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A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin 10 mg in Combination With Metformin as Initial Therapy as Compared With Dapagliflozin 10 mg Monotherapy and Metformin Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control.

Trial Profile

A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin 10 mg in Combination With Metformin as Initial Therapy as Compared With Dapagliflozin 10 mg Monotherapy and Metformin Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Apr 2020

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At a glance

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

    • 20 Apr 2020 Results (n=7005) of pooled analysis of 13 phase II/III trials: MB102008, MB102013, MB102014, MB102028, MB102029, MB102030, MB102032, MB102033, MB102034, MB102047, MB102061, MB102067, MB102080 were published in the British Journal of Clinical Pharmacology
    • 31 Aug 2018 Biomarkers information updated
    • 23 Jan 2018 Results (n=220) of pooled analysis of 11 phase 3 trial assessing effects of the sodium-glucose co-transporter 2 inhibitor dapagliflozin in patients with type 2 diabetes and stages 3b-4 chronic kidney disease, were published in the Nephrology Dialysis Transplantation.
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