NCT00419718已完成1 期
Effect of Exercise on the Pharmacokinetics and Pharmacodynamics of Inhaled Human Insulin in Subjects With Type 1 Diabetes
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Area under the plasma insulin profile in the interval
研究概览
简要总结
The trial is conducted in Europe. This clinical pharmacology trial investigates the effect of exercise on the pharmacokinetics and pharmacodynamics of inhaled insulin in subjects 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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes more than or equal to 12 months
- •Baseline HbA1c less than or equal to 11%
- •Body mass index (BMI) less than or equal to 29 kg/m2
- •Normal lung volumes
- •Treatment with intensified insulin therapy for at least 3 months
排除标准
- •Any present or history of pulmonary disease
- •Any findings from the cardiopulmonary exercise test compromising safety of moderate exercise
- •Impaired hepatic or renal function
- •Cardiac problems
- •Uncontrolled hypertension
- •Current proliferative retinopathy or maculopathy
- •Treatment with drugs, which may interfere with insulin action, glucose metabolism or recovery from hypoglycaemia (judged by investigator)
- •Current smoking or smoking within the last 6 months
- •Blood donation (more than 500 mL) within the last nine weeks
结局指标
主要结局
Area under the plasma insulin profile in the interval
时间窗: From 30-150 min after trial product administration
次要结局
- Area under the plasma insulin profile in the interval 0-600 min after trial product administration
- Area under the plasma insulin profile in the interval from 120-240 min after trial product administration
- Maximum plasma insulin concentration
- Area under the plasma insulin profile in the interval from 240-360 min after trial product administration
研究者
研究点 (2)
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