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: 05 Apr 2017
At a glance
- Drugs Semaglutide (Primary)
- Indications Type 2 diabetes mellitus
- Focus Adverse reactions; Registrational
- Acronyms SUSTAIN
- Sponsors Novo Nordisk
- 07 Jun 2017 Biomarkers information updated
- 28 Feb 2017 According to a Novo Nordisk media release, based on the results from the SUSTAIN clinical trial programme, company has submitted NDA to the Japanese Ministry of Health, Labour and Welfare for semaglutide, administrated once-weekly, for the treatment of adults with type 2 diabetes. This filing follows the recent once-weekly semaglutide regulatory submissions to the US FDA, the European Medicines Agency (EMA).
- 05 Dec 2016 According to a Novo Nordisk media release, company has submitted New Drug Application to the US Food and Drug Administration and a Marketing Authorisation Application to the European Medicines Agency for semaglutide administered once-weekly, for the treatment of adults with type 2 diabetes based on the results from the SUSTAIN clinical trial programme.