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: 02 Apr 2018
At a glance
- Drugs Dapagliflozin (Primary) ; Insulin
- Indications Type 1 diabetes mellitus
- Focus Registrational; Therapeutic Use
- Acronyms DEPICT 1
- Sponsors AstraZeneca; Bristol-Myers Squibb
- 05 Mar 2018 According to an AstraZeneca media release, the European Medicines Agency has accepted the Marketing Authorisation Variation for Forxiga (dapagliflozin), a selective SGLT-2 inhibitor, for use as an oral adjunct treatment to insulin in adults with type-1 diabetes (T1D). The submission acceptance is based on data from the DEPICT 1 and DEPICT2 studies.
- 28 Sep 2017 Status changed from active, no longer recruiting to completed.
- 10 Jun 2017 Biomarkers information updated