A Multicenter Randomized Double-Blind Active Controlled Parallel Group Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin as Initial Therapy as Compared With Dapagliflozin Monotherapy and Metformin Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control.
Phase of Trial: Phase III
Latest Information Update: 28 Feb 2017
At a glance
- Drugs Dapagliflozin (Primary) ; Metformin
- Indications Type 2 diabetes mellitus
- Focus Registrational; Therapeutic Use
- Sponsors AstraZeneca; Bristol-Myers Squibb
- 31 Aug 2018 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.
- 05 Oct 2012 Pooled analysis assessing the effect of dapagliflozin treatment on renal function presented at the 48th 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