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A multicenter, randomized, double-blind, placebo-controlled, parallel group, phase 3 trial to evaluate the safety and efficacy of dapagliflozin in combination with metformin in subjects with type 2 diabetes who have inadequate glycemic control on metformin alone.

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A multicenter, randomized, double-blind, placebo-controlled, parallel group, phase 3 trial to evaluate the safety and efficacy of dapagliflozin in combination with metformin in subjects with type 2 diabetes who have inadequate glycemic control on metformin alone.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Nov 2021

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At a glance

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

    • 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
    • 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.
    • 01 Nov 2016 Results of a pooled post-hoc analysis of five phase IIb and 16 phase III studies (including this study) assessing frequency and characteristics of hypersensitivity adverse events, published in the Clinical Drug Investigation.

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