The effect of Ezetimibe 10 mg, Simvastatin 20 mg and the Combination of Simvastatin 20 mg plus 10 mg Ezetimibe on LDL-Subfractions in patients with Type 2 Diabetes (Die Wirkung einer Monotherapie mit Ezetimib 10 mg vs. Monotherapie mit Simvastatin 20 mg vs. Kombinationsbehandlung mit Ezetimib 10 mg und Simvastatin 20 mg auf die LDL-Subfraktionen bei Patienten mit Typ II Diabetes)
- Conditions
- well controlled type II diabetes mellitus (HbA1c < 8.0 %) with a preponderance of atherogenic small, dense LDL (LDL-5 and LDL-6 > 25 mg/dL)MedDRA version: 8.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus
- Registration Number
- EUCTR2006-005906-30-DE
- Lead Sponsor
- niversitätsklinikum Freiburg, Abteilung klinische Chemie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
•men > 18 and = 75 years
•post-menopausal women = 75 years (FSH >30 mIU/ml, women > 60 years FSH > 20 mIU/ml )
•well controlled diabetes mellitus type II (HbA1c = 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•participation in a clinical trial within the last 30 d before screening-visit
•patient is unable to give written informed consent
•BMI <15 kg/m² and > 35 kg/m²
•clinical atherosclerotic disease (coronary heart disease, peripheral artery disease, carotid artery disease)
•malignome
•uncontrolled arterial hypertension(>160/>100 mmHg)
•clinically relevant disease od liver and/or kidneys
•clinically relevant endocrincally or hematologic problems
•allergy to study medication(Ezetimibe and/or Simvastatin)
•alcohol- or drug abuse
•laboratory: ALT, AST, total bilirubin > 3 x ULN, CK > 5 x ULN
•Concurrent treatment with potent CYP3A4-inhibitors (e.g. Itraconazol, Ketoconazol, HIV-protease-inhibitors, Erythromycin, Clarithromycin, Telithromycin und Nefazodon)
•other relevant diseases
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The selective cholesterol resorptiin 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 dLDL in patients with type II diabetes mellitus. The primary objective of this study will be whether there is a change of the concentrations of apoB in dLDL from baseline ineach of the 3 treatment groups. The comparison between treatment groups is exploratory due to insufficient power to detect any change between treatments.;Secondary Objective: change of the concentrations of the following parameters: total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyzerides;Primary end point(s): change of the concentration of apoB in dLDL from baseline in each of the 3 treatment groups
- Secondary Outcome Measures
Name Time Method