NCT00267683终止3 期
A Clinical Trial to Study the Efficacy and Safety of Insulin Aspart Three Times Per Day Compared to Glibenclamide Once or Twice Daily in Type 2 Diabetes by Comparison of Ability to Control Blood Glucose
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 9
- 主要终点
- HbA1c
研究概览
简要总结
This trial is conducted in Japan. This is a clinical trial to study the efficacy and safety of thrice daily Insulin Aspart compared to Glibenclamide in type 2 diabetic patients.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Diet therapy for at least 12 weeks, or diet therapy and oral hypoglycaemic agent(s) other than SU agents for at least 12 weeks
- •No previous treatment with insulin and/or SU agents
- •HbA1c between 7.5% and 10.0%
- •Body Mass Index (BMI) below 30.0 kg/m2
排除标准
- •Proliferative retinopathy or maculopathy requiring acute treatment
- •Impaired hepatic function
- •Impaired renal function
- •Cardiac diseases
- •Uncontrolled hypertension
- •Known hypoglycaemia unawareness or recurrent major hypoglycaemia
- •Current treatment with systemic corticosteroids
结局指标
主要结局
HbA1c
时间窗: after 24 weeks of treatment
次要结局
- Plasma glucose levels
- Percentage of subjects achieving the treatment target of HbA1c value < 6.5%
研究者
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