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: 23 Jan 2018
At a glance
- Drugs Dapagliflozin (Primary)
- Indications Type 2 diabetes mellitus
- Focus Registrational; Therapeutic Use
- Sponsors Bristol-Myers Squibb
- 31 Aug 2018 Biomarkers information updated
- 23 Jan 2018 Results (n=220) of pooled analysis of 11 phase 3 trial assessing effects of the sodium-glucose co-transporter 2 inhibitor dapagliflozin in patients with type 2 diabetes and stages 3b-4 chronic kidney disease, were published in the Nephrology Dialysis Transplantation.
- 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.