At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 182 enrolled
Drug / intervention
Dapagliflozin +3 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 24-week,Multi-centre,Int.,Double-blind,Rand.,Parallel-group,Plac.-Controlled,Phase III Study With a 78-week Ext.Per. to Evaluate the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone
In Brief
A Phase 3 clinical trial evaluating Dapagliflozin, Metformin, and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 182 participants across 21 sites in 5 countries.
Detailed Summary
This study is being carried out to see if dapagliflozin in addition to metformin decreases body weight and if so, how it compares with metformin alone.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesBulgaria, Czechia, Hungary, Poland, Sweden
CollaboratorsBristol-Myers Squibb
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2009
First PostedMar 2009
Primary CompletionJun 2010
Study CompletionDec 2011
TodayJul 2026
First PostedMar 4, 2009
Enrollment StartFeb 1, 2009
Primary CompletionJun 1, 2010
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.3 years ago
Interventions
Dapagliflozindrug
Tablet oral 10 mg total daily dose once daily 102 weeks
Metformindrug
Tablet oral 1500 - 2500 mg total daily dose 1-3 times a day104 weeks
Sitagliptindrug
Tablet oral 100 mg total daily dose once daily rescue medication
Placebodrug
Matching placebo for dapagliflozin, tablet, oral, once daily, 102 weeks