At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy in Asian Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise
In Brief
A Phase 3 clinical trial evaluating Dapagliflozin, Metformin, and 1 other intervention for Type 2 Diabetes. Completed, enrolled 1,179 participants across 39 sites in 4 countries.
Detailed Summary
The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can improve (decrease) blood glucose values in Asian patients with Type 2 Diabetes who have never been treated with medication or have been on medication for less than 24 weeks since their original diagnosis of Diabetes. The safety of this treatment will also be studied.
Study Details
Timeline
Interventions
Tablets, Oral, 5 mg, Once daily, 24 weeks
Tablets, Oral, 10 mg, Once daily, 24 weeks
Tablets, Oral, 500-2000 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks
Tablets, Oral, 0 mg, Once daily, 24 weeks