At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 728 enrolled
Drug / intervention
Dapagliflozindrug
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 Long Term Open Label Study to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy or Combination Therapies With Anti-diabetic Drugs in Japanese Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
In Brief
A Phase 3 clinical trial evaluating Dapagliflozin for Type2 Diabetes and High Blood Sugar. Completed, enrolled 728 participants across 38 sites.
Detailed Summary
This is a long term, single arm, open label study to evaluate the safety and efficacy of dapagliflozin as monotherapy or in combination therapy with other anti diabetic drug in Japanese subjects with type 2 diabetes mellitus who have inadequate blood sugar control on diet and exercise or on other anti-diabetic treatment will be included in this study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType2 Diabetes, High Blood Sugar
CountriesJapan
CollaboratorsBristol-Myers Squibb
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2011
First PostedFeb 2011
Primary CompletionSep 2012
TodayJul 2026
First PostedFeb 11, 2011
Enrollment StartFeb 1, 2011
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 15.4 years ago
Interventions
Dapagliflozindrug
Oral Dose 5 or 10 mg