Effect of Ezetimibe or Simvastatin or Both on Low Densitiy Lipoprotein -Subfractions in Patients With Type 2 Diabetes (EZE)

University Hospital Freiburg

Status and phase: Completed; Phase 4

Conditions: Hypercholesterolemia; Diabetes Mellitus Type 2

Treatments: Drug: ezetimibe; Drug: Ezetimibe 10/Simvastatin 20; Drug: simvastatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01384058

442006

2006-005906-30 (EudraCT Number)

Details and patient eligibility

About

It is of interest how ezetimibe alone or in combination with statin may influence atherogenic dense Low Density Lipoprotein (dLDL) in patients with type 2 diabetes mellitus. The primary objective of this study will be whether there is a change of the concentrations of Apolipoprotein B (ApoB) in dLDL from baseline in each of the 3 treatment groups.

Full description

The selective cholesterol resorption inhibitor ezetimibe belongs to a new class of cholesterol lowering drugs. It is of interest how ezetimibe alone or in combination with statin may influence atherogenic dense Low Density Lipoprotein (dLDL) in patients with type 2 diabetes mellitus.

The primary objective of this study will be whether there is a change of the concentrations of Apolipoprotein B (ApoB) in dLDL from baseline in each of the 3 treatment groups. The comparison between treatment groups is exploratory due to insufficient power to detect any change between treatments.

Enrollment: 41 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• men > 18 and ≤ 75 years
• post-menopausal women ≤ 75 years (follicle stimulating hormone (FSH) >30 mIU/ml, women > 60 years FSH > 20 mIU/ml )
• well controlled diabetes mellitus type II (glycohaemoglobin ≤ 8,0 %)
• LDL-cholesterol ≤ 160 mg/dl
• LDL-subfractions: concentration of apoB-100 in dLDL (LDL-5 und LDL-6) > 25 mg/dl
• written informed consent

Exclusion criteria

• participation in a clinical trial within the last 30 d before screening- visit
• patient is unable to give written informed consent
• Body mass index <15 kg/m² and > 35 kg/m²
• clinical atherosclerotic disease (coronary heart disease, peripheral artery disease, carotid artery disease)
• malignoma
• uncontrolled arterial hypertension (>160/>100 mmHg)
• clinically relevant disease of liver and/or kidneys
• clinically relevant endocrinally or hematologic problems
• allergy to study medication (Ezetimibe and/or Simvastatin)
• alcohol- or drug abuse
• laboratory: alanine aminotransferase, aspartate aminotransferase, total bilirubin > 3 x ULN, creatine kinase > 5 x ULN
• Concurrent treatment with potent CYP3A4-inhibitors (e.g. itraconazole, ketoconazole, HIV-protease-inhibitors, erythromycin, clarithromycin, telithromycin und nefazodone)
• other relevant diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 3 patient groups

Ezetimibe 10mg/d

Active Comparator group

Description:

intake of ezetimibe 10mg per day for six weeks after wash-out

Treatment:

Drug: ezetimibe

Simvastatin 20 mg per day

Active Comparator group

Description:

intake of simvastatin 20 mg per day for six weeks after wash-out

Treatment:

Drug: simvastatin

Ezetimibe 10 mg/d and Simvastatin 20mg/d

Active Comparator group

Description:

intake of ezetimibe 10 mg and simvastatin 20 mg per day for six weeks after wash-out

Treatment:

Drug: Ezetimibe 10/Simvastatin 20