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

Trial Profile

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

Completed
Phase of Trial: Phase III

Latest Information Update: 19 May 2017

At a glance

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

    • 07 Jun 2017 Biomarkers information updated
    • 19 Jul 2016 According to AstraZeneca media release, the European Commission (EC) has approved Qtern (saxagliptin/dapagliflozin) tablets for the treatment of type 2 diabetes in all 28 EU member countries plus Iceland, Liechtenstein and Norway.
    • 27 May 2016 According to an AstraZeneca media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of saxa/dapa (saxagliptin and dapagliflozin) tablets for the treatment of adults with type-2 diabetes.
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