Publication of the Results of Clinical Trials According to § 42B(1) AMG
Publication of the results of clinical trials according to § 42b(1) AMG Name of Sponsor: Novo Nordisk A/S Name of finished product: Ozempic® Name of Active Ingredient: Semaglutide To protect personal data names and other identifying details have been redacted. Semaglutide s.c. Date: 24 October 2016 Novo Nordisk Trial ID: NN9535-3744 Version: 1.0 Trial ID: NN9535-3744 CONFIDENTIAL Version: 1.0 Clinical Trial Report Status: Final Report Synopsis Page: 1 of 13 CTR synopsis Clinical Trial Report synopsis – ICH E3 Section 2 NAME OF SPONSOR Novo Nordisk A/S, Novo Allé 1, DK-2880 Bagsvaerd, Denmark NAME OF ACTIVE SUBSTANCE Semaglutide Trial ID NN9535-3744 Trial registration ID-number UTN – U1111-1131-7227 NCT01720446 IND number – 79,754 EudraCT number – 2012-002839-28 TITLE OF TRIAL SUSTAIN 6 – Long-term Outcomes A long-term, randomised, double-blind, placebo-controlled, multinational, multi-centre trial to evaluate cardiovascular and other long-term outcomes with semaglutide in subjects with type 2 diabetes. INVESTIGATORS One principal investigator was appointed at each of the 229 trial sites in the trial. The following investigators were designated signatory investigators for the trial, and were responsible for reviewing and approving the clinical trial report: , MD, , MD, . TRIAL SITES The trial was conducted at 229 sites in 20 countries, as follows: Algeria: 4 sites, Argentina: 7 sites, Australia: 8 sites, Brazil: 8 sites, Bulgaria: 5 sites, Canada: 13 sites, Denmark: 5 sites, Germany: 7 sites, Israel: 6 sites, Italy: 6 sites, Malaysia: 6 sites, Mexico: 9 sites, Poland: 5 sites, Russia: 11 sites, Spain: 6 sites, Taiwan: 4 sites, Thailand: 5 sites, Turkey: 10 sites, United Kingdom: 8 sites and United States: 96 sites.
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