Efficacy and Safety in Patients With Type 2 Diabetes Mellitus and Cardiovascular Disease

Phase 3 Completed 964 enrolled AstraZeneca Bristol-Myers Squibb · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is carried out to assess whether dapagliflozin improves glycemic control, decreases fasting plasma glucose levels, body weight and blood pressure when added to patient's existing medications and how it compares with their usual treatment without added dapagliflozin. Safety data will be collected and analysed to confirm that treatment with dapagliflozin is safe and well tolerated in patients who have diabetes and cardiovascular disease

Timeline

Start: 2010-03
Primary completion: 2011-05
Completion: 2012-12

Outcome

Met primary endpoint

registry analysis (superiority or other test); Dapagliflozin vs Placebo; p <0.0001; Mean Difference (Final Values) -0.40 (95% CI -0.50 to -0.30); ANCOVA NCT01042977 ↗

registry analysis (superiority or other test); Dapagliflozin vs Placebo; p <0.0001; Risk Difference (RD) 7.0 (95% CI 4.3 to 9.8); Cochran-Mantel-Haenszel NCT01042977 ↗

Publications

Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dapagliflozin	Small molecule	10 mg	Oral