NCT00593255已完成4 期
A Multi-centre, Randomised, Parallel, Open Labelled Study to Compare the Efficiency and Safety Profile of Insulin Aspart (NovoRapid®) and Human Soluble Insulin (Novolin® R) as Meal Related Insulin in a Three Times Daily Regimen With One Injection of Novolin® N at Bedtime in Chinese Type 1 and 2 Diabetics
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 5
- 主要终点
- 2-hours postprandial plasma glucose (PPPG)
研究概览
简要总结
This trial is conducted in Asia. The aim of this trial is to compare the efficacy of postprandial plasma glucose of two treatment regimens in Chinese subjects.
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 65 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 4 weeks
- •Treatment with oral antidiabetic drugs (OADs) and/or insulin for at least 4 weeks
- •HbA1c: 7.5-13.5%
- •Body Mass Index (BMI): 18-35 kg/m2
排除标准
- •Treatment with either soluble human insulin or insulin NPH three times daily within 3 months before trial participation
- •History of drug abuse or alcohol dependence
结局指标
主要结局
2-hours postprandial plasma glucose (PPPG)
时间窗: after 12 weeks of treatment
次要结局
- Hypoglycaemic episodes
- Percentage of subjects achieving 2-hours PPPG treatment target
- Fasting plasma glucose
- Percentage of subjects achieving HbA1c treatment target
- HbA1c
研究者
研究点 (5)
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