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Statistical Analysis Plan Study Code D5551C00002 Edition Number 2.0 Date 21MAY2020

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Statistical Analysis Plan Study Code D5551C00002 Edition Number 2.0 Date 21MAY2020 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 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 2 Statistical Analysis Plan Study Code D5551C00002 Edition Number 2.0 Date 21MAY2020 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...................................................................................................
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