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Statistical Analysis Plan Cover Page for Statistical Analysis Plan Sponsor name: Novo Nordisk A/S NCT number NCT03061214 Sponsor trial ID: NN9535-4114 Official title of study: SUSTAINTM CHINA - Efficacy and safety of semaglutide once-weekly versus sitagliptin once-daily as add-on to metformin in subjects with type 2 diabetes Document date: 22 August 2019 Semaglutide s.c (Ozempic®) Date: 22 August 2019 Novo Nordisk Trial ID: NN9535-4114 Version: 1.0 CONFIDENTIAL Clinical Trial Report Status: Final Appendix 16.1.9 16.1.9 Documentation of statistical methods List of contents Statistical analysis plan...................................................................................................................... /LQN Statistical documentation................................................................................................................... /LQN Redacted VWDWLVWLFDODQDO\VLVSODQ Includes redaction of personal identifiable information only. Statistical Analysis Plan Date: 28 May 2019 Novo Nordisk Trial ID: NN9535-4114 Version: 1.0 CONFIDENTIAL UTN:U1111-1149-0432 Status: Final EudraCT No.:NA Page: 1 of 30 Statistical Analysis Plan Trial ID: NN9535-4114 Efficacy and safety of semaglutide once-weekly versus sitagliptin once-daily as add-on to metformin in subjects with type 2 diabetes Author Biostatistics Semaglutide s.c. This confidential document is the property of Novo Nordisk. No unpublished information contained herein may be disclosed without prior written approval from Novo Nordisk. Access to this document must be restricted to relevant parties.This confidential document is the property of Novo Nordisk. No unpublished information contained herein may be disclosed without prior written approval from Novo Nordisk. Access to this document must be restricted to relevant parties. Statistical Analysis Plan Date: 28 May 2019 Novo Nordisk Trial ID: NN9535-4114 Version: 1.0 CONFIDENTIAL UTN:U1111-1149-0432 Status: Final EudraCT No.:NA Page: 2 of 30 Table of contents Page Table of contents.........................................................................................................................................2 List of abbreviations ...................................................................................................................................3 1 Introduction .........................................................................................................................................4 1.1 Trial information.......................................................................................................................4 1.2 Scope of the statistical analysis plan..........................................................................................4 2 Statistical considerations .....................................................................................................................5 2.1 General considerations ..............................................................................................................5 2.2 Sample size calculation .............................................................................................................6 2.3 Definition of analysis sets..........................................................................................................7 2.4 Primary endpoint.....................................................................................................................10 2.5 Secondary endpoints ...............................................................................................................16 2.5.1 Confirmatory secondary endpoints .........................................................................16 2.5.2 Supportive secondary endpoints .............................................................................18 2.5.2.1 Efficacy endpoints............................................................................18 2.5.2.2 Safety endpoints...............................................................................20 2.6 Health economics and/or patient reported outcomes.................................................................25 2.7 China cohort ...........................................................................................................................25 3 Changes to the statistical analyses planned in the protocol ..............................................................27 4 References ..........................................................................................................................................30 Statistical Analysis Plan Date: 28 May 2019 Novo Nordisk Trial ID: NN9535-4114 Version: 1.0 CONFIDENTIAL UTN:U1111-1149-0432 Status: Final EudraCT No.:NA Page: 3 of 30 List of abbreviations AACE American Association of Clinical Endocrinologists ADA American Diabetes Association AE adverse event ANCOVA analysis of covariance BG blood glucose BMI body mass index CTR clinical trial report DTSQ Diabetes Treatment Satisfaction Questionnaire status EAC event adjudication committee ECG electrocardiogram FAS full analysis set GLP-1 glucagon-like peptide-1 HDL high density lipoprotein hsCRP highly sensitive C-reactive protein ITT intention to treat IWRS interactive voice/web response system LLOQ lower limit of quantification LOCF last observation carried forward MAR missing at random MCAR missing completely at random MCMC markow chain Monte Carlo MedDRA Medical Dictionary for Regulatory Activities NDA new drug application PP per protocol PRO patient reported outcome PT preferred term REML restricted maximum likelihood SAP statistical analysis plan SAS safety analysis set s.c. subcutanous SD standard deviation SE standard error TEAE treatment emergent adverse event Statistical Analysis Plan Date: 28 May 2019 Novo Nordisk Trial ID: NN9535-4114 Version: 1.0 CONFIDENTIAL UTN:U1111-1149-0432 Status: Final EudraCT No.:NA Page: 4 of 30 1 Introduction 1.1 Trial information This is a 30-week randomised, double-blind, double-dummy, active-controlled, multi-centre, multinational trial, four-armed, parallel-group trial comparing semaglutide 0.5 mg and 1.0 mg once weekly against sitagliptin 100 mg once-daily. Primary objective To compare the effect of once-weekly dosing of two dose levels of semaglutide versus sitagliptin 100 mg once-daily on glycaemic control after 30 weeks of treatment. To further detail the primary objective an estimand is defined which is an efficacy estimand. The scientific question is: ! What is the treatment difference between semaglutide and sitagliptin at week 30 for all randomised subjects if all subjects completed treatment and did not initiate rescue medication ! The population is defined by the inclusion/exclusion criteria of the trial ! The primary endpoint is change from baseline in HbA1c after 30 weeks of treatment ! Only data collected before the occurrence of the intercurrent events initiation of rescue medication and discontinuation of trial product are used in the analysis. Secondary objectives To compare the effects of once-weekly dosing of two dose levels of semaglutide versus sitagliptin 100 mg once-daily after 30 weeks of treatment on: ! Inducing and maintaining weight loss ! Other parameters of efficacy, safety and tolerability An estimand similar to the one for the primary objective is defined for the secondary objective as addressed by weight loss, however with ‘change from baseline in HbA1c after 30 weeks’ replaced by ‘change from baseline in body weight after 30 weeks of treatment’. 1.2 Scope of the statistical analysis plan This SAP is based on the protocol “Efficacy and safety of semaglutide once-weekly versus sitagliptin once-daily as add-on to metformin in subjects with type 2 diabetes”, version 3.0, and amendment 3. The SAP is relevant both for the analysis of data for the entire trial population and for the analysis of the China cohort by it self. See Section 2.7. Statistical Analysis Plan Date: 28 May 2019 Novo Nordisk Trial ID: NN9535-4114 Version: 1.0 CONFIDENTIAL UTN:U1111-1149-0432 Status: Final EudraCT No.:NA Page: 5 of 30 2 Statistical considerations 2.1 General considerations Results from the statistical analysis will generally be presented by two-sided confidence intervals with a confidence level of 95% and associated p-value. Superiority will be formulated and tested as one-sided hypotheses at a 2.5% significance level. Non-inferiority between two treatments will be evaluated by comparing the upper limit of the associated two-sided 95% confidence interval for the difference with the pre-defined non-inferiority margin. The two sitagliptin/semaglutide placebo groups will be pooled in all outputs if not otherwise specified. When grouping or analysing data by country, subjects from Hong Kong and Taiwan will be grouped with Chinese subjects if not otherwise specified. The same is done when grouping or analysing by region China/Other where subjects from South Africa, Korea, Brazil and Ukraine will be analysed together in the group referred to as “Other”. Data transformations A number of the continuous parameters will be log-transformed prior to statistical analysis. The output tables and figures will show the results of the analysis back-transformed to the original scale, implying that log-treatment-differences are reported as treatment ratios. Confidence intervals for the treatment ratios will be calculated as exponentiated upper and lower limits for log-treatment difference confidence intervals. The standard errors (SE) of the back-transformed mean and ratio to baseline estimates are also provided; these SEs are
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