登记号
CTR20130003
相关登记号
无
曾用名
药物类型
生物制品
临床申请受理号
企业选择不公示
适应症
2型糖尿病
试验通俗题目
利拉鲁肽对糖尿病的影响和作用：心血管结局评估
试验专业题目
一项旨在确定利拉鲁肽对心血管事件影响的长期、多中心、国际、随机双盲、安慰剂对照试验
试验方案编号
EX2211-3748
方案最近版本号
版本日期
方案是否为联合用药
企业选择不公示
申请人信息
申请人名称
联系人姓名
临床试验发布组
联系人座机
010-59615789
联系人手机号
联系人Email
NNChinaDisclosure@novonordisk.com
联系人邮政地址
北京市朝阳区广顺南大街8号利星行中心3号楼5层
联系人邮编
100102
临床试验信息
试验分类
安全性和有效性
试验分期
III期
试验目的
该试验的目的是确定利拉鲁肽在2型糖尿病患者中对心血管事件的长期影响
随机化
随机化
盲法
双盲
试验范围
国际多中心试验
设计类型
平行分组
年龄
50岁(最小年龄)至
无岁(最大年龄)
性别
男+女
健康受试者
无
入选标准
- 2型糖尿病
- 筛选时的年龄≥50岁，以及伴有心血管、脑血管或周围血管疾病或慢性肾功能衰竭或慢性心脏衰竭；或者，筛选时年龄≥60岁，以及其他指定的血管疾病危险因素
- 糖化血红蛋白≥7.0％
- 初始服用抗糖尿病药物或经一个或多个口服抗糖尿病药物（OAD）或人NPH胰岛素或长效胰岛素类似物或预混胰岛素（单独或联合OAD）治疗的受试者
排除标准
- 1型糖尿病
- 筛选前3个月内，使用GLP-1受体激动剂（艾塞那肽，利拉鲁肽或其它）或普兰林肽或任何的二肽基肽酶4（DPP-4）抑制剂
- 筛选前3个月内，使用了除人中性鱼精蛋白（NPH）胰岛素或长效胰岛素类似物或预混胰岛素之外的胰岛素。在受试者并发疾病期间，经研究者同意，可允许短期使用其它胰岛素
试验分组
试验药
| 名称 | 用法 |
|---|---|
|
中文通用名:利拉鲁肽注射液
|
用法用量:注射液；6 mg/ml，3ml/支；一天一次皮下注射，最大剂量1.8 mg。伴随受试者标准治疗。用药时程：18个月的招募期以及最后1名受试者随机入组后的42个月
|
|
中文通用名:利拉鲁肽注射液
|
用法用量:注射液；6 mg/ml，3ml/支；一天一次皮下注射，最大剂量1.8 mg。伴随受试者标准治疗。用药时程：18个月的招募期以及最后1名受试者随机入组后的42个月
|
对照药
| 名称 | 用法 |
|---|---|
|
中文通用名:安慰剂注射液
|
用法用量:注射液；6 mg/ml，3ml/支；一天一次皮下注射，最大剂量1.8 mg。伴随受试者标准治疗。用药时程：18个月的招募期以及最后1名受试者随机入组后的42个月
|
|
中文通用名:安慰剂注射液
|
用法用量:注射液；6 mg/ml，3ml/支；一天一次皮下注射，最大剂量1.8 mg。伴随受试者标准治疗。用药时程：18个月的招募期以及最后1名受试者随机入组后的42个月
|
终点指标
主要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| 从随机入组至首次发生心血管死亡、非致死性心血管梗死、非致死性中风（心血管复合终点）的时间 | 从随机入组至60个月 | 安全性指标 |
次要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| 从随机入组至广义的心血管复合终点的时间，该复合终点定义为心血管死亡、非致死性心肌梗死、非致死性中风、血运重建、不稳定型心绞痛或慢性心脏衰竭而导致的住院。 | 从随机入组至60个月 | 安全性指标 |
| 从随机入组至全因死亡 | 从随机入组至60个月 | 安全性指标 |
| 从随机入组至广义心血管复合结局的任何单个成分 | 从随机入组至60个月 | 安全性指标 |
数据安全监察委员会（DMC）
有
为受试者购买试验伤害保险
有
研究者信息
| 姓名 | 学位 | 职称 | 电话 | 邮政地址 | 邮编 | 单位名称 | |
|---|---|---|---|---|---|---|---|
| 潘长玉 | 教授 | 010-66887329 | panchy301@126.com | 北京市海淀区复兴路28号 | 100853 | 中国人民解放军总医院 |
各参加机构信息
| 机构名称 | （主要）研究者 | 国家 | 地区 | 城市 |
|---|---|---|---|---|
| 中国人民解放军总医院 | 潘长玉 | 中国 | 北京 | 北京 |
| 北京大学人民医院 | 纪立农 | 中国 | 北京 | 北京 |
| 首都医科大学附属北京同仁医院 | 杨金奎 | 中国 | 北京 | 北京 |
| 青岛大学医学院附属医院 | 王颜刚 | 中国 | 山东 | 青岛 |
| 江苏大学附属医院 | 袁国跃 | 中国 | 江苏 | 镇江 |
| 上海长征医院 | 石勇铨 | 中国 | 上海 | 上海 |
| 中山大学孙逸仙纪念医院 | 徐明彤 | 中国 | 广东 | 广州 |
| Apex Medical Research Inc | N/A | United States | Illinois | Chicago |
| Northeast Clinical Research | N/A | United States | Texas | Schertz |
| Alzohaili Medical Consultants | N/A | United States | Michigan | Dearborn |
| Northwest Heart Center | N/A | United States | Texas | Tomball |
| Kernodle Clinic Depart of the Private Diagnostic Clinic PLLC | N/A | United States | North Carolina | Burlington |
| Comprehensive Weight Control Program | N/A | United States | New York | New York |
| Research Institute Of Dallas | N/A | United States | Texas | Dallas |
| Awasty Research Network | N/A | United States | Ohio | Marion |
| AMCR Institute, Inc. | N/A | United States | California | Escondido |
| University Of Miami/Diabetes R | N/A | United States | Florida | Miami |
| Professional Clinical Research | N/A | United States | Michigan | Interlochen |
| Blair Medical Associates | N/A | United States | Pennsylvania | Altoona |
| International Diabetes Center | N/A | United States | Minnesota | Minneapolis |
| Southern Peidmont Primary Care | N/A | United States | North Carolina | Monroe |
| Great Lakes Medical Research | N/A | United States | New York | Westfield |
| North Texas Endocrine Center | N/A | United States | Texas | Dallas |
| UNC Diabetes Care Center | N/A | United States | North Carolina | Chapel Hill |
| DHMC | N/A | United States | New Hampshire | Lebanon |
| Robley Rex VAMC | N/A | United States | Kentucky | Louisville |
| Instituto De Endronilogia Diab | N/A | United States | Pennsylvania | Bayamon |
| Radiant Research Inc. | N/A | United States | Alabama | Birmingham |
| COR Clinical Research | N/A | United States | Oklahoma | Oklahoma City |
| Tampa Clinical Research Inc. | N/A | United States | Florida | Tampa |
| Radiant Research Inc | N/A | United States | Illinois | Chicago |
| Omaha VA Medical Center | N/A | United States | Nebraska | Omaha |
| KD Medical Group Inc | N/A | United States | California | Los Banos |
| Paramount Medical Research & C | N/A | United States | Ohio | Middleburg Heights, |
| Columbia University Medical Ce | N/A | United States | New York | New York |
| Carolina Health Specialists | N/A | United States | South Carolina | Myrtle Beach |
| Crouse Medical Practice, PLLC | N/A | United States | New York | Syracuse |
| FB MED Research PSC | N/A | United States | Pennsylvania | Caguas |
| Grunberger Diabetes Institute | N/A | United States | Michigan | Bloomfield Hills |
| American Institute of Research | N/A | United States | California | Los Angeles |
| Maxine Hamilton PA | N/A | United States | Florida | Fort Lauderdale |
| Multiple Health Research LLC | N/A | United States | Texas | Arlington |
| Baylor Endocrine Center | N/A | United States | Texas | Dallas |
| Internal Medicine Associates Of Greenville | N/A | United States | South Carolina | Greenville |
| University Hospitals of Clevel | N/A | United States | Ohio | Cleveland |
| Thomas Jefferson University Di | N/A | United States | Pennsylvania | Philadelphia |
| Clinical Research Consultants, | N/A | United States | Alabama | Alabaster |
| Diabetes Research Group | N/A | United States | Kentucky | Lexington |
| The Carl & Edyth Lindner Cente | N/A | United States | Ohio | Cincinnati |
| Bala and Khaira Medical Cente | N/A | United States | California | StFresno |
| Tulane Medical Center | N/A | United States | Louisiana | New Orleans |
| University Medical Associates | N/A | United States | Kentucky | Louisville |
| Facey Medical Foundation | N/A | United States | California | Mission Hills |
| Preferred Primary Care Physici | N/A | United States | Pennsylvania | Uniontown |
| AM Diabetes And Endocrinology | N/A | United States | Tennessee | Bartlett |
| Albany Medical College | N/A | United States | New York | Albany |
| Christiana Care Health Services, Inc. | N/A | United States | Delaware | Newark |
| University of Texas Southweste | N/A | United States | Texas | Dallas |
| Central Florida Medical Associ | N/A | United States | Florida | Deland |
| Harold Hamm Diabetes Ctr | N/A | United States | Oklahoma | Oklahoma City |
| Michael R. MacAdams, MD | N/A | United States | Texas | Lubbock |
| Midwest Endocrinology | N/A | United States | Illinois | Crystal Lake |
| Martin Diagnostic Clinic | N/A | United States | Texas | Tomball |
| University Of Wisconsin-Madiso | N/A | United States | Wisconsin | Madison |
| Holston Medical Group | N/A | United States | Tennessee | Kingsport |
| La Porte County Institute For | N/A | United States | Indiana | Michigan City |
| The Diabetes Center, LLC | N/A | United States | South Carolina | Murrells Inlet |
| Physician Research Associates | N/A | United States | Georgia | Lawrenceville |
| Endocrine And Psychiatry Cente | N/A | United States | Texas | Houston |
| Fletcher Allen Health Care/The | N/A | United States | Vermont | South Burlington |
| Preferred PrimaryCare Physicia | N/A | United States | Pennsylvania | Pittsburgh |
| Internal Medicine Of Morris Co | N/A | United States | New Jersey | Mine Hill |
| Arthritis And Diabetes Clinic, | N/A | United States | Louisiana | Monroe |
| Optimum Clinical Research | N/A | United States | Utah | Salt Lake City |
| USC School Of Medicine | N/A | United States | South Carolina | Columbia |
| Northwest Houston Cardiology | N/A | United States | Texas | Houston |
| Oakland Medical Research Cente | N/A | United States | Michigan | Troy |
| University of Pennsylvania Rodebaugh Diabetes Center | N/A | United States | Pennsylvania | Philadelphia |
| Research Institute Of The Caro | N/A | United States | North Carolina | Mooresville |
| Endocrine Associates of Long I | N/A | United States | New York | Smithtown |
| Southern New Hampshire Diabete | N/A | United States | New Hampshire | Nashua |
| Central Arkansas Veterans | N/A | United States | Arkansas | Little Rock |
| Medical Investigations Inc. | N/A | United States | Arkansas | Little Rock |
| Whiteville Medical Associates | N/A | United States | North Carolina | Whiteville |
| Innovative Research of W Flori | N/A | United States | Florida | Clearwater |
| Catalina Research Institute, LLC | N/A | United States | California | Chino |
| Physicians East PA | N/A | United States | North Carolina | Greenville |
| DCOL Center for Clinical Resea | N/A | United States | Texas | Longview |
| Anaheim Clinical Trials, LLC | N/A | United States | California | Anaheim |
| Crescent City Clin Research | N/A | United States | Louisiana | Metairie |
| American Institute of Research | N/A | United States | California | Watsonville |
| Washington State University | N/A | United States | Washington | Spokane |
| Jsumc-Medicine & Endocrinology | N/A | United States | New Jersey | Neptune |
| Pioneer Medical Group | N/A | United States | California | Cerritos |
| Heritage Valley Medical Group | N/A | United States | Pennsylvania | Beaver |
| Mercy Medical Research Inst | N/A | United States | Missouri | Springfield |
| Naidu Clinic | N/A | United States | Texas | Odessa |
| Clinical Study Center Of Ashev | N/A | United States | North Carolina | Asheville |
| Diablo Clinical Research, Inc. | N/A | United States | California | Walnut Creek |
| Union Memorial Hsptl | N/A | United States | Maryland | Baltimore |
| Orange County Senior Care Clinical Trials | N/A | United States | California | Tustin |
| University Of Tennessee | N/A | United States | Tennessee | Memphis |
| Diabetes And Endocrinology Con | N/A | United States | North Carolina | Morehead City |
| Rush University Medical Center | N/A | United States | Illinois | Chicago |
| Eastern Shore Medical Speciali | N/A | United States | Alabama | Mobile |
| Va Med Center | N/A | United States | Ohio | Cleveland |
| Denver Va Med Center | N/A | United States | Colorado | Denver |
| Benefis Medical Group | N/A | United States | Montana | Great Falls |
| Linda Vista Health Care Center | N/A | United States | California | San Diego |
| Model Clinical Research | N/A | United States | Maryland | Baltimore |
| University Of Colorado Denver Hospital | N/A | United States | Colorado | Aurora |
| Medical University Of South Ca | N/A | United States | South Carolina | Charleston |
| Cincinnati Veterans Affairs | N/A | United States | Ohio | Cincinnati |
| UNC Diabetes Research | N/A | United States | North Carolina | Greensboro |
| Vanderbilt Diabetes Center | N/A | United States | Tennessee | Nashville |
| Alternative Solutions Research | N/A | United States | Florida | St. Petersburg |
| FPA Clinical Research | N/A | United States | Florida | Kissimmee |
| Dallas Diabetes & Endocrine Ce | N/A | United States | Texas | Dallas |
| Florida Hsptl Diabetes Inst | N/A | United States | Florida | Orlando |
| Medex HealthCare Research Inc | N/A | United States | Missouri | St. Louis |
| Panacea Clinical Research | N/A | United States | Texas | San Antonio |
| Covenant Clinical Research | N/A | United States | Texas | San Antonio |
| Dr Robert Bloomberg | N/A | United States | Arizona | Tempe |
| Iowa Diabetes & Endocrinology | N/A | United States | Iowa | Des Moines |
| Padre Coast Clinical Research | N/A | United States | Texas | Corpus Christi |
| Meridien Research | N/A | United States | Florida | Bradenton |
| Medex Healthcare Research, Inc | N/A | United States | New York | New York |
| Endocrine Research Solutions | N/A | United States | Georgia | Roswell |
| Natchitoches Internal Med | N/A | United States | Louisiana | Natchitoches |
| Awasty Research Network | N/A | United States | Ohio | Cadiz |
| Mountain View Clinical Researc | N/A | United States | South Carolina | Ext.Greer |
| Great Falls Clinic | N/A | United States | Montana | Great Falls |
| Eastern Clinical Research Unit | N/A | Australia | Victorian State | N/A |
| Ed | N/A | Australia | South Australia | N/A |
| Fremantle Hospital | N/A | Australia | Western Australia | N/A |
| The Townsville Hospital | N/A | Australia | Queensland | N/A |
| Royal Hobart Hospital | N/A | Australia | Tasmania | N/A |
| Logan Hospital | N/A | Australia | Queensland | N/A |
| Royal Brisbane & Womens Hospital | N/A | Australia | Queensland | N/A |
| Blacktown Hospital | N/A | Australia | New South Wales | N/A |
| St Vincent Hospital & University of Melbourne | N/A | Australia | Victorian State | N/A |
| South Australian Endocrine Research Pty Ltd | N/A | Australia | South Australia | N/A |
| LKH-Univ. Klinikum Graz | N/A | Austria | N/A | Graz |
| Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel | N/A | Austria | N/A | Wien |
| Krankenanstalt der Stadt Wien - Rudolfstiftung | N/A | Austria | N/A | Wien |
| Hanusch-Krankenhaus | N/A | Austria | N/A | Wien |
| AKH Wien | N/A | Austria | N/A | Wien |
| Universitair Ziekenhuis Antwerpen | N/A | Belgium | N/A | Edegem |
| UZ Leuven - Campus Gasthuisberg | N/A | Belgium | N/A | Leuven |
| CHU de Liège - Domaine Universitaire du Sart Tilman | N/A | Belgium | N/A | Liege |
| UZ Gent | N/A | Belgium | N/A | Gent |
| Servi？o de Diabetes- UFPR | N/A | Brazil | PR | Curitiba |
| Fac. Med. Marília - Diabetes | N/A | Brazil | SP | Marília |
| UNIFESP - Diabetes | N/A | Brazil | SP | Sao Paulo |
| CPCLIN | N/A | Brazil | SP | Sao Paulo |
| Sala Pesquisa Clínica - Incor | N/A | Brazil | SP | Sao Paulo |
| IEDE | N/A | Brazil | Rio de Janeiro | Rio de Janeiro |
| IPEC | N/A | Brazil | SP | Sao Paulo |
| IPCEM | N/A | Brazil | RS | Caxias do Sul |
| UNICAMP | N/A | Brazil | SP | Campinas |
| NúCLEO DE MEDICINA INTEGRADA | N/A | Brazil | SP | Mogi das Cruzes |
| CENTRO DE PESQ. MéDICAS | N/A | Brazil | PE | Espinheiro |
| CEDH | N/A | Brazil | CE | Fortaleza |
| Centro Pesq Diabetes e Endoc. | N/A | Brazil | CE | Fortaleza |
| Hosp Jo？o de Barros Barreto | N/A | Brazil | Para | Belém |
| Centro de Diabetes de Sergipe | N/A | Brazil | SE | Aracaju |
| RDM PESQUISAS CLíNICAS | N/A | Brazil | GO | Goiania |
| CEPCEM | N/A | Brazil | MG | Belo Horizonte |
| HC S？O PAULO | N/A | Brazil | SP | Sao Paulo |
| CPD | N/A | Brazil | RS | Porto Alegre |
| UNIVERSIDADE POSITIVO | N/A | Brazil | PR | Curitiba |
| IEJE-CAD | N/A | Brazil | SC | JOINVILLE |
| Centro de Diabetes de Curitiba | N/A | Brazil | PR | Curitiba |
| Hosp. das Clínicas | N/A | Brazil | SP | Sao Paulo |
| Endoclínica | N/A | Brazil | SP | Sao Paulo |
| Fadlo Fraige Filho | N/A | Brazil | SP | Sao Paulo |
| IEP | N/A | Brazil | RS | Porto Alegre |
| CEG Campinas | N/A | Brazil | SP | Campinas |
| Santa Casa de Curitiba | N/A | Brazil | PR | Curitiba |
| Hospital Sao Joaquim | N/A | Brazil | SP | Sao Paulo |
| I.Cearense de Endocrinologia | N/A | Brazil | CE | Fortaleza |
| ICF | N/A | Brazil | GO | Goiania |
| PUCCAMP | N/A | Brazil | SP | Campinas |
| Hospital Geral de Fortaleza | N/A | Brazil | CE | Fortaleza |
| Dr. Roy Allison | NA | Canada | Ontario | Thunder Bay |
| Canadian Centre for Research on Diabetes | NA | Canada | Ontario | Smiths Falls |
| Cornwall Clinical Trials | NA | Canada | Ontario | Cornwall |
| Credit Valley Endo Research | NA | Canada | Ontario | West Mississauga |
| Centre for Studies in Family Medicine | NA | Canada | Ontario | London |
| London Diabetes Clinical Trials Unit (LDCTU) | NA | Canada | Ontario | London |
| Institut Universitaire de Cardiologie et de Pneumologie de Quebec | NA | Canada | Quebec | Quebec |
| Health Science Centre Eastern Health/Memorial University of Newfoundland | NA | Canada | Newfoundland | St. John’s |
| Dr. Joanne Liutkus | NA | Canada | Ontario | Cambridge |
| Capital District Health Authority, QEII Health Sciences Centre, Division of Endocrinology and Metabolism | NA | Canada | Nova Scotia | Halifax |
| Mount Sinai Hospital | NA | Canada | Ontario | Toronto |
| Rouge Valley Metabolic Research Centre | NA | Canada | Quebec | Montreal |
| Dr. John Sigalas | NA | Canada | Ontario | Scarborough |
| Health Sciences Centre | NA | Canada | Manitoba | Winnipeg |
| St. Michael's Hospital | NA | Canada | Ontario | Toronto |
| Baker Clinic | NA | Canada | Alberta | Edmonton |
| Unité de recherche sur le diabète | NA | Canada | Quebec | Quebec |
| VFN-III. Interna | NA | Czech Republic | NA | Praha |
| FN Plzen | NA | Czech Republic | NA | Plzen-Lochotin |
| Steno Diabetes Center | NA | Denmark | NA | NA |
| Hvidovre Hospital | NA | Denmark | NA | Hvidovre |
| Odense Universitetshospital | NA | Denmark | NA | Odense C |
| Esbjerg Sygehus,Sydvestjysk Sygehus Esbjerg | NA | Denmark | NA | Esbjerg |
| Arhus Universitetshospital THG | NA | Denmark | NA | Arhus C |
| Aalborg Sygehus | NA | Denmark | NA | Alborg |
| Kuopio University Hospital | NA | Finland | NA | Kuopio |
| Myyrm？ki Health Centre | NA | Finland | NA | Vantaa |
| Mehil？inen Lahti | NA | Finland | NA | Lahti |
| FinnMedi Research Ltd | NA | Finland | NA | Tampere |
| Oulu Sis？tautien tutkimuslaboratorio | NA | Finland | NA | Oulu |
| Hopital BICHAT | NA | Finland | NA | Paris |
| Hopital CAREMEAU | NA | Finland | NA | Nimes |
| Hopital Sud-Francilien | NA | Finland | NA | Corbeil |
| Cabinet médical | NA | Finland | NA | Jarny |
| Diabetologische Schwerpunktpraxis | NA | Germany | NA | Gifhorn |
| Hauptstr | NA | Germany | NA | Essen |
| Zentrum für Klinische Studien | NA | Germany | NA | Elsterwerda |
| Praxis für Pr？vention und Therapie | NA | Germany | NA | Villingen-Schwenningen |
| ClinTrial Berlin | NA | Germany | NA | Berlin |
| Studienzentrum | NA | Germany | NA | Aschaffenburg |
| UnUniversit？tsklinikum Ulm | NA | Germany | NA | Ulm |
| Poststr | NA | Germany | NA | Falkensee |
| NA | NA | Germany | NA | Dresden |
| NA | NA | Germany | NA | Schweinfurt |
| NA | NA | Germany | NA | Wangen |
| Medizinische Klinik LMU | NA | Germany | NA | München |
| NA | NA | Germany | NA | St. Ingbert |
| Synexus ClinPharm GmbH | NA | Germany | NA | Leipzig |
| NA | NA | Germany | NA | Mannheim |
| Studienzentrum in Berlin | NA | Germany | NA | Berlin |
| Sana Kliniken Ostholstein GmbH | NA | Germany | NA | Oldenburg |
| NA | NA | Germany | NA | Schkeuditz |
| NA | NA | Germany | NA | Dillingen |
| NA | NA | Germany | NA | Hamburg |
| NA | NA | Germany | NA | Ludwigshafen |
| Polyclinic Athens | NA | Greece | NA | Athens |
| Laiko General Hospital of Athens | NA | Greece | NA | Athens |
| Clinic | NA | Greece | NA | Thessaloniki |
| Care Outpatient Centre | NA | India | NA | Hyderabad |
| Arthur Asirvatham hospital | NA | India | NA | Madurai |
| Post Graduate Institute of | NA | India | NA | Chandigarh |
| Bangalore Endocrinology and Diabetes Research Centre | NA | India | NA | Bangalore |
| TOTALL Diabetes Hormone Institute | NA | India | NA | Indore |
| Amitra Institute Of Medical Sciences & Research Centre | NA | India | NA | Kochi |
| Seth GS medical college and KEM Hospital | NA | India | NA | Mumbai |
| Madras Diabetes Research Foundation | NA | India | NA | Chennai |
| Christian Medical College Hospital | NA | India | NA | Vellore |
| Department of Medicine - Kasturba Hospital | NA | India | NA | Manipal |
| Excel Centre | NA | India | NA | Guwahati |
| Apollo Gleneagles Hospital | NA | India | NA | Kolkata |
| Osmania General Hospital | NA | India | NA | Hyderabad |
| Bangalore Diabetes Hospital | NA | India | NA | Bangalore |
| Bangalore Clinisearch | NA | India | NA | Bangalore |
| Bharti Research Insititute of Diabetes & Endocrinology | NA | India | NA | Karnal |
| Dr V Seshiah Research Institute and Dr Balaji Diabetes Care | NA | India | NA | Chennai |
| Jothydev's Diabetes & Research Center | NA | India | NA | Thriruvananthapuram |
| Diabetes Day Centre, St Vincent’s University Hospital | NA | Ireland | NA | Dublin |
| Diabetes Day Centre, Beaumont Hospital | NA | Ireland | NA | Dublin |
| Hadassah Ein Karem | NA | Israel | NA | Jerusalem |
| Sheba Medical Center | NA | Israel | NA | Tel Hashomer |
| Rambam MC | NA | Israel | NA | Haifa |
| Hasharon Dept. D | NA | Israel | NA | Petah-Tikva |
| Linn Medical Center | NA | Israel | NA | Haifa |
| Azienda Ospedaliero Universitaria Careggi | NA | Italy | NA | Firenze |
| Ospedale Civile Campo di Marte | NA | Italy | NA | Lucca |
| Policlinico Universitario P. Giaccone | NA | Italy | NA | Palermo |
| Università degli Studi | NA | Italy | NA | Chieti |
| Centro Antidiabetologico | NA | Italy | NA | Bologna |
| PU Umberto I | NA | Italy | NA | Roma |
| Ospedale San Raffaele | NA | Italy | NA | Milano |
| U.O. di Medicina Interna Policlinico Mater Domini Università di Catanzaro | NA | Italy | NA | Catanzaro |
| Centro Antidiabetologico | NA | Italy | NA | Bologna |
| Ospedale Santa Maria Goretti | NA | Italy | NA | Latina |
| The Catholic University of Korea, Seoul St. Mary's Hospital | NA | Korea | NA | Seoul |
| Seoul National University Bundang Hospital | NA | Korea | NA | Gyeonggi-do |
| Kyung Hee University Hospital | NA | Korea | NA | Seoul |
| National Health Insurance Corporation | NA | Korea | NA | Gyeonggi-do |
| Eulji General Hospital | NA | Korea | NA | Seoul |
| Unidad de Patología Clínica | NA | Mexico | NA | Jalisco |
| Hospital Universitario “Dr. Jose Eleuterio González” | NA | Mexico | NA | Nuevo León |
| Instituto Jalisciense de Investigación en Diabetes y Obesidad, S.C. | NA | Mexico | NA | Jalisco |
| Centro de Diabetes Durango | NA | Mexico | NA | Durango |
| Hospital Universitario “Dr. José Eleuterio González” | NA | Mexico | NA | Nuevo León |
| ICLE SC | NA | Mexico | NA | Jalisco |
| CardioPrevent | NA | Mexico | NA | Durango |
| Cardioarritmias e Investigación S.C. | NA | Mexico | NA | San Luis Potosí |
| UMC St. Radboud | NA | Netherlands | NA | Nijmegen |
| UMC Utrecht | NA | Netherlands | NA | Utrecht |
| Martini Ziekenhuis | NA | Netherlands | NA | Groningen |
| Maxima MC | NA | Netherlands | NA | Eindhoven |
| Slotervaart Ziekenhuis | NA | Netherlands | NA | Amsterdam |
| Bethesda diab. research center | NA | Netherlands | NA | Hoogeveen |
| Academisch Ziekenhuis Maastricht | NA | Netherlands | NA | Maastricht |
| SHL-Groep Wetenschappelijk Onderzoek | NA | Netherlands | NA | Etten-Leur |
| SHL-Groep Wetenschappelijk Onderzoek | NA | Netherlands | NA | Goes |
| Aker sykehus | NA | Norway | NA | NA |
| Stavanger Helseforskning | NA | Norway | NA | NA |
| Senter for sykelig overvekt | NA | Norway | NA | NA |
| St. Olav RSSO | NA | Norway | NA | NA |
| Diabetespoliklinikken, Ullev？l | NA | Norway | NA | NA |
| Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne | NA | Poland | NA | Kraków |
| KO-MED Marek Konieczny Centrum | NA | Poland | NA | Pu？awy |
| Przychodnia Specjalistyczna SPZOZ | NA | Poland | NA | Ruda ？l？ska |
| Klinika Chorób Wewn？trznych, Endokrynologii i Diabetologii | NA | Poland | NA | Warszawa |
| Centrum Medyczne OmniMed | NA | Poland | NA | ？ód？ |
| NZOZ Specjalistyczny O？rodek Internistyczno-Diabetologiczny Iwona Ma？gorzata Arciszewska | NA | Poland | NA | Bia？ystok |
| NZOZ ？l？skie Centrum Osteoporozy | NA | Poland | NA | Katowice |
| Bydgoskie Centrum Diabetologii i Endokrynologii Sp. z o.o. | NA | Poland | NA | Bydgoszcz |
| Synexus Polska Sp. z o.o. | NA | Poland | NA | Wroc？aw |
| UNICARDIA Specjalistyczne Centrum Leczenia | NA | Poland | NA | Kraków |
| SKPPUM im. K. Marcinkowskiego | NA | Poland | NA | Poznań |
| Synexus Polska Sp. z o.o. | NA | Poland | NA | Warszawa |
| Katedra Chorób Metabolicznych | NA | Poland | NA | Kraków |
| Clinical County Emergency Hospital | NA | Romania | NA | Craiova |
| Clinical County Emergency Hospital | NA | Romania | NA | Timisoara |
| Clinical County Emergency Hospital | NA | Romania | NA | Sibiu |
| Deva County Emergency Hospital | NA | Romania | NA | Deva |
| National Institute of Diabetes, Nutrition and Metabolic Diseases | NA | Romania | NA | Bucharest |
| County Emergency Hospital-Clinic of Diabet | NA | Romania | NA | Bacau |
| County Emergency Hospital-Clinic of Diabetes | NA | Romania | NA | Satu-Mare |
| Clinical County Emergency Hospital-Clinic of Diabetes, Nutrition and Metabolic Diseases | NA | Romania | NA | Sibiu |
| SC Consultmed SRL | NA | Romania | NA | Iasi |
| S.C. Cosamext S.R.L. | NA | Romania | NA | Targu Mures |
| Endocrinology Research Scientific Centre | NA | Russia | NA | Moscow |
| Central Clinical Hospital # 1 | NA | Russia | NA | Moscow |
| Moscow Medical Academy | NA | Russia | NA | Moscow |
| Regional clinical hospital | NA | Russia | NA | Saratov |
| Nizhny Novgorod regional clinical hospital | NA | Russia | NA | Nizhny Novgorod |
| Penza regional clinical hospital | NA | Russia | NA | Penza |
| City hospital №5, Barnaul | NA | Russia | NA | Barnaul |
| Tyumen State Medical Academy | NA | Russia | NA | Tyumen |
| KNMU, RH No.1 | NA | Russia | NA | Kazan |
| Arkhangelsk regional clinical hospital | NA | Russia | NA | Arkhangelsk |
| Smolensk State Medical Academy | NA | Russia | NA | Smolensk |
| Yaroslavl Regional Hospital | NA | Russia | NA | Yaroslavl |
| First City Clinical Hospital | NA | Russia | NA | Arkhangelsk |
| Clinical Hospital Center Zvezdara | NA | Serbia | NA | Belgrade |
| Clinical Centre of Serbia | NA | Serbia | NA | Belgrade |
| Clinical Centre of Serbia | NA | Serbia | NA | Belgrade |
| Clinical Centre of Serbia | NA | Serbia | NA | Belgrade |
| Dr Komati | NA | South Africa | NA | Pretoria |
| Centre for Diabetes & Endocrin | NA | South Africa | NA | Overport |
| Tread Research | NA | South Africa | NA | Parow |
| Dr S Pillay | NA | South Africa | NA | Amanzimtoti |
| Diabetes Care Centre | NA | South Africa | NA | Pretoria |
| Dr Lakha's Rooms | NA | South Africa | NA | Lenasia South |
| Wits Donald Gordon | NA | South Africa | NA | Parktown |
| Medi-Clinic Vergelegen | NA | South Africa | NA | Somerset West |
| Midrand Medical Centre | NA | South Africa | NA | Halfway House |
| Karl Bremer Hospital | NA | South Africa | NA | Bellville |
| Dr Moosa's Rooms | NA | South Africa | NA | Lenasia |
| Union Hospital | NA | South Africa | NA | Alberton |
| Medi-Clinic Heart Hospital | NA | South Africa | NA | Arcadia |
| Boanerges CC | NA | South Africa | NA | Fichardtpark |
| Netcare Umhlanga Medical Centr | NA | South Africa | NA | Umhlanga |
| Victoria Hospital | NA | South Africa | NA | Tongaat |
| IEN | NA | Spain | NA | Valladolid |
| Clínica San Pedro | NA | Spain | NA | Almería |
| Hospital Son Llatzer | NA | Spain | NA | Mallorca |
| Hospital de Mostoles | NA | Spain | NA | Madrid |
| Hospital Nuestra Se？ora de Valme | NA | Spain | NA | Sevilla |
| Hospital Clínico San | NA | Spain | NA | Madrid |
| Clínica Nuevas Tecnologías en Diabetes y Endocrinología | NA | Spain | NA | Sevilla |
| Clinic i Provincial Barcelona | NA | Spain | NA | Barcelona |
| Hospital Quirón | NA | Spain | NA | Madrid |
| C.H.Universitario A Coru？a | NA | Spain | NA | A Coru？a |
| Klinisk Forskning | NA | Sweden | NA | Stockholm |
| City Diabetes | NA | Sweden | NA | Stockholm |
| Clinical Research Support, CRS | NA | Sweden | NA | ？rebro |
| KTA, Karolinska Trial Alliance | NA | Sweden | NA | Stockholm |
| Endokrinologiska kliniken | NA | Sweden | NA | Malm？ |
| Lundberglaboratoriet f？r diabetesforskning | NA | Sweden | NA | G？teborg |
| Chung Gung Medical Foundation-Linkou Branch | NA | China | Taiwan | Taoyuan |
| Changhua Christian Hospital | NA | China | Taiwan | Changhua |
| Chi-Mei Medical Center | NA | China | Taiwan | Tainan |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | NA | China | Taiwan | Kaohsiung |
| Istanbul Universitesi Istanbul Tip Fakultesi | NA | Turkey | NA | CapaIstanbul |
| Marmara Universitesi Hospital | NA | Turkey | NA | Istanbul |
| Ankara University Ibni Sina Hastanesi | NA | Turkey | NA | Ankara |
| Hacettepe Universitesi Tip Fakultesi Hastanesi | NA | Turkey | NA | Ankara |
| Dokuz Eylul University Medical Faculty | NA | Turkey | NA | IZMIR |
| Haseki Egitim ve Arastirma Hastanesi | NA | Turkey | NA | Istanbul |
| Sisli Etfal Hospital | NA | Turkey | NA | Istanbul |
| Ankara Numune Training and Research Hospital | NA | Turkey | NA | Ankara |
| Gaziantep Universitesi Tip Fakultesi Hastanesi | NA | Turkey | NA | Gaziantep |
| Goztepe Egitim ve Arastirma Hastanesi | NA | Turkey | NA | Istanbul |
| Gazi University Medical Faculty | NA | Turkey | NA | Ankara |
| Erciyes Universitesi Tip Fakultesi | NA | Turkey | NA | Kayseri |
| Ege Universitesi Tip Fakultesi Hastanesi | NA | Turkey | NA | IZMIR |
| Dr Lutfu Kirdar Kartal Egitim ve Arastirma Hastanesi | NA | Turkey | NA | Istanbul |
| Akdeniz University Tip Fakultesi Hastanesi | NA | Turkey | NA | ANTALYA |
| Cerrahpasa Medical Faculty | NA | Turkey | NA | Istanbul |
| Florence Nightingale Hastanesi | NA | Turkey | NA | Istanbul |
| Uludag University Medical Faculty Endocrinology Unit | NA | Turkey | NA | BURSA |
| Rashid Hospital | NA | United Arab Emirates | NA | Dubai |
| Aberdeen Royal Infirmary | NA | United Kingdom | NA | Aberdeen |
| St John's Hospital | NA | United Kingdom | NA | West Lothian |
| Michael White Centre for Diabetes & Endocrinology | NA | United Kingdom | NA | Hull |
| Morriston Hospital | NA | United Kingdom | NA | Swansea |
| Birmingham Heartlands Hospital | NA | United Kingdom | NA | Birmingham |
| Salford Royal NHS | NA | United Kingdom | NA | Manchester |
| Southmead Hospital | NA | United Kingdom | NA | Bristol |
| University Hospitals Coventry & Warwickshire NHS | NA | United Kingdom | NA | Coventry |
| BHF Glasgow Research Centre | NA | United Kingdom | NA | Glasgow |
| Ninewells Hospital | NA | United Kingdom | NA | Dundee |
| Univ Dept of Med, Plymouth | NA | United Kingdom | NA | Plymouth |
| Ninewells Hospital | NA | United Kingdom | NA | Dundee |
| Sandwell General Hospital | NA | United Kingdom | NA | West Bromwich |
| Royal Surrey County Hospital | NA | United Kingdom | NA | Surrey |
| University of East Anglia | NA | United Kingdom | NA | Norfolk |
| George Eliot Hospital | NA | United Kingdom | NA | Warwickshire |
| Torbay Hospital | NA | United Kingdom | NA | Torquay |
| Royal Devon & Exeter NHS Foundation Trust | NA | United Kingdom | NA | Exeter |
| St Mary's Hospital | NA | United Kingdom | NA | London |
| St. Helens Hospital | NA | United Kingdom | NA | Merseyside |
伦理委员会信息
| 名称 | 审查结论 | 审查日期 |
|---|---|---|
| 中国人民解放军总医院伦理委员会 | 同意 | 2011-11-16 |
试验状态信息
试验状态
已完成
目标入组人数
国内: 65 人；
国际: 8754 人；
已入组例数
国内: 登记人暂未填写该信息；
国际: 登记人暂未填写该信息；
实际入组总例数
国内: 92 人 ；
国际: 9341 人；
第一例受试者签署知情同意书日期
国内：登记人暂未填写该信息；
国际：登记人暂未填写该信息；
第一例受试者入组日期
国内：2012-01-05；
国际：2010-08-31；
试验终止日期
国内：2015-10-28；
国际：2015-12-17；
临床试验结果摘要
| 版本号 | 版本日期 |
|---|
