Evaluation of Blood Pressure Reduction, Safety, and Tolerability of Canagliflozin in Patients With Hypertension and Type 2 Diabetes Mellitus on Stable Doses of Anti-hyperglycemic and Anti-hypertensive Agents

Summary

The purpose of this study is to evaluate the effect of canagliflozin (JNJ-28431754) on blood pressure reduction, compared to placebo, in patients with hypertension and type 2 diabetes mellitus and who are on stable doses of anti-hyperglycemic and anti-hypertensive agents. Overall safety and tolerability of canagliflozin will be assessed.

Timeline

Start

2013-10

Primary completion

2015-04

Completion

2015-04

Outcome

Mixed primary results

registry analysis (superiority or other test); Placebo vs Canagliflozin 100 Milligram (mg); p = 0.062; Difference of Least Square Means -3.29 (95% CI -6.743 to 0.163); ANCOVA NCT01939496 ↗

registry analysis (superiority or other test); Placebo vs Canagliflozin 300 mg; p = 0.006; Difference of Least Square Means -4.93 (95% CI -8.382 to -1.469); ANCOVA NCT01939496 ↗

Publications

• Pfeifer M, Townsend RR, Davies MJ, Vijapurkar U, Ren J. Effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor, on blood pressure and markers of arterial stiffness in patients with type 2 diabetes mellitus: a post hoc analysis. Cardiovasc Diabetol. 2017 Feb 27;16(1):29. doi: 10.1186/s12933-017-0511-0.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CANAGLIFLOZIN ANHYDROUS	Small molecule	100 mg	Oral
Subject	CANAGLIFLOZIN ANHYDROUS	Small molecule	300 mg	Oral

Indications