NCT02147431已完成1 期
A Randomised, Single-centre, Double-blind, Cross-over Trial Investigating the Effect of Semaglutide on Hypoglycaemic Counter-regulation Compared to Placebo in Subjects With Type 2 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
- 38
- 试验地点
- 1
- 主要终点
- Change in mean glucagon concentration during hypoglycaemia (change from target level 5.5 mmol/L to nadir (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 the effect of semaglutide on hypoglycaemic counter-regulation compared to placebo 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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with type 2 diabetes and on stable treatment for a period of 90 days prior to screening with metformin as monotherapy. Stable is defined as unchanged dose
- •Male or female, age between18-64 years (both inclusive) at the time of signing informed consent
- •Body Mass Index (BMI) between 20.0-35.0 kg/m^2 (both inclusive)
- •HbA1c (glycosylated haemoglobin) between 6.5-10.0% (both inclusive)
排除标准
- •Treatment with any glucose lowering agent(s) other than metformin in a period of 90 days before screening. An exception is short-term treatment (less than or equal to 7 days in total) with insulin in connection with intercurrent illness
- •Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
- •Blood or plasma donation within the past month or more than 500 mL within the last 3 months prior to first semaglutide dosing
研究组 & 干预措施
Semaglutide
Experimental
干预措施: semaglutide (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change in mean glucagon concentration during hypoglycaemia (change from target level 5.5 mmol/L to nadir (target 2.5 mmol/L))
时间窗: After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213)
次要结局
- Hypoglycaemic symptoms score(After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213))
- Change in mean concentrations of adrenaline, noradrenaline, cortisol and growth hormone from target level 5.5 mmol/L to 3.5 mmol/L and to nadir(After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213))
- Change in mean glucagon concentration from target level 5.5 mmol/L to 3.5 mmoL/L and from ambient plasma glucose to target levels 5.5 mmol/L, 3.5 mmol/L and nadir(After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213))
- Time from termination of insulin infusion at nadir to reach plasma glucose level 4.0 mmol/L(After 12 weeks 2 days of treatment in each treatment period (Day 87 and Day 213))
研究者
研究点 (1)
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