NCT00435019已完成3 期
An Efficacy and Safety Comparison of Insulin Detemir vs. NPH Insulin in Children and Adolescents Diagnosed With Type 1 Diabetes
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
- 348
- 试验地点
- 1
- 主要终点
- Glycosylated Haemoglobin A1c (HbA1c)
研究概览
简要总结
This trial is conducted in Europe.
The aim of this research is to compare the efficacy and safety of treatment with NPH insulin and insulin detemir. You will be treated with either insulin detemir or NPH insulin once or twice daily as basal insulin. Additionally you will receive insulin aspart as bolus insulin
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
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Insulin detemir naive
- •Type 1 diabetes for at least 12 months
- •HbA1c lesser than or equal to 11.0%
排除标准
- •Significant concomitant diseases
研究组 & 干预措施
insulin detemir
Experimental
insulin detemir + insulin aspart
干预措施: insulin detemir (Drug)
insulin detemir
Experimental
insulin detemir + insulin aspart
干预措施: insulin aspart (Drug)
NPH insulin
Experimental
NPH insulin + insulin aspart
干预措施: insulin NPH (Drug)
NPH insulin
Experimental
NPH insulin + insulin aspart
干预措施: insulin aspart (Drug)
结局指标
主要结局
Glycosylated Haemoglobin A1c (HbA1c)
时间窗: after 52 weeks of treatment
Glycosylated haemoglobin A1c (HbA1c) measured after 52 weeks of treatment and analysed by central laboratory.
次要结局
- Number of Subjects Reporting Adverse Events(from week -2 to week 52)
- Observed Insulin Antibody Values(at 0 and 52 weeks)
研究者
研究点 (1)
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