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A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Dapagliflozin as an Add-on to Insulin Therapy in Subjects With Type 1 Diabetes Mellitus - Study Two

Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Dapagliflozin as an Add-on to Insulin Therapy in Subjects With Type 1 Diabetes Mellitus - Study Two

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Jul 2019

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At a glance

  • Drugs Dapagliflozin (Primary)
  • Indications Type 1 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms DEPICT 2
  • Sponsors AstraZeneca
  • Most Recent Events

    • 15 Jul 2019 According to an AstraZeneca media release, the US Food and Drug Administration (FDA) has issued a complete response letter regarding the supplemental New Drug Application for Farxiga (dapagliflozin) as an adjunct treatment to insulin to improve glycaemic control in adult patients with type-1 diabetes (T1D), when insulin alone does not provide adequate glycaemic control. The company will work closely with the FDA to discuss the next steps.
    • 11 Jun 2019 Results assessing the inter-relationships between hypoglycemia, body mass index and quality of life, presented at the 79th Annual Scientific Sessions of the American Diabetes Association
    • 11 Jun 2019 Results analysing changes in HbA1c, weight and insulin dose following discontinuation of Dapagliflozin in the DEPICT 1 and DEPICT 2 trials presented at the 79th Annual Scientific Sessions of the American Diabetes Association.
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