At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 833 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, Parallel-Group, International Phase III Study With 24 Week Extension to Evaluate the Safety and Efficacy of Dapagliflozin 10 mg/Day in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on a DPP-4 Inhibitor Sitagliptin+/-Metformin
In Brief
A Phase 3 clinical trial evaluating Dapagliflozin and Placebo for Type 2 Diabetes. Completed, enrolled 833 participants across 88 sites in 6 countries.
Detailed Summary
This study aims to investigate how dapagliflozin can control blood sugar in patients with type 2 diabetes when added to existing treatments (sitagliptin alone or in combination with metformin). The effect of dapagliflozin on weight and blood pressure will also be studied.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesArgentina, Germany, Mexico, Poland, United Kingdom, United States
CollaboratorsBristol-Myers Squibb
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2009
Enrollment StartOct 2009
Primary CompletionMar 2011
Study CompletionSep 2011
TodayJul 2026
First PostedSep 25, 2009
Enrollment StartOct 1, 2009
Primary CompletionMar 1, 2011
Study CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 16.8 years ago
Interventions
Dapagliflozindrug
10 mg tablet, oral, once daily, 48 weeks
Placebodrug
Matching placebo tablet