drugset / Trial / NCT00736879

Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes

NCT00736879 ↗

Phase 3 Completed 497 enrolled AstraZeneca Bristol-Myers Squibb · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

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

Timeline

Start
2008-09-22
Primary completion
2009-12-29
Completion
2009-12-29

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Dapagliflozin 1mg; p <0.0001; Mean Difference (Final Values) -0.69 (95% CI -1.02 to -0.37); ANCOVA NCT00736879 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dapagliflozin Small molecule 1 mg Oral
Subject Dapagliflozin Small molecule 2.5 mg Oral
Subject Dapagliflozin Small molecule 5 mg Oral