NCT00343343已完成2 期
A Comparative, Randomised Study With NovoFine® 4 mm Needle Versus NovoFine® 6 mm Needle in Regard to Anatomical Deposition of Sterile Air in Children and Thin Adults With Diabetes and Backflow of Test Medium (Only Adults) After Injection in Thigh and Abdomen
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 3
- 主要终点
- Deposition of sterile air depositions.
研究概览
简要总结
This trial is conducted in Europe. The aim of this investigation is to explore the safety of a 4 mm needle compared to a 6 mm needle when injected in children and lean adults with diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes
- •Insulin treatment for more than ½ year
- •BMI lesser than or equal to 19 kg/m2
- •Last HbA1c taken within the last year lesser than 10.5%
- •Girls: only prepubertal
- •Boys: both pre pubertal and pubertal. Adults
- •Type 1 and 2 diabetes
- •Insulin treatment for more than ½ year
- •BMI lesser than or equal to 23 kg/m2
- •Last HbA1c taken within the last year lesser than 10.5%
排除标准
- •Known or suspected allergy to trial product(s) or related products.
- •Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (including country-specific adequate measures, if any).
- •Skin disease at abdomen and/or thigh
结局指标
主要结局
Deposition of sterile air depositions.
次要结局
- Amount of backflow
- Thickness of 1) dermis and 2) distance from skin surface to muscle fascia
研究者
研究点 (3)
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