NCT00569400已完成3 期
Comparison of Efficacy and Safety of Human Insulin Produced by the Current Process and the NN729 Process in Type 1 Diabetes Mellitus
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 241
- 试验地点
- 15
- 主要终点
- Change of human insulin antibodies
研究概览
简要总结
This trial is conducted in Asia and Oceania. The aim of this trial is to compare the efficacy and safety of human insulin produced by the current process and the NN729 process in type 1 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Duration of diabetes for at least 12 months
- •Basal/bolus treatment with human insulin for at least 2 months preceding trial start
- •Body Mass Index (BMI) lesser than or equal to 35.0 kg/m2
- •HbA1c lesser than or equal to 12.0%
排除标准
- •Proliferative retinopathy or maculopathy requiring acute treatment or laser treatment within the last 6 months
- •Any condition that the investigator and/or sponsor feel would interfere with trial participation
- •Known or suspected allergy against trial product or related products
结局指标
主要结局
Change of human insulin antibodies
时间窗: after 26 weeks of treatment
次要结局
- Frequency of adverse events
- Change of human insulin antibodies
研究者
研究点 (15)
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