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分析利拉鲁肽与二甲双胍对II型糖尿病的治疗效果以及比较高剂量利拉鲁肽与低剂量利拉鲁肽联合二甲双胍疗效分析
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注册号:

Registration number:

ChiCTR-IPR-16008578 

最近更新日期:

Date of Last Refreshed on:

2016-06-01 

注册时间:

Date of Registration:

2016-06-01 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

分析利拉鲁肽与二甲双胍对II型糖尿病的治疗效果以及比较高剂量利拉鲁肽与低剂量利拉鲁肽联合二甲双胍疗效分析 

Public title:

Analysis of curative effect of Liraglutide monotherapy, Metformin monotherapy and Liraglutide plus Metformin dual therapy in patients with type 2 diabetes mellitus complicated with coronary artery disease 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

利拉鲁肽和二甲双胍治疗II型糖尿病的研究 

Scientific title:

Liraglutide and Metformin treatment effects for type II diabetes 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

刘英 

研究负责人:

刘英 

Applicant:

Ying Liu 

Study leader:

Ying Liu 

申请注册联系人电话:

Applicant telephone:

+86 13920579655 

研究负责人电话:

Study leader's telephone:

+86 13920579655 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

liuyingchristing@163.com 

研究负责人电子邮件:

Study leader's E-mail:

liuyingchristing@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

天津市南开区复康路24号天津市第一中心医院内分泌科 

研究负责人通讯地址:

天津市南开区复康路24号天津市第一中心医院内分泌科 

Applicant address:

24 Fukang Road, Nankai District, Tianjin 

Study leader's address:

24 Fukang Road, Nankai District, Tianjin 

申请注册联系人邮政编码:

Applicant postcode:

300192 

研究负责人邮政编码:

Study leader's postcode:

300192 

申请人所在单位:

天津市第一中心医院内分泌科 

Applicant's institution:

Department of Endocrinology, Tianjin First Center Hospital 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2014N0016LW 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

天津市第一中心医院科学研究伦理委员会 

Name of the ethic committee:

Ethics Committee of Tianjin First Center Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

天津市第一中心医院 

Primary sponsor:

Tianjin First Center Hospital 

研究实施负责(组长)单位地址:

天津市南开区复康路24号 

Primary sponsor's address:

24 Fukang Road, Nankai District, Tianjin, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

天津

市(区县):

Country:

China

Province:

Tianjin

City:

单位(医院):

天津市第一中心医院

具体地址:

天津市南开区复康路24号

Institution
hospital:

Tianjin First Center Hospital

Address:

24 Fukang Road, Nankai District, Tianjin 300192, China

经费或物资来源:

科室研究经费 

Source(s) of funding:

Funding from the department of Endocrinology, Tianjin First Center Hospital 

研究疾病:

2型糖尿病伴有冠状动脉疾病 

Target disease:

type 2 diabetes mellitus complicated with coronary artery disease 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

比较利拉鲁肽和二甲双胍单独应用时对2型糖尿病合并冠心病患者的疗效分析以及比较利拉鲁肽联合二甲双胍与单独调整利拉鲁肽剂量对2型糖尿病合并冠心病患者在血糖及心血管方面的疗效分析。 

Objectives of Study:

To compare the effect of Liraglutide monotherapy, Metformin monotherapy or Liraglutide plus Metformin dual therapy in patients with type 2diabetes mellitus (T2DM) complicated with coronary artery disease (CAD) analysis. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

选取2012年4月至2013年9月我院内分泌科门诊及住院的2型糖尿病合并冠心病患者60例,各组病例均符合美国糖尿病学会(ADA)2015年公布的糖尿病诊疗标准(口服75g无水葡萄糖试验,空腹血糖≥7mmol/L,餐后2小时血糖≥11.1mmol/L,HbA1C≥6.5%)及2006年欧洲冠心病年会公布的诊断标准(经冠脉造影明确冠状动脉狭窄的患者)。 

Inclusion criteria

This study was conducted from April 2012 to September 2013 at the Department of Endocrinology. Both outpatients and inpatients were included. Eligible trial patients were men and women, were previously diagnosed with T2DM, according to diagnostic and classification criteria issued by American Diabetes Association in 2005 and Clinical Practice Guidelines by European Society of Cardiology in 2006. 

排除标准:

(1)1型糖尿病或其他特殊类型糖尿病;(2)怀孕、哺乳期、有妊娠计划的妇女;(3)慢性肾功能不全(血肌酐>150 μmol/L);肝功能损害(丙氨酸转氨酶、天冬氨酸转氨酶>2.5倍正常值上限);(4)既往发作过急、慢性胰腺炎;(5)有肿瘤病史及其他各种严重疾病,医师认为不宜入选者。 

Exclusion criteria:

(1) Type I diabetes or other type of diabetes; (2) Preanancy, breeding and women plan to be pregnant; (3) Chronic renal dysfunction ( serum creatinine >150umol/L), liver dysfunction (The upper limit of the normal value of alanine aminotransferase and aspartate aminotransferase >2.5 times); (4) Previous episodes of acute, chronic pancreatitis; (5) With a history of cancer and a variety of other serious diseases, doctors think it should not be selected. 

研究实施时间:

Study execute time:

From2012-04-01To 2013-09-01 

征募观察对象时间:

Recruiting time:

From2012-04-01To 2013-02-28 

干预措施:

Interventions:

组别:

1

样本量:

30

Group:

1

Sample size:

干预措施:

利拉鲁肽

干预措施代码:

Intervention:

Liraglutide

Intervention code:

组别:

2

样本量:

30

Group:

2

Sample size:

干预措施:

二甲双胍

干预措施代码:

Intervention:

Metformin

Intervention code:

组别:

3

样本量:

30

Group:

3

Sample size:

干预措施:

高剂量利拉鲁肽

干预措施代码:

Intervention:

high dose Liraglutide

Intervention code:

组别:

4

样本量:

30

Group:

4

Sample size:

干预措施:

低剂量利拉鲁肽和二甲双胍联合

干预措施代码:

Intervention:

low dose Liraglutide plus Metformin

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津市第一中心医院 

单位级别:

三级甲等 

Institution
hospital:

Tianjin First Center Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

血压

指标类型:

主要指标 

Outcome:

blood pressure

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血糖

指标类型:

主要指标 

Outcome:

Blood glucose

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

糖化血红蛋白

指标类型:

主要指标 

Outcome:

glycosylated hemoglobin

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

BMI

指标类型:

主要指标 

Outcome:

body mass index

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

甘油三脂

指标类型:

主要指标 

Outcome:

triglyceride

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总胆固醇

指标类型:

主要指标 

Outcome:

total cholesterol

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

低密度脂蛋白

指标类型:

主要指标 

Outcome:

low-density lipoprotein cholesterol

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

C反应蛋白

指标类型:

主要指标 

Outcome:

C reactive protein

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

左室舒张末期内径

指标类型:

主要指标 

Outcome:

left ventricular end-diastolic diameter

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

射血分数

指标类型:

主要指标 

Outcome:

ejection fraction

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

E/A 水平

指标类型:

主要指标 

Outcome:

E/A level

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

研究者根据随机数字表和入组时间顺序随机分组进行临床试验

Randomization Procedure (please state who generates the random number sequence and by what method):

According to the random number table and the time sequence of the entry group

盲法:

Blinding:

试验完成后的统计结果(上传文件):

点击下载

Calculated Results after
the Study Completed(upload file):

download

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

通过ResMan即时公开

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

Instant sharing via ResMan

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

Excel表进行数据保存,SPSS17.0统计学软件进行统计学处理

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Data was saved by microsoft excel, and statistical analysis was carried out by SPSS17.0

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-06-01
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