临床试验/NCT00571935

NCT00571935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 Diabetes Mellitus

Novo Nordisk A/S5 个研究点分布在 1 个国家目标入组 61 人开始时间: 2003年8月1日最近更新: 2016年12月21日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 61
试验地点: 5
主要终点: HbA1c

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This trial is conducted in Europe.

The aim of this trial is to investigate the efficacy of insulin aspart compared to soluble human insulin on blood glucose control in children below 7 years of age 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: — 至 7 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•Type 1 diabetes for at least 1 year
•HbA1c below 12.0%
•Treatment with regular human insulin and insulin NPH for at least 1 month
•Receive more than 2 injections daily

排除标准

•Receipt of investigational product within 6 months prior to trial participation
•Known or suspected allergy to investigational product
•Receipt of of insulin aspart within 3 months prior to trial participation

结局指标

主要结局

HbA1c

时间窗: after 26 weeks of treatment

次要结局

Occurrence of adverse events
Occurrence of serious adverse events
Overall glycaemic control
Frequency of hypoglycaemia episodes
Quality of Life (QoL)

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (5)

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