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A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Triple Therapy With Saxagliptin Added to Dapagliflozin in Combination With Metformin Compared to Therapy With Placebo Added to Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin and Dapagliflozin

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Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Triple Therapy With Saxagliptin Added to Dapagliflozin in Combination With Metformin Compared to Therapy With Placebo Added to Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin and Dapagliflozin

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2021

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At a glance

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

    • Most Recent Events

    • 01 Aug 2018 Results from NCT01619059 and NCT01646320 studies published in the Diabetes Therapy
    • 26 Jun 2018 Results (n=3134) of safety data were pooled from seven randomized phase 3 trials, were presented at the 78th Annual Scientific Sessions of the American Diabetes Association.
    • 28 Feb 2017 According to AstraZeneca media release, the US Food and Drug Administration (FDA) has approved once-daily Qtern for the treatment of type-2 diabetes based on data from this study.

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