Efficacy and safety of semaglutide once-weekly versus placebo as add-on to basal insulin alone or basal insulin in combination with metformin in subjects with type 2 diabetes

Trial Profile

Efficacy and safety of semaglutide once-weekly versus placebo as add-on to basal insulin alone or basal insulin in combination with metformin in subjects with type 2 diabetes

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Dec 2017

At a glance

  • Drugs Semaglutide (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms SUSTAIN 5
  • 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.
    • 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.
    • 12 Oct 2017 Results of a post hoc analysis of SUSTAIN 2-5 trials presented at the 20th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research
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