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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

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Apr 2022

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At a glance

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

    • 10 Apr 2022 Data from three studies (phase 2 (NCT01498185) and two phase 3 (DEPICT-1, NCT02268214; DEPICT-2, NCT02460978) studies) were used to characterize the dapagliflozin pharmacokinetics (PK) in patients with T1DM published in the Journal of Clinical Pharmacology
    • 06 Nov 2019 Results of two studies (DEPICT-1 & DEPICT-2) assessing impact of dapagliflozin on patient-reported treatment satisfaction, presented at the 22nd Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research.
    • 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.
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