NCT00872560已完成3 期
Insulin Leakage and Pain Perception in IDDM Children or Adolescents, Where the Injections Are Performed With NovoFine™ 6 x 0.30 mm Needles and NovoFine® 8 x 0.30 mm Needles: An Open, Randomized, Two-period Cross-over, Multi-centre, Phase IIIb Trial at 4 Centres
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Weighing of reflux of insulin
研究概览
简要总结
This trial is conducted in Europe. This trial aims to ensure that there is no substantial clinically relevant difference between the two Novo Nordisk needles NovoFine® 6 x 0.30 mm and NovoFine® 8 x 0.30 mm on reflux of insulin back to the surface of cutis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children/adolescents with type 1 diabetes mellitus
- •Usage of NovoPen® 1.5 for at least 3 months
- •Duration of insulin treatment more than 1 year
- •Normal weight according to Tanner scales
- •The means of the last 2 HbA1c measurements taken within the last 6 months must be less than 10.5%
排除标准
- •Pregnancy or desire to become pregnant
- •Clinical relevant peripheral neuropathy as judged by the investigators
- •Pronounced lipodystrophy in accordance with investigator's evaluation
- •Use of drugs that can influence the trial
- •Coagulation disorders (use of anti-coagulants)
- •Serious, chronic diseases, making it highly unlikely that the subject can complete the trial
结局指标
主要结局
Weighing of reflux of insulin
时间窗: 6 seconds after injection
次要结局
- Reactions at injection sites(after 6 weeks of treatment)
- Pain perception(after 6 weeks of treatment)
- Number and severity of bleedings(after 6 weeks of treatment)
研究者
研究点 (2)
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