NCT01536665已完成1 期
The Effect of Liraglutide Adjunct to Insulin on Glucagon Response to Hypoglycaemia in Subjects With Type 1 Diabetes
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
- 45
- 试验地点
- 1
- 主要终点
- Geometric mean glucagon concentration during hypoglycaemia (nadir glucose (target 2.5 mmol/L) )
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to investigate if liraglutide adjunct to insulin treatment changes the glucagon response during hypoglycaemia in subjects with type 1 diabetes compared with conventional insulin treatment after 4 weeks' treatment with liraglutide or placebo.
Subjects will initially be randomised to one of the three dose groups, and subsequently randomly allocated to one of two treatment sequences (liraglutide/placebo or placebo/liraglutide).
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months prior to randomisation
- •Body mass index (BMI) between 20.0 and 28.0 kg/m^2 (both inclusive)
排除标准
- •Use of liraglutide or exenatide within 3 months of randomisation
- •Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the trial physician or hospitalisation for diabetic ketoacidosis during the previous 6 months
- •Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
研究组 & 干预措施
Low
Experimental
干预措施: liraglutide (Drug)
Low
Experimental
干预措施: placebo (Drug)
High
Experimental
干预措施: placebo (Drug)
Medium
Experimental
干预措施: liraglutide (Drug)
Medium
Experimental
干预措施: placebo (Drug)
High
Experimental
干预措施: liraglutide (Drug)
结局指标
主要结局
Geometric mean glucagon concentration during hypoglycaemia (nadir glucose (target 2.5 mmol/L) )
时间窗: At week 4
次要结局
- Geometric mean concentrations of adrenaline and noradrenaline at nadir(At week 4)
- Time from termination of insulin infusion at nadir to reach plasma glucose 4.0(At week 4)
- Geometric mean glucagon concentration at plasma glucose levels other than nadir(At week 4)
研究者
研究点 (1)
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