Overview

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

Status:
Completed
Trial end date:
2010-06-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital Freiburg
Collaborator:
Essex Pharma GmbH
Treatments:
Ezetimibe
Simvastatin
Criteria
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