At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,217 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 52-Week International, Multi-centre, Randomised, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 156-Week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin in Combination With Metformin Compared With Sulphonylurea in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy Alone.
In Brief
A Phase 3 clinical trial evaluating dapagliflozin, glipizide, and 1 other intervention for Type 2 Diabetes. Completed, enrolled 1,217 participants across 76 sites in 10 countries.
Detailed Summary
This study is being carried out to see if dapagliflozin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glipizide (sulphonylurea) as an addition to metformin treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesArgentina, France, Germany, Italy, Mexico, Netherlands, South Africa, Spain, Sweden, United Kingdom
CollaboratorsBristol-Myers Squibb
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2008
First PostedApr 2008
Primary CompletionDec 2009
Study CompletionJan 2013
TodayJul 2026
First PostedApr 17, 2008
Enrollment StartMar 1, 2008
Primary CompletionDec 1, 2009
Study CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.2 years ago
Interventions
dapagliflozindrug
Tablet oral 2.5, 5, or 10 mg total daily dose once daily 208 weeks
glipizidedrug
Capsule oral 5, 10, or 20 mg total daily dose once or split/twice daily 208 weeks
metformin hydrochloridedrug
Tablet oral 1500, 2000, or 2500 mg total daily dose split/twice daily 218 weeks