At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 400 enrolled
Drug / intervention
dapagliflozin +4 moredrug
Likely dose
dapagliflozin 2.5 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 16-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Safety and Efficacy of Dapagliflozin 2.5 mg BID, 5 mg BID and 10 mg QD Versus Placebo in Patients With Type 2 Diabetes Who Are Inadequately Controlled on Metformin-IR Monotherapy
In Brief
A Phase 3 clinical trial evaluating dapagliflozin, metformin, and 1 other intervention for Type 2 Diabetes. Completed, enrolled 400 participants across 55 sites in 7 countries.
Detailed Summary
This study is being carried out to see if dapagliflozin - administered in a daily dose of 2.5 mg given twice a day or 5 mg twice a day or 10mg once daily - in addition to metformin, is beneficial in diabetes treatment, and if so, how it compares to treatment with metformin alone.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesGermany, Hungary, Romania, Slovakia, South Africa, Switzerland, Ukraine
CollaboratorsBristol-Myers Squibb
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2010
Enrollment StartNov 2010
Primary CompletionAug 2011
TodayJul 2026
First PostedOct 8, 2010
Enrollment StartNov 1, 2010
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 15.7 years ago
Interventions
dapagliflozindrug
2.5 mg tablet, taken orally, twice daily
dapagliflozindrug
5 mg tablet taken orally, twice daily
dapagliflozindrug
10 mg tablet taken orally, once daily
metformindrug
\>/= 1500 mg total daily dose, tablets taken orally, twice daily
placebodrug
placebo