NCT00983021已完成1 期
A Trial to Test for Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9068 and Compared With NN1250 and NN2211 in Healthy Subjects
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
- 24
- 试验地点
- 1
- 主要终点
- Number and severity of adverse events, number and severity of local tolerability issues at the injection site, number and severity of hypoglycaemic episodes
研究概览
简要总结
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, level of drug exposure and effect of NN9068.
The trial participants will be randomised to 4 different treatments in trial, receiving trial products in a pre-defined order.
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects, who are considered to be generally healthy, based on an assessment of medical history, physical examination, and clinical laboratory data, as judged by the Investigator.
- •Body mass index (BMI) between 18.0 and 27.0 kg/m2 (both inclusive)
- •Body weight between 60 kg and 90 kg (both inclusive)
排除标准
- •Subjects with a history of or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders that might have impact on the current trial, as judged by the Investigator
研究组 & 干预措施
A
Experimental
干预措施: insulin degludec/liraglutide (Drug)
A
Experimental
干预措施: placebo (Drug)
B
Experimental
干预措施: insulin degludec (Drug)
B
Experimental
干预措施: placebo (Drug)
C
Active Comparator
干预措施: liraglutide (Drug)
C
Active Comparator
干预措施: placebo (Drug)
D
Experimental
干预措施: insulin degludec (Drug)
D
Experimental
干预措施: liraglutide (Drug)
结局指标
主要结局
Number and severity of adverse events, number and severity of local tolerability issues at the injection site, number and severity of hypoglycaemic episodes
时间窗: assessed 0-96 hours after trial product administration
次要结局
- The area under the NN2211 concentration-time curve after single-dose(assessed 0-72 hours after trial product administration)
- The area under the NN1250 concentration-time curve after single-dose(assessed 0-96 hours after trial product administration)
研究者
研究点 (1)
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