A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase 2/3 Trial to Evaluate the Glycemic Efficacy, Renal Safety, Pharmacokinetics, and Pharmacodynamics of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment Who Have Inadequate Glycemic Control.
Phase of Trial: Phase II/III
Latest Information Update: 14 Feb 2017
At a glance
- Drugs Dapagliflozin (Primary)
- Indications Type 2 diabetes mellitus
- Focus Registrational; Therapeutic Use
- Sponsors Bristol-Myers Squibb
- 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.