NCT01611883

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

Examination of the Effect of Ezetimibe on Glucose Metabolism - Randomized, Double-blind, Placebo-controlled Study in Type 2 Diabetes Mellitus Patients With Hypercholesterolemia - Phase 4, Protocol No. 367 (Also Known as SCH 58235, P06541)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Ezetimibe	10 mg oral dose once daily for 24 weeks
DRUG	Placebo	Placebo to match ezetimibe orally once daily for 24 weeks.

Timeline

• Start date: 2012-07-02
• Primary completion: 2014-01-16
• Completion: 2014-01-16
• First posted: 2012-06-05
• Last updated: 2024-05-24
• Results posted: 2014-12-17