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A Clinical Pharmacology and Long Term Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With Type 1 Diabetes Who Have Inadequate Glycemic Control

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Trial Profile

A Clinical Pharmacology and Long Term Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With Type 1 Diabetes Who Have Inadequate Glycemic Control

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Dapagliflozin (Primary)
  • Indications Type 1 diabetes mellitus
  • Focus Adverse reactions
  • Acronyms DEPICT-5
  • Sponsors AstraZeneca

Most Recent Events

  • 27 Mar 2019 According to an AstraZeneca media release, based on data from the Phase III DEPICT clinical programme and a dedicated trial in Japanese patients (D1695C00001), the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Forxiga (dapagliflozin) as an oral adjunct treatment to insulin for adults with type-1 diabetes (T1D).
  • 26 Jun 2018 Results from 2 studies NCT01498185 and NCT02582814 presented at the 78th Annual Scientific Sessions of the American Diabetes Association
  • 07 Jul 2017 Status changed from active, no longer recruiting to completed.

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