A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin 10 mg in Combination With Metformin as Initial Therapy as Compared With Dapagliflozin 10 mg Monotherapy and Metformin Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control.
Phase of Trial: Phase III
Latest Information Update: 01 Nov 2016
At a glance
- Drugs Dapagliflozin (Primary) ; Metformin
- Indications Type 2 diabetes mellitus
- Focus Registrational; Therapeutic Use
- Sponsors AstraZeneca
- 07 Jun 2017 Biomarkers information updated
- 01 Nov 2016 Results of a pooled post-hoc analysis of five phase IIb and 16 phase III studies (including this study) assessing frequency and characteristics of hypersensitivity adverse events, published in the Clinical Drug Investigation.
- 16 Sep 2016 Results of a pooled analysis from this and 13 other trials, presented at the 52nd Annual Meeting of the European Association for the Study of Diabetes.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History