Efficacy and Safety of Azilsartan Medoxomil Used in Combination With Metformin in Participants With Hypertension and Diabetes

Summary

The purpose of this study was to evaluate the antihypertensive and antiglycemic effects, as well as the safety and tolerability of TAK-491 (azilsartan medoxomil), once daily (QD), in stage 1 hypertensive, type 2 diabetes mellitus (T2DM) participants whose glycemic control was inadequate on metformin alone.

Timeline

Start

2012-01

Primary completion

2013-05

Completion

2013-05

Outcome

Met primary endpoint

Stopped (Business): “Business Decision; No Safety Or Efficacy Concerns. (See below)”

registry analysis (superiority or other test); Placebo QD vs Azilsartan Medoxomil 80 mg QD; p = 0.007; ANCOVA; NCT01496430 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azilsartan medoxomil	Other / unclassified	40 mg	Oral
Subject	Azilsartan medoxomil	Other / unclassified	80 mg	Oral

Indications