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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
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:15 Apr 2019
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At a glance
Drugs
Dapagliflozin (Primary)
Indications
Type 1 diabetes mellitus
Focus
Adverse reactions
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).
31 Aug 2018
Biomarkers information updated
26 Jun 2018
Results from 2 studies NCT01498185 and NCT02582814 presented at the 78th Annual Scientific Sessions of the American Diabetes Association
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