A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone

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.

Timeline

Start

2010-06

Primary completion

2013-03

Completion

2013-03

Outcome

Met primary endpoint

registry Placebo + Metformin vs Dapagliflozin 5 mg + Metformin; p <0.0001; Mean Difference (Final Values) -0.59 (95% CI -0.76 to -0.42) NCT01095666 ↗

registry Placebo + Metformin vs Dapagliflozin 10 mg + Metformin; p <0.0001; Mean Difference (Final Values) -0.62 (95% CI -0.79 to -0.45) NCT01095666 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dapagliflozin	Small molecule	5 mg	Oral
Subject	Dapagliflozin	Small molecule	10 mg	Oral
Background	Metformin	Small molecule	1500 mg	Oral
Background	Metformin	Small molecule	3000 mg	Oral
Background	Pioglitazone	Small molecule	15 mg	Oral
Background	Pioglitazone	Small molecule	45 mg	Oral

Indications