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A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase III Trial to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise.

Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase III Trial to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 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
    • 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.
    • 05 Oct 2012 Pooled analysis assessing the effects of treatment on renal function presented at the 48th Annual Meeting of the European Association for the Study of Diabetes.
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