A Study to Explore the Effects of Azilsartan Compared to Telmisartan on Insulin Resistance of Patients With Essential Hypertension on Type 2 Diabetes Mellitus by HOMA-R

NCT02079805 ↗

Phase 4 Completed 33 enrolled Takeda

RandomizedParallel-groupOpen-labelTreatment

Summary

Multicenter, randomized, open-label, parallel-group exploratory study to explore the effects of azilsartan (Azirva), compared with telmisartan, on insulin resistance in participants with essential hypertension complicated by type 2 diabetes mellitus

Timeline

Start: 2014-06
Primary completion: 2016-04
Completion: 2016-04

Outcome

Missed primary endpoint

registry Mean Difference (Final Values) 0.44 (95% CI -0.89 to 1.78) NCT02079805 ↗

paper Neither azilsartan nor telmisartan had any clinically remarkable effects on insulin resistance parameters when administered for 12 weeks PMID 30943275 ↗

Publications

Naruse M, Koike Y, Kamei N, Sakamoto R, Yambe Y, Arimitsu M. Effects of azilsartan compared with telmisartan on insulin resistance in patients with essential hypertension and type 2 diabetes mellitus: An open-label, randomized clinical trial. PLoS One. 2019 Apr 3;14(4):e0214727. doi: 10.1371/journal.pone.0214727. eCollection 2019.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azilsartan	Unknown	20 mg	Oral
Comparator	Telmisartan	Other / unclassified	40 mg	Oral