At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 994 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 Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin as Initial Therapy as Compared With Dapagliflozin Monotherapy and Metformin Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
In Brief
A Phase 3 clinical trial evaluating Dapagliflozin and Metformin XR for Type 2 Diabetes. Completed, enrolled 994 participants across 99 sites in 7 countries.
Detailed Summary
The purpose of this clinical research study is to learn if initiating treatment with BMS-51248 (Dapagliflozin) in combination with metformin XR can improve diabetes control in patients with Type 2 Diabetes who do not receive any pharmacological treatment for diabetes, when compared to initial treatment with monotherapy dapagliflozin or metformin XR. The safety of this treatment will also be studied
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesMexico, Philippines, Puerto Rico, Russia, South Korea, Ukraine, United States
CollaboratorsBristol-Myers Squibb
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 2008
Enrollment StartJun 2008
Primary CompletionAug 2009
TodayJul 2026
First PostedMar 26, 2008
Enrollment StartJun 1, 2008
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 18.3 years ago
Interventions
Dapagliflozindrug
Tablets, Oral, Once daily, 24 weeks
Metformin XRdrug
Tablets, Oral, Once daily, 24 weeks