A Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Area under the serum insulin aspart concentration-time curve
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to test for bioequivalence between two formulations of insulin degludec/insulin aspart (IDegAsp) to see if the efficacy and safety obtained with formulation 1 can be assumed identical for formulation 2.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer
- •Body mass index from 18.0 to 28.0 kg/m^2 (both inclusive)
- •HbA1c below or equal to 9.5% by central laboratory analysis
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
Formulation 1
干预措施: insulin degludec/insulin aspart (Drug)
Formulation 2
干预措施: insulin degludec/insulin aspart (Drug)
结局指标
主要结局
Area under the serum insulin aspart concentration-time curve
时间窗: From 0 to 12 hours after single-dose
Maximum observed serum insulin degludec concentration
时间窗: After single-dose (within 0 to 120 hours after dosing)
Area under the serum insulin degludec concentration-time curve
时间窗: From 0 to 120 hours after single-dose (SD)
Maximum observed serum insulin aspart concentration
时间窗: After single-dose (within 0 to 12 hours after dosing)
次要结局
- Area under the glucose infusion rate curve(From 0 to 26 hours after single-dose)
- Maximum glucose infusion rate(After single-dose (within 0 to 120 hours after dosing))