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A 26-week International, Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3bTrial With a Blinded 26-week Long -Term Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

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Trial Profile

A 26-week International, Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3bTrial With a Blinded 26-week Long -Term Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Sep 2020

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At a glance

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

    • Most Recent Events

    • 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.
    • 15 Sep 2017 Results presented at the 53rd Annual Meeting of the European Association for the Study of Diabetes
    • 15 Sep 2017 Results assessing efficacy of combination of saxagliptin and dapagliflozin added concurrently to metformin in combination with diet and exercise versus sitagliptin added to metformin in combination with diet and exercise in reducing mean HbA1c over a treatment period of 26 weeks, were presented at the 53rd Annual Meeting of the European Association for the Study of Diabetes.
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