2022-502455-57-01已完成2 期
Glucagon enhanced insulin absorption in Diabetes Mellitus type 1
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Area under the glucose curve for the first 60 minutes.
研究概览
简要总结
To investigate if micro-doses of glucagon at the same site as subcutaneous insulin delivery enhances the absorption of insulin and reduces postprandial glucose excursions in patients with diabetes mellitus type 1
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
- •DM1 for at least 1 year.
- •Age 18 – 70 years
- •Last known HbA1c <86 mmol/mol (< 10.0%)
- •Treated with continuous SC insulin infusion (CSII) by an insulin pump or with multiple daily insulin injections (MDII).
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 any of the excipients of the drug formulation
- •Known phaeochromocytoma
结局指标
主要结局
Area under the glucose curve for the first 60 minutes.
Area under the glucose curve for the first 60 minutes.
次要结局
- Area under glucose curve for any other time span during the first 3 hours.
- Area under the insulin curve for any time span during the first 3 hours
- Area under the glucagon curve for any time span during thefirst 3 hours.
- Pharmacokinetic estimates for insulin.
- Pharmacokinetic estimates for glucagon.
- Thermal camera measurements.
- Laser doppler flowmetry measurements.
研究者
Forskningsavdelingen
Scientific
St. Olavs Hospital HF
研究点 (1)
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