NCT01507311已完成1 期
Effect of NNC90-1170 on Pulsatile Insulin Secretion in Type 2 Diabetic Patients. A Double-blind, Placebo-controlled, Randomised, Single-dose, Cross-over Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Insulin secretory burst mass
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to assess the effect of NNC 90-1170 (liraglutide) on pulsatile insulin secretion and insulin secretion after a standard meal 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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 2 diabetes, either newly diagnosed with at least two months of diet treatment, or in current OHA (oral hypoglycaemic agent) treatment with stable dose for at least six months
- •BMI (Body Mass Index) between 24 and 35 kg/m^2 (both inclusive)
- •Fasting plasma glucose between 6 and 15 mmol/l (both inclusive)
- •Anti-GAD (glutamic acid decarboxylase) negative
排除标准
- •Known or suspected allergy to trial product or related products
- •Receipt of any investigational drug within three months prior to this trial
- •Recurrent severe hypoglycaemia as judged by the investigator
- •Cardiac disease or any clinically significant abnormal ECG (electrocardiogram)
- •Use of any drug (except oral hypoglycaemic agents (OHAs)) which in the investigator's opinion could interfere
- •with the blood glucose level (i.e., insulin, systemic corticosteroids, thiazides)
- •Liver or renal disease
研究组 & 干预措施
NNC 90-1170
Experimental
干预措施: liraglutide (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Insulin secretory burst mass
次要结局
- Insulin secretion
- Insulin secretory pulse mass, amplitude, frequency and regularity
- Glucagon response
- Gastric emptying rate
- Adverse events
研究者
研究点 (1)
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