A Multicenter Study to Evaluate the Cholesterol Lowering Effects of Two Marketed Products in Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia

This study has been completed.

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00110435

Purpose

The purpose of this 10-week study is to compare the reduction in cholesterol following treatment with two different marketed drugs, in patients with type 2 diabetes mellitus and hypercholesterolemia.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus Hypercholesterolemia	Drug: MK0653A, ezetimibe (+) simvastatin Drug: Duration of Treatment: 4 wk placebo run in then 6 wk active Drug: Comparator: atorvastatin	Phase III

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Diabetes

Drug Information available for: Atorvastatin Atorvastatin calcium Simvastatin Ezetimibe Cholest-5-en-3-ol (3beta)-

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind, Parallel Group, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet Versus Atorvastatin in Patients With Type 2 Diabetes Mellitus (T2DM) and Hypercholesterolemia

Further study details as provided by Merck:

Primary Outcome Measures:

Percent reduction in LDL-C from baseline after 6 weeks of treatment

Secondary Outcome Measures:

Percent of patients attaining LDL-C <70 mg/dl after 6 weeks of treatment

Estimated Enrollment:	1125
Study Start Date:	June 2005

Eligibility

Ages Eligible for Study:	18 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men and women aged 18 to 79 years who have a confirmed diagnosis of type 2 diabetes mellitus with elevated cholesterol levels may be eligible to participate in a study to assess the efficacy and safety of the two marketed drugs.

Exclusion Criteria:

Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus that is poorly controlled

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110435

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Goldberg RB, Guyton JR, Mazzone T, Weinstock RS, Polis A, Edwards P, Tomassini JE, Tershakovec AM. Ezetimibe/simvastatin vs atorvastatin in patients with type 2 diabetes mellitus and hypercholesterolemia: the VYTAL study. Mayo Clin Proc. 2006 Dec;81(12):1579-88. Erratum in: Mayo Clin Proc. 2007 Mar;82(3):387.

Study ID Numbers:	2005_022
Study First Received:	May 9, 2005
Last Updated:	October 9, 2007
ClinicalTrials.gov Identifier:	NCT00110435
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Hyperlipidemias
Simvastatin
Diabetes Mellitus
Endocrine System Diseases
Ezetimibe
Diabetes Mellitus, Type 2

Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder
Hypercholesterolemia
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009