24 weeks of treatment to those achieved by 
PBO in children and adolescents with type 2 diabetes mellitus on the following:
-
Fasting plasma glucose concentration
-
Proportion of patients achieving HbA1c goals
-
Body weight and Tanner pubertal stage
-
Blood pressure and lipids
!
To assess the effects of long-term EQW therapy (~1 year) in children and adolescents 
with type 2 diabetes mellitus on the following:
-
Long-term safety and tolerability
-
Parameters related to glycemic control, including HbA1c, fasting plasma glucose 
concentration, and proportion of patients achieving HbA1c goals
-
Body weight and Tanner pubertal stage
-
Blood pressure and lipids (total cholesterol, HDL, LDL, triglycerides)
!
To examine the effect of EQW on beta-cell function (HOMA-B) and insulin sensitivity 
(HOMA-S) as measured by the homeostasis model assessment (HOMA) in children 
and adolescents with type 2 diabetes who are not taking insulin.
!
To assess the pharmacokinetics (PK) of EQW in children and adolescents with type 2 
diabetes.


Statistical Analysis Plan 
Study Code D5551C00002
Edition Number 2.0
Date 21MAY2020
12
1.2
Study design
This Phase 3, double-blind (controlled assessment period), randomized, multicenter, placebo-
controlled parallel study is designed to examine the efficacy and safety of EQW compared to 
PBO in adolescents with type 2 diabetes for 24 weeks.
This study will assess safety and efficacy of EQW (as monotherapy and adjunctive therapy to 
oral antidiabetic agents and/or insulin). A schematic overview of the study design is shown in 
Figure 1. See D5551C00002 Clinical Study Protocol version 4.0, dated 14th December 2017 
(CSP) Table 1 for the schedule of activities planned.
The study includes a 24-week, controlled assessment period, during which patients will 
receive study medication in accordance to their randomized treatment group, followed by a 
28-week, open-label, uncontrolled extension period in which all patients will receive EQW.
At least 40% and not more than 60% of the randomized patients must be females.  At least 
40% of patients should be recruited from areas with similar ethnicity and lifestyle to those of 
the European Union member states.
Approximately 77 patients will be randomly assigned across 2 treatment groups in a 5:2 ratio 
to receive either subcutaneous (SC) administration of EQW 2 mg (Group A) or PBO (Group 
B), respectively, with at least 50 evaluable patients in the EQW and at least 20 evaluable 
patients in the PBO group.
In addition to receiving study medications, all patients will participate in a lifestyle 
intervention program encompassing diet and physical activity modifications from Visit 1 
(Week -2) to Visit 10 (Week 52).  If patients are taking concomitant antidiabetic medication,
they should administer their usual concomitant antidiabetic medication therapy at 
approximately the same time each day throughout the study.
Following the 24-week controlled assessment period, all patients will enter the 28-week 
extension period.  During the 28-week extension period, all patients will receive EQW 2 mg 
for 28 weeks up to Visit 10 (Week 52/End of Treatment).  The patients will return to the study 
site at 4- or 12-week intervals for safety, efficacy, Pharmacodynamics, and PK assessments 
and will complete study termination procedures at Visit 11 (Week 62/Study Termination).
All patients will complete study termination procedures Visit 11 (Week 62/Study 
Termination) which is a follow-up visit occurring 10 weeks after administration of the last 
dose of EQW at Visit 10 (Week 52).


Statistical Analysis Plan 
Study Code D5551C00002
Edition Number 2.0
Date 21MAY2020
13
Figure 1: Study Design
Abbreviations: EQW, exenatide once weekly; P, phone call 
Note: All visits scheduled during the controlled assessment period and during the open-label extension 
period should occur within ±2 days of the scheduled date, relative to Visit 2 (Week 0).
Visit 11 must occur at least 10 weeks from final dose of study medication but no more than 12 weeks.
The Investigator and/or qualified study-site personnel will contact patients by phone at Week 2, Week 16, 
and Week 26 to discuss study compliance, address any questions related to study medication, and review 
adverse events.
Note: The first dose of open-label EQW during the extension period will be given at the Week 24 visit.
1.3
Number of patients
Assuming the following conditions, a sample size of 70 patients meeting all study 
requirements was calculated:
!
True treatment difference of -0.7% between EQW and PBO in changes from baseline 
for HbA1c (%).
!
Standard deviation (SD) of 1.0%
!
Two-sided level of significance of 0.05
!
74% power to detect treatment difference
With an estimated 10% dropout rate, approximately 77 patients who have met all study 
requirements will be randomized in a ratio of 5:2 to the EQW or PBO treatment group on 
Visit 2 (Week 0) and will be carried out with stratification to achieve a balanced distribution 
of patients across treatment groups with regard to the screening HbA1c strata (<9.0% or 
≥9.0%).


Statistical Analysis Plan 
Study Code D5551C00002
Edition Number 2.0
Date 21MAY2020
14
At least 40% and not more than 60% of the randomized patients must be females. At least 
40% of patients should be recruited from areas with similar ethnicity and lifestyle to those of 
the European Union member states. The restriction on gender in the study population and also 
on the ethnicity and lifestyle will be enforced through putting caps on enrollment of patients 
with different genders and from different regions (Europe, United States [US], and others).
1.4
Mixed meal sub-study
1.4.1
Sub-study objectives
The primary objective of this exploratory sub-study is:
!
To evaluate the effect of EQW on postprandial beta-cell function as assessed by C-
peptide secretion during a mixed-meal test, following approximately 28 weeks of 
EQW treatment and at approximately 10 to 12 weeks following cessation of drug 
therapy.
The secondary objective of this exploratory sub-study is:
!
To assess postprandial glucose and glucagon responses during a mixed-meal test 
following approximately 28 weeks of EQW treatment and at approximately 10 to 12 
weeks following cessation of drug therapy.
1.4.2
Sub-study design
At baseline Visit 2 (Week 0), the study procedures to be assessed are outlined in the CSP. 
Study medication will be administered after all study procedures outlined in the main CSP are 
completed.
At Visit 10 (Week 52), the study procedures to be assessed are outlined in the CSP. Ten to 
twelve weeks following the discontinuation of study medication administration, patients will 
return to the study site for Visit 11 (Week 62/Study Termination). At this visit, the study 
procedures to be assessed are outlined in the CSP and in addition, patients will receive the 
standardized mixed-meal test and have blood drawn for additional postprandial 
pharmacodynamic assessments for the sub-study. Sub-study procedures to be performed at 
this visit are outlined in Section 9.1.3 of the CSP Appendix F.
1.4.3
Number of patients in sub-study
Approximately 20 patients participating in Protocol BCB114 who have volunteered to 
participate will be included in the sub-study. Based on a paired t-test, assuming a standard 
deviation of 110 for the change in the incremental area under the curve from 0 to 240 minutes
(AUC(0-240)) of C-peptide, a sample size of 20 patients will be adequate to provide about 
93% power to detect a change of 90 in the incremental AUC(0-240) from baseline. Power 
calculations to support the number of patients to participate in this assessment are provided in 
Table 1 of the CSP.


Statistical Analysis Plan 
Study Code D5551C00002
Edition Number 2.0
Date 21MAY2020
15
1.4.4
Pharmacodynamic assessments: Plasma Glucose, Serum Insulin, C-Peptide, 
and Glucagon
Blood will be drawn for the measurement of glucose, insulin, C-peptide, and glucagon 
concentrations according to the schedules presented in Sections 9.1.1, 9.1.2, and 9.1.3 of 
Appendix F of the CSP. For each assessment specified in those sections, one fasting blood 
sample will be taken anytime within the 30 min prior to the start of the standardized meal at 
baseline Visit 2 (Week 0), Visit 10 (Week 52), and Visit 11 (Week 62/Study Termination).
Subsequent blood samples will be taken at 15 min, 30 min, 60 min, 120 min, 180 min, and 
240 min, relative to the start of the standardized meal.
1.4.5
Pharmacokinetic assessments
Blood samples for pharmacokinetic measurements of plasma exenatide concentrations for 
potential future analysis will be collected within the 30 min prior to the start of the 
standardized meal, according to the schedule presented in Section 9.1.2 and Section 9.1.3 of 
Appendix F of the CSP.
2.
ANALYSIS SETS
2.1
Definition of analysis sets
2.1.1
All patients analysis set
The All patients analysis set will include all patients who provided written informed 
consent/assent, as relevant.
2.1.2
Randomized analysis set
The Randomized analysis set will include all randomized patients. Randomized patients will 
be analyzed in accordance to their planned treatment group.
2.1.3
Intent-to-treat (ITT) analysis set
The ITT analysis set will consist of all randomized patients who receive at least 1 dose of 
randomized study medication. ITT patients will be analyzed in accordance to their planned 
treatment group.
2.1.4
Evaluable analysis set
The Evaluable analysis set will consist of all randomized patients who receive at least 1 dose 
of randomized study medication and have at least 1 baseline and post-baseline HbA1c 
assessment. Evaluable patients will be analyzed in accordance to their planned treatment 
group.
2.1.5
Safety analysis set
The Safety analysis set will consist of all patients who received at least one dose of study 
medication.
All safety analyses on adverse events (AEs), clinical laboratory measurements, physical 
examination findings, vital signs, and antibodies to exenatide will be based on the safety 


Statistical Analysis Plan 
Study Code D5551C00002
Edition Number 2.0
Date 21MAY2020
16
analysis set. Patients will be analyzed and presented in accordance to the actual treatment 
received, regardless of planned treatment assignment. If a patient randomized to the placebo 
arm receives at least one dose of EQW during the controlled assessment period, their actual 
arm will be derived as EQW.
2.1.6
Pharmacokinetic (PK) analysis set
The PK analysis set will consist of all patients who receive at least 1 dose of EQW, for whom 
at least 1 post-dose PK concentration assessment is available, and do not deviate from the CSP
in ways that would significantly affect the PK analyses, as determined at the final protocol 
deviations meeting prior to unblinding of this study. Patients will be presented in accordance
to the actual treatment received.
2.1.7
Standardized mixed meal test evaluable analysis set
The analysis set will consist of all ITT patients who provide informed consent/assent, as 
relevant, for the sub-study and participate in the Standardized Mixed-Meal Test, complete 
study procedures in compliance with the main CSP and the sub-study and have valid and 
adequate pharmacodynamic measurements (see CSP Appendix F, Section 10) for data 
analysis. Patients will be presented in accordance to their planned treatment group.
2.2
Violations and deviations
AstraZeneca use International Conference on Harmonization (ICH) E3 terminology for 
protocol deviations (PD), which are all important deviations related to study inclusion or 
exclusion criteria, conduct of the trial, patient management or patient assessment.  Deviations 
and/or other factors that may greatly impact the completeness, accuracy, and/or reliability of 
the study data or that may significantly affect a patient’s rights, safety, or well-being include, 
at a minimum, the following categories:
!
Patients who do not meet the inclusion criteria and/or who meet one or more of the 
exclusion criteria (eligibility and entry criteria) but enter the study and are potentially 
randomized and treated.
!
Patients who receive the incorrect randomized study medication at any time during the 
24-week double-blind treatment period. In addition, patients assigned to the incorrect 
IVRS randomization stratification factor as compared to HbA1c test result at 
screening: Screening HbA1c strata (<9.0% or ≥9.0%)
!
Patients who are not compliant with study medication administration requirements 
(dose, frequency and minimum exposure etc.). This criterion includes concomitant oral 
antidiabetic medication (SoC). Defined as: 
o
Stable dose of an oral antidiabetic agent (metformin and/or sulfonylurea [SU]) 
and/or insulin for at least 2 months prior to screening for the subset of patients 
who are not treatment naïve.
!
Patients taking concomitant medications not complying with:
o
Either is not treated with or has been on a stable treatment regimen with any of 
the following medications for a minimum of 1 month prior to Visit 1 


Statistical Analysis Plan 
Study Code D5551C00002
Edition Number 2.0
Date 21MAY2020
17
(Screening):

(a) Oral contraceptives (female patients)

(b) Antihypertensive agents

(c) Lipid-lowering agents

(d) Thyroid replacement therapy

(e) Antidepressant agents
!
Patients who develop withdrawal criteria during the study but were not discontinued 
from study medication/study. 
!
Patients who do not comply with the protocol-specified assessments criteria (efficacy 
+ safety).
!
Patients who do not adhere to the protocol-specified visit schedule. 
!
Other factors, for example GCP violations, fraudulent data which will exclude patients 
at that level.
!
Emergency unblinding during the 24-week double-blind treatment period.
!
Discrepancies in IVRS versus electronic case report form (eCRF) randomization 
stratification factors.
Important protocol deviations (PDs or other underlying factors), as detailed in a separate PD 
plan, will be identified and documented by the study physicians and statisticians prior to 
unblinding of the data.
3.
PRIMARY AND SECONDARY VARIABLES
3.1
Primary efficacy variable
The primary efficacy endpoint is change in HbA1c from baseline Visit 2 (Week 0) to Visit 7 
(Week 24).
3.2
Secondary efficacy variables 
The following are the secondary efficacy endpoints: 
!
Change in HbA1c from baseline Visit 2 (Week 0) to Visit 10 (Week 52), and to each 
intermediate visit as applicable
!
Change in fasting plasma glucose concentration from baseline Visit 2 (Week 0) to 
Visit 7 (Week 24), Visit 10 (Week 52), and to each intermediate visit as applicable
!
Proportions of patients achieving HbA1c goals of <6.5%, ≤6.5% and <7.0% at Visit 7 
(Week 24), Visit 10 (Week 52), and at each intermediate visit as applicable
!
Change in body weight from baseline Visit 2 (Week 0) to Visit 7 (Week 24), Visit 10 
(Week 52), and to each intermediate visit as applicable


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!
Change in fasting insulin from baseline Visit 2 (Week 0) to Visit 7 (Week 24), Visit 10 
(Week 52), and to each intermediate visit as applicable
!
Change in beta-cell function (HOMA-B) and insulin sensitivity (HOMA-S) as 
measured by homeostasis model assessments in EQW patients not taking insulin from 
baseline Visit 2 (Week 0) to Visit 7 (Week 24), Visit 10 (Week 52), and to each 
intermediate visit as applicable
!
Change in lipids (total cholesterol, high-density lipoprotein [HDL], low-density 
lipoprotein [LDL] and triglycerides) from baseline Visit 2 (Week 0) to Visit 5 (Week 
12), Visit 7 (Week 24), Visit 10 (Week 52), and to each intermediate visit as applicable
!
Change in blood pressure (systolic and diastolic) from baseline Visit 2 (Week 0) to 
Visit 7 (Week 24), Visit 10 (Week 52), and to each intermediate visit as applicable
!
Plasma exenatide concentrations at baseline Visit 2 (Week 0), Visit 7 (Week 24), Visit 
10 (Week 52), and each intermediate visit, as applicable
!
Proportions of patients discontinuing the study and the proportion of patients needing 
rescue due to failure to maintain glycemic control, and number of rescue episodes at 
Visit 7 (Week 24), Visit 10 (Week 52), and at each intermediate visit as applicable
3.3
Exploratory efficacy variables
The exploratory efficacy endpoints are:
!
Change in Body Mass Index (BMI) from baseline Visit 2 (Week 0) to Visit 7 (Week 
24), Visit 10 (Week 52), and to each intermediate visit as applicable
!
Change in body weight percentile and height percentile from baseline Visit 2 (Week 0) 
to Visit 7 (Week 24), Visit 10 (Week 52), and to each intermediate visit as applicable. 
The height and weight percentile will be determined based on the standardized growth 
chart for boys and girls (developed by the National Center for Health Statistics in 
collaboration with the National Center for Chronic Disease Prevention and Health 
Promotion).
3.4
Safety variables
!
Corresponding to the primary safety objective, safety and tolerability endpoints 
including the incidence of treatment emergent AEs (TEAEs; see section 4.2.4.1), 
antibodies to exenatide, physical examinations, laboratory measurements (clinical, 
chemistry/hematology), and vital sign measurements from baseline Visit 2 (Week 0) to 
Visit 7 (Week 24), Visit 10 (Week 52), and to each intermediate visit as applicable
!
Proportions of patients reporting different injection site reactions at Visit 3 (Week 4) 
through Visit 10 (Week 52) (see Section 4.2.4.2 for details of injection site reaction 
reporting)
!
Change in calcitonin, pancreatic amylase, and lipase from baseline Visit 2 (Week 0) to 
Visit 5 (Week 12) and Visit 10 (Week 52)


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!
Change in Thyroid-stimulating hormone (TSH), thyroxine (free T4), prolactin, 
cortisol, insulin-like growth factor 1 (IGF-1), and Dehydroepiandrosterone (DHEAS)
from baseline Visit 2 (Week 0) to Visit 5 (Week 12), Visit 7 (Week 24), and Visit 10 
(Week 52)
!
Tanner pubertal stage at baseline Visit 2 (Week 0), Visit 5 (Week 12), Visit 7 (Week 
24), Visit 9 (Week 40), and Visit 10 (Week 52)
3.5
Exploratory safety variables
!
Change in carcinoembryonic antigen (CEA) from baseline Visit 2 (Week 0) to Visit 5 
(Week 12) and Visit 10 (Week 52)
!
Change in bone specific alkaline phosphatase and N-telopeptide from baseline Visit 2 
(Week 0) to Visit 5 (Week 12), Visit 7 (Week 24) and Visit 10 (Week 52)
!
Change in follicle-stimulating hormone (FSH), luteinizing hormone (LH), FSH/LH, 
total testosterone, sex hormone binding globulin (SHBG), and estradiol from baseline 
Visit 2 (Week 0) to Visit 5 (Week 12), Visit 7 (Week 24), and Visit 10 (Week 52)
!
Change in total testosterone and SHBG also at Visit 9 (Week 40). Free testosterone 
will be calculated from total testosterone and SHBG values at Visit 5 (Week 12), Visit 
7 (Week 24), Visit 9 (Week 40), and Visit 10 (Week 52).
3.6
Definition of study variables
Refer to Section 4.3 for details on conventions such as visit windowing and handling of 
duplicate efficacy assessments.
3.6.1
Study baseline
The baseline measurement is defined as the last non-missing (either numerical or character)
value, including values from unscheduled visits, collected on or prior to the first dose of study 
medication in the double-blind treatment period.  Assessments carried out on the date of first 
dose are assumed to have been done pre-dose unless time information indicates otherwise. In 
case of multiple measurements for a given variable with tied collection date or date/time, the 
mean of the values will be calculated for baseline. If the baseline value is missing for a given 
variable, change from baseline will be missing. 
For change from baseline summaries of data collected during the extension period, the 
baseline value will not be rederived.
3.6.2
Change and percent change from baseline
Change from baseline to any randomized treatment period Week t is defined as follows:
CWeek t = MWeek t - Mbaseline,
Where:
−
CWeek t is the change from baseline at Week t,
−
MWeek t is the measurement at Week t,


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−
Mbaseline is the baseline measurement.
Percent change from baseline to any randomized treatment period Week t is defined as 
follows:
PWeek t =100×(MWeek t - Mbaseline) / Mbaseline.
If the baseline value is zero, the percent change will be missing.
3.6.3
Early Termination visit
If a patient discontinues after randomization but prior to completion of the study treatment 
period, the patient will be invited to return as soon as possible to the study site for an early 
termination (ET) visit. Patients will be invited to return to the study site for an ET visit to 
collect HbA1c, fasting plasma glucose, body weight, and clinical safety laboratory measures.
Patients who discontinue study medication prior to Visit 11 (Week 62/Study Termination) will 
also participate in the Extended Safety Follow-up Period, unless they have a height increase of 
less than 5 mm over a 6-month interval at study-site visits prior to discontinuation of study 
medication.
3.6.4
Rescue therapy
Rescue therapy is defined as any new concomitant medication (see Section 4.2.1.4 for detail) 
with therapy reason given as “Protocol defined exacerbation of disease under study”. 
A rescue episode will be defined as the first unique rescue therapy entry on the CM eCRF. If a 
patient has multiple entries on the CM form flagged as a rescue therapy, the first will be 
considered the point at which the patient was rescued. 
Increases in insulin from baseline in patients receiving insulin at baseline will be 
programmatically derived from the CM CRF and reviewed by the clinical team prior to 
unblinding. Increases identified as potential rescue episodes will be queried at the site-level 
and therapy reason may be updated to “Protocol defined exacerbation of disease under study”. 
For patients who require initiation of rescue therapy and continue study treatment, only data 
before initiation of rescue therapy will be included in the primary efficacy analysis. If HbA1c 
is measured before rescue therapy, then we will include the HbA1c measurement. If HbA1c is 
measured on the date of first rescue therapy but no time information is available to indicate if 
it was taken before rescue therapy, then HbA1c will be assumed to be prior and included in 
the primary efficacy analysis. Sensitivity analyses including data after initiation of rescue 
therapy will be carried out to test the robustness of the missing data assumption.
3.6.5
Study periods
The following definitions will be used to assign data to the correct study period. For details on 
which data will be presented in outputs for each endpoint, refer to Section 4.2.


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3.6.5.1
Efficacy
Controlled assessment period: For efficacy parameters, the controlled assessment period will 
be defined as date of first dose of randomized study medication to date of the Week 24 visit, 
or the Early Termination visit for patients who discontinue the study prior to Week 24.
Extension period: For efficacy parameters, the start date of the extension period will be 
defined as date of first dose of open-label EQW + 1 day, in order to ensure assessments done 
on the Week 24 visit date are assigned to the controlled assessment period. The end date of the 
extension period will be defined as the Week 52 visit, or the Early Termination visit for 
patients who discontinue the study prior to Week 52. The extension period will only be 
defined for patients who enter the extension period and receive at least one dose of open-label 
EQW.
Treatment period: The treatment period for efficacy parameters will be defined as the 
controlled assessment period and extension period combined i.e. date of first dose of 
randomized study medication to date of Week 52 visit or Early Termination visit for patients 
who discontinue the study prior to Week 52.
See Section 4.1.3 for details on missing data handling.
3.6.5.2
Safety and concomitant medications
Adverse events, hypoglycemic events and concomitant medications on the date of first dose of 
open-label EQW (Week 24 visit) will be assigned to the extension period as this is considered 
a conservative approach. Other safety assessments at the Week 24 visit will be considered to 
have been carried out pre-dose and will therefore be assigned to the controlled assessment 
period. This is reflected in the definitions below.
Controlled assessment period: 
!
For patients who do not enter the extension period, the controlled assessment period 
will be defined as date of first dose of randomized study medication to date of last dose 
of randomized study medication + 7 days (or + 90 days after last dose of study 
medication for reporting of serious adverse events (SAEs) and other clinically 
significant or related AEs). 
!
For patients who go on to enter the extension period, the controlled assessment period 
for all safety parameters except AEs, hypoglycemic events and concomitant 
medications will be defined as date of first dose of randomized study medication to 
date of first dose of open-label EQW. For AEs, hypoglycemic events and concomitant 
medications, the controlled assessment period will be defined as date of first dose of 
randomized study medication to date of the first dose of open-label EQW – 1 day, in 
order for AEs, hypoglycemic events and medications recorded on the date of first dose 
of open-label EQW to be assigned to the extension period.
Extension period: For all safety parameters, except AEs, hypoglycemic events and 
concomitant medications, the extension period will be defined as date of first dose of open-


Statistical Analysis Plan 
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label EQW + 1 to date of last dose of open-label EQW + 7 days. For AEs, hypoglycemic 
events and concomitant medications, the extension period will be defined as date of first dose 
of open-label EQW to date of last dose of open-label EQW + 7 days (or + 90 days for SAEs
and other clinically significant or related AEs). The extension period will only be defined for 
patients who enter the extension period and receive at least one dose of open-label EQW.
Treatment period: The treatment period for safety parameters will be defined as the controlled 
assessment period and the extension period combined i.e. date of first randomized study dose 
to the date of last dose of study medication + 7 days (randomized study medication for 
patients who do not enter the extension period or last dose of open-label EQW for patients 
who enter the extension period). For SAEs and other clinically significant or related AEs, the 
last dose of study medication + 90 days will be used for reporting.
See Section 4.1.3 for details on missing data handling.
3.6.5.3
Controlled assessment period treatment completion
A treatment completer for the controlled assessment period is defined as a patient who has a
Week 24 assessment without discontinuing study medication for the controlled assessment 
period prior to the visit.
3.6.5.4
Controlled assessment period completion
A completer of the controlled assessment period is defined as a patient who has a Week 24 
assessment regardless of study medication status at the visit. 
3.6.5.5
Extension period treatment completion
A treatment completer for the extension period is defined as a patient who has a Week 52
assessment without discontinuing open-label EQW for the extension period prior to the visit. 
3.6.5.6
Extension period completion
A completer of the extension period is defined as a patient who has a Week 52 assessment 
regardless of open-label EQW status at the visit. 
3.6.6
Total daily insulin dose
Baseline total daily insulin dose will be calculated as the sum of available insulin doses taken 
in the 7 days prior to date of first dose of randomized study treatment, divided by 7. This is 
because it is not possible to ascertain whether insulin taken on date of first study treatment 
was pre or post dose.
Total daily dose for all post-baseline visits to Week 52 will be calculated as the sum of 
available insulin doses taken 6 days before and additionally including the target day of each 
visit (e.g. Week 4 total daily dose will be based on insulin taken on study day 29, plus the 6 
days prior), divided by 7. If a subject is missing days with insulin records within the range, 
total daily dose will be set to zero for that day (i.e. absence of insulin implies the patient was 


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not taking insulin). For the Week 24 visit only, total daily dose will be calculated as 7 days 
prior to the Week 24 visit, divided by 7.
Overlapping records for short-acting insulin medications (i.e. multiple insulin records known 
to be received on the same day) will be summed to obtain the total daily dose on that day. 
Overlapping records for long-acting insulin medications will be queried to site. Where 
overlapping records of one day still occur, it will be assumed the new long-acting insulin dose 
started the day after the current long-acting insulin dose.
Only records with dose in units (IU) will be included in the derivation of total daily dose. Any 
medications identified as “Intermediate” will be classified under short-acting insulin 
medications.
For the purposes of derivation of total daily insulin dose, insulin records with completely 
missing start dates will have start date imputed as 7 days prior to first dose of randomized 
study treatment, except in the case where stop date of the medication is earlier than 7 days
before first dose. Completely missing end dates will be imputed as date of last contact. Partial 
start and end dates will be imputed using the rules in Section 7.2.
3.6.7
Free testosterone
Free testosterone will be derived at each visit using the following equations steps:
  N = 1 + Kalb*ALB/69000
  a = N*Kshbg
  b = N + Kshbg*(SHBG - TT)/10^9
  c = -TT/10^9
  FT = (-b + sqrt(b^2 - 4*a*c))/(2*a)*10^9
Where,
!
Kalb is constant for albumin, defined as 3.6×104
!
Kshbg is constant for SHBG, defined as 109
!
ALB is albumin in g/L
!
SHBG is sex hormone binding globulin in nmol/L
!
TT is total testosterone in nmol/L
!
FT is free testosterone
4.
ANALYSIS METHODS
4.1
General principles
All statistical evaluations as well as summaries and tabulations will be done by qualified 
personnel at IQVIA. Before breaking the treatment codes, following clean file declaration 
(database lock), all decisions on the evaluability of the data for each individual patient will be 
made and documented, and each patient will be assigned to the appropriate analysis set.


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Statistical analysis software (SAS) version 9.4 or later will be used to generate all statistical 
analyses, data summaries and listing.
4.1.1
Statistical notations and presentations
In general, all efficacy and safety variables will be summarized using descriptive statistics as 
appropriate.  Continuous variables will be summarized by descriptive statistics (sample size 
(n), mean, SD, minimum, median and maximum). Quartiles 1 and 3 may be included for some 
parameters where appropriate. The mean and median will be presented with one more decimal 
place than the original data.  Standard deviation with two more decimal places than the 
original data.  Minimum and maximum values with the same number of decimal places than 
the original data. Categorical variables will be summarized using frequency tables 
(frequencies and percentages). Percentages will be rounded to 1 decimal place.
For log-transformed data, the following descriptive statistics will be presented: n, geometric 
mean, geometric coefficient of variation (GCV%), geometric standard deviation factor (GSD), 
arithmetic mean, standard deviation, coefficient of variation (CV%), median, minimum and 
maximum.
GCV (%) will be calculated as
∀#
∀
#
1
exp
100
2 ∃
%
s
where s is the SD of the data on a log scale.  
Individual data will be presented in patient listings. All patient data listings will be sorted by 
treatment and patient ID. 
In outputs, the following treatment labels will be used, except where data from the extension 
period are displayed:
Summaries including data from the extension period will be presented by the controlled 
assessment period treatment group. The following treatment labels will be used:
4.1.2
Hypothesis testing significance level
All statistical tests will be conducted at a 2-sided significance level of 5% unless otherwise 
specified. Where appropriate, model-based point estimates, together with their 95% 
confidence intervals will be presented along with the 2-sided p-values for the tests. P-values 
will be rounded to 3 decimal places.
A hierarchy of the primary and selected secondary endpoints is defined in Section 4.2.3.2.
Treatment group
Label
Exenatide 2mg
EQW
Placebo 
Placebo
Treatment group during controlled 
assessment period
Label
Exenatide 2mg
EQW
Placebo 
Placebo -> EQW


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4.1.3
Handling of missing data
4.1.3.1
Missing efficacy data
Missing data in this study may result from patients discontinuing from the study prematurely 
or missing intermediate visits or selected assessments while remaining on study. Every effort 
will be made to obtain the CSP-required data for all study assessments that are scheduled for
all patients who have been enrolled. Data collected after initiation of rescue therapy will be 
excluded from most efficacy analyses (see Section 4.2.3 for details) and therefore these data 
will effectively be handled as missing in analyses. For efficacy analyses, in general missing 
observations will not be imputed, except those inherited from the mixed model repeated 
measures (MMRM) which implicitly assumes that data are missing at random (MAR).  A 
sensitivity for the primary analysis will be performed using pattern mixture model imputation
for missing values and details of this imputation is provided in Section 4.2.3.4.
Missing at Random (MAR) refers to missingness that is independent of missing responses, 
conditionally on observed responses and covariates. As the imputation strategy should always 
consider the dropout patterns and the time-course of the efficacy measurements by treatment, 
the pre- and post- withdrawal values will be assessed to understand the impact of dropouts on 
the efficacy results. The primary efficacy endpoint of HbA1c data will be visually examined 
to explore the missingness patterns by (1) plotting each individual patient’s HbA1c change 
trajectory in completers side-by-side with those who have prematurely discontinued study 
medication, and by (2) plotting the last HbA1c change from baseline for those who 
discontinue study medication prematurely, overlaid with the box plot of change from baseline 
in HbA1c by visit for completers.  
For categorical endpoints HbA1c goals of <6.5%, ≤6.5% and < 7% at 24 weeks, any patient
with missing HbA1c value at 24 weeks will be considered as failed to meet HbA1c <6.5%, 
≤6.5% and < 7%, respectively, at endpoint (24 Weeks). The same will apply for these 
endpoints at 52 weeks endpoint.
4.1.3.2
Missing baseline and demographic data
For demographic and baseline characteristics, each variable will be analyzed and/or 
summarized using the available data. For continuous variables, missing data will be indicated 
in the “n” count and for categorical variables, unless indicated otherwise, percentages will be 
calculated out of the total number of patients with data available. A count of patients with 
missing data will be tabulated.
4.1.3.3
Missing safety data
Safety analyses will be conducted on the observed data only.
However, imputation of missing or partial AE and concomitant medication onset/start and 
end/stop dates will be used to determine the status of each AE and the previous/concomitant 
status of each medication. Refer to Appendix B1 and B2 for the method of imputation of 
missing/partial AE/concomitant onset/start and end/stop dates. Missing/partial start/stop dates 
will appear as is (i.e., without imputation) in the patient data listings, but will be imputed to 
permit the proper tabulation of AE and concomitant medications data.


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4.1.3.4
Premature discontinuation
Patients who discontinue study medication prior to Visit 11 (Week 62/Study Termination)
should enter the Extended Safety Follow-up Period, unless they have a height difference of 
less than 5 mm over a 6-month interval at study-site visits prior to discontinuation of study 
medication. Efficacy data are not collected during the Extended Safety Follow-up Period and 
this period will be reported separately to the primary clinical study report (CSR), so data 
beyond discontinuation of study medication will not be included in analyses.
Patients who discontinue the study prematurely should have all early termination visit 
procedures done at the time of study discontinuation.
4.1.4
Handling of data post rescue medication
Instances of patients meeting rescue criteria and subsequently receiving rescue medication 
will be recorded by sites as defined in Section 3.6.3.
A loss of glycemic control observed by either 1) an increase from baseline in HbA1c values 
by 1.0% or more that is confirmed at a subsequent clinic visit scheduled at the Investigator’s 
discretion, or 2) fasting glucose value ≥250 mg/dL or random blood glucose >300 mg/dL for 4 
days during a 7-day period measured by home self-monitored blood glucose (SMBG), and 
confirmed by fasting or random glucose test within the same range of values (measured by 
local laboratory) at a clinic visit, will result in initiation of rescue medication. A clinic visit to 
confirm the values obtained by home SMBG or fasting/random glucose tests must take place 
within 2 weeks following the aforementioned self-measurements.
Patients meeting rescue criteria will be treated with antihyperglycemic therapy (e.g., insulin) 
by the Investigator or referred to their treating physician to seek conventional 
antihyperglycemic intervention. Patients meeting these criteria should remain in the study and 
continue to receive study medication, at the discretion of the Investigator. Acute 
decompensation due to an intercurrent illness treated briefly with insulin will be allowed for 2 
weeks, if longer this should be considered as rescue medication.
Derivation of variables at initiation of rescue medication
Efficacy
In general, efficacy data are to be continuously collected during the glycemic rescue therapy. 
For all efficacy endpoints, except the plasma exenatide concentration endpoint, data collected 
after the first administration of rescue therapy will be excluded from the descriptive statistical 
summary and inferential statistical analyses.
However, data collected after initiation of rescue medication will be included in several 
sensitivity and supportive analyses for the primary analysis to provide a comprehensive view 
of the treatment effect (see more details in Section 4.2.3.4). 


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Safety
Because patients can continuously receive study medication concurrent with the rescue 
therapy, all safety data collected during the rescue medication treatment period will be 
summarized and analyzed together with those collected prior to the rescue therapy.
4.1.5
Statistical modelling
In general, continuous variables will be analyzed using a MMRM if multiple post-baseline 
measurements are required by CSP. The MMRM analysis will be treated as the primary 
analysis method for continuous efficacy endpoints. The statistical analysis of categorical 
variables will be done using a stratified Cochran-Mantel-Haenszel (CMH) test.
Standard diagnostic approaches will be used to verify that the key statistical assumptions of 
the MMRM and CMH test hold.
If the distributional assumptions of the MMRM for the primary analysis do not hold, 
alternative models will be explored using appropriate transformed data.
4.2
Analysis methods
4.2.1
Study disposition and baseline demographics
4.2.1.1
Patient disposition
Patient disposition information for all patients who provided informed consent, including 
counts and percentages of patients who completed the controlled assessment period and 
extension period will be summarized. Patients who discontinue study medication early and 
patients who discontinue the study early (including reasons for early discontinuation) during 
the controlled assessment and extension periods, will be summarized overall and by region 
and country for each treatment group, for all patients. The denominator for percentages will 
be the total number of patients in the randomized analysis set, overall and by treatment group. 
No percentage will be displayed for number of patients enrolled. A listing of patient 
disposition will be provided, including reasons for early discontinuation and reasons for IP 
discontinuation. A flow diagram of patient disposition will be presented.
The number and percentage of patients in each analysis set will also be reported overall and 
by treatment group. The denominator for percentages will be the total number of patients in 
the randomized analysis set, overall and by treatment group.
4.2.1.2
Demographics and baseline characteristics
Demographic and baseline characteristics will be summarized for the ITT and safety analysis 
sets overall and by treatment group as per below table.
Table 1
Analysis for demographics, baseline patient and disease characteristics
Demographic and baseline characteristics
Categories
Age (years), (continuous)


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Table 1
Analysis for demographics, baseline patient and disease characteristics
Demographic and baseline characteristics
Categories
Age group 1 (years), (categorical)
<10
10 to 17
>17
Age group 2 (years), (categorical)
<10
10 to 12
13 to 16
> 16
Sex
Male
Female
Race
White 
Black or African American
Asian
Native Hawaiian or Other Pacific Islander
American Indian or Alaska Native
Other
Ethnic Group
Hispanic or Latino
Not Hispanic or Latino
Region
Europe 
Middle East
North America
South America
Country
Bulgaria
Hungary
Israel
Mexico
Ukraine
USA
Kuwait
Height (cm), (continuous)


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Table 1
Analysis for demographics, baseline patient and disease characteristics
Demographic and baseline characteristics
Categories
Weight (kg), (continuous)
Body Mass Index (BMI) (kg/m2), 
(continuous)
Height population percentile group 
(categorical)
<3
3 to < 85
85 to < 97
> = 97
Weight population percentile group
(categorical)
<3
3 to < 85
85 to < 97
> = 97
BMI population percentile group (categorical)
<3
3 to < 85
85 to < 97
> = 97
Baseline HbA1c (%), (continuous)
HbA1c stratum (%), (categorical)
<9.0
≥9.0
Duration of Diabetes (years), (continuous)
Duration of Diabetes (years), (categorical)
< 1
≥ 1 to ≤5
>5
Baseline FPG (fasting plasma glucose),
mg/dL, (continuous)
Baseline FPG (fasting plasma glucose),
mmol/L, (continuous)
Baseline eGFR (mL/min/1.732) (continuous)
Baseline eGFR (mL/min/1.732)
≥125
<125


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Table 1
Analysis for demographics, baseline patient and disease characteristics
Demographic and baseline characteristics
Categories
Baseline Tanner Stage
Stage 1
Stage 2
Stage 3
Stage 4
Stage 5
Patient’s age (years) will be presented as collected on the DM eCRF at screening.
BMI will be calculated as the ratio of patient’s baseline weight (in kilograms) to the square of 
the patient’s height (in meters): BMI = kg/m². The Investigator-calculated BMI will not be 
summarized or listed. Height is collected in cm and will be converted to meters (by dividing by 
100) before calculating BMI.
Percentile of body weight and percentile of height will be determined based on the 
standardized growth chart for boys and girls (developed by the National Center for Health 
Statistics in collaboration with the National Center for Chronic Disease Prevention and Health 
Promotion (Center for Disease Control and Prevention, 2000).
Duration of diabetes (years) will be calculated using the informed consent date and the date of 
diabetes diagnosis (see below).
If date of diabetes diagnosis is…
Then duration of diabetes (years) is…
Complete date
(Date of informed consent – Date of 
diabetes diagnosis + 1) / 365.25
Partial date
(a) Year and month are not missing, but day 
is missing
(b) Year is not missing, but month and date 
are both missing
(b1) Year of diabetes diagnosis is 
different from the year of informed 
consent (b2) Year of diabetes 
diagnosis is the same as year of 
informed consent
(a) Impute missing day 1st of the month, 
then use complete date rule
(b1) Difference between year of diabetes 
diagnosis and year of informed consent
(b2) 2/12 (2 months)
4.2.1.3
Medical/Surgical history
All medical/surgical history by each system organ class (SOC) and preferred term (PT) will be 
summarized by treatment group for the safety analysis set in accordance with the terminology 


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of the latest version of the Medical Dictionary for Regulatory Activities (MedDRA) available 
at database lock (DBL).
Percentages will be calculated out of the total number of patients in the analysis set displayed 
in the output, overall and by treatment group.
4.2.1.4
Concomitant medications
All medications will be coded using the latest version of WHO Drug Dictionary (WHODD)
available at DBL.  
Medications will be classified as:
!
Pre-treatment medication: Medications stopped prior to first randomized dose of study 
medication.
!
Prior concomitant medication:  
-
Controlled assessment period: Medications started prior to and that continue 
past the first randomized dose of study medication.
-
Extension period: Medications started prior to the first EQW dose at Visit 7 
(Week 24), that either stop or are ongoing in the extension period, continuing
past Visit 7 (Week 24). Note, for patients receiving EQW during the controlled 
assessment period, this definition includes medications started during the 
controlled assessment period, prior to the first EQW dose at Visit 7 (Week 24)
and continuing past Visit 7 (Week 24). These medications will be considered as 
"new concomitant' for the controlled assessment period in the tabulation of new 
concomitant medications (see below).
!
New concomitant medication:  
-
Controlled assessment period: Medications with a start date on or after the first 
randomized dose up to but not including Visit 7 (Week 24) for patients who 
enter the extension period. For patients who do not enter the extension period, 
medications initiated with a start date on or after the first randomized dose up 
to and including last dose of randomized study medication + 7 days. Hence, for 
patients who go into the extension period, any medications started on the date 
of the first open-label EQW dose will be assigned to the extension period.
-
Extension period: Medications with start date on or after Visit 7 (Week 24) up 
to and including last dose of open-label EQW + 7 days.
!
Post-treatment medications: Medications that started the day after the last dose of 
study medication + 7 days. If the patient discontinues prior to Week 24, the last dose is 
the last dose of randomized study medication. If the patient discontinues during the 
extension period, the last dose is the last dose of open-label EQW.
The number and percentage of patients receiving prior concomitant and new concomitant 
medications will be summarized by treatment and Anatomical Therapeutic Chemical (ATC)


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classification (level 4) for the ITT analysis set. The summary will be presented by study 
period (controlled assessment period and extension period).
Antidiabetic concomitant medications will be summarized separately by 
chemical/pharmacological/therapeutic subgroup (ATC level 4) and generic term in the same 
manner.
Background insulin therapy use during the study will be summarized as outlined in Section 
3.6.5 for long-acting, short-acting and overall total daily insulin dose. Data collected after 
discontinuation of study medication will be excluded.
Rescue medications will be summarized during the controlled assessment period for the ITT 
analysis set and separately during the extension period separately for the subset of ITT 
patients who received open-label EQW.
A listing for rescue medications will be provided. 
Pre-treatment medications and post-treatment medications will be summarized separately by 
treatment and ATC classification for the ITT analysis set.
Medications with start/stop dates that are partially/completely missing will be imputed as 
described in Appendix B2.
4.2.2
Overall compliance and extent of exposure
Treatment compliance (number of doses received relative to doses planned) will be 
summarized by treatment for the safety analysis set.
For the calculation of the compliance, the number of planned doses is defined as the duration 
of treatment exposure (in days) / 7, rounded to the highest integer.
Compliance will be presented for patients in the controlled assessment period (Week 0 to 
Week 24) for the Safety analysis set. It will also be presented for the Treatment period (see 
Section 4.1.1) in the subset of Safety patients who received open-label EQW. For this 
summary, PBO compliance will be calculated based on EQW exposure.  Treatment 
compliance for controlled assessment period of 24 weeks will be calculated for each patient
using the total number of doses received divided by the number of planned doses. Treatment 
compliance for the Treatment period will be calculated for each patient using the total number 
of EQW doses received divided by the number of planned EQW doses.  Percent compliance 
will then be categorized to <80%, 80% to <120%, and ≥120% and summarized by treatment 
group. 
The total number of doses received will be calculated as the total number of used/ partially 
used vials returned, based on returned used/unused study medication data collected in the 
eCRF page at each visit. 
The total number of medication packets dispensed will be calculated from the study 
medication dispensation information collected on the DA eCRF.
Exposure will be presented for patients in the controlled assessment period (Week 0 to Week 
24) for the Safety analysis set. Separately, it will be summarized for the subset of Safety
patients who received open-label EQW for the Treatment period based on EQW exposure.


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The following will be used to calculate the duration of exposure, in days:
!
Duration of EQW exposure for EQW patients during the Treatment period = Date of 
Last Injection of Study Medication - Date of First Injection of Study Medication + 7;
!
Duration of EQW exposure for PBO patients who enter the extension period = Date of 
Last Injection of EQW - Date of First Injection of EQW + 7;
!
Duration of PBO/EQW exposure during the controlled assessment period = Date of 
Last Injection of Study Medication during the controlled assessment period - Date of 
First Injection of Study Medication during the controlled assessment period + 7
Dose interruptions will not be taken into consideration for calculation of duration of exposure.
The mean, SD, median, minimum, and maximum duration of exposure will be provided by 
treatment group.  Extent of exposure will also be categorized into fixed intervals as follows, 
with number of patients and percentage summarized by treatment group:
!
For the summary of exposure during the controlled assessment period, intervals are 
defined: 1-13, 14-27, 28-55, 56-83, 84-111, 112-139, 140-167, ≥168 days
!
For the summary of exposure during the treatment period, intervals are defined: 1-13, 
14-27, 28-55, 56-83, 84-111, 112-139, 140-167, 168-195, 196–223, 224-251, 252-
279, 280-307, 308-335, 336-363, ≥364 days
In addition, the extent of exposure will also be summarized by country for both the controlled 
assessment period and the Treatment period. 


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4.2.3
Efficacy analysis
4.2.3.1
Estimands
Estimands for the study are defined in Table 2. Intercurrent events (IE) that may occur during the study are receipt of rescue 
therapy, IP discontinuation and study withdrawal.
Table 2 Estimand framework
Attributes
Estimand
Population
Variable
Intercurrent event strategy
Population-level 
summary
Primary
Evaluable
Change in HbA1c from 
baseline to Week 24
Rescue and IP 
discontinuation: Data after 
event excluded. Hypothetical 
approach due to missing at 
random (MAR) assumption of 
MMRM analysis. 
Withdrawal from study prior 
to Week 24: Hypothetical 
approach due to MAR 
assumption of MMRM 
analysis.
Least squares mean 
difference in CFBL at 
W24 between EQW and 
PBO
Sensitivity to 
primary
Evaluable
Change in HbA1c from 
baseline to Week 24
All IEs: Data after event 
excluded. Hypothetical 
approach using multiple 
imputation (MI) pattern 
mixture model imputation.
Least squares mean 
difference in CFBL at 
W24 between EQW and 
PBO


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Supplementary to 
primary
Evaluable
Change in HbA1c from 
baseline to Week 24
Rescue and IP 
discontinuation: Data after 
event included. Treatment 
policy approach. 
Withdrawal from study prior 
to Week 24: Hypothetical 
approach due to MAR 
assumption of MMRM 
analysis.
Least squares mean 
difference in CFBL at 
W24 between EQW and 
PBO
Sensitivity to 
supplementary of 
primary
Evaluable
Change in HbA1c from 
baseline to Week 24
Rescue and IP 
discontinuation: Data after 
event included. Treatment 
policy approach. 
Withdrawal from study prior 
to Week 24: Hypothetical 
approach using MI pattern 
mixture model imputation.
Least squares mean 
difference in CFBL at 
W24 between EQW and 
PBO
Secondary 1
Evaluable
Change in HbA1c from 
baseline to Week 24 and each 
intermediate visit
Rescue and IP 
discontinuation: Data after 
event excluded. Hypothetical 
approach due to MAR 
assumption of MMRM 
analysis.
Withdrawal from study prior 
to Week 24: Hypothetical 
approach due to MAR 
Least squares mean 
difference in CFBL at 
Week 24 and each 
intermediate visit.


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assumption of MMRM 
analysis.
Secondary 2
Evaluable
Proportions of patients having 
HbA1c goals of <6.5%, ≤6.5% 
and <7.0% at Week 24 and at 
each intermediate visit
Rescue and IP 
discontinuation: Data after 
event excluded. Composite 
approach used, with patients 
with missing data at endpoint 
treated as non-responders. 
Withdrawal from study prior 
to Week 24: Composite 
approach used, with patients 
with missing data at endpoint 
treated as non-responders.
Difference in proportion 
of responders at Week 
24 and each intermediate 
visit between EQW and 
PBO
Sensitivity to 
secondary 2
Evaluable
Proportions of patients having 
HbA1c goals of <6.5%, ≤6.5% 
and <7.0% at Week 24 and at 
each intermediate visit
Rescue and IP 
discontinuation: Data after 
event excluded. Hypothetical 
approach using MI pattern 
mixture model imputation. 
Withdrawal from study prior 
to Week 24: Hypothetical 
approach using MI pattern 
mixture model imputation.
Difference in proportion 
of responders at Week 
24 and each intermediate 
visit between EQW and 
PBO
Other continuous 
secondary 
endpoints 
ITT
Change in X from baseline to 
Week 24 and each 
intermediate visit
Rescue and IP 
discontinuation: Data after 
event excluded. Hypothetical 
approach due to MAR 
Least squares mean 
difference in CFBL at 
Week 24 and each 
intermediate visit, as 
applicable.


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assumption of MMRM 
analysis.
Withdrawal from study prior 
to Week 24: Hypothetical 
approach due to MAR 
assumption of MMRM 
analysis.
Exploratory
Safety
Change in eGFR from 
baseline to Week 24 and each 
intermediate visit by baseline 
eGFR category
Rescue and IP 
discontinuation: Data after 
event excluded. Hypothetical 
approach due to MAR 
assumption of MMRM 
analysis.
Withdrawal from study prior 
to Week 24: Hypothetical 
approach due to MAR 
assumption of MMRM 
analysis.
Least squares mean 
difference in CFBL at 
Week 24 and each 
intermediate visit.
Sensitivity to 
exploratory
Safety
Change in eGFR from 
baseline to Week 24 and each 
intermediate visit by baseline 
eGFR category
Rescue: Data after event 
included. Treatment policy 
approach.
IP discontinuation: Data after 
event excluded. Hypothetical 
approach due to MAR 
assumption of MMRM 
analysis.
Least squares mean 
difference in CFBL at 
Week 24 and each 
intermediate visit.


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Withdrawal from study prior 
to Week 24: Hypothetical 
approach due to MAR 
assumption of MMRM 
analysis.


4.2.3.2
Hierarchical testing strategy
To protect the family-wise error rate for the primary endpoint and secondary endpoints, a fixed 
sequence procedure hierarchical testing strategy will be followed i.e., only if superiority for the 
primary endpoint is established at the significance level α = 0.05 two-sided, the superiority test for 
the selected secondary endpoints will be tested in the order specified, also at the significance level 
α = 0.05 two-sided. Endpoints will be tested in the following order:
1. Change in HbA1c from baseline Visit 2 (Week 0) to Visit 7 (Week 24).
2. Change in fasting plasma glucose concentration from baseline Visit 2 (Week 0) to 
Visit 7 (Week 24)
3. Change in body weight from baseline Visit 2 (Week 0) to Visit 7 (Week 24)
4. Change in fasting insulin from baseline Visit 2 (Week 0) to Visit 7 (Week 24)
If the null hypothesis is not rejected for any of the first four tests in the hierarchy, for 
remaining endpoints a p-value will be presented in outputs but will be considered exploratory 
and inferences will not be drawn.
For all other secondary and exploratory endpoints, p-values will be presented but these will be 
considered exploratory in nature with no multiplicity adjustment applied. A nominal level of α 
= 0.05 will be used for inference.
4.2.3.3
Analysis of primary variable
The MMRM analysis of the primary endpoint in the Evaluable population will be considered 
the primary analysis.
The primary efficacy analysis will compare treatment groups (EQW vs. PBO) with respect to 
change in HbA1c from baseline (Visit 2 [Week 0]) to Visit 7 (Week 24) by using the MMRM 
approach. The model will include change in HbA1c as the dependent variable and treatment 
group, visit, interaction between visit and treatment, region, baseline HbA1c and interaction 
between visit and baseline HbA1c as the fixed effects. The variance - covariance structure to 
be used for this modelling will be unstructured (UN); if the model does not converge with 
unstructured variance – covariance matrix, then autoregressive order 1 (AR [1]) and 
heterogeneous autoregressive order 1 (ARH [1]) structures will be tried and the covariance 
structure will be decided based on model convergence status and the Akaike information 
criterion. The restricted maximum likelihood (REML) method will be used for parameter 
estimation, and the Kenward-Roget adjustment will be applied (ddfm=KR option in SAS 
PROC MIXED model statement. The least squares (LS) mean, 2-sided 95% confidence 
interval, and p-value of the difference in the change of HbA1c between the EQW and PBO
groups at Visit 7 (Week 24) will be provided. The mean (SD) observed HbA1c at baseline and 
Week 24 will also be given by treatment group.
HbA1c data from post-baseline visits (including Early Termination) will be included in the 
MMRM analysis. See Section 4.1.3 for details on missing data handling.


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For patients who initiate rescue medication or discontinue IP and continue study participation, 
only data before initiation of rescue medication or up to and including date of discontinuation 
from IP will be included in the MMRM analysis. If there is evidence that a measurement was 
taken prior to initiation of rescue medication, then this data will be included. If the 
measurement was taken on the date of initiation of rescue medication but time information is 
not available, then the measurement will be included. Namely, the data after initiation of 
rescue medication or after premature IP discontinuation will be excluded from the primary 
analysis.
Summaries and descriptive analysis of the primary endpoint will be performed using the 
Evaluable analysis set.
Subgroup analyses of primary endpoint
The primary endpoint, change from baseline in HbA1c at week 24, will be summarized 
descriptively for subgroups of interest listed below. Observed and change from baseline in 
HbA1c by visit will be presented. No statistical analyses will be conducted.
!
HbA1c baseline strata (<9.0% or ≥9.0%)
!
Age group: <10, 10 to 17, and >17.
!
Country 
!
Region (North America (USA), South America (Mexico), Europe (Israel, Hungary, 
Bulgaria, Ukraine), Middle East (Kuwait))
!
Sex –Male/Female
!
Race
!
Baseline BMI Percentile <3, 3-<85, 85-<97, >=97
BMI percentile will be calculated using height and weight data collected on the CRF. The 
SAS macro from CDC website listed below will be used to calculate BMI percentile and the 
method provided on the website will be followed for analysis. 
https://www.cdc.gov/nccdphp/dnpao/growthcharts/resources/sas.htm.
4.2.3.4
Sensitivity and supplementary analyses for primary endpoint
To further support the primary endpoint analysis and to examine the influence of missing data 
due to drop-out and/or receiving rescue therapy, sensitivity and supplementary estimands 
described in Section 4.2.3.1 are defined and will be addressed using an MMRM analysis at
Week 24. 
The MMRM model that will be used for analyzing the change in HbA1c will include 
treatment group, visit, interaction between visit and treatment, region, baseline HbA1c and 
interaction between visit and baseline HbA1c as the fixed effects. The variance - covariance 
structure to be used for this modelling will be the same as used for the primary analysis. The 
LS mean in each treatment group at Week 24, the standard error (SE), and the corresponding 
95% CI, as well as the LS mean difference between treatment groups, the SE, the 95% CI, and 


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the p-value, will all be derived and presented from the MMRM model. The mean (SD) 
observed HbA1c at baseline and Week 24 will also be given by treatment group.
In addition, an imputation sensitivity analysis will test the assumption of MAR that is made by 
the MMRM analysis. For this purpose, a model that assumes missing not at random (MNAR) 
will be used, whereby assumptions for the missing data “stress test” the MAR assumptions of 
the primary analysis, by positing outcomes that, while clinically plausible, are likely to be 
worse for the EQW group than the outcomes assumed by MAR. A plausible stress test could 
assume that the outcome for the EQW treatment is somewhat worse than would be predicted 
by MMRM from the study data. Such a stress test would appropriately disadvantage the 
estimate of treatment effect, compared to the estimate of the primary analysis. In this way the 
MAR assumption of the primary analysis could be stress tested.
The proposed MNAR sensitivity analysis assumes that the trajectory after the intercurrent 
event from the EQW group, regardless of the type of event, can be modelled by that of PBO 
patients. This assumption will tend to result in smaller estimates of difference between the 
treatment groups, compared to those under the MAR assumption, and as such constitutes a 
reasonable stress test of the MAR assumption. Note that this approach constitutes a pattern 
mixture model as defined by Molenberghs and Kenward4. The patterns here are defined by the 
time of the intercurrent event, with the imputed values for both treatment groups modeled by 
observed outcomes from the placebo group only.  Specifically, for a patient with 
missing/excluded observations after visit t, imputed value for the change from baseline at visit 
t+n will be based on a model estimated from all in the control group who have an outcome 
observed at visit t+n conditioning on that patient’s outcomes up to and including visit t. Then, 
the overall estimate of treatment effect is obtained by using Rubin’s rules to combine the 
imputed outcomes. Note that in this analysis, PBO missing/excluded observations are imputed 
assuming MAR and here follows the pattern of observed PBO observations, while
missing/excluded observations for the EQW group are assumed MNAR. This strategy for 
imputation is commonly referred to as the Copy-Reference approach.
In summary, the pattern mixture models will be implemented by multiple imputation via the 
following steps; 
Step 1: Non-monotone missing data (usually relatively infrequent) will be imputed using the 
MCMC statement of SAS PROC MI under the MAR assumption. The following variables 
will be included in the imputation model: treatment, region and HbA1c measurements from 
baseline to Week 24. Note: Dummy variables will be used for treatment and region. This 
will create a monotone missing pattern in the dataset within each treatment group. This step 
will create 1000 imputed datasets. 
Step 2: Then the values for each pattern will be imputed via the sequential regression method, 
using SAS PROC MI statement MONOTONE REG. The imputation model will be estimated 
from the observed data in the PBO group and it will be used to impute missing/excluded 
observations in both treatment groups using the MNAR statement of SAS PROC MI. The 
following variables will be included in the imputation model: region and HbA1c measurements 
from baseline to Week 24.


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Step 3: The imputed data from Step 1 and Step 2, along with observed data will be analyzed 
using the same MMRM model for the outcome of week 24 change from baseline as for the 
primary analysis. The estimates from multiple imputed datasets will be combined using 
Rubin’s combination rules for statistical inference5 (using PROC MI ANALYZE).
The seed used will be 88281 for both steps 1 and 2.
4.2.3.5
Analysis of secondary variables
Summary statistics and frequency tables will be provided for all secondary endpoints by visit 
and treatment for the ITT analysis set during the controlled assessment period and separately 
for the subset of ITT patients who received open-label EQW during the extension period for
the Treatment period (see Section 3.6.5 for Treatment period definition), unless otherwise 
stated.
Similar to the primary analysis, data including the Early Termination visit where applicable
will be included in the MMRM and CMH analysis for secondary analysis variables. Data 
collected from an Early Termination visit will be mapped to the next closest scheduled visit. 
For patients who initiate rescue medication and continue study participation, data collected 
after the initiation of rescue medication will be excluded from analyses. Data collected after 
discontinuation of IP will be excluded from analyses for all secondary efficacy endpoints.
Change in HbA1c from baseline Visit 2 (Week 0) to Visit 10 (Week 52), and to each 
intermediate visit as applicable
The MMRM method for change in HbA1c will be used until Week 24 and to each 
intermediate visit, using the Evaluable analysis set, which is the same approach as stated in 
Section 4.2.3.3.
The least squares mean (LSM) change from baseline and SE bar by visit will be presented in a 
figure by treatment group. The p-value for the difference between treatment groups by visit 
will also be provided in the figure.
The observed values and change from baseline will be summarized by visit using descriptive 
statistics (mean, median, standard deviation, minimum, maximum). This will be provided 
separately for both the Evaluable analysis set during the controlled assessment period and for 
the subset of Evaluable patients who received open-label EQW during the extension period 
analysis set for the Treatment period.
HbA1c measures will be listed.
Change in fasting plasma glucose concentration, body weight, fasting insulin, lipids, 
blood pressure from baseline Visit 2 (Week 0) to Visit 7 (Week 24), Visit 10 (Week 52), 
and to each intermediate visit as applicable
The same MMRM approach will be used to analyze the change in body weight, blood 
pressure, fasting plasma glucose, and fasting insulin from baseline (Week 0) to Week 24, and 
each intermediate visit.


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The least squares mean (LSM) change from baseline and SE bar by visit will be presented in a 
figure by treatment group. The p-value for the difference between treatment groups by visit 
will also be provided in the figure.
The observed values and change from baseline will be summarized by visit using descriptive 
statistics (mean, median, standard deviation, minimum, maximum) for body weight, blood 
pressure, fasting plasma glucose, fasting insulin and lipids. This will be provided separately 
for both the ITT analysis set during the controlled assessment period and for the subset of ITT 
patients who received open-label EQW during the extension period for the Treatment period.
The models for changes in body weight, blood pressure, fasting plasma glucose, and fasting 
insulin will include treatment group, visit, interaction between visit and treatment, region, 
baseline of the dependent variable, interaction between visit and baseline of the dependent 
variable and screening HbA1c strata (<9.0%,  ≥9.0%) as the fixed effects. The REML method 
will be used for parameter estimation. The least squares mean, 2-sided 95% confidence 
interval, and p-value of the difference in the endpoints of interests between the EQW and PBO 
groups will be provided.
FPG, body weight, fasting insulin, lipids and blood pressure (systolic and diastolic) will be 
presented in listings.
Proportions of patients achieving HbA1c goals at Visit 7 (Week 24), Visit 10 (Week 52), 
and at each intermediate visit
Proportions of patients having HbA1c goals of <6.5%, ≤6.5% and <7.0% at Week 24 and at 
each intermediate visit will be compared between treatments using the Evaluable analysis set 
via the CMH procedure, in which screening HbA1c strata (<9.0%,  ≥9.0%) will serve as the 
stratification factors.
A bar chart of the percentage of patients achieving HbA1c goals of <6.5%, ≤6.5% and <7.0% 
by visit and treatment group will be provided along with p-values.
Any Evaluable patient without HbA1c value at the endpoint will be considered as not 
achieving HbA1c goal at endpoint. The denominator will be the total number of Evaluable
patients in a treatment group, and the numerator will be the number of patients achieving 
HbA1c <6.5%, ≤6.5% and <7.0%.
As a sensitivity analysis also in the Evaluable analysis set, the probabilities of patients 
reaching HbA1c targets of <6.5%, ≤6.5% and <7.0% will be analyzed to Week 24 using the 
CMH procedure, with missing data imputed using MI pattern mixture model imputation. 
HbA1c strata (<9.0%,  ≥9.0%) will serve as the stratification factors. The imputed HbA1c data 
for the sensitivity analysis of the primary endpoint (Section 4.2.3.4) will be used for this 
analysis.
The number and percentage of patients having HbA1c target values of <6.5%, ≤6.5% and 
<7.0% will be summarized by visit and treatment group. This will be provided separately for 
both the Evaluable analysis set during the controlled assessment period and for the subset of 
Evaluable patients who received open-label EQW during the extension period for the 
Treatment period.


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Proportions of patients discontinuing the study, needing rescue due to failure to 
maintain glycemic control, and number of rescue episodes at Visit 7 (Week 24), Visit 10 
(Week 52), and at each intermediate visit
A Kaplan-Meier table and corresponding figure of time to rescue will be provided. Patients 
who are not rescued will be censored at Week 24 visit or last dose of study medication for 
those who discontinue study treatment for reasons unrelated to lack of glycemic control, as 
indicated by an adverse event withdrawal that required rescue medication prior to Week 24
visit.
The number and percentage of patients needing rescue due to failure to maintain glycemic 
control will be summarized by visit according to the windows defined in Section 4.3.1. This 
will be provided separately for both the ITT analysis set during the controlled assessment 
period and for the subset of ITT patients who received open-label EQW during the extension 
period for the Treatment period. The number of patients included at each analysis visit will be 
derived by including patients in the counts at every visit up to study completion date or date of 
last dose of study medication for patients who prematurely discontinue study medication.
Data collected after study treatment discontinuation will be excluded from summaries.
The proportion of patients discontinuing the study will be presented in the disposition table, 
by study period.
Change in beta-cell function (HOMA-B) and insulin sensitivity (HOMA-S) as measured 
by homeostasis model assessments in patients not taking insulin from baseline Visit 2 
(Week 0) to Visit 7 (Week 24), Visit 10 (Week 52), and to each intermediate visit as 
applicable
The same MMRM approach will be used to analyze the change in beta-cell function (HOMA-
B) and insulin sensitivity (HOMA-S) as measured by homeostasis model assessments in 
patients not taking insulin from baseline Visit 2 (Week 0) to Week 24, and each intermediate 
visit. 
The least squares mean (LSM) change from baseline and SE bar by visit will be presented in a 
figure by treatment group. The p-value for the difference between treatment groups by visit 
will also be provided in the figure.
The observed values and change from baseline for these parameters will be summarized by 
visit using descriptive statistics (mean, median, standard deviation, minimum, maximum). 
This will be provided separately for both the ITT analysis set during the controlled assessment 
period and for the subset of ITT patients who received open-label EQW during the extension 
period for the Treatment period.
The effects of the study medications on HOMA will be examined. The pancreatic beta-cell 
function (HOMA-B) and peripheral and hepatic insulin sensitivity (HOMA-S) will be 
computed from a computerized HOMA model, which can predict the plasma glucose, insulin, 
c-peptide, and proinsulin concentrations for any possible combination of these 2 parameters in 
the fasting state in patients not taking insulin.


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HOMA-B and HOMA-S will be computed from a computerized HOMA model, the HOMA 
Calculator2. The HOMA Calculator, developed by Diabetes Trials Unit at the Oxford Center 
for Diabetes, Endocrinology, and Metabolism, is a computer algorithm that that takes account 
of variations in hepatic and peripheral glucose resistance, increases in the insulin secretion 
curve for plasma glucose concentrations above 10 mmol/L (180 mg/dL), and the contribution 
of circulating proinsulin (e.g., C-peptide) to estimate the steady state beta-cell function and 
insulin sensitivity, as percentages of a normal reference population. The model assumes 
%HOMA-B and %HOMA-S values of 100% in normal young adults as a recalibration. 
All HOMA parameters will be analyzed on a logarithmic scale (natural logarithmic 
transformation), and then back-transformed to the original scale for result presentation using 
the following formulae:
Geometric Mean= exp(mean(log (X)))
SE of Geometric Mean = Geometric Mean* SE of Mean (log (X))
LS means will be back-transformed in the same way.
Separate tables of back-transformed and non-transformed results will be provided.
Homeostasis results will be listed.
Plasma exenatide concentrations at baseline Visit 2 (Week 0), Visit 7 (Week 24), Visit 10 
(Week 52), and each intermediate visit, as applicable.
Descriptive statistics (geometric mean, geometric coefficient of variation: GCV %, geometric
standard deviation factor: GSD, arithmetic mean, standard deviation, coefficient of variation: 
CV %, median, minimum, maximum) will be presented by visit and controlled assessment 
period treatment group for the PK analysis set.
The geometric mean plasma exenatide concentration with GSD bars will be plotted over time 
by treatment group.
Plasma exenatide concentrations will be listed.
4.2.3.6
Analysis of exploratory variables
Analysis of all exploratory endpoints will be performed in the ITT analysis set unless 
otherwise specified. Baseline values, the values at each visit, and changes from baseline 
values will be summarized for percentiles of body weight, percentile of height, and BMI by 
treatment.
Change in BMI from baseline Visit 2 (Week 0) to Visit 7 (Week 24), Visit 10 (Week 52), 
and to each intermediate visit
A similar MMRM modeling approach will be implemented to compare changes in BMI 
between treatment groups from Visit 2 (Week 0) to Week 24, and each intermediate visit.
The least squares mean (LSM) change from baseline and SE bar by visit will be presented in a 
figure by treatment group. The p-value for the difference between treatment groups by visit 
will also be provided in the figure.


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The observed values and change from baseline will be summarized by visit using descriptive 
statistics (mean, median, standard deviation, minimum, maximum). This will be provided 
separately for both the ITT analysis set during the controlled assessment period and for the 
subset of ITT patients who received open-label EQW during the extension period for the 
Treatment period.
Change in BMI percentile from baseline Visit 2 (Week 0) to Visit 7 (Week 24), Visit 10 
(Week 52), and to each intermediate visit
Observed and change from baseline in BMI percentile will be summarized by visit using 
descriptive statistics (mean, median, standard deviation, minimum, maximum). This will be 
provided separately for both the ITT analysis set during the controlled assessment period and 
for the subset of ITT patients who received open-label EQW during the extension period for
the Treatment period.
Change in body weight percentile and height percentile from baseline Visit 2 (Week 0) to 
Visit 7 (Week 24), Visit 10 (Week 52), and to each intermediate visit
The height and weight percentile will be determined based on the standardized growth chart 
for boys and girls (developed by the National Center for Health Statistics in collaboration with 
the National Center for Chronic Disease Prevention and Health Promotion). For this purpose,
the percentile values for weight and height will be calculated using the growth chart tables on 
CDC3 using the raw data available for weight and height. The growth chart tables for boys’
and girls’ population will be used separately for 3rd to 97th percentile.
A MMRM modeling approach will be implemented to compare changes in body weight 
percentile, and height percentile between treatment groups from Visit 2 (Week 0) to Week 24, 
and each intermediate visit.
The least squares mean (LSM) change from baseline and SE bar by visit will be presented in 
figures by treatment group. The p-value for the difference between treatment groups by visit 
will also be provided in the figure.
The observed values and change from baseline for body weight percentile and height 
percentile will be summarized by visit using descriptive statistics (mean, median, standard 
deviation, minimum, maximum). This will be provided separately for both the Evaluable
analysis set during the controlled assessment period and for the subset of Evaluable patients 
who received open-label EQW during the extension period for the Treatment period.
4.2.4
Safety and tolerability analysis
Analysis of safety data will be performed using the Safety analysis set. All safety and 
tolerability variables such as examination of AEs, clinical laboratory measurements, physical 
examination findings, vital signs, and antibodies to exenatide will be summarized 
descriptively by treatment groups. Observations post-rescue will be included for safety 
analyses.
For all safety endpoints summary tables will be presented by visit to Week 52, and where 
applicable also for the 10-week follow-up, for each treatment group. Continuous variables 
(observed, change from baseline, laboratory and vital signs parameters) will be summarized 
by visit using number, mean, median, standard deviation, minimum and maximum for each 


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treatment group. Categorical variables (incidence of AEs, antibodies, physical examination, 
Tanner pubertal stage) will be summarized by visit in the form of number and percentage (%)
for each treatment group.
A listing of Tanner pubertal stage data will also be provided.
4.2.4.1
Adverse event analysis
Adverse events (AE) will be classified in accordance to the Medical Dictionary for Regulatory 
Activities (MedDRA) dictionary. All adverse events will be coded using the latest available 
version of MedDRA by the database lock. 
Treatment-emergent AEs (TEAE) are defined as AEs occurring after the first dose of study 
medication through the end of the treatment plus 7 days (or + 90 days for SAEs and other 
clinically significant or related AEs), including AEs collected after patients initiate glycemic 
rescue therapy. 
AEs occurring after Study Termination but considered by the Investigator as clinically 
significant and as related to study medication or study procedure, and SAEs occurring within 
90 days of the last administration of study medication or EQW if in the extension phase will 
be recorded on the AE eCRF and reported in the AE listing. 
Any AE that is recorded as the reason for study discontinuation will be considered an adverse 
event leading to discontinuation (DAE) regardless of the date recorded. All DAEs will be 
reported regardless of when they occurred. Note, any AE that is a DAE under these rules will 
also count as an AE when reporting.
Off-treatment AEs will be defined for the following:
!
Treatment completers to Week 52: An AE that occurs between Week 52 to Week 62
and starts the day after last dose of open-label EQW + 7 days (or + 90 days for SAEs 
and other clinically significant or related AEs). Only patients completing study 
medication to Week 52 will be considered. Patients completing study medication to 
Week 52 but who withdraw prior to Week 62 will also be included.
!
Premature discontinuation: An AE that starts the day after last dose of study 
medication + 7 days (or + 90 days for SAEs and other clinically significant or related 
AEs), for patients who discontinue study medication before Week 24 or Week 52.
AEs for the combined periods are those that occur during the Treatment period or post-
treatment.
AEs with a start date prior to the first administration of study medication will be classified as 
pre-treatment (non-treatment emergent). 
AEs with a stop date prior to the date of the first administration of study medication will be 
classified as pre-treatment (non-treatment emergent) AEs. 
In case of missing AE severity, AE causality, or AE seriousness, a worst-case approach will 
be used. For AE missing severity, the AE will be considered severe; for missing causality, the 


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AE will be considered as possibly-related to study medication; for missing seriousness, the 
AE will be considered serious.
On-treatment AEs (TEAEs) will be summarized for 24-week controlled assessment period and 
28-week extension period as defined below. Off-treatment AEs for treatment completers to 
Week 52 will be tabulated where required. Off-treatment AEs for patients who prematurely 
discontinued will be listed only.
An overall summary of number and percentage of patients experiencing at least 1 TEAE will 
be presented for EQW and PBO. The summary will be presented by study period (controlled 
assessment period and extension period). A summary of AEs during the Treatment period for 
patients with actual treatment EQW during the controlled assessment period will be provided. 
The AE summary will include the number and percentage of patients experiencing any AE, 
any SAE, any AE related to treatment per Investigator’s discretion, any AE leading to 
treatment discontinuation, any AE leading to study withdrawal, and any fatal AE.  
Additionally, all TEAEs will be summarized for each treatment group as follows:
!
AEs summarized by SOC, PT, maximum intensity (Mild, Moderate, Severe), causality 
(Not related, Related), action taken, and outcome.
!
SAEs summarized by SOC and PT, maximum intensity (Mild, Moderate, and severe), 
causality (Not related, Related).
!
AEs leading to treatment discontinuation summarized by SOC and PT.
!
Frequent AEs (AE with at least 5% incidence in any treatment) summarized by
preferred term.
!
Non-serious frequent AEs summarized by SOC and PT.
!
Potentially immune-related AEs summarized by antibody status (positive versus 
negative), SOC and PT.
!
Potentially immune-related AEs summarized by antibody titer (higher: ≥625 versus 
low: <625), SOC and PT.
!
Potentially immune-related injection site-related AEs summarized by SOC and PT.
Summaries by maximum intensity will be presented separately for the controlled assessment 
period (Safety analysis set) and extension period (subset of Safety patients who received open-
label EQW during the extension period). All other AE summary tables will be presented by 
study period in a single table.
Potentially immune-related AEs will be identified using the PTs given in Appendix B4.
Injection site-related AEs will be identified using AEs within higher-level term “Injection site 
reactions”.
Tables of key patient information for SAEs and AEs leading to discontinuation of study 
medication will be provided. Adverse events will be listed.
The number of AEs and number of SAEs will be summarized for the controlled assessment 
period and extension period.


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The denominator for summaries will be the number of patients included in the analysis set by 
treatment group and total. Where the controlled assessment period and extension period are 
presented side-by-side in the same summary, the denominator for the controlled assessment 
period will be the number of patients in the Safety analysis set by treatment group and total; 
the denominator for the extension period will be the number of patients in the subset of Safety
patients who received open-label EQW during the extension period by treatment group and 
total.
4.2.4.2
Injection-site reactions
Proportions of patients reporting different injection site reactions at Visit 3 (Week 4) 
through Visit 10 (Week 52).
Injection-site reactions will be identified from the AE dataset using the higher-level term 
(HLT) “Injection site reactions”. Injection-site reactions reported on the INJECT eCRF will 
not be included in summaries as this eCRF was introduced part-way through the study and 
therefore does not provide a complete picture of the number of injection-site reactions. Data 
reported on the INJECT form will be listed only.
The number and percentage of patients reporting different injection site reactions, per the AE 
dataset, will be summarized by visit (see Section 4.3.3 for details on visit windows for 
injection site reactions). This will be provided separately for both the Safety analysis set 
during the controlled assessment period and for the subset of Safety patients who received 
open-label EQW during the extension period for the Treatment period. The injection site 
reactions will be additionally repeated by injection device type i.e. pre-filled syringe or dual-
chamber pen. All patients randomized to the study on or after 12th August 2018 are dispensed 
dual chamber pen devices.
4.2.4.3
Drug-induced liver injury
Number and percentage of patients meeting potential Hy's laws criteria (aspartate 
aminotransferase [AST] or alanine aminotransferase [ALT] ≥3x upper limit of normal [ULN]
and total bilirubin [TB] ≥2x ULN) at any point during the Treatment period or follow-up 
period will be presented in a summary table by visit and treatment group for Safety analysis 
set.  Similarly, a table with key patient data for patients with combined ALT or AST, and TB, 
elevations will be presented.
4.2.4.4
Clinical laboratory
Continuous clinical laboratory parameters will be summarized in standardized international 
(SI) and US conventional units.
For quantitative measurements, observed values and changes from baseline to each post-
baseline visit will be determined by visit windows described in Section 4.3.1 and 4.3.3.
All hematology, clinical chemistry, growth and development hormones and urinalysis results 
will be listed by treatment group, patient, and visit, including scheduled and 
unscheduled/repeat measurements. Laboratory assessments that are outside of normal ranges 
will be flagged.


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Baseline values, the observed values at each visit to Week 52 and including the 10-week 
follow-up, as well as change from baseline values will be summarized for each of the 
quantitative laboratory assessments by treatment group. Additionally, listings by individual 
patients’ data will be reported as appropriate.
Clinical laboratory results (chemistry, hematology, growth and development hormones and 
urinalysis) will be summarized using descriptive statistics for each visit. Shift from baseline to 
the minimum/maximum value during treatment will be presented for the controlled 
assessment period and extension period, separately, based on high/low/normal findings for 
clinical laboratory parameters if normal ranges are available (for quantitative measurements 
and categorical measurements).  For the categorical Urine-Blood parameters, a shift table 
from baseline to every planned visit will be performed. For the categorical measurements 
Urine Glucose, Ketones and Urine Total Protein, results will be presented under the following 
categories: 0, trace, +1, +2, +3.
Number and percentage of laboratory results that are potentially clinically significant (see 
Appendix B3) will be summarized by analyte name and criteria for each treatment group. 
Estimated glomerular filtration rate will be derived based on the Bedside Schwartz formula:
eGFR = 41.3 * (Height in meters / Serum creatinine in mg/dL)
A table of observed and change from baseline in eGFR values will be provided. This will be 
provided both overall and by baseline eGFR, hyperfiltrating versus non-hyperfiltrating, where 
hyperfiltration is defined as an eGFR ≥125 ml/min/1.73m2).
A MMRM analysis of change in eGFR from baseline to Week 24 and each intermediate visit 
by baseline eGFR (hyperfiltrating: ≥125 ml/min/1.73m2 versus non-hyperfiltrating: <125 
ml/min/1.73m2) will be provided. The same approach as stated in Section 4.2.3.3 will be used. 
The model will include treatment group, visit, interaction between visit and treatment, region, 
screening HbA1c strata (<9.0%,  ≥9.0%), baseline eGFR, and interaction between visit and 
baseline eGFR as the fixed effects. The REML method will be used for parameter estimation. 
The least squares mean, 2-sided 95% confidence interval, and p-value of the difference in the 
endpoints of interests between the EQW and PBO groups will be presented. This analysis will 
be done both excluding data after initiation of rescue therapy and separately including data 
after initiation of rescue therapy.
A shift table from baseline UACR category to highest post-baseline UACR category will be 
provided for the controlled assessment period and extension period, separately. Categories are 
defined as follows:
!
<30 mg/g (Normal)
!
≥30 mg/g and ≤300 mg/g (Micro or moderately increased albuminuria)
!
>300 mg/g (Macro or severely increased albuminuria)
!
Unknown
Strip Sign for Selected Laboratory Data
For selected laboratory test values that have been received with a qualifier as a part of the 
result (>, &, <, or ∋), a process to strip the qualifier will be applied and the resulting numeric 


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values will be used for data analysis. The raw value with operator will remain as such in the 
database and will be used when listed. 
4.2.4.5
Vital signs
Vital signs (systolic and diastolic blood pressure and heart rate) will be summarized by visit 
and treatment group.  Observed and change from baseline values will be summarized for each 
visit where appropriate. This summary will be repeated by age group (<12 years, ≥12 years).
Number and percentage of vital signs that are potentially clinically significant (see Appendix 
B3) will be summarized by parameter, category treatment group and age group (<12 years, 
≥12 years). Individual patient data for patients with marked abnormality criteria will be 
summarized.
Vital signs parameters will be listed.
4.2.4.6
Antibodies to exenatide 
A patient is said to have treatment emergent antibodies to exenatide at a visit if the antibody 
test is positive after the first injection of study medication following a negative or missing 
antibody measurement prior to the first injection of study medication, or the titer is increased 
by at least 3 dilutions from a detectable measurement prior to the first injection of study 
medication.
Number and percentage of patients incidence of antibodies to Exenatide for the categories
negative, any positive, low positive, and high positive will be summarized descriptively by 
visit for the safety analysis set, for the treatment period. 
The primary efficacy endpoint HbA1c will be summarized by antibody status (negative, any 
positive, low positive, higher positive) and by visit to evaluate the effect of antibody 
formation on efficacy.  
Descriptions of planned summaries of AEs by antibody status can be found in Section 4.2.4.1.
Antibodies to exenatide will be defined based on the highest antibody titer in each patient at 
any time during the on-treatment period.
4.2.4.7
Hypoglycemia
All summaries of hypoglycemic events will be presented for both the controlled assessment 
period (Safety analysis set) and the extension period (subset of Safety patients who received 
open-label EQW during the extension period). Hypoglycemic events will be presented as 
events occurring after the first dose of study medication through the end of the treatment plus 
7 days.
The number and percentage of patients with hypoglycemic events, per the HYAEBO eCRF, 
along with the number of events will be summarized by severity (mild, moderate, severe or 
unknown) defined as follows,
Mild: Usually transient, requires no special treatment, and does not interfere with the patient’s 
daily activities.
Moderate: Usually causes a low level of inconvenience or concern to the patient and may 
interfere with daily activities but is usually ameliorated by simple therapeutic measures.


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Severe: Requires the assistance of another person to obtain treatment (e.g., intravenous 
glucose, intramuscular glucagon, or oral carbohydrate) for the event.
Additionally, hypoglycemia will be programmatically classified as major, minor, or other 
hypoglycemia as follows,
!
Major hypoglycemia is defined as:
An event that results in loss of consciousness, seizure, or coma (or other mental status 
change consistent with neuroglycopenia in the judgment of the Investigator or 
physician), and which resolves after administration of glucagon or glucose 
Or 
An event that requires third party assistance to resolve because of severe impairment in 
consciousness or behavior (whether or not symptoms of hypoglycemia are detected by 
the patient) and is associated with a plasma or capillary glucose concentration of 
<3 mmol/L (54 mg/dL) 
!
Minor hypoglycemia is a non-major hypoglycemia event that has symptoms consistent 
with hypoglycemia and had a glucose value of <3 mmol/L (54 mg/dL) prior to treating 
the episode.
!
If a hypoglycemia event does not meet the criteria for a major or minor event 
described above, it will be classified as other.  
The number and percentage of patients with hypoglycemic events, along with the number of 
events will be summarized by major/minor classification.
Hypoglycemic events will also be programmatically classified into three levels6 according to 
severity:
!
Level 1: A glucose alert value of 3.9 mmol/L (70 mg/dL) or less. 
!
Level 2: A glucose level of <3.0 mmol/L (<54 mg/dL) is sufficiently low to indicate 
serious, clinically important hypoglycemia
!
Level 3: Severe hypoglycemia, as defined by the ADA7, 8, denotes severe cognitive 
impairment requiring external assistance for recovery
The number and percentage of patients with hypoglycemic events based on the 
aforementioned classification, along with the number of events will be summarized by level.
The number and percentage of patients with any hypoglycemic event by baseline insulin and 
sulfonylurea use will be summarized according to the following categories:
!
Any (includes patients with and without insulin/sulfonylurea use at baseline)
!
Insulin and sulfonylurea use at baseline
!
Insulin only
!
Sulfonylurea only


Statistical Analysis Plan 
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!
No insulin or sulfonylurea
Key patient information for hypoglycemic events will be presented.
4.2.5
Mixed meal sub-study
Baseline values, the observed values and change from baseline values will be summarized for 
C-peptide, glucose, glucagon and insulin results, over timepoints for the Standardized mixed 
meal test evaluable analysis set. A listing by individual patients’ data will also be reported.
4.3
Conventions
4.3.1
Visit assignments for efficacy variables
All visits scheduled during the 24-week controlled assessment and 28-week extension period 
should occur within ± 2 days of the scheduled date relative to Visit 2 (Week 0) per the CSP.
Patients do not always adhere strictly to the visit timing in the CSP. Therefore, the designation 
of visits during the treatment period will be based on the day of evaluation relative to the start 
of the controlled assessment period (day of study medication = Day 1) rather than the nominal 
visit recorded in the eCRF.
To assign a measurement to a Week t during the study, the first step is to select all 
measurements falling within the study period. Mutually exclusive relative day windows are 
used to determine the Week t measurement. These relative day windows are defined to 
provide derived visits that correspond to the post-baseline time points specified in the CSP. 
Some restrictions may exist on some laboratory assessments to be included in efficacy 
analyses. These restrictions will be reflected in the relative day ranges. Visit windows for 
efficacy variables are listed below.
Visit windows will not be used for Visit 11 (Week 62) and data will be presented per the visit
label.
Table 3.1 Visit Windows: HbA1c, Body weight, BMI, Rescue medication (based on start 
date of medication) and blood pressure
Visit
Analysis 
Visit
Week
Period
Target Day
Day range
2
0
0
CAP
1
Baseline
3
1
4
CAP
29
2-42
4
2
8
CAP
57
43-70
5
3
12
CAP
85
71-105
6
4
18
CAP
127
106-147
7
5
24
CAP
minimum (last day 
of CAP or 169)
148 to last day of CAP


Statistical Analysis Plan 
Study Code D5551C00002
Edition Number 2.0
Date 21MAY2020
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Visit
Analysis 
Visit
Week
Period
Target Day
Day range
8
6
28
EP
maximum (last 
day of CAP+1 or 
197)
last day of CAP +1 to 238
9
7
40
EP
281
239-322
10
8
52
EP
minimum (last day 
of EP or 365)
323 to last day of EP
CAP: Controlled assessment period. EP: Extension period.
Table 3.2 Visit Windows: Fasting plasma glucose, Fasting Insulin, Plasma Exenatide
Visit
Analysis 
Visit
Week
Period
Target Day
Day range
2
0
0
CAP
1
Baseline
3
1
4
CAP
29
2-42
4
2
8
CAP
57
43-70
5
3
12
CAP
85
71-126
7
5
24
CAP
minimum (last day 
of CAP or 169)
127 to last day of CAP
10
8
52
EP
minimum (last day 
of EP or 365)
last day of CAP +1 to last day 
of EP
CAP: Controlled assessment period. EP: Extension period.
Table 3.3 Visit Windows: Fasting Lipids
Visit
Analysis 
Visit
Week
Period
Target Day
Day range
2
0
0
CAP
1
Baseline
5
3
12
CAP
85
2-126
7
5
24
CAP
minimum (last day 
of CAP or 169)
127 to last day of CAP
10
8
52
EP
minimum (last day 
of EP or 365)
last day of CAP +1 to last day 
of EP
CAP: Controlled assessment period. EP: Extension period.


Statistical Analysis Plan 
Study Code D5551C00002
Edition Number 2.0
Date 21MAY2020
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Table 3.4 Visit Windows: Total daily insulin
Visit
Analysis 
Visit
Week
Period
Target Day
Day range
2
0
0
CAP
1
Baseline: -7 to -1
3
1
4
CAP
29
23 to 29
4
2
8
CAP
57
51 to 57
5
3
12
CAP
85
79 to 85
6
4
18
CAP
127
121 to 127
7
5
24
CAP
minimum (last day of 
CAP or 169)
[min (last day of CAP, 169) – 7] 
to [min (last day of CAP, 169) - 1]
8
6
28
EP
maximum (last day 
of CAP+1 or 197)
[max (last day of CAP +1, 197) –
6] to [max (last day of CAP +1, 
197)]
9
7
40
EP
281
275-281
10
8
52
EP
last day of EP 
(last day of EP – 6) to (last day of 
EP)
CAP: Controlled assessment period. EP: Extension period.
If a patient discontinues study medication prior to the upper day range specified in the Table 
3.4 window, the average total daily insulin will not be calculated for that visit.
4.3.2
Duplicate efficacy assessments
The assessments for laboratory parameters will be based only on central laboratory values. For 
laboratory efficacy parameters, if a patient has more than one measurement (scheduled or 
unscheduled) included within a relative day window, the assessment closest to the target day 
and time (the target time is always assumed to be 8:00 am) will be used. In case of ties 
between observations located on different sides of the target day and time, the later assessment 
will be used. In case of ties located on the same side of the target day and time (i.e. more than 
1 value for the same day and time), the mean of the values will be used.
For non-laboratory efficacy parameters, if a patient has more than one measurement 
(scheduled or unscheduled) included within a relative day window, the assessment closest to 
the target day will be used. In case of ties between observations located on different sides of 
the target day, the later assessment will be used. In case of ties located on the same side of the 
target day (i.e., more than 1 value for the same day), the mean of the values will be used.
4.3.3
Visit assignment for safety variables
Below tables provide day windows for vital signs, safety lab parameters (clinical 
chemistry/hematology), and growth and development hormones.


Statistical Analysis Plan 
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Edition Number 2.0
Date 21MAY2020
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Table 3.5 Visit Windows: Vital signs
Visit
Analysis 
Visit
Week
Period
Target Day
Day range
2
0
0
CAP
1
Baseline
3
1
4
CAP
29
2-42
4
2
8
CAP
57
43-70
5
3
12
CAP
85
71-105
6
4
18
CAP
127
106-147
7
5
24
CAP
minimum (last day of 
CAP or 169)
148 to last day of CAP
8
6
28
EP
maximum (last day of 
CAP+1 or 197)
last day of CAP +1 to 238
9
7
40
EP
281
239-322
10
8
52
EP
minimum (last day of 
EP or 365)
323 to last day of EP
CAP: Controlled assessment period. EP: Extension period.
Table 3.6 Visit Windows: Injection site reaction
Visit
Analysis 
Visit
Week
Period
Day range
3
1
4
CAP
1-42
4
2
8
CAP
43-70
5
3
12
CAP
71-105
6
4
18
CAP
106-147
7
5
24
CAP
Subjects not entering EP: 148 to last 
day of CAP
Subjects entering EP: 148 to last day of 
CAP -1
8
6
28
EP
Subjects not entering EP: last day of 
CAP +1 to 238
Subjects entering EP: last day of CAP 
to 238
9
7
40
EP
239-322
10
8
52
EP
323 to last day of EP


Statistical Analysis Plan 
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Edition Number 2.0
Date 21MAY2020
57
CAP: Controlled assessment period. EP: Extension period.
Table 3.7 Visit Windows: Total testosterone, SHBG, Tanner Pubertal Stage
Visit
Analysis 
Visit
Week
Period
Target Day
Day range
2
0
0
CAP
1
Baseline
5
3
12
CAP
85
2-126
7
5
24
CAP
minimum (last day of 
CAP or 169)
127 to last day of CAP
9
7
40
EP
maximum (last day of 
CAP+1 or 281)
last day of CAP +1 to 
322
10
8
52
EP
minimum (last day of 
EP or 365)
323- last day of EP
CAP: Controlled assessment period. EP: Extension period.
Table 3.8 Visit Windows: Laboratory (hematology, clinical chemistry, urinalysis), 
Growth and development hormones such as TSH, FSH etc., Bone specific Alkaline 
phosphatase and N-telopeptide.
Visit
Analysis 
Visit
Week
Period
Target Day
Day range
2
0
0
CAP
1
Baseline
5
3
12
CAP
85
71-126
7
5
24
CAP
minimum (last day of 
CAP or 169)
127 to last day of CAP
10
8
52
EP
minimum (last day of 
EP or 365)
last day of CAP +1 to last
day of EP
CAP: Controlled assessment period. EP: Extension period.
Table 3.9 Visit Windows: calcitonin, pancreatic amylase, lipase, CEA
Visit
Analysis Visit
Week
Period
Target Day
Day range
2
0
0
CAP
1
Baseline
5
3
12
CAP
minimum (last day of 
CAP or 85)
71 to last day of CAP
10
8
52
EP
minimum (last day of EP 
or 365)
last day of CAP +1 
to last day of EP
CAP: Controlled assessment period. EP: Extension period.


Statistical Analysis Plan 
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Edition Number 2.0
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4.3.4
Rules for safety observations
4.3.4.1
Multiple safety assessments
For tabulations of visit summaries, changes from baseline or shift analyses, if multiple 
measurements are included within a relative day window, the measurement closest to the 
target day will be used; in the case of a tie, the measurement obtained on the earlier day will 
be used in the analyses. In case of ties located on the same side of the target day (i.e., more 
than 1 value for the same day), the mean of the values will be used.
4.3.4.2
Adverse events at patient level
When a patient has the same adverse event, based on SOC/PT, reported multiple times in a 
single analysis period, the patient will only be counted once at the SOC/PT level in adverse 
event frequency tables.
When a patient has the same adverse event, based on preferred terminology, reported multiple 
times in a single analysis period, the following criteria, in order of precedence, will be used to 
select the event to be included in summary tables:
1. Relationship to study medication
2. Intensity of event
3. Onset date and time
When assessing relationship to study medication, relationship is reported by the Investigator 
into 2 categories - related and not related. Related events will take precedence over not related 
events in determining the event to include in summary tables.
More intense events will take precedence over less intense events in determining the event to 
include in summary tables.
Earlier onset date-time events will take precedence over late onset date-time events in 
determining the onset to include in summary tables.
4.3.4.3
Adverse event at event level
At event level, each unique AE record will be counted. Unique AE record can be obtained by 
collapsing all AE records following a standard algorithm described below. 
To ensure that multiple events for the same patient are counted accurately in the summaries, a 
methodology for collapsing AE records and reporting for the analysis will be followed as 
below. For each patient and PT, AE records will be collapsed into a single record (unique AE) 
when:
1. Multiple AE records have the same onset date,
2. The onset date of an event record is either the same day or 1 day later than the 
resolution date of a preceding event record (contiguous events),
3. The onset date of an event record is after the onset date and prior to or on the 
resolution date of a preceding event record (overlapping events).


Statistical Analysis Plan 
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Edition Number 2.0
Date 21MAY2020
59
The unique AE record will contain the earliest onset date, latest resolution date (if available), 
highest intensity, relationship (yes/no), and highest action taken in the following order 
(highest to lowest): drug discontinued, drug interrupted, none. In addition, the unique AE 
record will be classified as a SAE if at least 1 AE record was classified as a SAE and the 
unique AE record will be classified as requiring treatment if at least 1 AE record required 
treatment.


Statistical Analysis Plan 
Study Code D5551C00002
Edition Number 2.0
Date 21MAY2020
60
5.
CHANGES OF ANALYSIS FROM PROTOCOL
Section 3.1 of the CSP states that patients return to clinical study site at “6-, 10-, and 12-week 
intervals but in accordance to the study plan, patients return at 6- and 12-week intervals, with 
a follow-up visit at Week 62. Section 1.2 of the SAP reflects this.
Per CSP Section 12.1, a Per-Protocol (PP) analysis set is defined. However, given the 
limitations of PP analyses in that they lead to lack of preservation of the randomization and 
given the CSP states that efficacy analyses will be carried out on the Evaluable Population 
“and/or” the Per-Protocol population, i.e. allowing some flexibility, the team agrees to not 
define a PP analysis set. Additionally, an All Patients analysis set, Randomized analysis set
and PK analysis set.
CSP Section 12.1 states that safety will be assessed using the ITT population, however, the 
team decided a safety analysis set should be defined instead. Patients would be analyzed in 
accordance to actual treatment received.
CSP Section 12.1 states the Evaluable population will consist of all ITT patients who receive 
at least 1 dose of study medication and have at least 1 post-baseline HbA1c assessment. It was 
decided that this definition should be modified to include at least 1 baseline and post-baseline 
HbA1c assessment.
CSP Section 12.2 has change in C-peptide from baseline to each study week as a secondary 
endpoint but this was only collected at screening and then for patients in the mixed meal sub-
study at Week 52 and Week 62. Therefore this endpoint has been omitted from the SAP.
CSP section 12.2 lists the proportion of patients achieving HbA1c goals of ≤6.5% and <7.0%
as a secondary endpoint. To align with other exenatide studies the addition of goal <6.5% has 
been added.
CSP Section 12.3 states that demographic and baseline characteristics will be summarized for 
the ITT and Evaluable analysis sets, however the study team requested these be summarized 
for the ITT and Safety analysis sets.
CSP Section 12.4 states that treatment compliance will be summarized for the ITT analysis 
set, however, this will be summarized for the Safety analysis set.
A hierarchical testing strategy was not defined in the CSP but has been included in the SAP to 
protect the family-wise error rate for the primary and secondary endpoints.
CSP Section 12.6.1 states that last observation carried forward will be used for missing data at 
endpoint for proportion of patients meeting HbA1c goals of ≤6.5% and <7.0%, however, 
patients with missing HbA1c at endpoint will be considered as non-responders. Additionally, 
the logistic regression sensitivity analysis described in the CSP has been replaced with a more 
appropriate CMH analysis using MI pattern mixture model imputation (Sections 4.2.3.4 and 
4.2.3.5), as this tests the robustness of the results from the main analysis by altering the 
missing data assumption.
CSP Section 12.6.1 stipulates ‘The analyses of all other efficacy endpoints will be performed 
in ITT population.’ Upon review of the endpoints it was agreed that all endpoints related to 
HbA1c should be evaluated using the Evaluable analysis set.


Statistical Analysis Plan 
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Date 21MAY2020
61
CSP Section 12.6.1 outlines a MMRM method will be implemented for the secondary efficacy 
endpoint, lipids. It was agreed after blinded data review that the data could be sufficiently 
reviewed as summary statistics.
CSP Section 12.6.2 specifies that both baseline HbA1c and HbA1c strata will be included in 
the MMRM model for the primary analysis. However, these variables will be highly 
correlated resulting in multicollinearity in the statistical model. Therefore, HbA1c strata will 
not be included in the primary model. For secondary and exploratory MMRM analyses, 
screening HbA1c strata will be used in the model instead of continuous baseline HbA1c.
The sensitivity and supportive analyses in Section 4.2.3.4 were not specified in the CSP and 
have been added to further support the primary analysis and to examine the influence of 
missing data due to drop-out and/or receiving rescue therapy.
Section 12.6.3 of the CSP states that the proportion of patients discontinuing the study will be 
analyzed using a CMH test and logistic regression by visit. However, the team agreed it would 
be sufficient to summarize withdrawals during the study, which is presented in the disposition 
summary table. Hence no statistical analyses were planned for this endpoint. In the same 
section of the CSP, it is stated that the proportion of patients rescued due to failure to maintain 
glycemic control will be analyzed using a CMH test and logistic regression by visit. However, 
based on the observed number of patients rescued at Week 24 being low, the team agreed 
summaries of this endpoint would suffice. By way of a clarification to the CSP, the team also 
agreed that “number of rescue episodes” should be interpreted as “number of patients 
rescued”, given a patient is considered rescued after initiation of rescue therapy. Therefore, a 
summary of the cumulative proportion of patients rescued by visit will be considered 
sufficient to address this endpoint.
Section 12.6.3 of the CSP states that for MMRM analyses, country will be included as a 
covariate. However, to align to the approach for the primary endpoint, region will be used 
instead.
The CSP does not specify BMI percentile as an endpoint, however the study team requested 
this be included and therefore summaries of observed and change from baseline in BMI 
percentile will be provided as specified in Section 4.2.3.6 of this SAP.
The CSP does not specify eGFR as an endpoint, nor is it provided by the laboratory. However, 
the team felt it would provide important information for this study so it will be derived and 
analyzed as stated in Section 4.2.4.4 of this SAP.
Hypoglycemia analyses are not defined in the CSP. However, the team requested events be 
classified and summaries be included as defined in Section 4.2.4.7 of this SAP.
Free testosterone in the CSP has been outlined as calculated at Visit 5 (Week 12), Visit 7 
(Week 24), Visit 9 (Week 40) and Visit 10 (Week 52). Since this endpoint is calculated using 
Albumin, total testosterone and SHBG and these parameters are not collected at Week 40, this 
visit will not be presented in the outputs.
Appendix F of the CSP (Mixed Meal Substudy) lists statistical analyses and summaries will 
be presented. However, due to an insufficient amount of data being collected for the study, the 
study team decided no formal analysis will be presented, only summary tables and listings.


Statistical Analysis Plan 
Study Code D5551C00002
Edition Number 2.0
Date 21MAY2020
62
6.
REFERENCES
1. Levy et al 1998
!
Correct Homeostasis Model Assessment (HOMA) evaluation uses the computer 
program. Diabetes Care; 21:2191-2192.
2. National Research Council 2010
!
The prevention and treatment of missing data in clinical trials. Washington, DC: 
National Academies Press.
3. Set 2: Clinical charts with 3rd and 97th percentiles 
http://www.cdc.gov/growthcharts/cdc_charts.htm
4. Molenberghs and M.G Kenward. Missing Data in Clinical Studies, p221. John Wiley 
and Sons, 2007.
5. Rubin, D. 1987. Multiple Imputation for Nonresponse in Surveys. Wiley.
6. Workgroup on Hypoglycemia, American Diabetes Association. Defining and reporting 
hypoglycemia in diabetes: a report from the American Diabetes Association 
Workgroup on Hypoglycemia. Diabetes Care 2005;28:1245–1249
7. Seaquist ER, Anderson J, Childs B, et al. Hypoglycemia and diabetes: a report of a 
workgroup of the American Diabetes Association and The Endocrine Society. 
Diabetes Care 2013;36:1384–1395
8. Simon R. Heller. Glucose Concentrations of Less Than 3.0 mmol/L (54 mg/dL) 
Should Be Reported in Clinical Trials: A Joint Position Statement of the American 
Diabetes Association and the European Association for the Study of Diabetes; 
Diabetes Care 2017;40:155–157
9. Kliegman, Robert., et al. Nelson Textbook of Pediatrics. Edition 20. Philadelphia, PA: 
Elsevier, 2016.
10. Holmes, DT (2017, August 7). Determine the CV of a Calculated Lab Reportable –
Bioavailable Testosterone. Retrieved from https://labrtorian.com/tag/vermeulen-
equation/


Statistical Analysis Plan 
Study Code D5551C00002
Edition Number 2.0
Date 21MAY2020
63
7.
APPENDIX
7.1
Appendix B1
Partial date conventions for AEs 
Missing type
Action
If only the day part of the AE onset date is 
missing 
If the month and year are the same as that of 
first dose of study medication, the date of first 
dose of study medication will be used as the 
onset date of the AE.  Otherwise, the first day 
of the month will be used to complete the 
onset date of the AE  
If the day and month parts of the AE onset 
date are missing 
If the year is the same as that of the first dose 
of study medication, the date of the first dose 
of study medication will be used as the onset 
date of the AE.  Otherwise, January 1st will be 
used to complete the onset date of the AE.
If the AE onset date is completely missing
The date of the first dose of study medication 
will be used as the onset date of the AE.
If only the day part of the AE end date is 
missing 
The last day of the month will be used to 
complete the end date of the AE.  
If the day and month parts of the AE end 
date are missing
December 31st will be used to complete the 
end date of the AE.  
If the end date of the AE is completely
missing and the AE is not ongoing, and the 
onset date of the AE occurs after the date of 
the first dose of study medication, 
Then the onset date of the AE will be used as 
the AE end date.  Otherwise, the date of the 
first dose of study medication will be used as 
the AE end date.


Statistical Analysis Plan 
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Edition Number 2.0
Date 21MAY2020
64
7.2
Appendix B2
Algorithm for prior /concomitant medications
START 
DATE
STOP 
DATE
Action
Known
Known
If stop date < study med start date, assign as pre-treatment 
If stop date ≥ study med start date and start date < study med 
start date, assign as prior concomitant 
If stop date ≥ study med start date and start date ≥study med 
start date, assign as new concomitant
Partial
Impute stop date as latest possible date (ie, last day of month if 
day unknown or 31st December if day and month are unknown), 
then:
Follow the same algorithm above for a known start date and 
known stop date.
Missing
If stop date is missing could never be assumed a prior 
medication
If start date < study med start date, assign as prior concomitant 
If start date ≥ study med start date, assign as new concomitant
Partial
Known
Impute start date as earliest possible date (ie, first day of month 
if day unknown or 1st January if day and month are unknown), 
then:
Follow the same algorithm above for a known start date and 
known stop date.
Partial
Impute start date as earliest possible date (ie, first day of month 
if day unknown or 1st January if day and month are unknown) 
and impute stop date as latest possible date (ie, last day of 
month if day unknown or 31st December if day and month are 
unknown), then:
Follow the same algorithm above for a known start date and 
known stop date.


Statistical Analysis Plan 
Study Code D5551C00002
Edition Number 2.0
Date 21MAY2020
65
START 
DATE
STOP 
DATE
Action
Missing
Impute start date as earliest possible date (ie, first day of month 
if day unknown or 1st January if day and month are unknown), 
then:
If stop date is missing could never be assumed a prior 
medication
Follow the same algorithm above for a known start date and 
missing stop date.
Missing
Known
If stop date < study med start date, assign as pre-treatment
If stop date ≥ study med start date, assign as prior concomitant
Partial
Impute stop date as latest possible date (ie, last day of month if 
day unknown or 31st December if day and month are unknown), 
then:
Follow the same algorithm above for a missing start date and 
known stop date.
Missing
Assign as prior concomitant


Statistical Analysis Plan 
Study Code D5551C00002
Edition Number 2.0
Date 21MAY2020
66
7.3
Appendix B3
Units and marked abnormality criteria for safety laboratory 
variables and vital sign parameters
Clinical laboratory variables will be summarized using the reference ranges in the lab manual. 
Potentially clinically significant changes are assessed with the following marked 
abnormality criteria for vital signs9:
Age: 6 - <12 years
Marked abnormality criteria
Vital signs variables
Units
Low
High
Heart Rate
Value
bpm
< 60
> 95 
Value - Baseline
bpm
> 20
Baseline - Value
bpm
>10
Systolic Blood Pressure
Value
mmHg
< 100
> 120
Value - Baseline
mmHg
> 10
Baseline - Value
mmHg
>10
Diastolic Blood Pressure
Value
mmHg
< 60
> 75
Value - Baseline
mmHg
> 10
Baseline - Value
mmHg
>10
Age: ≥12 years
Marked abnormality criteria
Vital signs variables
Units
Low
High
Heart Rate
  Value
bpm
< 55
> 85 
  Value - Baseline
bpm
> 20
  Baseline - Value
bpm
>10
Systolic Blood Pressure


Statistical Analysis Plan 
Study Code D5551C00002
Edition Number 2.0
Date 21MAY2020
67
Marked abnormality criteria
Vital signs variables
Units
Low
High
Heart Rate
  Value
mmHg
< 110
> 135
  Value - Baseline
mmHg
> 10
  Baseline - Value
mmHg
>10
Diastolic Blood Pressure
  Value
mmHg
< 65
> 85
  Value - Baseline
mmHg
> 10
  Baseline - Value
mmHg
>10
7.4
Appendix B4 Preferred terms for potentially immune-related 
adverse events
Allergic bronchitis
Immediate post-injection 
reaction
Rash
Allergic colitis
Injection site dermatitis
Rash erythematous
Allergic cough
Injection site eczema
Rash follicular
Allergic cystitis
Injection site erythema
Rash macular
Allergic keratitis
Injection site 
hypersensitivity
Rash maculo-papular
Allergic oedema
Injection site induration
Rash maculovesicular
Allergic otitis media
Injection site inflammation
Rash papular
Allergic pharyngitis
Injection site macule
Rash pruritic
Allergic respiratory 
symptom
Injection site nodule
Rash pustular
Hypersensitivity 
pneumonitis
Injection site oedema
Rash vesicular
Anaphylactic reaction
Injection site papule
Reaction to excipient
Anaphylactic shock
Injection site 
photosensitivity reaction
Reaction to preservatives
Anaphylactoid reaction
Injection site pruritus
Reversible airways 
obstruction
Anaphylactoid shock
Injection site pustule
Scleral oedema
Angioedema
Injection site rash
Scleritis allergic
Arthralgia
Injection site reaction
Skin oedema


Statistical Analysis Plan 
Study Code D5551C00002
Edition Number 2.0
Date 21MAY2020
68
Arthritis
Injection site recall reaction
Intestinal angioedema
Arthritis allergic
Injection site streaking
Stevens-Johnson syndrome
Asthma
Injection site swelling
Stridor
Auricular swelling
Injection site urticaria
Suffocation feeling
Bronchial hyperreactivity
Injection site vesicles
Swelling face
Bronchial oedema
Joint effusion
Swollen tongue
Bronchospasm
Joint swelling
Throat tightness
Circumoral oedema
Laryngeal obstruction
Tongue oedema
Conjunctival oedema
Laryngeal oedema
Tongue pruritus
Corneal oedema
Laryngitis allergic
Toxic epidermal necrolysis
Dermatitis
Laryngotracheal oedema
Toxic skin eruption
Dermatitis allergic
Lip oedema
Tracheal obstruction
Diffuse cutaneous 
mastocytosis
Swelling
Tracheal oedema
Drug eruption
Local swelling
Type I hypersensitivity
Drug hypersensitivity
Localised oedema
Type II hypersensitivity
Drug reaction with 
eosinophilia 
and systemic symptoms
Mechanical urticaria
Type III immune complex 
mediated reaction
Encephalopathy allergic
Nasal oedema
Type IV hypersensitivity 
reaction
Eosinophilia
Nephritis allergic
Urticaria
Eosinophilic oesophagitis
Oculorespiratory syndrome
Urticaria cholinergic
Epiglottic oedema
Oedema mouth
Urticaria chronic
Erythema multiforme
Oedema mucosal
Urticaria contact
Erythema nodosum
Oesophageal oedema
Urticaria papular
Eye oedema
Orbital oedema
Urticaria physical
Eye swelling
Oropharyngeal swelling
Urticaria pigmentosa
Eyelid oedema
Palatal oedema
Urticaria pressure
Face oedema
Periarthritis
Urticaria thermal
Gastrointestinal oedema
Periorbital oedema
Urticaria vesiculosa
Gingival oedema
Pharyngeal oedema
Urticaria vibratory
Gingival swelling
Photosensitivity reaction
Visceral oedema
Haemorrhagic urticaria
Pruritus
Wheezing
Hereditary angioedema
Pruritus allergic
Hypersensitivity
Idiopathic urticaria


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Document Name: d5551c00002-sap-ed-2
Document Title:
Statistical Analysis Plan Edition 2
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Version Label:
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Server Date
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