ChiCTR-TRC-11001613 版本V1.0 版本创建时间2015/07/21 18:54:42 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR-TRC-11001613 

最近更新日期：

Date of Last Refreshed on：

 2015-05-03 11:56:17 

注册时间：

Date of Registration：

 2011-11-05 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

甲福明二甲双胍治疗糖尿病合并慢性心力衰的效果研究

Public title：

The efficacy of metformin in patients with diabetes and chronic heart failure

注册题目简写：

English Acronym：

研究课题的正式科学名称：

甲福明二甲双胍治疗糖尿病合并慢性心力衰的效果研究：随机对照试验

Scientific title：

The efficacy of metformin in patients with diabetes and chronic heart failure: a randomized controlled trial

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：

徐强 

研究负责人：

徐强 

Applicant：

Qiang Xu 

Study leader：

Qiang Xu 

申请注册联系人电话：

Applicant telephone：

 +86 13983882281

研究负责人电话：

Study leader's
telephone：

+86 13983882281

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：

 xuqaing7147@163.com

研究负责人电子邮件：

Study leader's E-mail：

 xuqaing7147@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：

中国重庆市沙坪坝区高滩岩西南医院

研究负责人通讯地址：

中国重庆市沙坪坝区高滩岩西南医院

Applicant address：

Department of Geriatrics, Southwest Hospital, The Third Military Medical University, Shapingba District, Chongqing, China

Study leader's address：

Department of Geriatrics, Southwest Hospital, The Third Military Medical University, Shapingba District, Chongqing, China

申请注册联系人邮政编码：

Applicant postcode：

 400038

研究负责人邮政编码：

Study leader's postcode：

 400038

申请人所在单位：

第三军医大学西南医院

Applicant's institution：

Southwest Hospital, The Third Military Medical University

研究负责人所在单位：

Affiliation of the Leader：

是否获伦理委员会批准：

否

Approved by ethic committee：

No

伦理委员会批件文号：

Approved No. of ethic committee：

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

Name of the ethic committee：

伦理委员会批准日期：

Date of approved by ethic committee：

 2013-08-26 00:00:00

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：

第三军医大学西南医院

Primary sponsor：

Southwest Hospital, The Third Military Medical University

研究实施负责（组长）单位地址：

中国重庆市沙坪坝区高滩岩西南医院

Primary sponsor's address：

Department of Geriatrics, Southwest Hospital, The Third Military Medical University, Shapingba District, Chongqing, 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)：

重庆

市(区县)：

Country：

China

Province：

ChongQing

City：

单位(医院)：

重庆市科技厅

具体地址：

重庆市科技厅

Institution
hospital：

Chongqing Science and Technology Commission

Address：

Chongqing Science and Technology Commission

经费或物资来源：

重庆市科技厅、西南医院

Source(s) of funding：

Chongqing Science and Technology Commission and Souwest Hospital

研究疾病：

II型糖尿病  

Target disease：

type 2 diabetes mellitus

研究疾病代码：

E11.901

Target disease code：

E11.901

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 IV期临床试验 

Study phase：

4

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

The efficacy of metformin in patients with diabetes and chronic heart failure  

Objectives of Study：

The efficacy of metformin in patients with diabetes and chronic heart failure

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1) Volunteers who can compliance the treatment and have signed the informed consent form prior to performance of study-related procedures. 2) Age from 18 years to 80 years. 3) A diagnosis of type 2 diabetes defined as: a previous physician diagnosis of type 2 diabetes as documented in the subject's clinical record or a new diagnosis of type 2 diabetes ( fasting blood glucose ≥7.0 mmol/L or random blood glucose ≥11.1 mmol/L accompanied by acute metabolic decompensation or 2 hour plasma glucose in a 75 gram oral glucose tolerance test ≥11.1 mmol/L). 4) All the patient also have been diagnosed as chronic heart failure.

Inclusion criteria

1) Volunteers who can compliance the treatment and have signed the informed consent form prior to performance of study-related procedures. 2) Age from 18 years to 80 years. 3) A diagnosis of type 2 diabetes defined as: a previous physician diagnosis of type 2 diabetes as documented in the subject's clinical record or a new diagnosis of type 2 diabetes ( fasting blood glucose ≥7.0 mmol/L or random blood glucose ≥11.1 mmol/L accompanied by acute metabolic decompensation or 2 hour plasma glucose in a 75 gram oral glucose tolerance test ≥11.1 mmol/L). 4) All the patient also have been diagnosed as chronic heart failure.

排除标准：

Patients who meet any of the following exclusion criteria will be excluded from the study : 1) acute diabetic complications, acute cardiovascular diseases, or acute cerebrovascular diseases. 2) subjects who are intolerance to metformin therapy, or are using metformin currently. 3) type 1 diabetes mellitus. 4) subjects who have been given reasonable treatment, but their heart failure still can be relieve. 5) subjects who have been or intend to do coronary artery bypass grafting, percutaneous coronary intervention or cardiac transplantation in 4 months. 6) severe comorbidities, such as HIV infection, cancer, serious infection, mezzo or severe anemia, severe renal or liver insufficiency. 7) those participating in another clinical trial.

Exclusion criteria：

Patients who meet any of the following exclusion criteria will be excluded from the study : 1) acute diabetic complications, acute cardiovascular diseases, or acute cerebrovascular diseases. 2) subjects who are intolerance to metformin therapy, or are using metformin currently. 3) type 1 diabetes mellitus. 4) subjects who have been given reasonable treatment, but their heart failure still can be relieve. 5) subjects who have been or intend to do coronary artery bypass grafting, percutaneous coronary intervention or cardiac transplantation in 4 months. 6) severe comorbidities, such as HIV infection, cancer, serious infection, mezzo or severe anemia, severe renal or liver insufficiency. 7) those participating in another clinical trial.

研究实施时间：

Study execute time：

从 From 2011-11-01 00:00:00至 To 1990-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2011-11-01 00:00:00 至 To 2012-11-30 00:00:00

干预措施：

Interventions：

组别：

A

样本量：

 100

Group：

A

Sample size：

干预措施：

diabetes standard treatment and metformin ( 0.25g oral for 3 times one day)

干预措施代码：

Intervention：

diabetes standard treatment and metformin ( 0.25g oral for 3 times one day)

Intervention code：

组别：

B

样本量：

 100

Group：

B

Sample size：

干预措施：

diabetes standard treatment and placebo ( also 3 times one day)

干预措施代码：

Intervention：

diabetes standard treatment and placebo ( also 3 times one day)

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 重庆 

市(区县)：

  

Country：

China

Province：

Chongqing

City：

单位(医院)：

 西南医院 

单位级别：

 三甲 

Institution
hospital：

Westsouth Hospital

Level of the institution：

Tertiary A hospital

测量指标：

Outcomes：

指标中文名：

rehospitalisation because of heart failure

指标类型：

主要指标

Outcome：

rehospitalisation because of heart failure

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

病死率

指标类型：

主要指标

Outcome：

Rate of death

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

left ventricular function

指标类型：

次要指标

Outcome：

left ventricular function

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

生活质量

指标类型：

次要指标

Outcome：

quality of life

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

glycosylated hemoglobin

指标类型：

次要指标

Outcome：

glycosylated hemoglobin

Type：

Secondary 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：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 80 岁 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）：

完全随机

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

individual randomization

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

statistician: Bliding patients: Bliding observer: Bliding investigators: Bliding

Blinding：

statistician: Bliding patients: Bliding observer: Bliding investigators: Bliding

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

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）：

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

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：

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

数据与安全监察委员会：

Data and Safety Monitoring Committee：

注册人：

Name of Registration：

  2011-11-05 00:00:00