Phase IV Study on Predictive Markers for the Effectiveness of Nateglinide or Acarbose for Controlling Post-Prandial Glucose in Type 2 Diabetics Already on Optimized Insulin Glargine Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 4
- 主要终点
- 7 point SMBG (self monitoring of blood glucose)
研究概览
简要总结
In type 2 diabetic patients, tight blood glucose control often requires both fasting and post-prandial glucose control separately. In the diabetic patients already on the insulin glargine treatment for the control of fasting blood glucose, additional measures for the control of post-prandial glucose level are often required. Nateglinide and acarbose are frequently used for this purpose. We hypothesized that the short acting sulfonylurea "nateglinide" may be more efficacious in diabetic patients with appreciable endogenous insulin secretion, while acarbose may be more efficacious in patients with lower endogenous insulin secretion. And we also want to clarify the clinical and biochemical parameters that can predict the responsiveness to each agent in this multi-center randomized open cross-over clinical study.
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
- 40 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus
- •No prior history of diabetic ketoacidosis
- •HbA1c between 7.5-10.0%
排除标准
- •Type 1 diabetes mellitus
- •Gestational diabetes mellitus
- •Secondary diabetes mellitus
- •Severe hyperglycemia with symptoms
- •Severe chronic diabetic complications (PDR,s-Cr>1.3mg/dL)
结局指标
主要结局
7 point SMBG (self monitoring of blood glucose)
次要结局
- HOMA-beta for predicting the effectiveness of each agents
