Study Evaluating the Efficacy and Safety of Simvastatin Alone Compared With Simvastatin Plus Ezetimibe in Type 2 Diabetic Patients (0653-021)(COMPLETED)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2003-01-31

Brief Summary

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The purpose of this study is to determine if the addition of ezetimibe 10 mg daily to ongoing 20 mg simvastatin daily will reduce LDL Cholesterol to a greater extent than increasing the dose of simvastatin to 40 mg daily in Type 2 diabetics treated with Thiazolidinediones (TZD).

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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MK0653, ezetimibe / Duration of Treatment: 30 Weeks

Intervention Type DRUG

Comparator : ezetimibe (+) simvastatin / Duration of Treatment: 30 Weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men or women age between 30 and 75 with Type 2 diabetes mellitus who are treated with pioglitazone or rosiglitazone
* Additionally, patients must have an LDL-C \>100 mg/dL at Visit 1 or prior to initiation of statin therapy

Exclusion Criteria

* Patients taking sliding scale insulin, selected lipid lowering medications, oral anticoagulants and cyclical sex hormones
* Patients with heart disease, kidney disease, liver disease, uncontrolled high blood pressure, and insulin dependent diabetes

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No