NCT01508923已完成2 期
Effect of NNC 90-1170 on 24-hour Glucose and Hormonal Profiles, Gastric Emptying, and Fasting Gluconeogenesis in Type 2 Diabetic Subjects. A Double-blind, Placebo-controlled, Randomised, Cross-over Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- 24-hour glucose profiles after three fixed meals
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to determine the effect of NNC 90-1170 (liraglutide) on glucose and hormonal profiles, fasting gluconeogenesis and insulin secretion 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus
- •Diet treated and/or subjects in monotherapy with max. 50 % of maximal dose of sulphonylurea (SU). In addition, subjects in treatment with metformin and/or repaglinide could be included
- •Body Mass Index (BMI) maximum 35 kg/m^2
- •Fasting plasma glucose 7-15 mmol/l, both inclusive
排除标准
- •Impaired liver function
- •Impaired renal function
- •Cardiac disease
- •Uncontrolled treated/untreated hypertension
- •Recurrent major hypoglycaemia as judged by the Investigator
- •Known or suspected allergy to trial product or related products
- •Females of child bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant or are not using adequate contraceptive measures
- •Current treatment with thiazolidinediones or chronic daily use of insulin (more than 7 days) within three months in the absence of intercurrent illness
- •Loss of more than 400 ml blood during the three months prior to study start
- •Allergy to paracetamol
研究组 & 干预措施
Treatment period 1
Experimental
干预措施: liraglutide (Drug)
Treatment period 1
Experimental
干预措施: placebo (Drug)
Treatment period 2
Placebo Comparator
干预措施: liraglutide (Drug)
Treatment period 2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
24-hour glucose profiles after three fixed meals
次要结局
- 24-hour insulin profiles after three fixed meals
- First phase insulin and maximal insulin secretory capacity
- GNG (gluconeogenesis) expressed in mg/kg/min
- EGR (endogenous glucose release) expressed in mg/kg/min
- 24-hour glucagon profiles after three fixed meals
- 24-hour FFA (free fatty acids) profiles after three fixed meals
- 4-hour paracetamol profiles after two fixed meals
- 30-hour NNC 90-1170 profile
- Adverse events
研究者
研究点 (1)
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