NCT00597233已完成4 期
Comparative Evaluation of Human NPH Insulin + Insulin Aspart and Human NPH Insulin + Human Soluble Insulin in Type 1 Diabetes Mellitus
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Prandial blood glucose lowering profile
研究概览
简要总结
This trial is conducted in South America. This aim of this trial is to evaluate the comparative prandial blood glucose lowering profile in subjects with type 1 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes for at least 12 months
- •Treatment with insulin NPH
- •Body Mass Index (BMI) below 30 kg/m2
排除标准
- •Total daily insulin dose greater than 1.40 IU/kg
- •Treatment with oral antidiabetic drugs (OADs)
结局指标
主要结局
Prandial blood glucose lowering profile
时间窗: between 1st and 2nd post prandial hours
次要结局
- Adverse events
- Serious adverse events
- Hypoglycaemic events
研究者
研究点 (2)
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