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Cover Page for Protocol Cover Page for Protocol Sponsor name: Novo Nordisk A/S NCT number NCT03191396 Sponsor trial ID: NN9535-4339 Official title of study: Efficacy and safety of semaglutide 1.0 mg once-weekly versus liraglutide 1.2 mg once-daily as add-on to 1–3 oral anti-diabetic drugs (OADs) in subjects with type 2 diabetes. (SUSTAIN 10) Document date: 27 May 2019 Semaglutide s.c. Ozempic® Date: 27 May 2019 Novo Nordisk Trial ID: NN9535-4339 Version: 1.0 CONFIDENTIAL Clinical Trial Report Status: Final Appendix 16.1.1 16.1.1 Protocol and protocol amendments List of contents Protocol ............................................................................................................................................... Link Appendix A - Monitoring of calcitonin............................................................................................. Link Appendix B - Adverse events requiring additional data collection................................................ Link Appendix C - Questionnaire SF-36v2™ and DTSOs ...................................................................... Link Attachment I and II............................................................................................................................ Link Protocol amendment 1 - FR............................................................................................................... Link Protocol amendment 2 - IT................................................................................................................ Link Protocol amendment 3 - PL............................................................................................................... Link Protocol amendment 4 - BG (substantial amendment 1-BG)......................................................... Link Protocol amendment 5 - BG (substantial amendment 2-BG)......................................................... Link Protocol amendment 6 - BG (substantial amendment 3-BG)......................................................... Link Redacted protocol Lncludes redaction of personal identifiable information. Protocol Date: 03 February 2017 Novo Nordisk Trial ID:NN9535-4339 Version: 2.0 CONFIDENTIAL UTN:U1111-1190-5868 Status: Final EudraCT no.: 2016-004965-22 Page: 1 of 96 Protocol Trial ID: NN9535-4339 SUSTAIN 10 Efficacy and safety of semaglutide 1.0 mg once-weekly versus liraglutide 1.2 mg once-daily as add-on to 1-3 oral anti-diabetic drugs (OADs) in subjects with type 2 diabetes Trial phase: 3b Protocol originator 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 This confidential document is the property of Novo Nordisk. No unpublished information contained herein may be parties. disclosed without prior written approval from Novo Nordisk. Access to this document must be restricted to relevant parties. Protocol Date: 03 February 2017 Novo Nordisk Trial ID:NN9535-4339 Version: 2.0 CONFIDENTIAL UTN:U1111-1190-5868 Status: Final EudraCT no.: 2016-004965-22 Page: 2 of 96 Table of Contents Page Table of Figures................................................................................................................................................6 Table of Tables..................................................................................................................................................6 List of abbreviations.........................................................................................................................................7 1 Summary....................................................................................................................................................9 2 Flow chart ................................................................................................................................................12 3 Background information and rationale for the trial............................................................................16 3.1 Background information..............................................................................................................16 3.1.1 Type 2 diabetes ..........................................................................................................16 3.1.2 Glucagon-like peptide-1 (GLP-1)..............................................................................16 3.1.3 Semaglutide ...............................................................................................................17 3.1.4 Nonclinical data - semaglutide...................................................................................17 3.1.5 Clinical data – semaglutide........................................................................................18 3.1.6 Liraglutide..................................................................................................................20 3.2 Rationale for the trial ...................................................................................................................20 4 Objectives and endpoints........................................................................................................................21 4.1 Objectives ....................................................................................................................................21 4.2 Endpoints .....................................................................................................................................21 4.2.1 Primary endpoint........................................................................................................21 4.2.2 Secondary endpoints..................................................................................................21 5 Trial design ..............................................................................................................................................23 5.1 Type of trial .................................................................................................................................23 5.2 Rationale for trial design..............................................................................................................24 5.3 Treatment of subjects...................................................................................................................24 5.3.1 Trial Products/Investigational medicinal Products supplied by Novo Nordisk.........25 5.3.2 Background medication .............................................................................................25 5.4 Injection site.................................................................................................................................26 5.5 Missed dose..................................................................................................................................26 5.6 Treatment after discontinuation of trial product ..........................................................................26 5.7 Rationale for treatment ................................................................................................................26 6 Trial population.......................................................................................................................................27 6.1 Number of subjects ......................................................................................................................27 6.2 Inclusion criteria ..........................................................................................................................27 6.3 Exclusion criteria .........................................................................................................................27 6.4 Rescue criteria..............................................................................................................................29 6.5 Criteria for premature discontinuation of trial product................................................................29 6.6 Withdrawal from trial ..................................................................................................................30 6.7 Subject replacement.....................................................................................................................30 6.8 Rationale for trial population.......................................................................................................30 7 Milestones.................................................................................................................................................31 8 Methods and assessments .......................................................................................................................32 Protocol Date: 03 February 2017 Novo Nordisk Trial ID:NN9535-4339 Version: 2.0 CONFIDENTIAL UTN:U1111-1190-5868 Status: Final EudraCT no.: 2016-004965-22 Page: 3 of 96 8.1 Visit procedures ...........................................................................................................................32 8.1.1 Investigator site log....................................................................................................32 8.1.2 Screening, visit 1........................................................................................................32 8.1.3 Fasting visits ..............................................................................................................33 8.1.4 Premature discontinuation of trial product
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