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
Phase of Trial: Phase III
Latest Information Update: 06 Nov 2019
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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
- 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.
- 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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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History