北京利拉鲁肽注射液III期临床试验-利拉鲁肽对糖尿病的影响和作用：心血管结局评估
北京中国人民解放军总医院开展的利拉鲁肽注射液III期临床试验信息，需要患者受试者,主要适应症为2型糖尿病
| 登记号 | CTR20130003 | 试验状态 | 已完成 |
|---|---|---|---|
| 申请人联系人 | 临床试验发布组 | 首次公示信息日期 | 2015-12-16 |
| 申请人名称 | 丹麦诺和诺德公司/ 诺和诺德（中国）制药有限公司 | ||
一、题目和背景信息
| 登记号 | CTR20130003 | ||
|---|---|---|---|
| 相关登记号 | 无 | ||
| 药物名称 | 利拉鲁肽注射液 | ||
| 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 | ||
| 试验方案编号 | EX2211-3748 | 方案最新版本号 | 暂无 |
| 版本日期: | 暂无 | 方案是否为联合用药 | 企业选择不公示 |
二、申请人信息
| 申请人名称 |
1
2
|
||||
|---|---|---|---|---|---|
| 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 | 暂无 |
| 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 |
三、临床试验信息
1、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 2、试验设计
| 试验分类 | 安全性和有效性 | 试验分期 | III期 | 设计类型 | 平行分组 |
|---|---|---|---|---|---|
| 随机化 | 随机化 | 盲法 | 双盲 | 试验范围 | 国际多中心试验 |
3、受试者信息
| 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 |
|
||||||||||
| 排除标准 |
|
||||||||||
4、试验分组
| 试验药 |
|
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 对照药 |
|
5、终点指标
| 主要终点指标及评价时间 |
|
||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 次要终点指标及评价时间 |
|
四、研究者信息
1、主要研究者信息
| 1 | 姓名 | 潘长玉 | 学位 | 暂无 | 职称 | 教授 |
|---|---|---|---|---|---|---|
| 电话 | 010-66887329 | panchy301@126.com | 邮政地址 | 北京市海淀区复兴路28号 | ||
| 邮编 | 100853 | 单位名称 | 中国人民解放军总医院 | |||
2、各参加机构信息
| 序号 | 机构名称 | 主要研究者 | 国家 | 省（州） | 城市 |
|---|---|---|---|---|---|
| 1 | 中国人民解放军总医院 | 潘长玉 | 中国 | 北京 | 北京 |
| 2 | 北京大学人民医院 | 纪立农 | 中国 | 北京 | 北京 |
| 3 | 首都医科大学附属北京同仁医院 | 杨金奎 | 中国 | 北京 | 北京 |
| 4 | 青岛大学医学院附属医院 | 王颜刚 | 中国 | 山东 | 青岛 |
| 5 | 江苏大学附属医院 | 袁国跃 | 中国 | 江苏 | 镇江 |
| 6 | 上海长征医院 | 石勇铨 | 中国 | 上海 | 上海 |
| 7 | 中山大学孙逸仙纪念医院 | 徐明彤 | 中国 | 广东 | 广州 |
| 8 | Apex Medical Research Inc | N/A | United States | Illinois | Chicago |
| 9 | Northeast Clinical Research | N/A | United States | Texas | Schertz |
| 10 | Alzohaili Medical Consultants | N/A | United States | Michigan | Dearborn |
| 11 | Northwest Heart Center | N/A | United States | Texas | Tomball |
| 12 | Kernodle Clinic Depart of the Private Diagnostic Clinic PLLC | N/A | United States | North Carolina | Burlington |
| 13 | Comprehensive Weight Control Program | N/A | United States | New York | New York |
| 14 | Research Institute Of Dallas | N/A | United States | Texas | Dallas |
| 15 | Awasty Research Network | N/A | United States | Ohio | Marion |
| 16 | AMCR Institute, Inc. | N/A | United States | California | Escondido |
| 17 | University Of Miami/Diabetes R | N/A | United States | Florida | Miami |
| 18 | Professional Clinical Research | N/A | United States | Michigan | Interlochen |
| 19 | Blair Medical Associates | N/A | United States | Pennsylvania | Altoona |
| 20 | International Diabetes Center | N/A | United States | Minnesota | Minneapolis |
| 21 | Southern Peidmont Primary Care | N/A | United States | North Carolina | Monroe |
| 22 | Great Lakes Medical Research | N/A | United States | New York | Westfield |
| 23 | North Texas Endocrine Center | N/A | United States | Texas | Dallas |
| 24 | UNC Diabetes Care Center | N/A | United States | North Carolina | Chapel Hill |
| 25 | DHMC | N/A | United States | New Hampshire | Lebanon |
| 26 | Robley Rex VAMC | N/A | United States | Kentucky | Louisville |
| 27 | Instituto De Endronilogia Diab | N/A | United States | Pennsylvania | Bayamon |
| 28 | Radiant Research Inc. | N/A | United States | Alabama | Birmingham |
| 29 | COR Clinical Research | N/A | United States | Oklahoma | Oklahoma City |
| 30 | Tampa Clinical Research Inc. | N/A | United States | Florida | Tampa |
| 31 | Radiant Research Inc | N/A | United States | Illinois | Chicago |
| 32 | Omaha VA Medical Center | N/A | United States | Nebraska | Omaha |
| 33 | KD Medical Group Inc | N/A | United States | California | Los Banos |
| 34 | Paramount Medical Research & C | N/A | United States | Ohio | Middleburg Heights, |
| 35 | Columbia University Medical Ce | N/A | United States | New York | New York |
| 36 | Carolina Health Specialists | N/A | United States | South Carolina | Myrtle Beach |
| 37 | Crouse Medical Practice, PLLC | N/A | United States | New York | Syracuse |
| 38 | FB MED Research PSC | N/A | United States | Pennsylvania | Caguas |
| 39 | Grunberger Diabetes Institute | N/A | United States | Michigan | Bloomfield Hills |
| 40 | American Institute of Research | N/A | United States | California | Los Angeles |
| 41 | Maxine Hamilton PA | N/A | United States | Florida | Fort Lauderdale |
| 42 | Multiple Health Research LLC | N/A | United States | Texas | Arlington |
| 43 | Baylor Endocrine Center | N/A | United States | Texas | Dallas |
| 44 | Internal Medicine Associates Of Greenville | N/A | United States | South Carolina | Greenville |
| 45 | University Hospitals of Clevel | N/A | United States | Ohio | Cleveland |
| 46 | Thomas Jefferson University Di | N/A | United States | Pennsylvania | Philadelphia |
| 47 | Clinical Research Consultants, | N/A | United States | Alabama | Alabaster |
| 48 | Diabetes Research Group | N/A | United States | Kentucky | Lexington |
| 49 | The Carl & Edyth Lindner Cente | N/A | United States | Ohio | Cincinnati |
| 50 | Bala and Khaira Medical Cente | N/A | United States | California | StFresno |
| 51 | Tulane Medical Center | N/A | United States | Louisiana | New Orleans |
| 52 | University Medical Associates | N/A | United States | Kentucky | Louisville |
| 53 | Facey Medical Foundation | N/A | United States | California | Mission Hills |
| 54 | Preferred Primary Care Physici | N/A | United States | Pennsylvania | Uniontown |
| 55 | AM Diabetes And Endocrinology | N/A | United States | Tennessee | Bartlett |
| 56 | Albany Medical College | N/A | United States | New York | Albany |
| 57 | Christiana Care Health Services, Inc. | N/A | United States | Delaware | Newark |
| 58 | University of Texas Southweste | N/A | United States | Texas | Dallas |
| 59 | Central Florida Medical Associ | N/A | United States | Florida | Deland |
| 60 | Harold Hamm Diabetes Ctr | N/A | United States | Oklahoma | Oklahoma City |
| 61 | Michael R. MacAdams, MD | N/A | United States | Texas | Lubbock |
| 62 | Midwest Endocrinology | N/A | United States | Illinois | Crystal Lake |
| 63 | Martin Diagnostic Clinic | N/A | United States | Texas | Tomball |
| 64 | University Of Wisconsin-Madiso | N/A | United States | Wisconsin | Madison |
| 65 | Holston Medical Group | N/A | United States | Tennessee | Kingsport |
| 66 | La Porte County Institute For | N/A | United States | Indiana | Michigan City |
| 67 | The Diabetes Center, LLC | N/A | United States | South Carolina | Murrells Inlet |
| 68 | Physician Research Associates | N/A | United States | Georgia | Lawrenceville |
| 69 | Endocrine And Psychiatry Cente | N/A | United States | Texas | Houston |
| 70 | Fletcher Allen Health Care/The | N/A | United States | Vermont | South Burlington |
| 71 | Preferred PrimaryCare Physicia | N/A | United States | Pennsylvania | Pittsburgh |
| 72 | Internal Medicine Of Morris Co | N/A | United States | New Jersey | Mine Hill |
| 73 | Arthritis And Diabetes Clinic, | N/A | United States | Louisiana | Monroe |
| 74 | Optimum Clinical Research | N/A | United States | Utah | Salt Lake City |
| 75 | USC School Of Medicine | N/A | United States | South Carolina | Columbia |
| 76 | Northwest Houston Cardiology | N/A | United States | Texas | Houston |
| 77 | Oakland Medical Research Cente | N/A | United States | Michigan | Troy |
| 78 | University of Pennsylvania Rodebaugh Diabetes Center | N/A | United States | Pennsylvania | Philadelphia |
| 79 | Research Institute Of The Caro | N/A | United States | North Carolina | Mooresville |
| 80 | Endocrine Associates of Long I | N/A | United States | New York | Smithtown |
| 81 | Southern New Hampshire Diabete | N/A | United States | New Hampshire | Nashua |
| 82 | Central Arkansas Veterans | N/A | United States | Arkansas | Little Rock |
| 83 | Medical Investigations Inc. | N/A | United States | Arkansas | Little Rock |
| 84 | Whiteville Medical Associates | N/A | United States | North Carolina | Whiteville |
| 85 | Innovative Research of W Flori | N/A | United States | Florida | Clearwater |
| 86 | Catalina Research Institute, LLC | N/A | United States | California | Chino |
| 87 | Physicians East PA | N/A | United States | North Carolina | Greenville |
| 88 | DCOL Center for Clinical Resea | N/A | United States | Texas | Longview |
| 89 | Anaheim Clinical Trials, LLC | N/A | United States | California | Anaheim |
| 90 | Crescent City Clin Research | N/A | United States | Louisiana | Metairie |
| 91 | American Institute of Research | N/A | United States | California | Watsonville |
| 92 | Washington State University | N/A | United States | Washington | Spokane |
| 93 | Jsumc-Medicine & Endocrinology | N/A | United States | New Jersey | Neptune |
| 94 | Pioneer Medical Group | N/A | United States | California | Cerritos |
| 95 | Heritage Valley Medical Group | N/A | United States | Pennsylvania | Beaver |
| 96 | Mercy Medical Research Inst | N/A | United States | Missouri | Springfield |
| 97 | Naidu Clinic | N/A | United States | Texas | Odessa |
| 98 | Clinical Study Center Of Ashev | N/A | United States | North Carolina | Asheville |
| 99 | Diablo Clinical Research, Inc. | N/A | United States | California | Walnut Creek |
| 100 | Union Memorial Hsptl | N/A | United States | Maryland | Baltimore |
| 101 | Orange County Senior Care Clinical Trials | N/A | United States | California | Tustin |
| 102 | University Of Tennessee | N/A | United States | Tennessee | Memphis |
| 103 | Diabetes And Endocrinology Con | N/A | United States | North Carolina | Morehead City |
| 104 | Rush University Medical Center | N/A | United States | Illinois | Chicago |
| 105 | Eastern Shore Medical Speciali | N/A | United States | Alabama | Mobile |
| 106 | Va Med Center | N/A | United States | Ohio | Cleveland |
| 107 | Denver Va Med Center | N/A | United States | Colorado | Denver |
| 108 | Benefis Medical Group | N/A | United States | Montana | Great Falls |
| 109 | Linda Vista Health Care Center | N/A | United States | California | San Diego |
| 110 | Model Clinical Research | N/A | United States | Maryland | Baltimore |
| 111 | University Of Colorado Denver Hospital | N/A | United States | Colorado | Aurora |
| 112 | Medical University Of South Ca | N/A | United States | South Carolina | Charleston |
| 113 | Cincinnati Veterans Affairs | N/A | United States | Ohio | Cincinnati |
| 114 | UNC Diabetes Research | N/A | United States | North Carolina | Greensboro |
| 115 | Vanderbilt Diabetes Center | N/A | United States | Tennessee | Nashville |
| 116 | Alternative Solutions Research | N/A | United States | Florida | St. Petersburg |
| 117 | FPA Clinical Research | N/A | United States | Florida | Kissimmee |
| 118 | Dallas Diabetes & Endocrine Ce | N/A | United States | Texas | Dallas |
| 119 | Florida Hsptl Diabetes Inst | N/A | United States | Florida | Orlando |
| 120 | Medex HealthCare Research Inc | N/A | United States | Missouri | St. Louis |
| 121 | Panacea Clinical Research | N/A | United States | Texas | San Antonio |
| 122 | Covenant Clinical Research | N/A | United States | Texas | San Antonio |
| 123 | Dr Robert Bloomberg | N/A | United States | Arizona | Tempe |
| 124 | Iowa Diabetes & Endocrinology | N/A | United States | Iowa | Des Moines |
| 125 | Padre Coast Clinical Research | N/A | United States | Texas | Corpus Christi |
| 126 | Meridien Research | N/A | United States | Florida | Bradenton |
| 127 | Medex Healthcare Research, Inc | N/A | United States | New York | New York |
| 128 | Endocrine Research Solutions | N/A | United States | Georgia | Roswell |
| 129 | Natchitoches Internal Med | N/A | United States | Louisiana | Natchitoches |
| 130 | Awasty Research Network | N/A | United States | Ohio | Cadiz |
| 131 | Mountain View Clinical Researc | N/A | United States | South Carolina | Ext.Greer |
| 132 | Great Falls Clinic | N/A | United States | Montana | Great Falls |
| 133 | Eastern Clinical Research Unit | N/A | Australia | Victorian State | N/A |
| 134 | Ed | N/A | Australia | South Australia | N/A |
| 135 | Fremantle Hospital | N/A | Australia | Western Australia | N/A |
| 136 | The Townsville Hospital | N/A | Australia | Queensland | N/A |
| 137 | Royal Hobart Hospital | N/A | Australia | Tasmania | N/A |
| 138 | Logan Hospital | N/A | Australia | Queensland | N/A |
| 139 | Royal Brisbane & Womens Hospital | N/A | Australia | Queensland | N/A |
| 140 | Blacktown Hospital | N/A | Australia | New South Wales | N/A |
| 141 | St Vincent Hospital & University of Melbourne | N/A | Australia | Victorian State | N/A |
| 142 | South Australian Endocrine Research Pty Ltd | N/A | Australia | South Australia | N/A |
| 143 | LKH-Univ. Klinikum Graz | N/A | Austria | N/A | Graz |
| 144 | Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel | N/A | Austria | N/A | Wien |
| 145 | Krankenanstalt der Stadt Wien - Rudolfstiftung | N/A | Austria | N/A | Wien |
| 146 | Hanusch-Krankenhaus | N/A | Austria | N/A | Wien |
| 147 | AKH Wien | N/A | Austria | N/A | Wien |
| 148 | Universitair Ziekenhuis Antwerpen | N/A | Belgium | N/A | Edegem |
| 149 | UZ Leuven - Campus Gasthuisberg | N/A | Belgium | N/A | Leuven |
| 150 | CHU de Liège - Domaine Universitaire du Sart Tilman | N/A | Belgium | N/A | Liege |
| 151 | UZ Gent | N/A | Belgium | N/A | Gent |
| 152 | Servi？o de Diabetes- UFPR | N/A | Brazil | PR | Curitiba |
| 153 | Fac. Med. Marília - Diabetes | N/A | Brazil | SP | Marília |
| 154 | UNIFESP - Diabetes | N/A | Brazil | SP | Sao Paulo |
| 155 | CPCLIN | N/A | Brazil | SP | Sao Paulo |
| 156 | Sala Pesquisa Clínica - Incor | N/A | Brazil | SP | Sao Paulo |
| 157 | IEDE | N/A | Brazil | Rio de Janeiro | Rio de Janeiro |
| 158 | IPEC | N/A | Brazil | SP | Sao Paulo |
| 159 | IPCEM | N/A | Brazil | RS | Caxias do Sul |
| 160 | UNICAMP | N/A | Brazil | SP | Campinas |
| 161 | NúCLEO DE MEDICINA INTEGRADA | N/A | Brazil | SP | Mogi das Cruzes |
| 162 | CENTRO DE PESQ. MéDICAS | N/A | Brazil | PE | Espinheiro |
| 163 | CEDH | N/A | Brazil | CE | Fortaleza |
| 164 | Centro Pesq Diabetes e Endoc. | N/A | Brazil | CE | Fortaleza |
| 165 | Hosp Jo？o de Barros Barreto | N/A | Brazil | Para | Belém |
| 166 | Centro de Diabetes de Sergipe | N/A | Brazil | SE | Aracaju |
| 167 | RDM PESQUISAS CLíNICAS | N/A | Brazil | GO | Goiania |
| 168 | CEPCEM | N/A | Brazil | MG | Belo Horizonte |
| 169 | HC S？O PAULO | N/A | Brazil | SP | Sao Paulo |
| 170 | CPD | N/A | Brazil | RS | Porto Alegre |
| 171 | UNIVERSIDADE POSITIVO | N/A | Brazil | PR | Curitiba |
| 172 | IEJE-CAD | N/A | Brazil | SC | JOINVILLE |
| 173 | Centro de Diabetes de Curitiba | N/A | Brazil | PR | Curitiba |
| 174 | Hosp. das Clínicas | N/A | Brazil | SP | Sao Paulo |
| 175 | Endoclínica | N/A | Brazil | SP | Sao Paulo |
| 176 | Fadlo Fraige Filho | N/A | Brazil | SP | Sao Paulo |
| 177 | IEP | N/A | Brazil | RS | Porto Alegre |
| 178 | CEG Campinas | N/A | Brazil | SP | Campinas |
| 179 | Santa Casa de Curitiba | N/A | Brazil | PR | Curitiba |
| 180 | Hospital Sao Joaquim | N/A | Brazil | SP | Sao Paulo |
| 181 | I.Cearense de Endocrinologia | N/A | Brazil | CE | Fortaleza |
| 182 | ICF | N/A | Brazil | GO | Goiania |
| 183 | PUCCAMP | N/A | Brazil | SP | Campinas |
| 184 | Hospital Geral de Fortaleza | N/A | Brazil | CE | Fortaleza |
| 185 | Dr. Roy Allison | NA | Canada | Ontario | Thunder Bay |
| 186 | Canadian Centre for Research on Diabetes | NA | Canada | Ontario | Smiths Falls |
| 187 | Cornwall Clinical Trials | NA | Canada | Ontario | Cornwall |
| 188 | Credit Valley Endo Research | NA | Canada | Ontario | West Mississauga |
| 189 | Centre for Studies in Family Medicine | NA | Canada | Ontario | London |
| 190 | London Diabetes Clinical Trials Unit (LDCTU) | NA | Canada | Ontario | London |
| 191 | Institut Universitaire de Cardiologie et de Pneumologie de Quebec | NA | Canada | Quebec | Quebec |
| 192 | Health Science Centre Eastern Health/Memorial University of Newfoundland | NA | Canada | Newfoundland | St. John’s |
| 193 | Dr. Joanne Liutkus | NA | Canada | Ontario | Cambridge |
| 194 | Capital District Health Authority, QEII Health Sciences Centre, Division of Endocrinology and Metabolism | NA | Canada | Nova Scotia | Halifax |
| 195 | Mount Sinai Hospital | NA | Canada | Ontario | Toronto |
| 196 | Rouge Valley Metabolic Research Centre | NA | Canada | Quebec | Montreal |
| 197 | Dr. John Sigalas | NA | Canada | Ontario | Scarborough |
| 198 | Health Sciences Centre | NA | Canada | Manitoba | Winnipeg |
| 199 | St. Michael's Hospital | NA | Canada | Ontario | Toronto |
| 200 | Baker Clinic | NA | Canada | Alberta | Edmonton |
| 201 | Unité de recherche sur le diabète | NA | Canada | Quebec | Quebec |
| 202 | VFN-III. Interna | NA | Czech Republic | NA | Praha |
| 203 | FN Plzen | NA | Czech Republic | NA | Plzen-Lochotin |
| 204 | Steno Diabetes Center | NA | Denmark | NA | NA |
| 205 | Hvidovre Hospital | NA | Denmark | NA | Hvidovre |
| 206 | Odense Universitetshospital | NA | Denmark | NA | Odense C |
| 207 | Esbjerg Sygehus,Sydvestjysk Sygehus Esbjerg | NA | Denmark | NA | Esbjerg |
| 208 | Arhus Universitetshospital THG | NA | Denmark | NA | Arhus C |
| 209 | Aalborg Sygehus | NA | Denmark | NA | Alborg |
| 210 | Kuopio University Hospital | NA | Finland | NA | Kuopio |
| 211 | Myyrm？ki Health Centre | NA | Finland | NA | Vantaa |
| 212 | Mehil？inen Lahti | NA | Finland | NA | Lahti |
| 213 | FinnMedi Research Ltd | NA | Finland | NA | Tampere |
| 214 | Oulu Sis？tautien tutkimuslaboratorio | NA | Finland | NA | Oulu |
| 215 | Hopital BICHAT | NA | Finland | NA | Paris |
| 216 | Hopital CAREMEAU | NA | Finland | NA | Nimes |
| 217 | Hopital Sud-Francilien | NA | Finland | NA | Corbeil |
| 218 | Cabinet médical | NA | Finland | NA | Jarny |
| 219 | Diabetologische Schwerpunktpraxis | NA | Germany | NA | Gifhorn |
| 220 | Hauptstr | NA | Germany | NA | Essen |
| 221 | Zentrum für Klinische Studien | NA | Germany | NA | Elsterwerda |
| 222 | Praxis für Pr？vention und Therapie | NA | Germany | NA | Villingen-Schwenningen |
| 223 | ClinTrial Berlin | NA | Germany | NA | Berlin |
| 224 | Studienzentrum | NA | Germany | NA | Aschaffenburg |
| 225 | UnUniversit？tsklinikum Ulm | NA | Germany | NA | Ulm |
| 226 | Poststr | NA | Germany | NA | Falkensee |
| 227 | NA | NA | Germany | NA | Dresden |
| 228 | NA | NA | Germany | NA | Schweinfurt |
| 229 | NA | NA | Germany | NA | Wangen |
| 230 | Medizinische Klinik LMU | NA | Germany | NA | München |
| 231 | NA | NA | Germany | NA | St. Ingbert |
| 232 | Synexus ClinPharm GmbH | NA | Germany | NA | Leipzig |
| 233 | NA | NA | Germany | NA | Mannheim |
| 234 | Studienzentrum in Berlin | NA | Germany | NA | Berlin |
| 235 | Sana Kliniken Ostholstein GmbH | NA | Germany | NA | Oldenburg |
| 236 | NA | NA | Germany | NA | Schkeuditz |
| 237 | NA | NA | Germany | NA | Dillingen |
| 238 | NA | NA | Germany | NA | Hamburg |
| 239 | NA | NA | Germany | NA | Ludwigshafen |
| 240 | Polyclinic Athens | NA | Greece | NA | Athens |
| 241 | Laiko General Hospital of Athens | NA | Greece | NA | Athens |
| 242 | Clinic | NA | Greece | NA | Thessaloniki |
| 243 | Care Outpatient Centre | NA | India | NA | Hyderabad |
| 244 | Arthur Asirvatham hospital | NA | India | NA | Madurai |
| 245 | Post Graduate Institute of | NA | India | NA | Chandigarh |
| 246 | Bangalore Endocrinology and Diabetes Research Centre | NA | India | NA | Bangalore |
| 247 | TOTALL Diabetes Hormone Institute | NA | India | NA | Indore |
| 248 | Amitra Institute Of Medical Sciences & Research Centre | NA | India | NA | Kochi |
| 249 | Seth GS medical college and KEM Hospital | NA | India | NA | Mumbai |
| 250 | Madras Diabetes Research Foundation | NA | India | NA | Chennai |
| 251 | Christian Medical College Hospital | NA | India | NA | Vellore |
| 252 | Department of Medicine - Kasturba Hospital | NA | India | NA | Manipal |
| 253 | Excel Centre | NA | India | NA | Guwahati |
| 254 | Apollo Gleneagles Hospital | NA | India | NA | Kolkata |
| 255 | Osmania General Hospital | NA | India | NA | Hyderabad |
| 256 | Bangalore Diabetes Hospital | NA | India | NA | Bangalore |
| 257 | Bangalore Clinisearch | NA | India | NA | Bangalore |
| 258 | Bharti Research Insititute of Diabetes & Endocrinology | NA | India | NA | Karnal |
| 259 | Dr V Seshiah Research Institute and Dr Balaji Diabetes Care | NA | India | NA | Chennai |
| 260 | Jothydev's Diabetes & Research Center | NA | India | NA | Thriruvananthapuram |
| 261 | Diabetes Day Centre, St Vincent’s University Hospital | NA | Ireland | NA | Dublin |
| 262 | Diabetes Day Centre, Beaumont Hospital | NA | Ireland | NA | Dublin |
| 263 | Hadassah Ein Karem | NA | Israel | NA | Jerusalem |
| 264 | Sheba Medical Center | NA | Israel | NA | Tel Hashomer |
| 265 | Rambam MC | NA | Israel | NA | Haifa |
| 266 | Hasharon Dept. D | NA | Israel | NA | Petah-Tikva |
| 267 | Linn Medical Center | NA | Israel | NA | Haifa |
| 268 | Azienda Ospedaliero Universitaria Careggi | NA | Italy | NA | Firenze |
| 269 | Ospedale Civile Campo di Marte | NA | Italy | NA | Lucca |
| 270 | Policlinico Universitario P. Giaccone | NA | Italy | NA | Palermo |
| 271 | Università degli Studi | NA | Italy | NA | Chieti |
| 272 | Centro Antidiabetologico | NA | Italy | NA | Bologna |
| 273 | PU Umberto I | NA | Italy | NA | Roma |
| 274 | Ospedale San Raffaele | NA | Italy | NA | Milano |
| 275 | U.O. di Medicina Interna Policlinico Mater Domini Università di Catanzaro | NA | Italy | NA | Catanzaro |
| 276 | Centro Antidiabetologico | NA | Italy | NA | Bologna |
| 277 | Ospedale Santa Maria Goretti | NA | Italy | NA | Latina |
| 278 | The Catholic University of Korea, Seoul St. Mary's Hospital | NA | Korea | NA | Seoul |
| 279 | Seoul National University Bundang Hospital | NA | Korea | NA | Gyeonggi-do |
| 280 | Kyung Hee University Hospital | NA | Korea | NA | Seoul |
| 281 | National Health Insurance Corporation | NA | Korea | NA | Gyeonggi-do |
| 282 | Eulji General Hospital | NA | Korea | NA | Seoul |
| 283 | Unidad de Patología Clínica | NA | Mexico | NA | Jalisco |
| 284 | Hospital Universitario “Dr. Jose Eleuterio González” | NA | Mexico | NA | Nuevo León |
| 285 | Instituto Jalisciense de Investigación en Diabetes y Obesidad, S.C. | NA | Mexico | NA | Jalisco |
| 286 | Centro de Diabetes Durango | NA | Mexico | NA | Durango |
| 287 | Hospital Universitario “Dr. José Eleuterio González” | NA | Mexico | NA | Nuevo León |
| 288 | ICLE SC | NA | Mexico | NA | Jalisco |
| 289 | CardioPrevent | NA | Mexico | NA | Durango |
| 290 | Cardioarritmias e Investigación S.C. | NA | Mexico | NA | San Luis Potosí |
| 291 | UMC St. Radboud | NA | Netherlands | NA | Nijmegen |
| 292 | UMC Utrecht | NA | Netherlands | NA | Utrecht |
| 293 | Martini Ziekenhuis | NA | Netherlands | NA | Groningen |
| 294 | Maxima MC | NA | Netherlands | NA | Eindhoven |
| 295 | Slotervaart Ziekenhuis | NA | Netherlands | NA | Amsterdam |
| 296 | Bethesda diab. research center | NA | Netherlands | NA | Hoogeveen |
| 297 | Academisch Ziekenhuis Maastricht | NA | Netherlands | NA | Maastricht |
| 298 | SHL-Groep Wetenschappelijk Onderzoek | NA | Netherlands | NA | Etten-Leur |
| 299 | SHL-Groep Wetenschappelijk Onderzoek | NA | Netherlands | NA | Goes |
| 300 | Aker sykehus | NA | Norway | NA | NA |
| 301 | Stavanger Helseforskning | NA | Norway | NA | NA |
| 302 | Senter for sykelig overvekt | NA | Norway | NA | NA |
| 303 | St. Olav RSSO | NA | Norway | NA | NA |
| 304 | Diabetespoliklinikken, Ullev？l | NA | Norway | NA | NA |
| 305 | Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne | NA | Poland | NA | Kraków |
| 306 | KO-MED Marek Konieczny Centrum | NA | Poland | NA | Pu？awy |
| 307 | Przychodnia Specjalistyczna SPZOZ | NA | Poland | NA | Ruda ？l？ska |
| 308 | Klinika Chorób Wewn？trznych, Endokrynologii i Diabetologii | NA | Poland | NA | Warszawa |
| 309 | Centrum Medyczne OmniMed | NA | Poland | NA | ？ód？ |
| 310 | NZOZ Specjalistyczny O？rodek Internistyczno-Diabetologiczny Iwona Ma？gorzata Arciszewska | NA | Poland | NA | Bia？ystok |
| 311 | NZOZ ？l？skie Centrum Osteoporozy | NA | Poland | NA | Katowice |
| 312 | Bydgoskie Centrum Diabetologii i Endokrynologii Sp. z o.o. | NA | Poland | NA | Bydgoszcz |
| 313 | Synexus Polska Sp. z o.o. | NA | Poland | NA | Wroc？aw |
| 314 | UNICARDIA Specjalistyczne Centrum Leczenia | NA | Poland | NA | Kraków |
| 315 | SKPPUM im. K. Marcinkowskiego | NA | Poland | NA | Poznań |
| 316 | Synexus Polska Sp. z o.o. | NA | Poland | NA | Warszawa |
| 317 | Katedra Chorób Metabolicznych | NA | Poland | NA | Kraków |
| 318 | Clinical County Emergency Hospital | NA | Romania | NA | Craiova |
| 319 | Clinical County Emergency Hospital | NA | Romania | NA | Timisoara |
| 320 | Clinical County Emergency Hospital | NA | Romania | NA | Sibiu |
| 321 | Deva County Emergency Hospital | NA | Romania | NA | Deva |
| 322 | National Institute of Diabetes, Nutrition and Metabolic Diseases | NA | Romania | NA | Bucharest |
| 323 | County Emergency Hospital-Clinic of Diabet | NA | Romania | NA | Bacau |
| 324 | County Emergency Hospital-Clinic of Diabetes | NA | Romania | NA | Satu-Mare |
| 325 | Clinical County Emergency Hospital-Clinic of Diabetes, Nutrition and Metabolic Diseases | NA | Romania | NA | Sibiu |
| 326 | SC Consultmed SRL | NA | Romania | NA | Iasi |
| 327 | S.C. Cosamext S.R.L. | NA | Romania | NA | Targu Mures |
| 328 | Endocrinology Research Scientific Centre | NA | Russia | NA | Moscow |
| 329 | Central Clinical Hospital # 1 | NA | Russia | NA | Moscow |
| 330 | Moscow Medical Academy | NA | Russia | NA | Moscow |
| 331 | Regional clinical hospital | NA | Russia | NA | Saratov |
| 332 | Nizhny Novgorod regional clinical hospital | NA | Russia | NA | Nizhny Novgorod |
| 333 | Penza regional clinical hospital | NA | Russia | NA | Penza |
| 334 | City hospital №5, Barnaul | NA | Russia | NA | Barnaul |
| 335 | Tyumen State Medical Academy | NA | Russia | NA | Tyumen |
| 336 | KNMU, RH No.1 | NA | Russia | NA | Kazan |
| 337 | Arkhangelsk regional clinical hospital | NA | Russia | NA | Arkhangelsk |
| 338 | Smolensk State Medical Academy | NA | Russia | NA | Smolensk |
| 339 | Yaroslavl Regional Hospital | NA | Russia | NA | Yaroslavl |
| 340 | First City Clinical Hospital | NA | Russia | NA | Arkhangelsk |
| 341 | Clinical Hospital Center Zvezdara | NA | Serbia | NA | Belgrade |
| 342 | Clinical Centre of Serbia | NA | Serbia | NA | Belgrade |
| 343 | Clinical Centre of Serbia | NA | Serbia | NA | Belgrade |
| 344 | Clinical Centre of Serbia | NA | Serbia | NA | Belgrade |
| 345 | Dr Komati | NA | South Africa | NA | Pretoria |
| 346 | Centre for Diabetes & Endocrin | NA | South Africa | NA | Overport |
| 347 | Tread Research | NA | South Africa | NA | Parow |
| 348 | Dr S Pillay | NA | South Africa | NA | Amanzimtoti |
| 349 | Diabetes Care Centre | NA | South Africa | NA | Pretoria |
| 350 | Dr Lakha's Rooms | NA | South Africa | NA | Lenasia South |
| 351 | Wits Donald Gordon | NA | South Africa | NA | Parktown |
| 352 | Medi-Clinic Vergelegen | NA | South Africa | NA | Somerset West |
| 353 | Midrand Medical Centre | NA | South Africa | NA | Halfway House |
| 354 | Karl Bremer Hospital | NA | South Africa | NA | Bellville |
| 355 | Dr Moosa's Rooms | NA | South Africa | NA | Lenasia |
| 356 | Union Hospital | NA | South Africa | NA | Alberton |
| 357 | Medi-Clinic Heart Hospital | NA | South Africa | NA | Arcadia |
| 358 | Boanerges CC | NA | South Africa | NA | Fichardtpark |
| 359 | Netcare Umhlanga Medical Centr | NA | South Africa | NA | Umhlanga |
| 360 | Victoria Hospital | NA | South Africa | NA | Tongaat |
| 361 | IEN | NA | Spain | NA | Valladolid |
| 362 | Clínica San Pedro | NA | Spain | NA | Almería |
| 363 | Hospital Son Llatzer | NA | Spain | NA | Mallorca |
| 364 | Hospital de Mostoles | NA | Spain | NA | Madrid |
| 365 | Hospital Nuestra Se？ora de Valme | NA | Spain | NA | Sevilla |
| 366 | Hospital Clínico San | NA | Spain | NA | Madrid |
| 367 | Clínica Nuevas Tecnologías en Diabetes y Endocrinología | NA | Spain | NA | Sevilla |
| 368 | Clinic i Provincial Barcelona | NA | Spain | NA | Barcelona |
| 369 | Hospital Quirón | NA | Spain | NA | Madrid |
| 370 | C.H.Universitario A Coru？a | NA | Spain | NA | A Coru？a |
| 371 | Klinisk Forskning | NA | Sweden | NA | Stockholm |
| 372 | City Diabetes | NA | Sweden | NA | Stockholm |
| 373 | Clinical Research Support, CRS | NA | Sweden | NA | ？rebro |
| 374 | KTA, Karolinska Trial Alliance | NA | Sweden | NA | Stockholm |
| 375 | Endokrinologiska kliniken | NA | Sweden | NA | Malm？ |
| 376 | Lundberglaboratoriet f？r diabetesforskning | NA | Sweden | NA | G？teborg |
| 377 | Chung Gung Medical Foundation-Linkou Branch | NA | China | Taiwan | Taoyuan |
| 378 | Changhua Christian Hospital | NA | China | Taiwan | Changhua |
| 379 | Chi-Mei Medical Center | NA | China | Taiwan | Tainan |
| 380 | Kaohsiung Medical University Chung-Ho Memorial Hospital | NA | China | Taiwan | Kaohsiung |
| 381 | Istanbul Universitesi Istanbul Tip Fakultesi | NA | Turkey | NA | CapaIstanbul |
| 382 | Marmara Universitesi Hospital | NA | Turkey | NA | Istanbul |
| 383 | Ankara University Ibni Sina Hastanesi | NA | Turkey | NA | Ankara |
| 384 | Hacettepe Universitesi Tip Fakultesi Hastanesi | NA | Turkey | NA | Ankara |
| 385 | Dokuz Eylul University Medical Faculty | NA | Turkey | NA | IZMIR |
| 386 | Haseki Egitim ve Arastirma Hastanesi | NA | Turkey | NA | Istanbul |
| 387 | Sisli Etfal Hospital | NA | Turkey | NA | Istanbul |
| 388 | Ankara Numune Training and Research Hospital | NA | Turkey | NA | Ankara |
| 389 | Gaziantep Universitesi Tip Fakultesi Hastanesi | NA | Turkey | NA | Gaziantep |
| 390 | Goztepe Egitim ve Arastirma Hastanesi | NA | Turkey | NA | Istanbul |
| 391 | Gazi University Medical Faculty | NA | Turkey | NA | Ankara |
| 392 | Erciyes Universitesi Tip Fakultesi | NA | Turkey | NA | Kayseri |
| 393 | Ege Universitesi Tip Fakultesi Hastanesi | NA | Turkey | NA | IZMIR |
| 394 | Dr Lutfu Kirdar Kartal Egitim ve Arastirma Hastanesi | NA | Turkey | NA | Istanbul |
| 395 | Akdeniz University Tip Fakultesi Hastanesi | NA | Turkey | NA | ANTALYA |
| 396 | Cerrahpasa Medical Faculty | NA | Turkey | NA | Istanbul |
| 397 | Florence Nightingale Hastanesi | NA | Turkey | NA | Istanbul |
| 398 | Uludag University Medical Faculty Endocrinology Unit | NA | Turkey | NA | BURSA |
| 399 | Rashid Hospital | NA | United Arab Emirates | NA | Dubai |
| 400 | Aberdeen Royal Infirmary | NA | United Kingdom | NA | Aberdeen |
| 401 | St John's Hospital | NA | United Kingdom | NA | West Lothian |
| 402 | Michael White Centre for Diabetes & Endocrinology | NA | United Kingdom | NA | Hull |
| 403 | Morriston Hospital | NA | United Kingdom | NA | Swansea |
| 404 | Birmingham Heartlands Hospital | NA | United Kingdom | NA | Birmingham |
| 405 | Salford Royal NHS | NA | United Kingdom | NA | Manchester |
| 406 | Southmead Hospital | NA | United Kingdom | NA | Bristol |
| 407 | University Hospitals Coventry & Warwickshire NHS | NA | United Kingdom | NA | Coventry |
| 408 | BHF Glasgow Research Centre | NA | United Kingdom | NA | Glasgow |
| 409 | Ninewells Hospital | NA | United Kingdom | NA | Dundee |
| 410 | Univ Dept of Med, Plymouth | NA | United Kingdom | NA | Plymouth |
| 411 | Ninewells Hospital | NA | United Kingdom | NA | Dundee |
| 412 | Sandwell General Hospital | NA | United Kingdom | NA | West Bromwich |
| 413 | Royal Surrey County Hospital | NA | United Kingdom | NA | Surrey |
| 414 | University of East Anglia | NA | United Kingdom | NA | Norfolk |
| 415 | George Eliot Hospital | NA | United Kingdom | NA | Warwickshire |
| 416 | Torbay Hospital | NA | United Kingdom | NA | Torquay |
| 417 | Royal Devon & Exeter NHS Foundation Trust | NA | United Kingdom | NA | Exeter |
| 418 | St Mary's Hospital | NA | United Kingdom | NA | London |
| 419 | St. Helens Hospital | NA | United Kingdom | NA | Merseyside |
五、伦理委员会信息
| 序号 | 名称 | 审查结论 | 批准日期/备案日期 |
|---|---|---|---|
| 1 | 中国人民解放军总医院伦理委员会 | 同意 | 2011-11-16 |
六、试验状态信息
1、试验状态
已完成
2、试验人数
| 目标入组人数 | 国内: 65 ； 国际: 8754 ； |
|---|---|
| 已入组人数 | 国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息； |
| 实际入组总人数 | 国内: 92 ； 国际: 9341 ； |
3、受试者招募及试验完成日期
| 第一例受试者签署知情同意书日期 | 国内：2012-01-05； 国际：2010-08-31； |
|---|---|
| 第一例受试者入组日期 | 国内：登记人暂未填写该信息； 国际：登记人暂未填写该信息； |
| 试验完成日期 | 国内：2015-10-28； 国际：2015-12-17； |
TOP