NCT01173926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 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 mellitus.
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
Experimental
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 6 to 24 hours after single-dose (only for IDegAsp and IAsp)
次要结局
- Area under the serum insulin aspart concentration-time curve(From 0 to 12 hours after single-dose (only for IDegAsp and IAsp))
- Area under the serum insulin degludec concentration-time curve(From 0 to 120 hours after single-dose (only for IDeg and IDegAsp))
研究者
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