NCT01497535已完成1 期
A Single-centre, Parallel-group, Randomised, Double Blind Trial in Healthy Japanese Subjects Comparing the Within-subject Variability of Insulin Detemir and Insulin Glargine With Respect to Pharmacodynamic and Pharmacokinetic Properties
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
- 40
- 试验地点
- 1
- 主要终点
- Maximum glucose infusion rate (GIRmax)
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to compare the within-subject variability of insulin detemir to that of another basal insulin analogue, insulin glargine in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy Japanese men or women
- •Holding a Japanese pass-port and Japanese-born parents
- •Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
- •Body Mass Index (BMI) between 18 and 30 kg/m^2, incl.
- •Fasting blood glucose maximum 6 mmol/L
排除标准
- •Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator
- •Any serious systemic infectious disease that occurred during the four weeks prior to the first dose of the trial product, as judged by the Investigator
- •Subject with history of alcohol or drug dependence
研究组 & 干预措施
Insulin detemir
Experimental
干预措施: insulin detemir (Drug)
Insulin glargine
Active Comparator
干预措施: insulin glargine (Drug)
结局指标
主要结局
Maximum glucose infusion rate (GIRmax)
次要结局
- Area under the glucose infusion rate curve (AUCGIR)
- Time to maximum glucose infusion rate (tGIRmax)
- Area under the insulin concentration curve (AUC)
- Maximum insulin concentration (Cmax)
- Adverse events
研究者
研究点 (1)
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