NCT00617565已完成3 期
A Multi-centre, Randomised, Parallel, Open Labelled Study to Compare the Efficacy and Safety Profile of Biphasic Insulin Aspart 30 (BIAsp 30) and Biphasic Human Insulin 30/70 (BHI 30/70) in Chinese Type 1 and 2 Diabetics
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 219
- 试验地点
- 7
- 主要终点
- 2-hr postprandial plasma glucose (PPPG) excursion
研究概览
简要总结
This trial is conducted in Asia. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 on postprandial glycaemic control.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 or 2 diabetes for at least 3 months
- •Stabilised on current treatment with premixed human insulin for at least 4 weeks
- •Body mass index (BMI) between 18-40 kg/m2
- •HbA1c below 13.0%
- •Able and willing to perform self-blood glucose monitoring
排除标准
- •The receipt of any investigational drug within the last three months prior to this trial
- •Has a history of drug abuse or alcohol dependence within the last 5 years
- •Active proliferative retinopathy requiring laser or surgical intervention within the last year
- •Recurrent major hypoglycaemia as judged by the Investigator
- •Known or suspected allergy to trial product or related product
结局指标
主要结局
2-hr postprandial plasma glucose (PPPG) excursion
时间窗: after 12 weeks of treatment
次要结局
- HbA1c
- Fasting plasma glucose
研究者
研究点 (7)
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