NCT00567775已完成2 期
Comparison of Pharmacokinetic Profiles of Human Soluble Insulin With Insulin Inhalation Solution in Paediatric Type 1 Diabetes Mellitus
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Area under the serum insulin curve
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to compare the pharmacokinetic profile of two different methods of insulin administration in children 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
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes
- •Treatment for at least 12 months
- •HbA1c lesser or equal to 11.0%
- •Body weight between 25 and 80 Kg
- •Capable to use the device
排除标准
- •Any diseases other than diabetes requiring prescriptive medication
- •Known or suspected allergy to trial product or related products
- •Active proliferative retinopathy as judged by the Investigator
- •Recurrent severe hypoglycaemia as judged by the Investigator
- •The receipt of any investigational drug within 4 weeks prior to this trial
结局指标
主要结局
Area under the serum insulin curve
时间窗: from 0 to 5 hours post-dosing
次要结局
- Time to maximum serum insulin concentration(in the interval from 0 to 5 hours post-dosing)
- Maximum serum insulin concentration(in the interval from 0 to 5 hours post-dosing)
研究者
研究点 (2)
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