NCT00569998已完成3 期
An Open-label, Multi-centre, Multi-national, Comparative, Randomised, Cross-over Trial Evaluating Preference as Well as Performance, Acceptance, Handling and Safety of NovoPen™ 4 (MS236) Versus NovoPen 3® in Insulin Treated Diabetic Patients
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 23
- 主要终点
- Evaluation of overall pen preference
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to compare two insulin delivery pens in the everyday life setting of patients with diabetes treated with insulin.
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
- 9 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 or type 2 diabetes mellitus for at least 12 months
- •Adults at least 18 years
- •Children/adolescents between 9-18 years
- •HbA1c lesser than or equal to 11.0%
排除标准
- •Known or suspected alcohol or drug abuse
- •Patients who are not able to read the user manual (may wear glasses if needed)
- •Hypoglycaemic unawareness as judged by the investigator
- •Visual and/or dexterity impairments as judged by the investigator
结局指标
主要结局
Evaluation of overall pen preference
时间窗: after 12 weeks of treatment
次要结局
- Adverse events
- HbA1c
- Adverse device effects
研究者
研究点 (23)
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