NCT00071448已完成3 期
Basal/Bolus Therapy With Insulin Aspart (NovoLog®) Versus Regular Human Insulin (Novolin® R) or Insulin Lispro (Humalog®) in Combination With NPH: An Open-Label, Randomized, Parallel Group, Multicenter Study in Children and Adolescents With Type 1 Diabetes
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 378
- 试验地点
- 77
- 主要终点
- HbA1c (glycosylated haemoglobin A1c)
研究概览
简要总结
This trial is conducted in the United States of America (USA). The aim of this trial is to to determine whether insulin aspart can be used effectively and safely in paediatric patients.
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
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pediatric patients with Type 1 diabetes for at least one year
- •HbA1c less than 12%
- •Willing to administer at least 3 injections per day
- •Willing to perform self monitored blood glucose (SMBG) at least 4 times per day, includes subject and/or parent/guardian, as necessary
排除标准
- 未提供
结局指标
主要结局
HbA1c (glycosylated haemoglobin A1c)
次要结局
- FPG (fasting plasma glucose)
研究者
研究点 (77)
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