A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase III study to Evaluate the Glycemic Efficacy and Renal Safety of dapagliflozin in patients with Type 2 Diabetes Mellitus and Moderate Renal Impairment (CKD 3A) who have Inadequate Glycemic Control

Trial Profile

A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase III study to Evaluate the Glycemic Efficacy and Renal Safety of dapagliflozin in patients with Type 2 Diabetes Mellitus and Moderate Renal Impairment (CKD 3A) who have Inadequate Glycemic Control

Completed
Phase of Trial: Phase III

Latest Information Update: 22 Mar 2018

At a glance

  • Drugs Dapagliflozin (Primary)
  • Indications Renal failure; Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms DERIVE
  • Sponsors AstraZeneca
  • Most Recent Events

    • 20 Mar 2018 Results (n=321) assessing dapagliflozin in patients with type 2 diabetes and and moderate renal impairment (CKD 3A) who have Inadequate glycemic control, were presented at The 100th Annual Meeting of the Endocrine Society.
    • 19 Mar 2018 According to an AstraZeneca media release, study met its all primary and secondary efficacy endpoints. Company is planning to submit the data from this study to FDA to add the data to already contained existing FARXIGA (Dapagliflozin) Prescribing Information.
    • 19 Mar 2018 According to an AstraZeneca media release, results from this study were presented at the Endocrine Society's 100th Annual Meeting and Expo (ENDO).
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