NCT01135927已完成1 期
A Trial Investigating the Pharmacodynamic Properties of NN1250 in Japanese 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
- 22
- 试验地点
- 1
- 主要终点
- Area under the NN1250 GIR (glucose infusion rate) curve
研究概览
简要总结
This trial is conducted in Japan. The aim of this clinical trial is to investigate the effect of NN1250 (insulin degludec) in Japanese subjects with type 1 diabetes.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 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
- •Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months
- •Current daily basal insulin requirement above or equal to 0.3 (I)U/kg/day
- •Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0% (one retest within a week is permitted with the result of the last test being conclusive)
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
- •Surgery or trauma with significant blood loss (more than 500 mL) within the last 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 (only clamp period)
研究组 & 干预措施
A
Experimental
干预措施: insulin degludec (Drug)
B
Active Comparator
干预措施: insulin detemir (Drug)
结局指标
主要结局
Area under the NN1250 GIR (glucose infusion rate) curve
时间窗: During one dosing interval at steady state
次要结局
- Area under the serum insulin detemir concentration-time curve(During one dosing interval at steady state)
研究者
研究点 (1)
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