Comparison of the FGM Profiles in Patients of Type 2 Diabetes Treated With Sitagliptin and Acarbose
2021年8月30日 更新者:Nanjing First Hospital, Nanjing Medical University
The aim of the study is to compare the FGM glycemic profiles in patients with type 2 diabetes mellitus treated with sitagliptin and acarbose.
研究概览
详细说明
In this study, 60 patients with type 2 diabetes were randomly divided into group A or group B after stable glucose control.
Flash Glucose Mornitoring(FGM) will be used in patients with two groups.
Patients in group A were given sitagliptin and metformin for the first two weeks, and then were treated with acarbose and metformin for the second two weeks.
FGM was used to monitor glycemic variations during the whole four weeks.
The opposite therapy was true for patients in group B.
研究类型
介入性
注册 (实际的)
60
阶段
- 不适用
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
-
-
-
Nanjing、中国
- Gu Gao
-
-
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
18年 至 75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:
- Participate voluntarily and sign the subject informed consent before the test.
- Patients with type 2 diabetes, aged 18-75 years, meeting the diagnostic criteria of WHO1999, have not been treated with any hypoglycemic drugs.
- No acute complications such as diabetic ketoacidosis and diabetic hyperosmolar syndrome.
- Subjects are able and willing to undergo FGM examination, diet and exercise regularly.
Exclusion Criteria:
- Patients allergic to insulin.
- Impaired liver and renal function, ALT 2.5 times higher than the upper limit of normal value;Serum creatinine was 1.3 times higher than the upper limit of normal.
- A history of drug abuse and alcohol dependence within the past 5 years.
- Systemic hormone therapy was used in recent 3 months.
- Patients with poor compliance and irregular diet and exercise.
- Patients with infection and stress within four weeks.
- Patients who cannot tolerate flash glucose mornitoring(FGM).
- Patients who are pregnant, nursing or preparing to become pregnant.
- Any other apparent condition or comorption as determined by the investigator, such as severe heart and lung disease, endocrine disease, neurological disease, tumor disease, other pancreatic disease, history of mental illness.
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:交叉作业
- 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:Group A
Patients in group A were given sitagliptin and metformin for the first two weeks, and then were treated with acarbose and metformin for the second two weeks.
FGM was used to monitor glycemic variations during the whole four weeks.
|
One group used first sitagliptin and metformin, then used acarbose and metformin.
Another group used first acarbose and metformin, then used sitagliptin andmetformin.
|
|
有源比较器:Group B
Patients in group B were given acarbose and metformin for the first two weeks, and then were treated with sitagliptin and metformin for the second two weeks.FGM was used to monitor glycemic variations during the whole four weeks.
|
One group used first sitagliptin and metformin, then used acarbose and metformin.
Another group used first acarbose and metformin, then used sitagliptin andmetformin.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Glycemic variations
大体时间:Endpoint at the third month
|
CV
|
Endpoint at the third month
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Glycemic variations
大体时间:Endpoint at the third month
|
TIR
|
Endpoint at the third month
|
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
- 学习椅:Jianhua Ma, MD、Nanjing First Hospital, Nanjing, Jiangsu, China, 210012
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 (实际的)
2020年1月30日
初级完成 (实际的)
2021年4月30日
研究完成 (实际的)
2021年5月5日
研究注册日期
首次提交
2021年4月14日
首先提交符合 QC 标准的
2021年8月30日
首次发布 (实际的)
2021年9月5日
研究记录更新
最后更新发布 (实际的)
2021年9月5日
上次提交的符合 QC 标准的更新
2021年8月30日
最后验证
2021年8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.