A Study of the Effect of Ezetimibe on Glucose Metabolism in Type 2 Diabetics With Hypercholesterolemia (P06541)

Phase 4 Completed 152 enrolled Organon and Co

RandomizedParallel-groupDouble-blindTreatment

Summary

This study will examine the effect of ezetimibe on glucose metabolism in participants with Type 2 diabetes and hypercholesterolemia.The primary hypothesis is that change in glycated hemoglobin (HbA1c) from baseline in the ezetimibe treatment group will be non-inferior to the placebo control group.

Timeline

Start: 2012-07-02
Primary completion: 2014-01-16
Completion: 2014-01-16

Outcome

Met primary endpoint

paper Ezetimibe was statistically non-inferior to placebo. PMID 25929253 ↗

paper between-treatment difference 0.08 [95% CI: -0.07 to 0.23] PMID 25929253 ↗

Publications

Results Saito I, Azuma K, Kakikawa T, Oshima N, Hanson ME, Tershakovec AM. A randomized, double-blind, placebo-controlled study of the effect of ezetimibe on glucose metabolism in subjects with type 2 diabetes mellitus and hypercholesterolemia. Lipids Health Dis. 2015 May 1;14:40. doi: 10.1186/s12944-015-0036-z.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ezetimibe	Unknown	10 mg	Oral

Indications

No indication recorded.