A Multicenter Study to Evaluate the Cholesterol Lowering Effects of Two Marketed Products in Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia (MK-0653A-077)

Organon and Co1,229 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,229

Conditions

Type 2 Diabetes Mellitus Hypercholesterolemia

Interventions

MK0653A, ezetimibe (+) simvastatinDRUG

Duration of Treatment: 4 wk placebo run in then 6 wk activeDRUG

Comparator: atorvastatinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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