NCT01121276已完成1 期
A Trial Investigating the Pharmacodynamic Properties of NN1218 in Subjects With Type 1 and Type 2 Diabetes
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Area under the blood glucose concentration-time curve
研究概览
简要总结
This trial is conducted in Europe and in the United States of America (USA). The aim of this trial is to investigate the absorption and effect in the body of NN1218 in subjects with type 1 and type 2 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
- 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 or type 2 diabetes mellitus for more than 12 months
- •Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for 12 months or longer for subjects with type 1 diabetes and for 3 months or longer for subjects with type 2 diabetes
- •Body Mass Index (BMI) between 18.0-32.0 kg/m2 (both inclusive)
排除标准
- •Surgery or trauma with significant blood loss (more than 500 mL) within the last 3 months prior to trial start
- •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
NN1218, formulation A
Experimental
干预措施: Faster-acting insulin aspart (Drug)
NN1218, formulation B
Experimental
干预措施: Faster-acting insulin aspart (Drug)
NN1218, formulation C
Experimental
干预措施: Faster-acting insulin aspart (Drug)
NN1218, formulation D
Experimental
干预措施: Faster-acting insulin aspart (Drug)
insulin aspart
Active Comparator
干预措施: insulin aspart (Drug)
结局指标
主要结局
Area under the blood glucose concentration-time curve
时间窗: from 0-2 hours
次要结局
- Area under the blood glucose concentration-time curve(from 0-6 hours)
研究者
研究点 (1)
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