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A 52-Week, Multi-Centre, Randomised, Parallel-Group, Double-Blind, Active Controlled, Phase IV Study to Evaluate the Safety and Efficacy of Dapagliflozin or Dapagliflozin Plus Saxagliptin Compared With Sulphonylurea All Given as Add-on Therapy to Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Monotherapy

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Trial Profile

A 52-Week, Multi-Centre, Randomised, Parallel-Group, Double-Blind, Active Controlled, Phase IV Study to Evaluate the Safety and Efficacy of Dapagliflozin or Dapagliflozin Plus Saxagliptin Compared With Sulphonylurea All Given as Add-on Therapy to Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Monotherapy

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 03 Oct 2021

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At a glance

  • Drugs Dapagliflozin (Primary) ; Saxagliptin (Primary) ; Glimepiride; Metformin
  • Indications Type 2 diabetes mellitus
  • Focus Therapeutic Use
  • Sponsors AstraZeneca

Most Recent Events

  • 26 Jun 2018 Results (n=3134) of safety data were pooled from seven randomized phase 3 trials, were presented at the 78th Annual Scientific Sessions of the American Diabetes Association.
  • 08 Dec 2017 Primary endpoint (Change in hemoglobin A1c (HbA1c) from baseline to end of treatment) has been met, according to the results presented at the 2017 Congress of the International Diabetes Federation
  • 08 Dec 2017 Results presented at the 2017 Congress of the International Diabetes Federation

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