A Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes and Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor or Angiotensin Receptor Blocker

Summary

The purpose of this study is to learn whether dapagliflozin, after 12 weeks, can improve (decrease) blood pressure in patients with type 2 diabetes with uncontrolled hypertension who are on an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker. The safety of this treatment will also be studied.

Timeline

Start

2010-07

Primary completion

2013-02

Completion

2013-02

Outcome

Met primary endpoint

registry analysis (superiority or other test); Dapagliflozin 10 mg vs Placebo; p = 0.0010; Mean Difference (Final Values) -3.05 (95% CI -4.87 to -1.24) NCT01137474 ↗

registry analysis (superiority or other test); Placebo vs Dapagliflozin 10 mg; p <0.0001; Mean Difference (Final Values) -0.46 (95% CI -0.59 to -0.33) NCT01137474 ↗

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	2.5 mg	Oral
Subject	Dapagliflozin	Small molecule	5 mg	Oral
Subject	Dapagliflozin	Small molecule	10 mg	Oral

Indications