At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 497 enrolled
Drug / intervention
Dapagliflozin +1 moredrug
Likely dose
Not stated in 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 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
In Brief
A Phase 3 clinical trial evaluating Dapagliflozin and Placebo for Type 2 Diabetes Mellitus. Completed, enrolled 497 participants across 62 sites in 7 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 diet and exercise alone. The safety of this treatment will also be studied
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesCanada, India, Mexico, Puerto Rico, Russia, South Africa, United States
CollaboratorsBristol-Myers Squibb
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2008
Enrollment StartSep 2008
Primary CompletionDec 2009
TodayJul 2026
First PostedAug 18, 2008
Enrollment StartSep 22, 2008
Primary CompletionDec 29, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.9 years ago
Interventions
Dapagliflozindrug
Tablets, Oral, Once Daily, Up to 24 weeks
Placebodrug
Tablets, Oral, Once Daily, Up to 24 weeks