At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 972 enrolled
Drug / intervention
Dapagliflozin +3 moredrug
Likely dose
Dapagliflozin 5.0 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, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Thiazolidinedione Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Thiazolidinedione Therapy Alone
In Brief
A Phase 3 clinical trial evaluating Dapagliflozin, Placebo matching Dapagliflozin, and 1 other intervention for Type 2 Diabetes. Completed, enrolled 972 participants across 89 sites in 9 countries.
Detailed Summary
The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well controlled on TZD alone. The safety of this treatment will also be studied
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesArgentina, Canada, India, Mexico, Peru, Philippines, Puerto Rico, Taiwan, United States
CollaboratorsAstra Zeneca, Bristol-Myers Squibb
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 2008
Enrollment StartJul 2008
Primary CompletionJan 2010
Study CompletionJun 2010
TodayJul 2026
First PostedMay 26, 2008
Enrollment StartJul 1, 2008
Primary CompletionJan 1, 2010
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 18.1 years ago
Interventions
Dapagliflozindrug
Tablets, Oral, 5.0 mg, once daily, up to 48 weeks
Dapagliflozindrug
Tablets, Oral, 10.0 mg, once daily, up to 48 weeks
Placebo matching Dapagliflozindrug
Tablets, Oral, 0 mg, once daily, up to 48 weeks
Thiazolidinedione (Pioglitazone)drug
Tablets, ≥ 30 mg, Once daily, up to 48 weeks