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: |
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English Acronym: |
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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): |
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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 |
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Applicant's institution: |
Guangzhou ZhongYi Pharmaceutical Company Ltd. |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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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: |
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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 |
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Name of the ethic committee: |
Ethic Committee of PKU People's Hospital |
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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: |
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Contact Name of the ethic committee: |
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伦理委员会联系地址: |
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Contact Address of the ethic committee: |
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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 |
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Primary sponsor: |
PKU People's Hospital |
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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 |
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Primary sponsor's address: |
No.11, Xizhimen South Road, Xicheng District, Beijing |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
广州中一药业有限公司 |
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Source(s) of funding: |
Guangzhou ZhongYi Pharmaceutical Company Ltd |
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研究疾病: |
2型糖尿病 |
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Target disease: |
Type II diabetes mellitus |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
上市后药物 | ||||||||||||||||||||||
Study phase: |
4 |
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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。 |
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Objectives of Study: |
To evaluate the difference of efficacy and safety between Xiaoke Wan and glibenclamide in the treatment of diabetes mellitus. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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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)。 |
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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). |
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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。 |
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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: |
从From2007-10-01至To 2009-09-30 |
征募观察对象时间: Recruiting time: |
从From2008-02-15至To 2008-08-15 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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