The Effect of Ezetimibe 10 mg, Simvastatin 20 mg and the Combination of Simvastatin 20 mg Plus 10 mg Ezetimibe on Low Density Lipoprotein (LDL)-Subfractions in Patients With Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Ezetimibe 10mg/d
intake of ezetimibe 10mg per day for six weeks after wash-out
干预措施: ezetimibe (Drug)
Simvastatin 20 mg per day
intake of simvastatin 20 mg per day for six weeks after wash-out
干预措施: simvastatin (Drug)
Ezetimibe 10 mg/d and Simvastatin 20mg/d
intake of ezetimibe 10 mg and simvastatin 20 mg per day for six weeks after wash-out
干预措施: Ezetimibe 10/Simvastatin 20 (Drug)
结局指标
主要结局
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
时间窗: 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.
次要结局
- Change of the concentrations of triglycerides(baseline and 6 weeks)
- 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)
研究者
Karl Winkler
MD, Prof. Dr. med., Kommissarischer Ärztlicher Direktor
University Hospital Freiburg