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 Dec 2017
At a glance
- Drugs Semaglutide (Primary) ; Sitagliptin
- Indications Type 2 diabetes mellitus
- Focus Adverse reactions; Registrational
- Acronyms SUSTAIN
- Sponsors Novo Nordisk
- 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.
- 18 Oct 2017 According to a Novo Nordisk media release, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and Drug Administration (FDA) voted 16-0, supporting the approval of once-weekly semaglutide to improve glycemic control in adults with type 2 diabetes. The recommendation was based on data from SUSTAIN phase IIIa global clinical development program.