NCT00410033已完成不适用
Safety/Efficacy Trial Using Stored Serum Samples to Investigate the Immunogenicity of Insulin Aspart and Soluble Human Insulin in Children and Adolescents From Onset of Type 1 Diabetes
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Insulin aspart specific, human insulin specific and cross reacting antibodies
研究概览
简要总结
This trial is conducted in Europe. This is a single-centre, retrospective trial aiming at comparing the antibody levels in children and adolescents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before any trial-related activities
- •Any subjects at onset of Type 1 Diabetes
- •Treatment with either Insulin Aspart and Soluble Human Insulin or Soluble Human Insulin and Isophane Human Insulin / Mixtard® for at least 9 months from the time of diagnosis of diabetes
排除标准
- •Treatment with immunosuppressive agents
- •For the Insulin Aspart + Isophane Human Insulin: Treatment with insulin analogues other than Insulin Aspart or treatment with fast acting human insulin for a period of 7 days or more during the treatment period
- •For the Soluble Human Insulin and Isophane Human Insulin group: Treatment with insulin analogues
- •Other diseases influencing immune response
- •Unable or unwilling to provide consent
结局指标
主要结局
Insulin aspart specific, human insulin specific and cross reacting antibodies
时间窗: measured up to at most 2.5 years after diagnosis
次要结局
- Insulin requirements
- HbA1c
- Incidence of hypoglycaemic episodes
研究者
研究点 (2)
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