Effect of Short-Term Intensive Insulin Sequential Exenatide Therapy in Newly Diagnosed Type 2 Diabetic Patients
2015年3月8日 更新者:The First Affiliated Hospital of Xiamen University
Effect of Short-Term Intensive Insulin Sequential Exenatide Therapy on β-cell Function and Glycemic Remission Rate in Newly Diagnosed Type 2 Diabetic Patients
The randomized, controlled trial is to investigate and evaluate the effects of short-term continuous subcutaneous insulin infusion (CSII) sequential exenatide therapy on β-cell function, long-term glycemic control and glycemic remission rate in newly diagnosed type 2 diabetic patients.
研究概览
详细说明
The UK Prospective Diabetes Study has shown that β-cell function progressively deteriorates over time in people with type 2 diabetes mellitus, irrespective of lifestyle and existing pharmacological interventions.
The progressive nature of type 2 diabetes is one of the major challenges in the treatment of affected patients, and agents that could alter the natural history of this condition would add greatly to current treatment approaches.
Short-term intensive insulin therapy of newly diagnosed type 2 diabetes will improve beta-cell function and usually leading to a temporary remission time.
The effect of GLP-1 receptor agonists on beta-cells is stimulation of glucose-dependent insulin release, followed by enhancement of insulin biosynthesis.
It is stimulating beta-cell proliferation, induction of islet neogenesis, and inhibition of ß-cell apoptosis.
Exenatide is synthetic exendin-4, GLP-1 receptor agonist.
Exenatide exerts direct effects on β-cell, which indicates that may contribute to delay disease progression.
However, no study has evaluated effect of short-term intensive insulin sequential exenatide therapy model on β-cell function and glycemic remission rate in newly diagnosed type 2 diabetic patients.
This current study is thus designed to evaluate effect of short-term intensive insulin sequential exenatide therapy model on β-cell function , glycemic control and glycemic remission rate in newly diagnosed type 2 diabetic patients.
研究类型
介入性
注册 (实际的)
156
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Fujian
-
Xiamen、Fujian、中国、361003
- The first afilliated hospital of Xiamen university
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
30年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- newly-diagnosed type 2 diabetic patients, drug naïve
- age 30~70 years
- FPG 7.0~16.7mmol/L
- BMI 20~35 kg/m2, stable body weight (≤10% variation) for at least 3 months prior to screening
- female patients of reproductive age should practice a reliable method of birth control throughout the study
Exclusion Criteria:
- acute or severe chronic diabetic complications
- Recently suffered from MI or CVA.
- severe gastrointestinal disease
- other severe intercurrent illness
- serum aminotransferase (ALT and AST) level higher than 2 times of the upper normal limits and/or serum creatinie≥133µmol/L (1.5mg/dL)
- tested positive for glutamic acid decarboxylase antibody
- use of weight loss drugs, corticosteroids, drugs known to affect gastrointestinal motility, transplantation medications, or any investigational drug
- history of pancreatitis
- Pregnant or lactation women.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
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 |
|---|---|
|
实验性的:insulin lispro injection, exenatide injection
|
First, Patients in the exenatide group will receive short-term continuous subcutaneous insulin (CSII)therapy.
The doses will be titrated every day in order to attain the glycaemic goal which is defined as a fasting capillary blood glucose of less than 6.1 mmol/L and capillary blood glucose at 2 h after each of three meals of less than 8.0 mmol/L.
Treatments will be maintained for 2 weeks after the glycaemic target will be reached.
Then, patients will Sequential be treated with 5 mcg bid for 4 weeks and then 10 mcg bid for 8 weeks.
After interventions will be stopped, patients will be instructed to continue diet and physical exercise only and will be followed-up with glycaemic monitoring monthly
|
|
有源比较器:insulin lispro injection
|
Patients in the control group will receive insulin with an insulin pump.
The doses will be titrated every day in order to attain the glycaemic goal.
Treatments will be maintained for 2 weeks after the glycaemic target will be reached.
Then interventions will be stop, patients will be instructed to continue diet and physical exercise only and will be followed-up with glycaemic monitoring monthly.
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
the glycemic remission rate in different groups
大体时间:one year
|
one year
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
the improvement of β-cell function in different groups.
大体时间:one year
|
one year
|
|
the time of glycemic remission in different groups
大体时间:one year
|
one year
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任:Xue-jun Li, MD,PhD、The First Affiliated Hospital of Xiamen University, China
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年8月1日
初级完成 (实际的)
2015年2月1日
研究完成 (实际的)
2015年2月1日
研究注册日期
首次提交
2013年1月22日
首先提交符合 QC 标准的
2013年1月23日
首次发布 (估计)
2013年1月28日
研究记录更新
最后更新发布 (估计)
2015年3月10日
上次提交的符合 QC 标准的更新
2015年3月8日
最后验证
2013年1月1日
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.