At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 311 enrolled
Drug / intervention
dapagliflozin +1 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, Multicentre, Randomised, Double-Blind, Placebo-Controlled, International Phase III Study With a 28-week Extension Period to Evaluate the Safety and Efficacy of Dapagliflozin 10mg Once Daily in Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on a Background Combination of Metformin and Sulfonylurea
In Brief
A Phase 3 clinical trial evaluating dapagliflozin and placebo for Type 2 Diabetes Mellitus and 2 related conditions. Completed, enrolled 311 participants across 42 sites in 6 countries.
Detailed Summary
This study intends to compare the efficacy and safety of dapagliflozin versus placebo in patients with type 2 diabetes who have inadequate glycaemic control on a background combination of metformin and sulfonylurea.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Czechia, Germany, Poland, Slovakia, Spain
CollaboratorsBristol-Myers Squibb
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 2011
Enrollment StartOct 2011
Primary CompletionJan 2013
Study CompletionAug 2013
TodayJul 2026
First PostedJul 12, 2011
Enrollment StartOct 1, 2011
Primary CompletionJan 1, 2013
Study CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.0 years ago
Interventions
dapagliflozindrug
10 mg tablet, oral, once daily, 24- week treatment and 28- week extension period
placebodrug
matching placebo tablet, oral, once daily, 24- week treatment and 28- week extension period