Additional GLP-1 Analogue on CSII Treatment for Poorly Controlled Type 2 Diabetic Patients (AGAC2)
Background: Continuous subcutaneous insulin infusion (CSII) has been demonstrated to be an effective clinical tool for intensive insulin therapy in Type 1 diabetic patients. Type 2 diabetes patients have been proved to have decreased of glucagon-like peptide-1 (GLP-1) levels. Injection of GLP-1 receptor agonists are associated with improved glycemic control. Nevertheless, the clinical effects and mechanisms are still unclear when additional supplement of GLP-1 analogue in cooperation with intensive CSII treatment for poorly controlled Type 2 diabetes patients. This study is designed to understand the complementary pharmacological effects of GLP-1 analogue on intensive CSII treatment.
Methods: Sixty poorly controlled Type 2 diabetes patients will be admitted to the ward for 6 days CSII intensive treatment. Following the normalization of blood glucose at first 3 days, the patients are randomly assigned with combined therapy with exenatide injection or saline for another 3 days. The clinical assessments of insulin requirement, insulin secretion, insulin resistance glycemic excursions and cytokines will perform immediately during or after the study.
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Taoyuan、台湾、333
- Chang Gung Memorial Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age > 20 years old
- DM diagnosed > 2 years
- HbA1c level of 8% to 12%
- Receiving insulin premixed insulin twice daily and total insulin daily dose > 0.6 u/kg/day
Exclusion Criteria:
- Severe comorbidity, including CHF, CVA, liver cirrhosis, COPD, Cushing's syndrome etc.
- Psychologic problems, including anxiety
- Incorporation, including personal and familial factors
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:GLP-1
|
Exenatide 5 microgram bid sc.
其他名称:
|
|
安慰剂比较:生理盐水
|
Normal saline 2 u bid sc.
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Mean amplitude of glycaemic excursions (MAGE)
大体时间:During 6-day treatment course
|
During 6-day treatment course
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
homeostasis model assessment(HOMA)
大体时间:During 6-day treatment course
|
During 6-day treatment course
|
合作者和调查者
调查人员
- 首席研究员:CHIA-HUNG LIN, M.D.、Chang Gung Memorial Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.