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A multicenter randomized controlled, double blind trial on efficacy and safety of "Zhongyi" Xiaoke Wan for diabetes mellitus
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注册号:

Registration number:

ChiCTR-TRC-08000074 

最近更新日期:

Date of Last Refreshed on:

2015-04-19 

注册时间:

Date of Registration:

2008-04-03 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

随机、双盲双模拟、阳性药平行对照、多中心临床研究评价 

Public title:

A multicenter randomized controlled, double blind trial on efficacy and safety of "Zhongyi" Xiaoke Wan for diabetes mellitus 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中一牌消渴丸循证医学研究——随机、双盲双模拟、阳性药平行对照、多中心临床研究评价 

Scientific title:

Double blind, randomized and controlled multicenter clinical trial on efficacy and safety of "Zhongyi" Xiaoke Wan for diabetes mellitus 

研究课题代号(代码):

Study subject ID:

ZYXKW01 

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:

杨龙飞 

研究负责人:

纪立农 

Applicant:

Longfei Yang 

Study leader:

Linong Ji 

申请注册联系人电话:

Applicant telephone:

+86 0 13520638727 

研究负责人电话:

Study leader's telephone:

+86 010 88325578 

申请注册联系人传真 :

Applicant Fax:

+86 020 81949532 

研究负责人传真:

Study leader's fax:

+86 10 68314422-5578 

申请注册联系人电子邮件:

Applicant E-mail:

foxlens_young@yahoo.com.cn 

研究负责人电子邮件:

Study leader's E-mail:

jiln@bjmu.edu.cn 

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:

广州市丛桂路丛桂新街50号 

研究负责人通讯地址:

北京市西城区西直门南大街11号 

Applicant address:

No. 50, Conggui Xin Jie, Conggui Road, Guangzhou 

Study leader's address:

No. 11, Xizhimen South Road, Xicheng District, Beijing 

申请注册联系人邮政编码:

Applicant postcode:

510140 

研究负责人邮政编码:

Study leader's postcode:

100034 

申请人所在单位:

广州中一药业有限公司 

Applicant's institution:

Guangzhou ZhongYi Pharmaceutical Company Ltd. 

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:

【2007】院伦审药临字第(16)号 

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:

北京大学人民医院医学伦理委员 

Name of the ethic committee:

Ethic Committee of PKU People's Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2007-10-30 

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:

北京大学人民医院 

Primary sponsor:

PKU People's Hospital 

研究实施负责(组长)单位地址:

北京市西城区西直门南大街11号 

Primary sponsor's address:

No.11, Xizhimen South Road, Xicheng District, Beijing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东

市(区县):

Country:

China

Province:

Guangdong

City:

单位(医院):

广州中一药业有限公司

具体地址:

广州市天河北路28号时代广场西座11楼

Institution
hospital:

Guangzhou ZhongYi Pharmaceutical Company Ltd

Address:

Building 11, Times Square, No.28,North Tianhe Road, Guangzhou, China

经费或物资来源:

广州中一药业有限公司 

Source(s) of funding:

Guangzhou ZhongYi Pharmaceutical Company Ltd 

研究疾病:

2型糖尿病 

Target disease:

Type II diabetes mellitus 

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:

评价含有中西药物成份的消渴丸与格列本脲在治疗2型糖尿病有效性和安全性方面的差别。为指导消渴丸在临床上的应用,提高药物的有效性,在基因组学和代谢组学水平,探讨遗传、代谢及环境因素在消渴丸药物治疗反应差异中的作用及其机制,并在此基础上为不同2型糖尿病患者个体化治疗奠定基础,建立基于分子分型基础上的消渴丸临床治疗方案。 

Objectives of Study:

To evaluate the difference of efficacy and safety between Xiaoke Wan and glibenclamide in the treatment of diabetes mellitus. 

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、自愿参加试验,并签署受试者知情同意书。2、2型糖尿病的病人。3、中医辨证为气阴两虚证(中医院做此项)。4、年龄在21~70岁。5、初治者:未用过任何降糖药物且非肥胖者,体重指数(BMI)在18kg/m2 ~ 28 kg/m2(不包含)。6、 二甲双胍治疗者:筛查前病人已经接受了二甲双胍(速释型)≥750 mg/日稳定剂量治疗至少3个月,体重指数(BMI)在18kg/m2 ~ 35 kg/m2(不包含)。7、体重保持恒定(筛查前至少3个月内的体重波动幅度不超过10%)。8、血糖控制不佳,空腹血糖大于126 mg/dl(7.0mmol/L)和HbA1c >7.0% (初筛),空腹血糖大于126 mg/dl(7.0mmol/L)(导入期后)。9、经过4周导入期后仍符合上述标准者(不考虑HbA1c)。 

Inclusion criteria

1. Participant attend voluntarily and sign the informed consent form; 2. Patients with type II diabetes mellitus; 3. Patients are diagnosed as Qi-Yin Deficiency Syndrome; 4. Age: 21-70 years; 5. Naive patients: without medication history of hypoglycemic drug and obesity and the BMI is between 18kg/m2-28 kg/m2 (not included); 6. Patients taking metformin: receive metformin >750 mg/day 3 months at least before screening and the BMI is between 18kg/m2-35 kg/m2 (not included); 7. Stable body weight (fluctuation is less than 10%); 8. Bad control of blood sugar. The fasting blood sugar is more than 126 mg/dl(7.0mmol/L) and HbA1c >7.0% (first screen) and fasting blood sugar is more than 126 mg/dl (7.0mmol/L)(after lead-in period); 9. meet the above standard after lead-in period of 4 weeks (HbA1c is not considered). 

排除标准:

(一)与研究有直接关系的研究基地人员及他们的近亲。近亲是指配偶、父母、子女或兄弟姐妹,无论是血缘的或合法收养的。(二)受雇于申办方的员工(包括职员、临时合同工或参与研究的指定人员)。(三)以往曾经参加过本研究或其他使用磺脲类药物的研究。(四)在筛查前30天内参加过干预性内科、外科或药理学研究(给予试验用药物、内科或外科治疗的研究)。该标准包括在进入研究时,尚未获得药政部门批准的药物。(五)符合以下情况的育龄妇女(未接受外科节育以及在月经初潮到绝经后1年之间)1、哺乳妇女。2、入组时妊娠试验阳性。3、在研究过程中计划受孕。4、在筛查前3个月内,未采取有效的节育措施。5、由研究者判定,病人在试验过程中不同意继续使用有效的节育手段。(六)空腹血糖≥13mmol/L,或HbA1c ≥11%。(七)在筛查前6个月内有3次以上的严重低血糖发作。(八)已知对磺脲类药物或其成分过敏者。(九)依据药品说明书,存在二甲双胍或磺脲类药物使用禁忌症。(十)在筛查前3个月内,曾经接受外源性胰岛素治疗1周以上。(十一)在进入研究的前1年内有临床显著的心脏病史,或患有活动性心脏病,包括心肌梗死、严重的心律失常、不稳定性心绞痛、中重度心力衰竭(纽约心脏病学会的心功能分级:III级或IV级)、冠脉搭桥术或血管重建术,或者在研究过程中估计需要进行冠脉搭桥术或血管重建术者。(十二)有肾脏移植史或目前正在接受透析治疗或血肌酐浓度正常值上限者。(十三)存在明显的肝病临床体征或症状、急性或慢性肝炎、或谷丙转氨酶(ALT或AST)大于正常值上限的2.5倍。(十四)患有血红蛋白病或慢性贫血。(十五)患有活动期增殖型肾脏病变。(十六) 正在接受以下任何一种须排除的药物治疗:1、在筛查前的3个月内,使用过噻唑烷二酮类药物(TZD)。2、在筛查前的1个月内,使用胰岛素促分泌剂(磺脲类或格列奈类药物)。3、在筛查前的1个月内,使用过α-糖苷酶抑制剂(如米格列醇或阿卡波糖)。4、直接影响胃肠动力的药物,包括:胃复安、西沙必利以及长期服用大环内酯类抗生素,但不仅限于这些药物。5、定期地(1个月以上)或在筛查前的1个月内,经口服、静脉(IV)或肌注(IM)进行全身性糖皮质激素治疗(不包括局部或吸入性用药)。(十七)患有活动期或未经治疗的恶性肿瘤,或恶性肿瘤的临床缓解不足5年(基底细胞癌或皮肤鳞状细胞癌、宫颈原位癌或前列腺原位癌除外)。(十八)有器官移植史。(十九)目前或以往有药物或酒精滥用史,研究者认为这可能导致受试者的依从性不佳。(二十)其他任何理由,研究者认为不适宜参加本项研究。 

Exclusion criteria:

1. Research stuff and their relatives; 2. Employed personnel in the applicant company; 3. The patients have participated in this or other research with medication of sulfonylurea drug; 4. The patients have participated in researches of intervention therapy of internal meidicine, sugery or pharmacology 30 days before screening; 5. Pregnant or breast-feeding women at reproductive age; 6. The pasting blood sugar >13mmol/L or HbA1c >11%; 7. Three onsets of serious hypoglycemia 6 months before screening; 8. Allergic to sulfonylurea drug; 9. Contraindications of metformin and sulfonylurea drug; 10. Insulin therapy of more than one week three months before screening; 11. History of various heart disease including myocardial infarction, arrhythmia, unstable angina and heart failure (Grade III or IV); 12. History of kidney transplantation or dialysis therapy or blood creatine concentration is higher than upper normal limit; 13. With conspicuous clinical symptoms or signs of hepatic disease, acute or chronic hepatitis or ALT/AST is 2.5 times more than upper normal limit; 14. Complicated with hemoglobinpathy or chronic anemia; 15. Complicated with active proliferative renal disease; 16. Medication of TZD, insulinotropic agents, a-glucosidase inhibitors or glucocorticoid; 17. Malignant tumor is active or not treated or clinical relief shorter than five years except basal cell carcinoma, squamous cell carcinoma, cervical cancer and prostate cancer; 18. History of organ transplantation; 19. Abuse of drug or alcohol; 20. Other conditions are not proper for the trial. 

研究实施时间:

Study execute time:

From2007-10-01To 2009-09-30 

征募观察对象时间:

Recruiting time:

From2008-02-15To 2008-08-15 

干预措施:

Interventions:

组别:

1

样本量:

200

Group:

Group 1

Sample size:

干预措施:

消渴丸

干预措施代码:

Intervention:

Xiaoke Wan

Intervention code:

组别:

2

样本量:

200

Group:

Group 2

Sample size:

干预措施:

格列本脲

干预措施代码:

Intervention:

Glibenclamide

Intervention code:

组别:

3

样本量:

200

Group:

Group 3

Sample size:

干预措施:

二甲双胍加消渴丸

干预措施代码:

Intervention:

Metformin and Xiaoke Wan

Intervention code:

组别:

4

样本量:

200

Group:

Group 4

Sample size:

干预措施:

二甲双胍加格列本脲

干预措施代码:

Intervention:

Metformin and Glibenclamide

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京大学人民医院 

单位级别:

三甲医院 

Institution
hospital:

The people's hospital of Beijing university  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京大学第一医院 

单位级别:

三甲医院 

Institution
hospital:

The first hospital, Beijing university  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国中医科学院广安门医院 

单位级别:

三甲医院 

Institution
hospital:

China's traditional Chinese medicine academy of sciences hospital gate  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

四川大学华西医院 

单位级别:

三甲医院 

Institution
hospital:

West China Hospital, Sichuan University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海交通大学瑞金医院 

单位级别:

三甲医院 

Institution
hospital:

Shanghai jiaotong university ruijin hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

中山二院等全国15家分中心 

单位级别:

三甲医院 

Institution
hospital:

Zhongshan. 2 hospital of the country such as rapidly 15 companies  

Level of the institution:

Tertiary A hospitals 

测量指标:

Outcomes:

指标中文名:

达标率

指标类型:

主要指标 

Outcome:

Control rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

失败率

指标类型:

主要指标 

Outcome:

Failure rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

并发症发生率

指标类型:

次要指标 

Outcome:

Incidence rate of complications

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

实验室指标

指标类型:

次要指标 

Outcome:

Laboratory index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

基因组和代谢组学变化与疗效和安全性间的关系

指标类型:

次要指标 

Outcome:

The relation between the genetic and metabolic change and efficacy and safety

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医证候疗效评价

指标类型:

次要指标 

Outcome:

Evaluation of curative effects on symptoms

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 21 years
最大 Max age 70 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):

计算机软件

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

Computer software

盲法:

研究者、受试者 是.

Blinding:

Trialist and participants: Blinding

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

广州博济新药临床研究中心

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

Guangzhou Boji Clinical Research Center of New Drug

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:

广州博济新药临床研究中心

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

Guangzhou Boji Clinical Research Center of New Drug

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2008-04-03
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