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A 52-Week International, Multi-centre, Randomised, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 156-Week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin in Combination With Metformin Compared With Sulphonylurea in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy Alone

Trial Profile

A 52-Week International, Multi-centre, Randomised, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 156-Week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin in Combination With Metformin Compared With Sulphonylurea in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy Alone

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Apr 2022

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At a glance

  • Drugs Dapagliflozin (Primary) ; Glipizide
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Sponsors AstraZeneca
  • 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.
    • 09 Jun 2015 Post-hoc analysis results assessing safety and efficacy presented at the 75th Annual Scientific Sessions of the American Diabetes Association.
    • 09 Jun 2015 Results assessing maintenance of weight loss after 4 years presented at the 75th Annual Scientific Sessions of the American Diabetes Association.
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