At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 261 enrolled
Drug / intervention
Dapagliflozin +2 moredrug
Likely dose
Dapagliflozin 5mgfrom 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 Randomised, Double-blind, Parallel-group, Multi-centre, Placebo-controlled Phase III Trial to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Japanese Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise
In Brief
A Phase 3 clinical trial evaluating Dapagliflozin and Placebo for Type 2 Diabetes and High Blood Sugar. Completed, enrolled 261 participants across 26 sites.
Detailed Summary
This is a 24-week randomised, multi-centre phase III study to evaluate the efficacy and safety of dapagliflozin as monotherapy in Japanese subjects with Type 2 diabetes mellitus who have inadequate glycemic control with diet and exercise.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes, High Blood Sugar
CountriesJapan
CollaboratorsBristol-Myers Squibb
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2011
First PostedFeb 2011
Primary CompletionMar 2012
TodayJul 2026
First PostedFeb 11, 2011
Enrollment StartFeb 1, 2011
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 15.4 years ago
Interventions
Dapagliflozindrug
Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
Dapagliflozindrug
Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
Placebodrug
Matching placebo for Dapagliflozin 5mg/10mg oral dose