Ezetimibe and Statins on Postprandial Lipemia in Type 2 Diabetes

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

PHASE4

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-10-31

Brief Summary

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The purpose of this study is to determine whether ezetimibe in association with statins is more effective than statins alone on postprandial lipemia in type 2 diabetic patients.

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Detailed Description

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Conditions

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Postprandial Lipemia Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

ezetimibe tablets 10 mg/die + simvastatin tablets 20 mg/die six weeks

Group Type EXPERIMENTAL

ezetimibe tablets

Intervention Type DRUG

ezetimibe tablets 10 mg/die

simvastatin tablets

Intervention Type DRUG

simvastatin tablets 20 mg/die

2

placebo + simvastatin tablets 20 mg/die six weeks

Group Type PLACEBO_COMPARATOR

simvastatin tablets

Intervention Type DRUG

simvastatin tablets 20 mg/die

placebo

Intervention Type DRUG

placebo

Interventions

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ezetimibe tablets

ezetimibe tablets 10 mg/die

Intervention Type DRUG

simvastatin tablets

simvastatin tablets 20 mg/die

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes since at least two years
* Stable metabolic control (HbA1c\<8.0%) for at least six months on diet or diet+oral hypoglycemic drugs (insulin secretagogues or metformin), not to be changed during the study period.
* BMI\<30 kg/m2 and body weight stable during the last six months.
* Both sexes; only post-menopausal women.
* LDL-cholesterol \>130 mg/dl, plasma triglycerides \<400 mg/dl.
* No use of hypolipidemic drugs in the last three months.

Exclusion Criteria

* Patient with renal (serum creatinine \>1.5 mg/dl) or hepatic (serum transaminases \>three times upper normal values) impairment.
* Patients with history of cardiovascular disease.
* Pre-menopausal women.
* Any other acute or chronic degenerative disease.
* Anemia (Hb\<12 g/dl).
* Uncontrolled blood pressure.
* Use of any drugs able to interfere with the study medications

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No