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A Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 2 Trial to Explore the Safety, Pharmacokinetics and Pharmacodynamics of Dapagliflozin as an Add-on to Insulin Therapy in Subjects With Type 1 Diabetes Mellitus.

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Trial Profile

A Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 2 Trial to Explore the Safety, Pharmacokinetics and Pharmacodynamics of Dapagliflozin as an Add-on to Insulin Therapy in Subjects With Type 1 Diabetes Mellitus.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 14 Apr 2022

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At a glance

  • Drugs Dapagliflozin (Primary) ; Insulin
  • Indications Type 1 diabetes mellitus
  • Focus Proof of concept; Therapeutic Use
  • Sponsors 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
    • 26 Jun 2018 Results from 2 studies NCT01498185 and NCT02582814 presented at the 78th Annual Scientific Sessions of the American Diabetes Association
    • 09 Jun 2015 Results of a post hoc analysis of insulin dose adjustment in response to dapagliflozin therapy presented at the 75th Annual Scientific Sessions of the American Diabetes Association.
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