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临床试验/NCT00097071
NCT00097071已完成3 期

Safety and Efficacy of Insulin Aspart Versus Insulin Lispro in Insulin Pumps in Children and Adolescents With Type 1 Diabetes

Novo Nordisk A/S52 个研究点 分布在 1 个国家目标入组 299 人开始时间: 2004年10月1日最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
299
试验地点
52
主要终点
HbA1c

研究概览

简要总结

This trial is conducted in the United States of America (USA). It is demonstrated that intensive insulin therapy resulting in good glycaemic control can reduce or delay the incidence of complications secondary to Type 1 Diabetes. Insulin Aspart (NovoLog®) is an ideal insulin to use in an intensive insulin regimen using continuous subcutaneous insulin injection (CSII) therapy in the pediatric and adolescent age population. This trial compares the safety and efficacy of Insulin Aspart (NovoLog®) and Insulin Lispro (Humalog®) delivered by CSII in children and adolescents with type 1 diabetes.

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
3 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Type 1 Diabetes

排除标准

  • 未提供

结局指标

主要结局

HbA1c

时间窗: After 16 weeks treatment

次要结局

  • Measurements of glycaemic control, safety parameters including frequency of hypoglycaemia, laboratory tests, clinical evaluations and adverse events

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (52)

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