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Safety and Efficacy of Semaglutide Once Weekly Versus Sitagliptin Once Daily, Both as Monotherapy in Japanese Subjects With Type 2 Diabetes

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Trial Profile

Safety and Efficacy of Semaglutide Once Weekly Versus Sitagliptin Once Daily, Both as Monotherapy in Japanese Subjects With Type 2 Diabetes

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Apr 2022

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At a glance

  • Drugs Semaglutide (Primary) ; Sitagliptin
  • Indications Type 2 diabetes mellitus
  • Focus Adverse reactions; Registrational
  • Acronyms SUSTAIN
  • Sponsors Novo Nordisk

Most Recent Events

  • 25 Sep 2020 Results (n=9680) of analysis from twelve clinical studies: SUSTAIN 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 and two Japanese SUSTAIN trials assessing risk predictors for Gastrointestinal adverse events with once weekly subcutaneous Semaglutide identifying high-risk patients presented at the 56th Annual Meeting of the European Association for the Study of Diabetes
  • 15 Dec 2017 According to a Novo Nordisk media release, the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorisation for Ozempic (semaglutide) for the treatment of adults with type 2 diabetes mellitus.
  • 05 Dec 2017 According to a Novo Nordisk media release, based on the results from SUSTAIN phase IIIa global clinical development program, the US Food and Drug Administration (FDA) has approved Ozempic (semaglutide injection) for once-weekly administration in adults with type 2 diabetes.

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