CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,484 enrolled
Drug / intervention
Dapagliflozin +4 moredrug
Likely dose
Dapagliflozin 5 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.

Search/NCT01095666
NCT01095666Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin in Asian Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

AstraZeneca·interventional·Posted Mar 30, 2010·Updated Sep 11, 2017

In Brief

A Phase 3 clinical trial evaluating Dapagliflozin, Metformin, and 2 other interventions for Type 2 Diabetes. Completed, enrolled 1,484 participants across 33 sites in 3 countries.

Detailed Summary

The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in Asian patients with Type 2 Diabetes who are not well controlled on metformin alone. The safety of this treatment will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesChina, India, South Korea
CollaboratorsAstraZeneca, Bristol-Myers Squibb

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 30, 2010
Enrollment StartJun 1, 2010
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 16.3 years ago

Interventions

Dapagliflozindrug

Tablets, Oral, 5 mg, Once daily, 24 weeks

Dapagliflozindrug

Tablets, Oral, 10 mg, Once daily, 24 weeks

Metformindrug

Tablets, Oral, 1500-3000 mg, Twice daily, 24 weeks

Dapagliflozin Placebodrug

Tablets, Oral, 0 mg, Once daily, 24 weeks

Pioglitazonedrug

Tablets, Oral, 15-45 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks