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

Trial Profile

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

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Dec 2017

At a glance

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

    • 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.
    • 05 Dec 2017 According to a Novo Nordisk media release, based on the results of this study and other study (249945), 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.
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