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A Multicenter, Randomized, Double-Blind, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Insulin Alone or on Insulin in Combination With Metformin

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Trial Profile

A Multicenter, Randomized, Double-Blind, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Insulin Alone or on Insulin in Combination With Metformin

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Oct 2021

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At a glance

  • Drugs Saxagliptin (Primary)
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Sponsors AstraZeneca; Bristol-Myers Squibb

    • Most Recent Events

    • 01 Sep 2016 Results of pooled analysis of this and eight other trials assessing efficacy and safety of sexagliptin published in the Diabetes Therapy (2016).
    • 03 Jul 2012 Planned number of patients changed from 435 to 1082 as reported by European Clinical Trials Database.
    • 12 Jun 2012 Results from a sub-analysis presented at the 72nd Annual Scientific Sessions of the American Diabetes Association.

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