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A 52-week International, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase 3bTrial With a Blinded 104-week Long -Term Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin ≥1500 mg in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone

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Trial Profile

A 52-week International, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase 3bTrial With a Blinded 104-week Long -Term Extension Period to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin ≥1500 mg 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: 13 Jan 2022

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At a glance

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

    • Most Recent Events

    • 16 Jun 2020 Results evaluating gender differences in diabetes distress comparing Dapagliflozin plus Saxagliptin to Glimepiride added to Metformin in poorly controlled Type 2 Diabetes, presented at the 80th Annual Scientific Sessions of the American Diabetes Association
    • 17 Sep 2019 Status changed from active, no longer recruiting to completed.
    • 07 Jun 2019 Trial has been completed in Czech Republic according to European Clinical Trials Database record.

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