NCT01704417已完成1 期
A Trial Comparing the Effect of Exercise on Blood Glucose Between Insulin Degludec and Insulin Glargine in Subjects 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
- 40
- 试验地点
- 1
- 主要终点
- BGpre-exe - BGminimum,exe, difference between blood glucose concentration before exercise and the minimum blood glucose concentration observed during exercise
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to compare the effect of exercise on blood glucose in subjects with type 1 diabetes, who are treated with either insulin degludec (IDeg) or insulin glargine (IGlar).
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
- •Body mass index 18.0-27.0 kg/m^2 (both inclusive)
- •Subjects performing regular physical cardiorespiratory activity
- •Glycosylated haemoglobin (HbA1c) below or equal to 9.5 %
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
- •Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
- •Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
- •Supine blood pressure at screening (after resting for at least 5 minutes) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic
研究组 & 干预措施
IGlar followed by IDeg
Experimental
干预措施: insulin degludec (Drug)
IDeg followed by IGlar
Experimental
干预措施: insulin degludec (Drug)
IDeg followed by IGlar
Experimental
干预措施: insulin glargine (Drug)
IGlar followed by IDeg
Experimental
干预措施: insulin glargine (Drug)
结局指标
主要结局
BGpre-exe - BGminimum,exe, difference between blood glucose concentration before exercise and the minimum blood glucose concentration observed during exercise
时间窗: From 0 to 30 minutes
次要结局
- BGmean,exe, mean blood glucose concentration during exercise(From 0 to 30 minutes)
- BGmean,30-180min,post-exe, mean blood glucose concentration(Between 30 and 180 minutes, i.e. post-exercise)
- BGminimum,30-180min,post-exe, minimum blood glucose concentration(Between 30 and 180 minutes, i.e. post-exercise)
研究者
研究点 (1)
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