Effect of Ezetimibe or Simvastatin or Both on Low Densitiy Lipoprotein -Subfractions in Patients With Type 2 Diabetes
- Conditions
- Diabetes Mellitus Type 2Hypercholesterolemia
- Interventions
- Registration Number
- NCT01384058
- Lead Sponsor
- University Hospital Freiburg
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ezetimibe 10mg/d ezetimibe intake of ezetimibe 10mg per day for six weeks after wash-out Simvastatin 20 mg per day simvastatin intake of simvastatin 20 mg per day for six weeks after wash-out Ezetimibe 10 mg/d and Simvastatin 20mg/d Ezetimibe 10/Simvastatin 20 intake of ezetimibe 10 mg and simvastatin 20 mg per day for six weeks after wash-out
- Primary Outcome Measures
Name Time Method Change of the concentration of apolipoprotein B (ApoB) in dense Low Densitiy Lipoprotein (dLDL) from baseline with ezetimibe, simvastatin or the combination of both drugs baseline and 6 weeks multicentre, randomized, open-label study investigation in 6-week effect of ezetimibe (10mg/d), simvastatin (20mg/d) or combination of ezetimibe 10mg/simvastatin 20mg/d on concentrations of dLDL separated by preparative gradient ultracentrifugation in patients with type 2 diabetes.
- Secondary Outcome Measures
Name Time Method Change of the concentrations of Total Cholesterol baseline and 6 weeks Change of the concentrations of Low Densitiy Lipoprotein (LDL) -Cholesterol baseline and 6 weeks Change of the concentrations of High Density Lipoprotein (HDL) -Cholesterol baseline and 6 weeks Change of the concentrations of triglycerides baseline and 6 weeks
Trial Locations
- Locations (2)
Institut für Stoffwechselforschung
🇩🇪Frankfurt, Germany
Stephan Jacob, MD
🇩🇪Villingen-.Schwenningen, Germany