NCT00494988已完成4 期
Self-control Trial to Evaluate the Remission Rate and Safety in Newly Diagnosed Type 2 Diabetes Patients After Short-term Intensive Insulin Aspart and Insulin NPH Treatment
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Remission rate
研究概览
简要总结
This trial is conducted in Asia. The aim of this trial is evaluate the remission rate in newly diagnosed subjects with type 2 diabetes after short-term intensive treatment with insulin aspart and insulin NPH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes newly diagnosed within 6-12 months
- •FBG: 11.1-17.0 mmol/L
- •Body mass index (BMI) larger than 25.0 kg/m2
排除标准
- •Known or suspected allergy to trial product(s) or related products
- •Recurrent major hypoglycaemia as judged by the Investigator
结局指标
主要结局
Remission rate
时间窗: after 24 weeks
次要结局
- HbA1c
- blood glucose profiles
研究者
研究点 (1)
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