At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 477 enrolled
Drug / intervention
Dapagliflozin +1 moredrug
Likely dose
Not stated in 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 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Trial to Evaluate Efficacy and Safety of Dapagliflozin Added to Therapy of Asian Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Insulin
In Brief
A Phase 3 clinical trial evaluating Dapagliflozin and Dapagliflozin Placebo for Diabetes. Completed, enrolled 477 participants across 29 sites in 3 countries.
Detailed Summary
The purpose is to determine if after 24 weeks of oral daily administration, there will be a greater mean reduction from baseline in glycosylated hemoglobin (HbA1c) achieved with Dapagliflozin 10 mg plus insulin compared to placebo plus insulin in subjects with type 2 diabetes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes
CountriesChina, Singapore, South Korea
CollaboratorsBristol-Myers Squibb
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 2014
Enrollment StartMar 2014
Primary CompletionJan 2016
TodayJul 2026
First PostedMar 26, 2014
Enrollment StartMar 31, 2014
Primary CompletionJan 28, 2016
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.3 years ago
Interventions
Dapagliflozindrug
Tablet
Dapagliflozin Placebodrug
Tablet