well controlled type II diabetes mellitus (HbA1c 25 mg/dL) MedDRA version: 8.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Trade Name: Ezetrol
Pharmaceutical Form: Tablet
INN or Proposed INN: EZETIMIBE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Trade Name: Inegy
Pharmaceutical
Sponsors
Universitätsklinikum Freiburg, Abteilung klinische Chemie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • participation in a clinical trial within the last 30 d before screening-visit • patient is unable to give written informed consent • BMI 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Outcome results
None listed