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A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, International Phase III Study With 24 Week Extension to Evaluate the Safety and Efficacy of Dapagliflozin 10 mg/Day in Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on a DPP-4 Inhibitor Sitagliptin+/-Metformin.

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Trial Profile

A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, International Phase III Study With 24 Week Extension to Evaluate the Safety and Efficacy of Dapagliflozin 10 mg/Day in Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on a DPP-4 Inhibitor Sitagliptin+/-Metformin.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Jul 2021

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At a glance

  • Drugs Dapagliflozin (Primary)
  • Indications 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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