NCT01134224已完成1 期
A Trial Investigating the Pharmacodynamic Response of NN5401 in Subjects With Type 2 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
- 39
- 主要终点
- Area under the glucose infusion rate curve (only for IDegAsp)
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to evaluate the blood glucose-lowering effect of NN5401 (insulin degludec/insulin aspart (IDegAsp)) in subjects with 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
- •Body mass index below or equal to 35.0 kg/m^2
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
biphasic insulin aspart 30 - high dose
Active Comparator
干预措施: biphasic insulin aspart 30 (Drug)
NN5401 - low dose
Experimental
干预措施: insulin degludec/insulin aspart (Drug)
NN5401 - medium dose
Experimental
干预措施: insulin degludec/insulin aspart (Drug)
NN5401 - high dose
Experimental
干预措施: insulin degludec/insulin aspart (Drug)
biphasic insulin aspart 30 - low dose
Active Comparator
干预措施: biphasic insulin aspart 30 (Drug)
biphasic insulin aspart 30 - medium dose
Active Comparator
干预措施: biphasic insulin aspart 30 (Drug)
结局指标
主要结局
Area under the glucose infusion rate curve (only for IDegAsp)
时间窗: From 0 to 24 hours after single-dose
次要结局
- Area under the insulin aspart concentration-time curve(From 0 to 12 hours after single-dose administration)
- Area under the insulin aspart concentration-time curve (only for BIAsp 30)(From 0 to 24 hours after single-dose administration)
研究者
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