Trial record 12 of 103 for: Open Studies | "Hypercholesterolemia"
A Study of the Effect of Ezetimibe on Glucose Metabolism in Type 2 Diabetics With Hypercholesterolemia (P06541)
This study is currently recruiting participants.
Verified March 2013 by Merck
Information provided by (Responsible Party):
First received: June 1, 2012
Last updated: March 13, 2013
Last verified: March 2013
This study will examine the effect of ezetimibe on glucose metabolism in participants with Type 2 diabetes and hypercholesterolemia.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Examination of the Effect of Ezetimibe on Glucose Metabolism - Randomized, Double-blind, Placebo-controlled Study in Type 2 Diabetes Mellitus Patients With Hypercholesterolemia - Phase4, Protocol No. 367 (Also Known as SCH 58235, P06541)|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Merck:
Primary Outcome Measures:
- Change in Glycosylated Hemoglobin (HbA1c) from Baseline [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Change in Glycoalbumin from Baseline [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: Yes ]
- Change in Fasting Plasma Glucose (FPG) from Baseline [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: Yes ]
- Percent Change in Low-density Lipoprotein (LDL) Cholesterol from Baseline [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
10 mg oral dose once daily for 24 weeks
|Placebo Comparator: Placebo||
Placebo to match ezetimibe orally once daily for 24 weeks.
Contacts and Locations