NCT00992537已完成1 期
A Trial Comparing the Pharmacokinetic and Pharmacodynamic Properties Between NN5401 and NN1250 and Between NN5401 and Insulin Aspart in Subjects With Type 1 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
- 27
- 主要终点
- Area under the glucose infusion rate curve
研究概览
简要总结
This trial is conducted in Europe. The aim of this clinical trial is to compare the blood glucose lowering effect of NN5401(insulin degludec/insulin aspart (IDegAsp)) with NN1250 (insulin degludec (IDeg)) and insulin aspart (IAsp) in subjects with type 1 diabetes where the trial participant will receive one single dose of each trial product in varying order.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
- •Body mass index 18.0-28.0 kg/m^2 (both inclusive)
排除标准
- •Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
- •Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day).
- •Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
研究组 & 干预措施
IAsp
Active Comparator
干预措施: insulin aspart (Drug)
IDeg
Experimental
干预措施: insulin degludec (Drug)
IDegAsp
Experimental
干预措施: insulin degludec/insulin aspart (Drug)
结局指标
主要结局
Area under the glucose infusion rate curve
时间窗: From 4 to 24 hours after single-dose administration
次要结局
- Area under the insulin degludec concentration-time curve(From 0 to 120 hours after single-dose administration)
- Maximum observed insulin degludec concentration(From 0 to 120 hours after single-dose administration)
- Area under the insulin aspart concentration-time curve(From 0 to 12 hours after single-dose administration)
- Maximum observed insulin aspart concentration(0-12 hours after single-dose administration)
研究者
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