NCT00871416已完成3 期
Localisation of Potential Insulin Deposits in Normal Weight and Obese Diabetics Using 6 mm and 12 mm Long Needles. Furthermore, the Thickness of Cutis/Subcutis Is Measured on Recommended Insulin Injection Sites
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Location of the injected sterile, atmospheric air
研究概览
简要总结
This trial is conducted in Europe. The primary aim of this clinical trial is to locate and compare simulated insulin injections (injections of sterile atmospheric air) in normal weight and obese patients with diabetes mellitus. Injections are done with 6 mm and 12 mm needles with and without lifting of skin fold at different injection sites.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus
- •Use NovoPen®, NovoPen® 1.5, NovoPen® 3, NovoLet® 1.5 or NovoLet® 3 for at least 3 months
- •Body mass index (BMI) for normal weight between 19-25 kg/m2
- •Body mass index (BMI) for obese between 25-33 kg/m2
排除标准
- •Pregnancy or plans thereof
- •Local reactions on injection sites
- •Acute, severe infection diseases
- •Coagulation disorders
结局指标
主要结局
Location of the injected sterile, atmospheric air
时间窗: after 4 injections at visit 1 and 2, respectively
次要结局
- Cutis/subcutis thickness on 14 recommended injection sites
研究者
研究点 (1)
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