NCT01698931已完成4 期
Efficacy of Repaglinide Compared to Glyburide and Placebo on Hepatic Glucose Metabolism in Type 2 Diabetic Subjects Treated With Diet or With Antidiabetic Oral Agents. A Randomized, Open, Cross-over Single-centre Placebo-controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Basal hepatic glucose production
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to compare the efficacy of repaglinide to glyburide and placebo on hepatic glucose metabolism in subjects with type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •HbA1c (glycosylated haemoglobin A1c) above 7 %
- •BMI (body mass index) below 32 kg/m^2
- •FBG (fasting blood glucose) after wash out period 130-220 mg/dl
- •Currently treated with diet or OHA (oral hypoglycaemic agent)
排除标准
- •Current systemic treatment with concomitant medication
- •Known or suspected history of drug or alcohol dependence
- •Any other significant concomitant disease such as cerebrovascular or symptomatic peripheral vascular disease, malignant, disease or severe treated or untreated hypertension
- •Hepatic disease
- •Cardiac problems
- •Active proliferative retinopathy
- •Known or suspected allergy to trial product or related products
- •Women in fertile age and women having the intention of becoming pregnant
- •Body Mass Index (BMI) above 32 kg/m^2
研究组 & 干预措施
Treatment period 1
Experimental
干预措施: repaglinide (Drug)
Treatment period 1
Experimental
干预措施: glyburide (Drug)
Treatment period 1
Experimental
干预措施: placebo (Drug)
Treatment period 2
Active Comparator
干预措施: repaglinide (Drug)
Treatment period 2
Active Comparator
干预措施: glyburide (Drug)
Treatment period 2
Active Comparator
干预措施: placebo (Drug)
Treatment period 3
Placebo Comparator
干预措施: repaglinide (Drug)
Treatment period 3
Placebo Comparator
干预措施: glyburide (Drug)
Treatment period 3
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Basal hepatic glucose production
时间窗: Day 0; day 44
次要结局
- Change in body weight(Day 0; day 44)
- Number of adverse events(Day 0; day 44)
- Number of hypoglycaemic episodes(Day 0; day 44)
研究者
研究点 (1)
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