At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 631 enrolled
Drug / intervention
Dapagliflozin +2 moredrug
Likely dose
Dapagliflozin 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Dapagliflozin and Placebo for Diabetes Mellitus, Type 2. Completed, enrolled 631 participants across 96 sites in 13 countries.
Detailed Summary
The purpose of this study is to determine whether dapagliflozin is effective in the treatment of type 2 diabetes in subjects with poor blood sugar control and moderate renal impairment
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesArgentina, Australia, Canada, Denmark, France, India, Italy, Mexico, Peru, Puerto Rico, Singapore, Spain, United States
CollaboratorsBristol-Myers Squibb
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 2008
Enrollment StartJun 2008
Primary CompletionDec 2009
Study CompletionJun 2011
TodayJul 2026
First PostedApr 22, 2008
Enrollment StartJun 1, 2008
Primary CompletionDec 1, 2009
Study CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 18.2 years ago
Interventions
Dapagliflozindrug
Tablets, Oral, 10 mg, Once Daily, 104 weeks
Dapagliflozindrug
Tablets, Oral, 5 mg, Once Daily, 104 weeks
Placebodrug
Tablets, Oral, 0 mg, Once Daily, 104 weeks