Safety and Efficacy of Semaglutide Once Weekly Versus Sitagliptin Once Daily, Both as Monotherapy in Japanese Subjects With Type 2 Diabetes
Phase of Trial: Phase III
Latest Information Update: 15 Sep 2018
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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
- 31 Aug 2018 Biomarkers information updated
- 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.