Safety and Efficacy of Semaglutide Once Weekly in Monotherapy or in Combination With One OAD in Japanese Subjects With Type 2 Diabetes Who Are Insufficiently Controlled on Diet/Exercise Therapy or OAD Monotherapy
Phase of Trial: Phase III
Latest Information Update: 15 Dec 2017
At a glance
- Drugs Semaglutide (Primary)
- 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.
- 08 Dec 2017 Results of population pharmacokinetic analysis using data from 5 randomised trials (NCT02054897, NCT01930188, NCT01885208, NCT01720446 and NCT02207374) presented at the 2017 Congress of the International Diabetes Federation
- 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.