NCT04712266已完成早期 1 期
A Randomized, Double-blinded Trial to Investigate Glycemic Excursions Following an Oral Mixed Meal Challenge in Subjects With Type 1 Diabetes When Concomitantly Treated With Insulin Alone or Co-administered Insulin and Glucagon
Abvance Therapeutics1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2020年9月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- hyperglycemic excursions
研究概览
简要总结
This is a single center, double-blind, randomized trial in subjects with type 1 diabetes mellitus applying an adaptive design approach.
详细描述
Subjects were be studied on two occasions, in randomized sequence, whereby glycemic excursions are assessed following an oral mixed meal challenge while treated with either insulin alone or co-administered insulin and glucagon.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged between 18 and 64 years (both inclusive)
- •Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months prior to the screening visit
- •Treated with daily insulin for T1DM ≥ 12 months prior to the screening visit
排除标准
- 未提供
研究组 & 干预措施
Insulin IV
Active Comparator
calculated insulin rate
干预措施: Insulin (Drug)
Insulin and Glucagon IV
Experimental
calculated molar ratio insulin:glucagon
干预措施: Glucagon (Drug)
Insulin and Glucagon IV
Experimental
calculated molar ratio insulin:glucagon
干预措施: Insulin (Drug)
结局指标
主要结局
hyperglycemic excursions
时间窗: 60-120 minutes post meal
\>150mg/dl
hypoglycemic excursions
时间窗: 180-360 minutes post meal
\< 50mg/dl
次要结局
未报告次要终点
研究者
研究点 (1)
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