A 24-Week, Multi-Centre, International, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Phase III Study With a 78-Week Extension Period to Evaluate the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycaemic Control on Metformin Alone.

Trial Profile

A 24-Week, Multi-Centre, International, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Phase III Study With a 78-Week Extension Period to Evaluate the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycaemic Control on Metformin Alone.

Completed
Phase of Trial: Phase III

Latest Information Update: 23 Jan 2018

At a glance

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

    • 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.
    • 16 Sep 2016 Results of a pooled analysis from this and 13 other trials, presented at the 52nd Annual Meeting of the European Association for the Study of Diabetes.
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