注册号: Registration number: |
ChiCTR-TRC-11001218 |
最近更新日期: Date of Last Refreshed on: |
2015-07-05 |
注册时间: Date of Registration: |
2011-02-13 |
注册号状态: |
补注册 |
Registration Status: |
Retrospective registration |
注册题目: |
多中心、随机、开放2型糖尿病优化胰岛素强化治疗方案研究 |
Public title: |
A study Comparising three intensification therapies for Type 2 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: |
多中心、随机、开放2型糖尿病优化胰岛素强化治疗方案研究 |
Scientific title: |
A Comparison of Premixed Insulin (three times per day), three pre-meal insulin and Basal-Bolus Insulinand insulin pump Intensification Therapies for Newly Diagnosed Type 2 Diabetes Mellitus and Type 2 Diabetes Mellitus With Inadequate Glycaemic Control treated with Oral Drugs |
研究课题代号(代码): Study subject ID: |
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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: |
付丽媛 |
研究负责人: |
马建华 |
Applicant: |
Liyuan FU |
Study leader: |
Jianhua MA |
申请注册联系人电话: Applicant telephone: |
+86 18951670115 |
研究负责人电话: Study leader's telephone: |
+86 18951670116 |
申请注册联系人传真 : Applicant Fax: |
+86 025 52887016 |
研究负责人传真: Study leader's fax: |
+86 025 52887016 |
申请注册联系人电子邮件: Applicant E-mail: |
fuly0210@yahoo.com.cn |
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): |
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申请注册联系人通讯地址: |
南京市共青团路32号 |
研究负责人通讯地址: |
南京市共青团路32号 |
Applicant address: |
32 Gongqingtuan Road, Nanjing, Jiangsu, China |
Study leader's address: |
32 Gongqingtuan Road, Nanjing, Jiangsu, China |
申请注册联系人邮政编码: Applicant postcode: |
210012 |
研究负责人邮政编码: Study leader's postcode: |
210012 |
申请人所在单位: |
南京医科大学附属南京第一医院 |
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Applicant's institution: |
Nanjing First Hospital, Nanjing Medical University |
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: |
ky2010002 |
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: |
南京医科大学附属第一医院伦理委员会 |
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Name of the ethic committee: |
Ethics Committee of Nanjing First Hospital |
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伦理委员会批准日期: Date of approved by ethic committee: |
2010-01-29 | ||
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: |
南京医科大学附属南京第一医院 |
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Primary sponsor: |
Nanjing First Hospital, Nanjing Medical University |
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研究实施负责(组长)单位地址: |
南京市长乐路68号 |
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Primary sponsor's address: |
68 Changle Road, Nanjing, Jiangsu, China |
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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: |
自筹经费 |
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Source(s) of funding: |
self-funded |
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研究疾病: |
2型糖尿病 |
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Target disease: |
type 2 daibetes |
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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: |
◆ 应用不同的强化治疗方案(胰岛素泵、诺和锐30三餐前、诺和锐三餐前加睡前甘精胰岛素)对初诊及口服药治疗效果不佳(促泌剂半量,其他药物不限,二种以上)的2型糖尿病患者进行强化治疗2周左右,治疗前后应用CGMS对糖尿病患者的血糖谱进行观察,通过CGMS对血糖进行调整,通过比较三组的达标后血糖波动(MAGE、MODD)、整体血糖控制水平、达标时间、胰岛素用量对有效性进行评价,通过低血糖发生率、不良事件对三组进行安全性评价。 ◆ 应用CGMS对初诊断、口服药治疗效果不佳的2型糖尿病患者血糖谱进行观察,并评价糖脂代谢、胰岛功能、并发症等指标,研究2型糖尿病患者血糖波动与并发症的相关性,评价影响血糖波动的相关危险因素。 |
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Objectives of Study: |
To compare the effects among three insulin Intensification Therapy regimens (premixed insulin (3 times per day), three pre-meal insulin and Basal-Bolus Insulin and insulin pump) on MAGE and MODD in the 72th CGMS in patients with normal finger-stick blood glucose and in patients with newly diagnosed type 2 diabetes mellitus and type 2 diabetes mellitus with inadequate glycaemic control treated with oral drugs. |
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药物成份或治疗方案详述: |
门冬胰岛素30 诺和锐30 甘精胰岛素 来得时 门冬胰岛素 诺和锐 |
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Description for medicine or protocol of treatment in detail: |
insulin Aspart 30 injection NovoMix 30 Penfill insulin Aspart injection Novo rapid Penfill |
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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 自愿参加并在试验前签署受试者知情同意书。 2 年龄≥18及≤70周岁。 3 按照WHO的标准,受试者应诊断为2型糖尿病。 4 初诊断患者及应用口服药物稳定剂量一个月,仍不达标。口服药治疗效果不佳(促泌剂半量,其他药物不限,二种以上,病程3年以上),一周之内FBS>11.1mmol/L,PBS<22.2mmol/L。 5 BMI为≥18及≤35kg/m2。 6 无糖尿病急性并发症如糖尿病酮症酸中毒、糖尿病高渗综合症等。 7 受试者能够及愿意进行血糖监测,并进行胰岛素强化治疗,饮食运动规律,预计住院时间能达十天左右。 |
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Inclusion criteria |
1. Present with type 2 diabetes mellitus;
2. 18 years old= |
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排除标准: |
1 在参加本试验前3个月曾接受过其他研究药物。 2 肝、肾功能受损,其ALT大于正常值上限的2.5倍;血清肌酐大于正常值上限的1.3倍。 3 在过去的5年内有药物滥用史及酒精依赖史。 4 由研究者判断的反复发作的主要低血糖事件。 5 现在使用全身激素治疗。 6 心脏病:失代偿性心衰(NYHA Ⅲ型及Ⅵ型)、不稳定性心绞痛、12个月内有心梗发作。 7 已知对试验药品或相关产品过敏(胰岛素过敏、金属过敏),胰岛素注射部位容易出现局部硬结的患者。 8 妊娠、哺乳或有意妊娠,或判断为未使用足够的避孕措施(足够的避孕措施是指宫内节育器、口服避孕药及阻碍措施)。 9 依从性差,不能配合强化治疗,饮食运动不规律的患者。 10任何其他的由研究者判定的明显情况或合并疾病:如内分泌、心脏、神经、肿瘤等疾患,其他胰腺疾病,有精神疾病史,不能使用胰岛素泵的患者。 11 四周内存在感染,存在应激状态的患者。 |
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Exclusion criteria: |
1. Take any other drugs within the last 3 months prior to entry into the study; 2. liver or kidney dysfunction: ALT>=2.5 times of the upper limit and serum creatinine>=the upper limit; 3. History of drug abuse or alcohol dependency within 5 years; 4. Have had more than one episode of severe hypoglycaemia within 24 weeks prior to entry into the study; 5. Being treated with glucocorticoids; 6. Encountered the cardiovascular events such as the angina pectoris, myocardial infarction, severe ventricular arrhythmia, cerebral hemorrhage, cerebral infarction, heart failure ect. within the last 12 months; 7. Allergic history to insulin; 8. Pregnant women or women that intend to become pregnant during the course of the study, or sexually active women of childbearing potential not practicing birth control; 9. With poor compliance, and do not regularly consume three meals per day; 10. Comorbidity with other diseases, such as diseases of endocrine system, cardiovascular system, nerve system and tumor, or with other panreatic disorders and mental disorders; 11. With infection or stree within the last four weeks. |
研究实施时间: Study execute time: |
从From2010-01-01至To 2013-05-31 |
征募观察对象时间: Recruiting time: |
从From2010-05-01至To 2012-12-31 |
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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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
结束 Completed |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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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 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
computer generation |
盲法: |
研究者 是 治疗前 患者 是 治疗前 |
Blinding: |
patient: blinding investigator: blinding |
试验完成后的统计结果(上传文件): |
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Calculated Results after
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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): |
南京医科大学附属南京第一医院 |
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
Nanjing First Hospital, Nanjing Medical University |
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: |
南京医科大学 |
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
暂未确定/Not yet |