NCT00569426已完成4 期
An Open-label, Randomised, Multi-centre Cross-over Trial in Diabetes Patients Evaluating Preference, Injection Pressure, Pain Perception and Handling When Injections Are Performed With Two Different Needles i.e. NovoFine® 32 Gauge Tip x 6mm and NovoFine® 30 Gauge x 8mm Using a FlexPen® Disposable Insulin Injection Pen
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 10
- 主要终点
- Overall needle preference
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to compare two needle types when used with a disposable insulin injection pen in the everyday life setting of an insulin treated patient with diabetes.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent obtained before any trial-related activities
- •Diagnosed type 1 or type 2 diabetes
- •Treated with insulin
排除标准
- •Previous participation in this trial
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
- •Any disease or condition which the investigator feels would interfere with the trial
结局指标
主要结局
Overall needle preference
时间窗: after 2-3 weeks of treatment
次要结局
- Handling and acceptance of needles
- Injection pressure
- Pain perception
研究者
研究点 (10)
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