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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-02

Study Completion Date

2014-01-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ezetimibe

10 mg oral dose once daily for 24 weeks

Group Type EXPERIMENTAL

Ezetimibe

Intervention Type DRUG

10 mg oral dose once daily for 24 weeks

Placebo

Placebo to match ezetimibe orally once daily for 24 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo to match ezetimibe orally once daily for 24 weeks.

Interventions

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Ezetimibe

10 mg oral dose once daily for 24 weeks

Intervention Type DRUG

Placebo

Placebo to match ezetimibe orally once daily for 24 weeks.

Intervention Type DRUG

Other Intervention Names

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MK-0653 SCH 058235

Eligibility Criteria

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Inclusion Criteria

* Have hypercholesterolemia (high cholesterol) and have been diagnosed with type 2 diabetes that is being treated with oral anti-diabetic drugs or insulin or both.
* No change in the medication (drugs, dose and administration) for the treatment of diabetes within previous 12 weeks with exception of small changes in insulin dosing
* No change in diet and exercise therapy within previous 4 weeks

Exclusion Criteria

* Coexisting disease (hemoglobinopathy, hemolytic anemia, etc.) that may affect HbA1c measurement
* Homozygous or heterozygous familial hypercholesterolemia
* Previously received ezetimibe
* Hypercholesterolemia associated with: hypothyroidism, obstructive gall bladder or biliary disease, chronic renal failure or pancreatitis
* Hyperlipidemia caused by medication

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No