Trial Profile
A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase III Trial to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise.
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 09 Nov 2021
Price :
$35
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At a glance
- Drugs Dapagliflozin (Primary)
- Indications Type 2 diabetes mellitus
- Focus Registrational; Therapeutic Use
- Sponsors Bristol-Myers Squibb
- 20 Apr 2020 Results (n=7005) of pooled analysis of 13 phase II/III trials: MB102008, MB102013, MB102014, MB102028, MB102029, MB102030, MB102032, MB102033, MB102034, MB102047, MB102061, MB102067, MB102080 were published in the British Journal of Clinical Pharmacology
- 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 effects of treatment on renal function presented at the 48th Annual Meeting of the European Association for the Study of Diabetes.