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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 Feb 2023

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At a glance

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

Most Recent Events

  • 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 effect of dapagliflozin treatment on renal function presented at the 48th Annual Meeting of the European Association for the Study of Diabetes.
  • 13 Mar 2012 Results published in the International Journal of Clinical Practice.

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