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Clinical trial

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

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Last updated:1st Sep 2007

The purpose of this clinical research study is to learn whether dapagliflozin can help reduce blood sugar levels in participants with Type 2 diabetes that is not well controlled on metformin alone. The safety of this treatment will also be studied.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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 Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone
Enrollment: 915
Study Start Date: September 2007
Study Completion Date: May 2010
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)

Arms:
- Placebo Comparator:
Placebo + Metformin
- Experimental: Dapagliflozin, 2.5 mg + Metformin
- Experimental: Dapagliflozin, 5 mg + Metformin
- Experimental: Dapagliflozin, 10 mg + Metformin

Category Value
Study start date 2007-09-01

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