Glucagon Enhanced Insulin Absorption in Diabetes Mellitus Type 1
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Area under the glucose curve
研究概览
简要总结
The investigators will study the effect of microdoses of glucagon at the site of subcutaneous insulin injection. The investigators have unpublished data from anesthetized pigs indicating a major enhancement of insulin absorption.
详细描述
People with type 1 diabetes will come fasting in the morning to the research facility on two separate days. Both days participants will have a breakfast of their own choice and their regular dose of meal insulin injected. Lyumjev will be used. Frequently collected blood sampled will be analysed for glucose, insulin and glucagon for 3.5 hours. The procedures will be exactly the same both days except that on one of the days they will be randomised to a small dose of glucagon that will be injected at exactly the same site as Lyumjev insulin is injected.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1: Type 1 diabetes for at least 1 year.
- •Age 18 - 70 years.
- •Last known HbA1c <86 mmol/mol.
- •Treated with continuous subcutaneous insulin infusion (CSII) by an insulin pump or multiple daily insulin injections (MDII).
排除标准
- •Pregnant women or women trying to conceive.
- •Any chronic disease, including psychiatric illness, judged incompatible with participation in the study.
- •Unfit for participation for any reason judged by the investigators.
- •Known hypersensitivity to glucagon or any of the excipients of the drug formulation.
- •Known phaeochromocytoma. -
研究组 & 干预措施
Glucagon
Micro dose of glucagon is aded at the insulin injection site
干预措施: Glucagon (Drug)
结局指标
主要结局
Area under the glucose curve
时间窗: From time 0 minutes to time 60 minutes
The area under the glucose curve (change from baseline glucose level)
次要结局
- Area under glucose curve(Any other time span from time 0 minutes to time 180 minutes)
- Area under insulin curve(Any time frame from time 0 minutes to time 180 minutes)
- Area under glucagon curve(Any time frame from time 0 minutes to time 180 minutes)
- Pharmacokinetics of insulin(Start from time 0)
- Pharmacokinetics of glucagon(Start from time 0)