NCT01030926已完成1 期
A Trial Investigating the Pharmacokinetic Properties of NN1250 in Children, Adolescents and Adults 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
- 39
- 试验地点
- 1
- 主要终点
- Area under the NN1250 concentration-time curve after single dose
研究概览
简要总结
This trial was conducted in Europe. The aim of this clinical trial was to look into the concentration of NN1250 (insulin degludec/insulin 454) in the blood after one injection of NN1250 in children, adolescents and adults 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
- 6 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 6-65 years (both inclusive)
- •Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
- •Body mass index for children: 15.0-20.0 kg/m^2 (both inclusive), for adolescents: 18.0-28.0 kg/m^2 (both inclusive) and for adults maximum 30.0 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
- •Not able or willing to refrain from smoking during the inpatient period
- •Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods
研究组 & 干预措施
A1, first period
Experimental
干预措施: insulin degludec (Drug)
A2, second period
Active Comparator
干预措施: insulin glargine (Drug)
B1, first period
Active Comparator
干预措施: insulin glargine (Drug)
B2, second period
Experimental
干预措施: insulin degludec (Drug)
结局指标
主要结局
Area under the NN1250 concentration-time curve after single dose
时间窗: 0-72 hours after dosing
次要结局
- Maximum observed NN1250 concentration after single dose(0-72 hours after dosing)
- Time to maximum observed NN1250 concentration after single dose(0-72 hours after dosing)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Trial Investigating the Pharmacokinetic Properties of FIAsp in Children, Adolescents and Adults With Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1NCT02035371Novo Nordisk A/S41
已完成
1 期
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp in Subjects With Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1NCT01924637Novo Nordisk A/S36
已完成
1 期
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp in Geriatric and Younger Adult Subjects With Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1NCT02003677Novo Nordisk A/S67
已完成
1 期
A Trial Investigating the Pharmacokinetic Properties of Formulations of NN1218 in Subjects With Type 1 DiabetesDiabetes Mellitus, Type 1DiabetesNCT01469143Novo Nordisk A/S40
已完成
1 期
A Trial Investigating NN1218 in Subjects With Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1NCT01121289Novo Nordisk A/S26