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2型糖尿病强化治疗研究
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注册号:

Registration number:

ChiCTR-IPR-17010338 

最近更新日期:

Date of Last Refreshed on:

2017-01-05 

注册时间:

Date of Registration:

2017-01-05 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

2型糖尿病强化治疗研究 

Public title:

Effects of intensive insulin therapy on type 2 diabetes 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

2型糖尿病强化治疗研究 

Scientific title:

Effects of intensive insulin therapy on type 2 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:

刘晓梅 

研究负责人:

马建华 

Applicant:

Xiaomei Liu 

Study leader:

Jianhua Ma 

申请注册联系人电话:

Applicant telephone:

+86 15366110069 

研究负责人电话:

Study leader's telephone:

+86 025-86621776 

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:

lxmxjtu@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

majianhua@china.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:

南京市秦淮区长乐路68号 

研究负责人通讯地址:

南京市秦淮区长乐路68号 

Applicant address:

68 Changle Road, Qinhuai District, Nanjing, Jiangsu, China  

Study leader's address:

68 Changle Road, Nanjing, Jiangsu, China  

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

南京医科大学附属南京医院 

Applicant's institution:

Nanjing First Hospital, Nanjing Medical University  

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:

ky20130605-02 

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:

南京市第一医院伦理委员会 

Name of the ethic committee:

Nanjing First Hospital, Nanjing Medical University  

伦理委员会批准日期:

Date of approved by ethic committee:

2013-06-05 

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:

南京医科大学附属南京医院 

Primary sponsor:

Nanjing First Hospital, Nanjing Medical University  

研究实施负责(组长)单位地址:

南京市秦淮区长乐路68号 

Primary sponsor's address:

68 Changle Road, Nanjing, Jiangsu, 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):

江苏

市(区县):

南京

Country:

China

Province:

Jiangsu

City:

nanjing

单位(医院):

南京医科大学附属南京医院

具体地址:

南京市秦淮区长乐路68号

Institution
hospital:

Nanjing First Hospital, Nanjing Medical University

Address:

68 Changle Road, Nanjing, Jiangsu, China

经费或物资来源:

江苏省科技厅 

Source(s) of funding:

Science and Technology Support Program of Jiangsu Province(CN)(no.BL2014010) 

研究疾病:

糖尿病 

Target disease:

diabetes 

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:

观察二甲双胍联合胰岛素泵对新诊断2型糖尿病患者血糖、胰岛功能以及胰岛素用量的影响。 

Objectives of Study:

To investigate the effect of metformin add-on to continuous subcutaneous insulin infusion (CSII) therapy on glycemic control, beta cell function, insulin doses in patients with newly diagnosed type 2 diabetes (T2D) in the hospital setting. 

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:

1.糖尿病患者,年龄>18及<80周岁。 2.诊断时HbA1c>9.0%.  

Inclusion criteria

1) patients with diabetes with aged 18 to 80 years; 2) HbA1c values >9.0% at diagnosis.  

排除标准:

1.肌酐水平男性≥1.5 mg/dL,女性≥1.4 mg/dL,或者不正常的肌酐清除率; 2.已知对二甲双胍敏感; 3.急性或慢性的代谢性酸中毒,如糖尿病酮症酸中毒,无论有无昏迷。 

Exclusion criteria:

1. serum creatinine levels ≥1.5 mg/dL (males), ≥1.4 mg/dL (females) or abnormal creatinine clearance; 2. known hypersensitivity to metformin; 3. acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. 

研究实施时间:

Study execute time:

From2017-01-06To 2017-07-31 

征募观察对象时间:

Recruiting time:

From2017-01-06To 2017-03-31 

干预措施:

Interventions:

组别:

A

样本量:

30

Group:

A

Sample size:

干预措施:

速秀霖+二甲双胍

干预措施代码:

Intervention:

Lispro+Metformin

Intervention code:

组别:

B

样本量:

30

Group:

B

Sample size:

干预措施:

诺和锐+二甲双胍

干预措施代码:

Intervention:

Insulin Aspart+Metformin

Intervention code:

组别:

C

样本量:

30

Group:

C

Sample size:

干预措施:

诺和锐

干预措施代码:

Intervention:

Insulin Aspart

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

南京 

Country:

China 

Province:

Jiangsu 

City:

Nanjing 

单位(医院):

南京医科大学附属南京医院 

单位级别:

三级甲等 

Institution
hospital:

Nanjing First Hospital, Nanjing Medical University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

末梢血糖

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:

次要指标 

Outcome:

HBA1c

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

糖化血清白蛋白

指标类型:

次要指标 

Outcome:

Glycated albumin

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胰岛素

指标类型:

次要指标 

Outcome:

insulin

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

C肽

指标类型:

次要指标 

Outcome:

C-reactive protein

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胰高糖素

指标类型:

次要指标 

Outcome:

glucagon

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规

指标类型:

次要指标 

Outcome:

blood routine examination

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿常规

指标类型:

次要指标 

Outcome:

routine urine test

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝功能

指标类型:

次要指标 

Outcome:

liver function

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:

标本中文名:

血液

组织:

Sample Name:

blood

Tissue:

none

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 80 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):

随机数字表

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

random number table

盲法:

Blinding:

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

否No

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):

上传至临床试验网站

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

Uploaded to the website of clinical trial

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,SPSS

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

EXCEL,SPSS

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2017-01-05
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