NCT01486940已完成3 期
A Multi-centre, Multinational, Open-labelled, Randomised, Parallel-Group Comparison of Insulin Detemir Plus Insulin Aspart With NPH Insulin Plus Human Soluble Insulin in Subjects With Type 1 Diabetes on a Basal-Bolus Regimen
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 598
- 试验地点
- 1
- 主要终点
- HbA1c (glycosylated haemoglobin)
研究概览
简要总结
This trial is conducted in Europe and South America. The aim of this trial is to compare the glycaemic control of insulin detemir plus insulin aspart with that of insulin NPH plus human soluble insulin in subjects with type 1 diabetes on a basal/bolus regimen.
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
- None
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
- •Type 1 diabetes for at least 12 months
- •Current treatment with any basal/bolus regimen or any biphasic insulin treatment for at least 6 months
- •BMI below or equal to 35 kg/m^2
- •HbA1c below or equal to 12%
排除标准
- •Proliferative retinopathy or maculopathy requiring acute treatment
- •Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the Investigator)
- •Subjects with known hypoglycaemic unawareness as judged by the Investigator
研究组 & 干预措施
Basal/bolus regimen 1
Experimental
干预措施: insulin detemir (Drug)
Basal/bolus regimen 1
Experimental
干预措施: insulin aspart (Drug)
Basal/bolus regimen 2
Active Comparator
干预措施: insulin NPH (Drug)
Basal/bolus regimen 2
Active Comparator
干预措施: human soluble insulin (Drug)
结局指标
主要结局
HbA1c (glycosylated haemoglobin)
次要结局
- 8-point blood glucose profiles
- Incidence of self-recorded hypoglycaemic episodes
- Incidence of adverse events
- Intra-subject variation in home measured blood glucose (3-point blood glucose profiles)
研究者
研究点 (1)
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