跳至主要内容
临床试验/NCT00437918
NCT00437918已完成4 期

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

Inje University4 个研究点 分布在 2 个国家目标入组 85 人开始时间: 2007年1月1日最近更新:
适应症
相关药物

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

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

研究者

申办方类型
Other

研究点 (4)

Loading locations...

相似试验