2023-510408-32-02暂停2 期
Premixed glucagon/insulin solution for faster insulin absorption in Type 1 diabetes.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The area under the glucose consumption curve and area under the insulin curve for the first 30 minutes.
研究概览
简要总结
a) To investigate if adding 5 ng glucagon/unit insulin increases the speed of absorption of SC injected insulin in patients with T1D b) To investigate if adding 5 ng glucagon/unit insulin increases the effect on glucose metabolism insulin in patients with T1D
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •T1D for at least one year.
- •Age 18 – 70 years.
- •Last known HbA1c <75 mmol/mol (< 9.0%).
- •Treated with an insulin pump or a hybrid artificial pancreas (AP).
排除标准
- •Pregnant women or women trying to conceive (women will not be screened by a pregnancy test).
- •Any chronic disease, including psychiatric illnesses, judged incompatible with participation in the study.
- •Unfit for participation for any reason as judged by the investigators.
- •Known hypersensitivity to glucagon or to any of the excipients of the drug formulations.
- •Known phaeochromocytoma.
结局指标
主要结局
The area under the glucose consumption curve and area under the insulin curve for the first 30 minutes.
The area under the glucose consumption curve and area under the insulin curve for the first 30 minutes.
次要结局
- Area under glucose consumption curve for any other time span during the first 4 hours
- Area under insulin curve for any other time span during the first 4 hours
- Pharmacokinetic estimates for insulin
- Pharmacodynamic estimates for insulin
研究者
Sven M Carlsen
Scientific
St. Olavs Hospital HF
研究点 (1)
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