NCT01467141已完成4 期
Meal-related Insulin Aspart Therapy Versus Meal-related Human Insulin Therapy in Children 2-6 Years of Age With Type 1 Diabetes Mellitus: A Multi-centre Randomised, Open-labelled, Cross-over, Safety and Efficacy Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Incidence of hypoglycaemic episodes during the treatment
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to evaluate safety and efficacy 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
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes
- •Treatment with insulin for at least 6 months prior to inclusion
- •HbA1c below or equal to 11.0 %
- •Currently treated with short acting, intermediate acting, long acting human insulin or analogues or a self-mix of these insulins at least 1 month prior to inclusion
排除标准
- •The receipt of any investigational drug within one month prior to this trial
- •Recurrent severe hypoglycaemia or hypoglycaemic awareness as judged by the investigator
- •Total daily insulin doses at least 1.80 IU/kg
- •Treatment with oral hypoglycaemic agents
- •Known or suspected allergy to trial product or related products
研究组 & 干预措施
IAsp
Experimental
干预措施: insulin aspart (Drug)
IAsp
Experimental
干预措施: isophane human insulin (Drug)
HI
Active Comparator
干预措施: human insulin (Drug)
HI
Active Comparator
干预措施: isophane human insulin (Drug)
结局指标
主要结局
Incidence of hypoglycaemic episodes during the treatment
时间窗: Week 0; week 24
Change in HbA1c (glycosylated haemoglobin A1c)
时间窗: Week 0; week 24
次要结局
- Incidence of Adverse Events (AEs)(Week 0; week 24)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Efficacy and Safety of Insulin Aspart in MDI or CSII in Children Below 7 Years of Age With Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1NCT00571935Novo Nordisk A/S61
已完成
4 期
Efficacy and Safety of a Fixed or a Flexible Supplementary Insulin Therapy in Type 2 DiabetesDiabetes Mellitus, Type 2DiabetesNCT00274274Novo Nordisk A/S373
已完成
3 期
Efficacy and Safety of Insulin Detemir in Combination With Insulin Aspart and Biphasic Insulin Aspart 30 in Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT00605020Novo Nordisk A/S719
已完成
4 期
Initiation of Insulin Aspart in Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT00572806Novo Nordisk A/S6
已完成
3 期
Comparison of NPH Insulin and Insulin Detemir in Children and Adolescents With Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1NCT00435019Novo Nordisk A/S348