登记号
CTR20140661
相关登记号
曾用名
药物类型
化学药物
临床申请受理号
企业选择不公示
适应症
糖尿病肾病
试验通俗题目
Atrasentan的糖尿病肾病研究
试验专业题目
评价Atrasentan对Ⅱ型糖尿病肾病受试者肾脏预后影响的随机多国家多中心双盲平行安慰剂对照研究 SONAR：Atrasentan的糖尿病肾病研究
试验方案编号
M11-352
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
康越
联系人座机
021-62631384
联系人手机号
联系人Email
yue.kang@abbvie.com
联系人邮政地址
上海市南京西路288号创兴金融中心17楼
联系人邮编
200003
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
评价与安慰剂相比, Atrasentan对2型糖尿病肾病受试者血清肌酐倍增所需时间或终末期肾病（ESRD）出现时间的影响。此外，本研究评估与安慰剂相比, Atrasentan对下述结果的影响：心血管发病率和死亡率、尿白蛋白排泄率、估算的肾小球滤过率变化，还评估对Ⅱ型糖尿病肾病受试者生活质量的影响。
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
18岁(最小年龄)至
85岁(最大年龄)
性别
男+女
健康受试者
无
入选标准
- 受试者身患Ⅱ型糖尿病，在筛选期之前3个月内，至少接受一种降糖药物和ACEi/或ARB（RAS抑制剂）治疗。受试者不能为Ⅰ型糖尿病患者（定义为：在35岁之前发病，并在1型糖尿病确诊后12月内需要长期胰岛素治疗）。
- HbA1c ≤ 12%
- 为了进入准备期，根据实验室筛选指标，受试者必须满足下述标准：估算的GFR为25~75mL/min/1.73m2，UACR≥300、<5000 mg/g（eGFR在60~75 mL/min/1.73m2之间的受试者人数应占总人群的10%以下；血清白蛋白≥3.0g/dL（30 g/L）；BNP≤200pg/mL（200 ng/L）；SBP≥100、≤160 mmHg；血钾>3.0（3 mmol/L）、≤5.5 mEq/L（5.5 mmol/L）；
- 为了进入强化期，根据准备期最后一次访视结果，受试者必须满足下述标准：接受RAS抑制剂MTLDD剂量已治疗4周，且未调整过剂量；在筛选时，接受RAS抑制剂MTLDD剂量治疗、但未接受利尿剂治疗（除非有医疗禁忌症）的受试者必须进入至少两周的准备期。
- 为了进入双盲治疗期，根据强化期最后一次访视结果，受试者必须满足下述标准：在强化期内，已接受RAS抑制剂MTLDD剂量治疗过6周，且未曾调整过剂量；接受任一剂量利尿剂，除非经研究者判断有医疗禁忌症或临床不能耐受（即：低血压或低钾血症）；从强化期开始的6周强化期间，体重变化<3kg，血清BNP绝对值<300pg/mL（300 ng/L）；在强化期结束时，受试者不得发生AKI事件（定义为：在强化期第6周访视时即访视E5，血清肌酐相对基线变化升高0.5 mg/dL以上，相对基线升高率大于20%）。
排除标准
- 在筛选前6个月内，有中度或重度外周水肿、与外伤无关的肺水肿或面部水肿等病史的受试者，或有粘液性水肿病史的受试者；
- 有肺动脉高血压病史且需要输氧治疗和/或内皮素受体拮抗剂或磷酸二酯酶治疗的受试者；或有任一种肺病（比如：慢性阻塞性肺病、肺气肿、肺纤维化）且需要输氧治疗的受试者；
- 受试者已有记录诊断为心衰，或因心衰或与心衰相符的症状（运动性呼吸困难、脚肿、端坐呼吸、发作性夜间呼吸困难；其他原因未能解释这些症状）而住院，且治疗心衰的药物或其他治疗措施有变化。
- 已知受试者罹患非糖尿病肾病（肾结石除外）；
- 在过去6个月内，受试者有症状性低血压病史；
试验分组
试验药
| 名称 | 用法 |
|---|---|
|
中文通用名:Atrasentan (ABT-627)
|
用法用量:薄膜衣片；规格0.75mg；口服，一日一次，48个月。
|
对照药
| 名称 | 用法 |
|---|---|
|
中文通用名:安慰剂
|
用法用量:薄膜衣片；口服，一日一次，48个月。
|
终点指标
主要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| 首次出现肾脏复合终点所需时间：血清肌酐倍增（30天血清肌酐确认）或ESRD发病（需要长期透析或肾移植或肾死亡）。 | 大约48个月 | 有效性指标+安全性指标 |
次要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| UACR从基线至随机分组第24个月访视时的变化； | 从第0天至第24个月 | 有效性指标+安全性指标 |
| 从随机分组起治疗3个月后，eGFR下降30%所需时间； | 大约24个月 | 有效性指标+安全性指标 |
| 出现心肾复合终点所需时间：血清肌酐倍增、ESRD、CV死亡、非致命性心肌梗死、非致命性卒中； | 大约48个月 | 有效性指标+安全性指标 |
| 出现CV复合终点所需时间：CV死亡、非致命性心肌梗死和非致命性卒中； | 大约48个月 | 有效性指标+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 | |
|---|---|---|---|---|---|---|---|
| 侯凡凡 | 教授，主任医师，中国科学院院士 | 020-61641591 | ffhouguangzhou@163.com | 广东省广州市广州大道北1838号 | 510515 | 南方医科大学南方医院 |
各参加机构信息
| 机构名称 | （主要）研究者 | 国家 | 地区 | 城市 |
|---|---|---|---|---|
| 南方医科大学南方医院 | 侯凡凡 | 中国 | 广东省 | 广州 |
| 广东省人民医院 | 史伟 | 中国 | 广东省 | 广州 |
| 复旦大学附属华山医院 | 郝传明 | 中国 | 上海 | 上海 |
| 北京大学人民医院 | 左力 | 中国 | 北京 | 北京 |
| 北京大学人民医院 | 纪立农 | 中国 | 北京 | 北京 |
| 北京协和医院 | 李玉秀 | 中国 | 北京 | 北京 |
| 北京大学第一医院 | 郭晓蕙 | 中国 | 北京 | 北京 |
| 北京大学第三医院 | 王松 | 中国 | 北京 | 北京 |
| 上海交通大学医学院附属仁济医院 | 倪兆慧 | 中国 | 上海 | 上海 |
| 武汉大学人民医院 | 丁国华 | 中国 | 湖北省 | 武汉 |
| 上海交通大学医学院附属瑞金医院 | 陈楠 | 中国 | 上海 | 上海 |
| 山东省立医院 | 赵家军 | 中国 | 山东省 | 济南 |
| 青岛大学附属医院 | 徐岩 | 中国 | 山东省 | 青岛 |
| 第四军医大学第一附属医院（西京医院） | 姬秋和 | 中国 | 陕西省 | 西安 |
| 第四军医大学第一附属医院（西京医院） | 孙世仁 | 中国 | 陕西省 | 西安 |
| 中国人民解放军第三军医大学第一附属医院 | 吴雄飞 | 中国 | 重庆 | 重庆 |
| 南京医科大学第一附属医院 | 邢昌赢 | 中国 | 江苏省 | 南京 |
| 西安交通大学第一附属医院 | 施秉银 | 中国 | 陕西省 | 西安 |
| 佛山市第一人民医院 | 肖观清 | 中国 | 广东省 | 佛山 |
| 华中科技大学同济医学院附属同济医院 | 徐钢 | 中国 | 湖北省 | 武汉 |
| 四川大学华西医院 | 付平 | 中国 | 四川省 | 成都 |
| 东南大学附属中大医院 | 刘必成 | 中国 | 江苏省 | 南京 |
| 复旦大学附属中山医院 | 丁小强 | 中国 | 上海 | 上海 |
| 上海市第六人民医院 | 贾伟平 | 中国 | 上海 | 上海 |
| 首都医科大学附属北京同仁医院 | 杨金奎 | 中国 | 北京 | 北京 |
| 大连医科大学附属第二医院 | 苏本利 | 中国 | 辽宁省 | 大连 |
| 中山大学附属第三医院 | 翁建平 | 中国 | 广东省 | 广州 |
| 北京大学第一医院 | 赵明辉 | 中国 | 北京 | 北京 |
| 上海长征医院 | 郁胜强 | 中国 | 上海 | 上海 |
| Apex Medical Research, Inc. | Ahmed Azazuddin | United States | Illinois | Chicago |
| Farmington Research LLC | Amin Mohammad | United States | Missouri | Farmington |
| Biolab Research, LLC | Belledonne Mario | United States | MARYLAND | Rockville |
| California Institute of Renal Research | Belo Diogo | United States | CALIFORNIA | Chula Vista |
| Academic Medical Research Institute | El-Shahawy Mohamed | United States | California | Los Angeles |
| California Institute of Renal Research | Fadda George | United States | California | La Mesa |
| East West Medical Research Institute | Fitz-Patrick David | United States | Hawaii | Honolulu |
| Brookview Hills Research Associates, LLC | Greenwood Gregory | United States | North Carolina | Winston-Salem |
| Hypertension and Renal Research Group | Herman Theodore | United States | New York | Orchard Park |
| North Shore Diabetes and Endocrine Associates | Hershon Kenneth | United States | NEW YORK | New Hyde Park |
| North America Research Institute | Jamal Aamir | United States | CALIFORNIA | Azusa |
| Metabolic Research Institute, Inc. | Kaye William | United States | FLORIDA | West Palm Beach |
| Northeast Clinical Research Centers, LLC | Kopyt Nelson | United States | Pennsylvania | Bethlehem |
| South Texas Kidney Specialists, PA | Mangoo-Karim Roberto | United States | Texas | McAllen |
| Model Clinical Research | Mersey James | United States | MARYLAND | Baltimore |
| Hurley Medical Center | Osama Sayed | United States | Michigan | Flint |
| Clinical Advancement Center, PLLC | Pergola Pablo | United States | Texas | San Antonio |
| Creighton University Medical Center | Rendell Marc | United States | Nebraska | Omaha |
| Tulane University Health Sciences Center | Simon Eric | United States | Louisiana | New Orleans |
| Pines Clinical Research, Inc. | Zeig Steven | United States | Florida | Pembroke Pines |
| Metrolina Nephrology Associates, PA | Chuang Peale | United States | North Carolina | Charlotte |
| Sansum Clinic | Elder John | United States | California | Santa Barbara |
| Desert Medical Group, Inc. | Jardula Michael | United States | California | Palm Springs |
| Texas Tech University Health Sciences Center | Ahmed Vaqar | United States | Texas | Lubbock |
| George Washington University Medical Faculty Associates | Cohen Scott | United States | District of Columbia | Washington |
| MetroHealth Medical Center | Sedor John | United States | Ohio | Cleveland |
| Rhode Island Hospital | Bayliss George | United States | Rhode Island | Providence |
| Axis Clinical Trials | Hazan Lydie | United States | California | Los Angeles |
| FPA Family Health Care Clinical Studies | Link Michael | United States | FLORIDA | Kissimmee |
| Down East Medical Associates, P.A. | Lawrence Mary | United States | North Carolina | Morehead |
| University of Cincinnati, College of Medicine | El-Khatib Mahmoud | United States | Ohio | Cincinnati |
| Gwinnett Biomedical Research | Lalwani Tarik | United States | Georgia | Lawrenceville |
| San Diego Coastal Endocrinology Group, aMC | Argoud Georges | United States | California | Chula Vista |
| PrimeCare Medical Group | Doshi Ankur | United States | Texas | Houston |
| Green Clinic LLC | Nammour Michael | United States | Louisiana | Ruston |
| Eastern Nephrology Associates, PLCC | Montero Manuel | United States | North Carolina | New Bern |
| St. Jude Hospital | Gilbert John | United States | California | Fullerton |
| University of Chicago | Bakris George | United States | Illinois | Chicago |
| Emory University Hospital | Guasch Antonio | United States | Atlanta | Georgia |
| Providence Clinical Research | Sligh Teresa | United States | North Hollywood | California |
| University of Tennessee Health Sciences Center | Kovesdy Csaba | United States | Memphis | Tennessee |
| Hypertension and Nephrology Associates PA | Liss Kenneth | United States | Eatontown | New Jersey |
| Endocrinology Associates, Inc. | Christofides Elena | United States | Columbus | Ohio |
| Louisiana State University Health Sciences Center | Reisin Efrain | United States | New Orleans | Louisiana |
| Clinical Research Development Associates, LLC | Scott David | United States | Rosedale | New York |
| University of Mississippi Medical Center | Juncos Luis | United States | Jackson | Mississippi |
| Capital Nephrology Medical Group | Atray Naveen | United States | Sacramento | California |
| East Carolina University Nephrology Research | Hames Melanie | United States | Greenville | North Carolina |
| Boice-Willis Clinic, P.A. | Jere Charles | United States | Rocky Mount | North Carolina |
| My Kidney Center, LLC | Bedros Fadi | United States | Manhattan | Kansas |
| Jersey Shore University Medical Center | Asnani Sunil | United States | Neptune | New Jersey |
| Sierra Nevada Nephrology Consultants | Vicks Steven | United States | Reno | Nevada |
| Stamford Nephrology | Brown Eric | United States | Connecticut | Stamford |
| Briggs Clinical Research, LLC | Gaona, Sr. Raul | United States | Texas | San Antonio |
| National Research Institute | Frias Juan | United States | California | Los Angeles |
| Cooper Nephrology | McFadden Christopher | United States | New Jersey | Camden |
| Herman Clinical Research, LLC | Herman Lee | United States | Georgia | Suwanee |
| Columbia Nephrology Associates, PA | Buerkert John | United States | South Carolina | Columbia |
| Apex Medical Research, MI,Inc. | Arif Ahmed | United States | Michigan | Flint |
| Alta Pharmaceutical Research Center, Inc. | Miller Alan | United States | GEORGIA | Dunwoody |
| University of Utah | Beddhu Srinivasan | United States | Utah | Salt Lake City |
| Central Florida Internists | Khan Muhammad | United States | Florida | St. Cloud |
| Remedica LLC | Tatu Horia | United States | Michigan | Rochester |
| Lucita M. Cruz MD | Cruz Lucita | United States | California | Norwalk |
| Knoxville Kidney Center, PLLC | Newman George | United States | Tennessee | Knoxville |
| West Virginia University, School of Medicine | Schmidt Rebecca | United States | West Virginia | Morgantown |
| Nephrology Associates of Northern Virginia, Inc. | Assefi Ali | United States | VIRGINIA | Fairfax |
| Kaufman, New York, NY | Kaufman Allen | United States | New York | New York |
| Lee County Internal Medicine Associates | Bohm Guillermo | United States | Florida | Fort Myers |
| California Institute of Renal Research | Boiskin Mark | United States | CALIFORNIA | San Diego |
| Nephrology Associates P.C. | Brantley Roman | United States | Alabama | Birmingham |
| Houston Nephrology Group | Chatha Rupi | United States | Texas | Houston |
| Hanson Clinical Research Center | Hanson Lenita | United States | Florida | Port Charlotte |
| South Florida Nephrology Group, PA | Jacob Radu | United States | Florida | Coral Springs |
| Seacoast Kidney and Hypertension Specialists, PLLC | Joshi Sucharit | United States | New Hampshire | Portsmouth |
| Oregon Health and Science University | Rueda Jose | United States | Oregon | Portland |
| Palm Research Center, Inc. | Nakhle Samer | United States | Nevada | Las Vegas |
| Preferred Primary Care Physicians, Inc | Purighalla Raman | United States | Pennsylvania | Pittsburgh |
| Anne Arundel Medical Center (AAMC) | Welker James | United States | Maryland | Annapolis |
| Diagnostic Clinic Of Houston | Varghese Freemu | United States | Texas | Houston |
| University of Louisville | Jacobs Alfred | United States | Kentucky | Louisville |
| Texas Health Physicians Group | Arauz-Pacheco Carlos | United States | Texas | Dallas |
| Thomas Jefferson University Hospital | Jabbour Serge | United States | Pennsylvania | Philadelphia |
| Renal Medicine Associates | Kumar Jayant | United States | New Mexico | Albuquerque |
| NYU Langone Medical Center | Wissner-Greene Loren | United States | New York | New York |
| East Texas Nephrology Associates | Nazeer Imran | United States | Texas | Lufkin |
| Rogosin Institute | Perlman Alan | United States | New York | New York |
| Drexel University College of Medicine | Ahmed Ziauddin | United States | Pennsylvania | Philadelphia |
| Arizona Kidney Disease and Hypertension Center | Desai Sachin | United States | Arizona | Phoneix |
| Carolina Health Specialists | Eagerton Donald | United States | South Carolina | Myrtle Beach |
| Penn State, Milton S. Hershey Medical Center | Farooq Umar | United States | Pennsylvania | Hershey |
| Diabetes Associates Medical Group | Madu Ivy-Joan | United States | California | Orange |
| Fletcher Allen Health Care, Burlington, Vermont | Solomon Richard | United States | Vermont | Burlington |
| APEX Research of Riverside | Lee Joseph | United States | CALIFORNIA | Riverside |
| Univ of Texas Health Science Center at San Antonio | Bansal Shweta | United States | Texas | San Antonio |
| University of New Mexico | Adolphe Allen | United States | New Mexico | Albuquerque |
| University of Iowa | Dixon Brad | United States | Iowa | Iowa City |
| Temple University Hospital | Benjamin Joseph | United States | Pennsylvania | Philadelphia |
| North Texas Endocrine Center | Bressler Peter | United States | Texas | Dallas |
| Northside Internal Medicine DEXA | Cathcart Harold | United States | Washington | Spokane |
| Kaiser Foundation Health Plan of Georgia, Inc. | Muoneke Rosemary | United States | Georgia | Duluth |
| Atlanta Nephrology Referral Center | Sharon Zeev | United States | Georgia | Decatur |
| San Antonio Kidney Disease Center Physicians Group, PLLC | Gouge Steven | United States | Texas | San Antonio |
| Ladan Golestaneh, MD, MS | Golestaneh Laden | United States | New York | Bronx |
| Maine Research Associates | Weiss Robert | United States | Maine | Auburn |
| Mohammed Ismail, MD, Inc. | Ismail Mohammad | United States | California | Paramount |
| Four Rivers Clinical Research, Inc. | De La Rosa, Raymond | United States | Kentucky | Paducah |
| Internal Medicine Specialists | Rodriguez-Araya Eduardo | United States | Louisiana | New Orleans |
| Community Clinical Research Center | Bakdash Wa'el | United States | Indiana | Anderson |
| Independent Clinical Research | Butt Salman | United States | Texas | McKinney |
| Yale Univ School of Medicine | Dahl Neera | United States | Connecticut | New Haven |
| San Marcus Research Clinic, Inc. | Acosta Idalia | United States | Florida | Miami |
| Compass Research, LLC | Stoica George | United States | Florida | Orlando |
| Texas Renal Care | Ijaz Adeel | United States | TEXAS | Greenville |
| Pines Care Research Center, Inc. | Moya Hechevarria Jaynier | United States | Florida | Pembroke Pines |
| Cleveland Clinic Foundation | Taliercio John | United States | Ohio | Cleveland |
| Ochsner Clinic Foundation | Reichel Ronald | United States | Louisiana | New Orleans |
| NY Clinical Trials | Bloom Scott | United States | New York | New York |
| Erie County Medical Center | Gundroo Aijaz | United States | New York | Buffalo |
| Angiocardiac Care of Texas, PA | Karim Amin | United States | Texas | Houston |
| SUNY Downstate Medical Center | Markell Mariana | United States | New York | Brooklyn |
| Sensenbrenner Primary Care, Charlotte, NC | Sensenbrenner John | United States | NORTH CAROLINA | Charlotte |
| Pentucket Medical Associates, LLC | Dulude Emily | United States | Massachusetts | Haverhill |
| Crescent City Clinical Research Center, LLC | Wise Jonathan | United States | Louisiana | Metairie |
| Diagnostic Clinic Of Houston | Tulloch Brian | United States | Texas | Houston |
| National Institute of Clinical Research | Joshi Sudhir | United States | California | Bakersfield |
| Kidney Innovations | Levine Andrew | United States | Texas | Weslaco |
| Renaissance Renal Research Institute, LLC | Khairullah Quresh | United States | Michigan | Detroit |
| Kidney Care Center | Awua-Larbi Stella | United States | Illinois | Joliet |
| Kidney and Hypertension Care Center | Khan Mehreen | United States | Texas | Houston |
| Meridien Research Group | Chaykin Louis | United States | Florida | Bradenton |
| Premier Research Associate, Inc | De la Calle Gilda | United States | Florida | Hialeah |
| Nephrology Associates Research Center | Minga Todd | United States | Florida | Panama City |
| NorthShore University HealthSystem | Sarav Menaka | United States | Illinois | Evanston |
| Innovative Medical Research of South Florida, Inc. | Schlessinger Fabiola | United States | Florida | Aventura |
| University of Florida | Hall Karen | United States | Florida | Gainesville |
| Southern Utah Kidney and Hypertension Center | Leon-Forero Carlos | United States | Utah | Saint George |
| AKDHC Medical Research Services, LLC | Nica Romanita | United States | Arizona | Prescott |
| California Renal Research Network, LLC | Minasian Raffi | United States | California | Glendale |
| Professional Health Care of Pinellas | Saba Fadi | United States | Florida | St. Petersburg |
| Clinical Research of Brandon, LLC | Alvarez German | United States | Florida | Brandon |
| Audie L. Murphy VA Hospital, STVHCS | Fanti Paolo | United States | Texas | San Antonio |
| Pentucket Medical Associates, LLC | Tarkan Joshua | United States | Massachusetts | Newburyport |
| VAMC Cincinnati | Thakar Charuhas | United States | Ohio | Cincinnati |
| Emory University and Atlanta VA Medical Center | Phillips Lawrence | United States | Georgia | Decatur |
| Zablocki VA Medical Center | Blumenthal Samuel | United States | Wisconsin | Milwaukee |
| VA Long Beach Healthcare System | Levin Ellis | United States | CALIFORNIA | Long Beach |
| CEREHA | Elbert Alicia | Argentina | Avellaneda | Avellaneda |
| Instituto de Investigaciones Clinicas Bahia Blanca | Vogel Daniel | Argentina | Buenos Aires | Buenos Aires |
| Instituto de Investigaciones Medicas Alfredo Lanari | Zucchini Alfredo | Argentina | Buenos Aires | Buenos Aires |
| Consultorios Asociados de Endocrinologia / Inv Clin Aplicado | Maffei Laura | Argentina | Buenos Aires | Buenos Aires |
| Hospital Italiano de Buenos Aires | Greloni Gustavo | Argentina | Buenos Aires | Buenos Aires |
| CEMIC (Centro Educacion Medica e Investigacion Clinica) | Diaz Carlos | Argentina | Buenos Aires | Buenos Aires |
| Instituto Latinoamericano de Investigaciones Medicas | Ulla Maria | Argentina | Cordoba | Cordoba |
| Fundacion J. Robert Cade | Juncos Luis | Argentina | Cordoba | Cordoba |
| Blossom DMO | Garcia Nestor | Argentina | Cordoba | Cordoba |
| Instituto Cardiologia de Corrientes Juana Francisca Cabral | Farias Eduardo | Argentina | Corrientes | Corrientes |
| Centro de Salud Renal Junin S.R.L. | Vallejos Augusto | Argentina | Junin | Junin |
| Instituto de Nefrologia Pergamino S.R.L. | Cusumano Ana | Argentina | Pergamino | Pergamino |
| Investigaciones Clinicas Tucuman | Santos Juan | Argentina | San Miguel de Tucuman | San Miguel de Tucuman |
| Royal Prince Alfred Hospital | Chadban Steve | Australia | New South Wales | Camperdown |
| Renal Research | Roger Simon | Australia | New South Wales | Gosford |
| Liverpool Hospital | Suranyi Michael | Australia | New South Wales | Liverpool |
| The Prince of Wales Hospital | Endre Zoltan | Australia | New South Wales | Randwick |
| Royal North Shore Hospital | Pollock Carol | Australia | New South Wales | St Leonards |
| Nambour General Hospital | Gray Nicholas | Australia | Queensland | Nambour |
| Southern Adelaide Diabetes Endocrine Services | Stranks Stephen | Australia | South Australia | Daw Park |
| Royal Melbourne Hospital | Toussaint Nigel | Australia | Victoria | Parkville |
| Fremantle Hospital | Davis Tim | Australia | Western Australia | Fremantle |
| Sir Charles Gairdner Hospital | Chan Doris | Australia | Western Australia | Nedlands |
| Box Hill Hospital | Fraenkel Margaret | Australia | Box Hill | Box Hill |
| Concord Repatriation and General Hospital | Gallagher Martin | Australia | Concord | Concord |
| Launceston General Hospital | Cooke Duncan | Australia | Launceston | Launceston |
| John Hunter Hospital | Acharya Shamasunder | Australia | New Lambton | New Lambton |
| St. Vincents Hospital Melbourne | MacIsaac Richard | Australia | Victoria | Victoria |
| CHR de la Citadelle | Warling Xavier | Belgium | Liege | Liege |
| Cliniques Universitaires Saint Luc | Jadoul Michel | Belgium | Brussels | Brussels |
| Onze Lieve Vrouw Hospital | Van Vlem Bruno | Belgium | Aalst | Aalst |
| Universitair Ziekenhuis Leuven | Gillard Pieter | Belgium | Leuven | Leuven |
| Centro de Estudos em Diabetes e Hipertensao | Forti Adriana Costa | Brazil | Ceara | Fortaleza |
| Hospital Geral de Goiania | Rassi Nelson | Brazil | Goias | Goiania |
| Hospital Sao Lucas-PUCRS | D'Avila Domingos | Brazil | Rio Grande do Sul | Porto Alegre |
| Irmandade da Santa Casa de Misericordia de Porto Alegre | Keitel Elizete | Brazil | Rio Grande do Sul | Porto Alegre |
| Clinica de Endocrinologia | Fraige Filho Fadlo | Brazil | Sao Paulo | Sao Paulo |
| University Federal de Sao Paulo | Chacra Antonio | Brazil | Sao Paulo | Sao Paulo |
| IPEC - Instituto de Pesquisa Clinica | Salles, Joao Eduardo | Brazil | Sao Paulo | Sao Paulo |
| Instituto Dante Pazzanese de Cardiologia | Amodeo Celso | Brazil | Sao Paulo | Sao Paulo |
| The Bailey Clinic | Bailey Gordon | Canada | Alberta | Red Deer |
| St. Paul's Hospital | Levin Adeera | Canada | British Columbia | Vancouver |
| Clinical Research Solutions Inc. | Jolly Shivinder | Canada | Ontario | Kitchener |
| OTT Healthcare Inc. | Tam Paul | Canada | Ontario | Scarborough |
| Toronto East General Medical Centre | Chow Stephen | Canada | Ontario | East York |
| LMC Diabetes and Endocrinology | Bajaj Harpeet | Canada | Ontario | Brampton |
| LMC Diabetes and Endocrinology | Khandwala Hasnain | Canada | Ontario | Etobicoke |
| LMC Diabetes and Endocrinology | Aronson Ronnie | Canada | Ontario | Toronto |
| Co-Medica Research Network, Inc | Steele Andrew | Canada | Ontario | Courtice |
| Humber River Regional Hospital | Nesrallah Gihad | Canada | Ontario | Toronto |
| JBN Medical Diagnostic Services Inc. | Berlingieri Joseph | Canada | Ontario | Burlington |
| St. Joseph's Healthcare | Rabbat Christian | Canada | Ontario | Hamilton |
| Medicor Research Inc. | Goluch Richard | Canada | Ontario | Sudbury |
| Centre de Sante et de Services Sociaux Champlain | Cournoyer Serge | Canada | Quebec | Greenfield Park |
| Hospital Maisonneuve-Rosemont | Pichette Vincent | Canada | Quebec | Montreal |
| CHUM - Hopital Saint-Luc | Roy Louise | Canada | Quebec | Montreal |
| CALMED | Castillo Alvaro | Chile | La Serena | La Serena |
| Servicios Medicos Godoy Limitada | Godoy Gonzalo | Chile | Santiago | Santiago |
| Biomedica Research Group | Gutierrez Vicente | Chile | Santiago | Santiago |
| Hospital Clinico Regional Dr. Guillermo Grant Benavente | Munoz Rodrigo | Chile | Concepcion | Concepcion |
| Hospital del Salvador | Gonzalez Fernando | Chile | Providencia, Santiago | Providencia, Santiago |
| Petr Bucek s.r.o. | Bucek Petr | Czech Republic | Frydek-Mistek | Frydek-Mistek |
| Masarykova mestska nemocnice | Oplustilova Alexandra | Czech Republic | Jilemnice | Jilemnice |
| Fakultni Nemocnice Ostrava | Valkovsky Ivo | Czech Republic | Ostrava-Poruba | Ostrava-Poruba |
| Diabetologicka ambulance | Pavlickova Jirina | Czech Republic | Pardubice | Pardubice |
| PeMedica.CZ, s.r.o. | Petr Martin | Czech Republic | Prague | Prague |
| Vseobecna fakultni nemocnice v Praze (VFN) | Tesar Vladimir | Czech Republic | Prague | Prague |
| Fakultni Nemocnice Kralovske Vinohrady FNKV | Rychlik Ivan | Czech Republic | Prague 10 | Prague 10 |
| Milan Kvapil s.r.o. | Bartaskova Dagmar | Czech Republic | Prague 4 | Prague 4 |
| Nemocnice Trebic | Chmelickova Hana | Czech Republic | Trebic | Trebic |
| Slagelse Hospital | Gaede Peter | Denmark | Slagelse | Slagelse |
| University Hospital of Frederiskberg | Urhammer Soren | Denmark | Frederiksberg | Frederiksberg |
| Roskilde Hospital | Ostergaard Ove | Denmark | Rosklide | Rosklide |
| Regional Hospital Holstebro | Oczachowska-Kulik, Anna Ewa | Denmark | Holstebro | Holstebro |
| Aarhus University Hospital, Skejby | Povlsen Johan | Denmark | Aarhus C | Aarhus C |
| Steno Diabetes Center | Rossing Peter | Denmark | Gentofte | Gentofte |
| Terveystalo Oulu | Strand Jorma | Finland | Oulu | Oulu |
| Tampere University Hospital | Lahtela Jorma | Finland | Tampere | Tampere |
| Turku University Hospital | Kantola Ilkka | Finland | Turku | Turku |
| CHU de Grenoble - Hopital Albert Michallon | Zaoui Philippe | France | Grenoble | Grenoble |
| CHU de Nice | Esnault Vincent | France | Nice | Nice |
| Clinique du Landy | Urena Torres Pablo | France | Saint Ouen | Saint Ouen |
| Hopital de la Conception | Dussol Bertrand | France | Marseille | Marseille |
| Hospital European, Georges Pompidou | Thervet Eric | France | Paris | Paris |
| Dimokritio University Hospital of Alexandroupoli | Passadakis Ploumis | Greece | Alexandroupolis | Alexandroupolis |
| Interbalkan Medical Center | Papadimitriou Menelaos | Greece | Thessaloniki | Thessaloniki |
| University General Hospital of Patras | Goumenos Dimitrios | Greece | Patras | Patras |
| University General Hospital | Liakopoulos Vasilios | Greece | Thessaloniki | Thessaloniki |
| University General Hospital of Ioannina | Siamopoulos Konstantinos | Greece | Ionnina | Ionnina |
| SISMANOGLEIO General Hospital of Komotini | Mavromatidis Konstantinos | Greece | Komotini | Komotini |
| General Hospital of Athens, Evangelismos | Apostolou Theofanis | Greece | Athens | Athens |
| Universitaetsklinikum Aachen | Muehlfeld Anja | Germany | Aachen | Aachen |
| Klinische Forschung Berlin GbR | Schenkenberger Isabella | Germany | Berlin | Berlin |
| Charite Campus Mitte | Budde Klemens | Germany | Berlin | Berlin |
| Universitaetklinikum Dresden | Hugo Christian | Germany | Dresden | Dresden |
| Studienzentrum Karlstrasse GmbH | Dellanna Frank-Hans | Germany | Duesseldorf | Duesseldorf |
| St. Josefskrankenhaus | Hasslacher Christoph | Germany | Heidelberg | Heidelberg |
| Nephrologisches Zentrum | Pistrosch Frank | Germany | Hoyerswerda | Hoyerswerda |
| Universitaetsklinikum Jena | Wolf Gunter | Germany | Jena | Jena |
| Ludwig Maximiliam Universitaet Muenchen | Vielhauer Volker | Germany | Munich | Munich |
| Diabetologische Schwerpunktpraxis Pirna | Kosch Christine | Germany | Pirna | Pirna |
| Bieler, Riesa, DE | Bieler Tasso | Germany | Riesa | Riesa |
| Diabetologische Schwerpunktpraxis | Segiet Thomas | Germany | Speyer | Speyer |
| Robert-Bosch-Krankenhaus | Alscher Mark | Germany | Stuttgart | Stuttgart |
| Universitaetsklinikum Wuerzburg | Wanner Christoph | Germany | Wuerzburg | Wuerzburg |
| Cork University Hospital | Eustace Joesph | Ireland | Cork | Cork |
| St. Vincent's University Hospital | O'Shea Donal | Ireland | Dublin 4 | Dublin 4 |
| The Adelaide and Meath Hospital | Lavin Peter | Ireland | Dublin 24 | Dublin 24 |
| Connolly Hospital | Sreenan Seamus | Ireland | Dublin 15 | Dublin 15 |
| Maccabi Health Services | Cohen Josef | Israel | Rishon Le zion | Rishon Le zion |
| Ziv Medical Center | Adawi Faiad | Israel | Safed | Safed |
| Ha'Emek Medical Center | Mazen Elias | Israel | Afula | Afula |
| Carmel Medical Center | Frajewicki Victor | Israel | Haifa | Haifa |
| Barzilai Medical Center | Yagil Yoram | Israel | Ashkelon | Ashkelon |
| The Edith Wolfson Medical Center | Bar-Dayan Yosefa | Israel | Holon | Holon |
| Meir Medical Center | Nacasch Naomi | Israel | Kfar Saba | Kfar Saba |
| IRCCS Fondazione Salvatore Maugeri | Esposito Ciro | Italy | Pavia | Pavia |
| Azienda ASST Paga Giovanni XXIII | Ruggenenti Piero | Italy | Bergamo | Bergamo |
| Azi Soc Sanitaria Territoriale | Rombola Giuseppe | Italy | Varese | Varese |
| Azienda Ospedaliera Sant' Andrea | Pugliese Giuseppe | Italy | Rome | Rome |
| Universita della Campania Luig | Capasso Giovabattista | Italy | Naples | Naples |
| Ospedale S. Maria della Pieta di Naples | Nappi Felice | Italy | Naples | Naples |
| Policlinico Universitario degli Federico II di Naples | Russo Domenico | Italy | Naples | Naples |
| Azienda Ospedaliera Bianchi Melacrino Morelli | Marino Francesco | Italy | Reggio Calabria | Reggio Calabria |
| Nakadori General Hospital | Awasaki Hiroshi | Japan | Akita-shi | Akita-shi |
| National Hospital Organization Asahikawa Medical Center | Hirano Fuminori | Japan | Asahikawa-shi | Asahikawa-shi |
| Shimizu Internal Medicine Clinic | Taya Noriyasu | Japan | Asahikawa-shi | Asahikawa-shi |
| National Hospital Organization Chiba-East-Hospital | Nishimura Motonobu | Japan | Chiba-shi | Chiba-shi |
| Fukuoka University Chikushi Hospital | Kobayashi Kunihisa | Japan | Chikushino-shi | Chikushino-shi |
| Kyushu Central Hospital of Mutual Aid Association | Goto Daisuke | Japan | Fukuoka | Fukuoka |
| Japanese Red Cross Fukuoka Hospital | Sasaki Nobuhiro | Japan | Fukuoka-shi | Fukuoka-shi |
| Funabashi Municipal Medical Center | Iwaoka Hideaki | Japan | Fukuyama-shi | Fukuyama-shi |
| Anzai Clinic | Anzai Jiichi | Japan | Hakodate | Hakodate |
| Harada Clinic | Harada Hiroyuki | Japan | Hakodate-shi | Hakodate-shi |
| Takahashi Hospital, Social Medical Corporation | Tsutsui Masahiro | Japan | Hakodate-shi | Hakodate-shi |
| Hamamatsu Medical Center | Nagayama Koji | Japan | Hamamatsu-shi | Hamamatsu-shi |
| Higashihiroshima Medical Center | Kishimoto Rui | Japan | Higashihiroshima | Higashihiroshima |
| Iwata City Hospital | FURUYA Ryuichi | Japan | Iwata-shi | Iwata-shi |
| Rinku General Medical Center | KASHINE Susumu | Japan | Izumisano-shi | Izumisano-shi |
| Shimane University Hospital | Yamamoto Masahiro | Japan | Izumo | Izumo |
| Tempozan Clinic of Internal Medicine | Hashiguchi Yasuhiro | Japan | Kagoshima | Kagoshima |
| Kawanishi City Hospital | Ueda Shinichiro | Japan | Kawanishi-shi | Kawanishi-shi |
| St. Marianna University School of Medicine Hospital | Shibagaki Yugo | Japan | Kawasaki-shi | Kawasaki-shi |
| Kokura Memorial Hospital | Kanai Hidetoshi | Japan | Kitakyushu | Kitakyushu |
| Kobe City Medical Center West Hospital | Nakamura Takehiro | Japan | Kobe-shi | Kobe-shi |
| Showa General Hospital | Fujita Akira | Japan | Kodaira-shi | Kodaira-shi |
| Itabashi Clinic | Itabashi Naoki | Japan | Koga-shi | Koga-shi |
| Koshigaya Municipal Hospital | Makita Yuichiro | Japan | Koshigaya | Koshigaya |
| Dokkyo Medical University Koshigaya Hospital | Takeda Tetsuro | Japan | Koshigaya-shi | Koshigaya-shi |
| Kumamoto Medical Center | ONO Keiko | Japan | Kumamoto-shi | Kumamoto-shi |
| Kawasaki Medical School Hospital | Kashihara Naoki | Japan | Kurashiki-shi | Kurashiki-shi |
| St. Mary's Hospital | SATO Yuichi | Japan | Kurume-shi | Kurume-shi |
| Rakuwakai Otowa Hosptial | YAMAGUCHI Yukinari | Japan | Kyoto | Kyoto |
| Kyoto City Hospital | Iehara Noriyuki | Japan | Kyoto-shi | Kyoto-shi |
| Takeda General Hospital | Azuma Nobuyuki | Japan | Kyoto-shi | Kyoto-shi |
| Matsue Red Cross Hospital | Sato Toshiaki | Japan | Matsue-shi | Matsue-shi |
| Saiseikai Matsuyama Hospital | Miyaoka Hiroaki | Japan | Matsuyama-shi | Matsuyama-shi |
| Chita Kosei Hospital | Nimura Toshinori | Japan | Mihama-cho | Mihama-cho |
| Miyazaki Prefectural Miyazaki Hospital | Ikeda Naoko | Japan | Miyazaki-shi | Miyazaki-shi |
| Ato Internal Medicine Clinic | Ato Keita | Japan | Muroran | Muroran |
| Chubu Rosai Hospital | Nakashima Eitaro | Japan | Nagoya-shi | Nagoya-shi |
| Meitetsu Hospital | Okamoto Hideki | Japan | Nagoya-shi | Nagoya-shi |
| NHO Nagoya Medical Center | Yambe Yuko | Japan | Nagoya-shi | Nagoya-shi |
| Nakakinen Clinic | Osonoi Takeshi | Japan | Naka | Naka |
| Saiseikai Niigata Daini Hospital | Suzuki Katsunori | Japan | Niigata-shi | Niigata-shi |
| Kobari General Clinic | Watanabe Shuichi | Japan | Noda | Noda |
| Jiyugaoka Yamada Clinic | Yamada Daishiro | Japan | Obihiro | Obihiro |
| Obihiro Dai-ichi Hospital | Sakai Takashi | Japan | Obihiro-shi | Obihiro-shi |
| Takagi Hospital | Ono Yasuhiro | Japan | Okawa-shi | Okawa-shi |
| Osaka Gyoumeikan Hospital | Makino Shinya | Japan | Osaka | Osaka |
| Osaka General Medical Center | Umayahara Yutaka | Japan | Osaka-shi | Osaka-shi |
| Otsu Municipal Hospital | Isono Motohide | Japan | Otsu-shi | Otsu-shi |
| Ibaraki Seinan Medical Center Hospital | Iitsuka Tadashi | Japan | Sakai-machi | Sakai-machi |
| Asama General Hospital | Naka Motoji | Japan | Saku-shi | Saku-shi |
| Sanuki Municipal Hospital | Inoue Toshihiko | Japan | Sanuki-shi | Sanuki-shi |
| Sapporo Medical Center NTT EC | Nagai Sou | Japan | Sapporo-shi | Sapporo-shi |
| Manda Memorial Hospital | Tsuchida Kenichi | Japan | Sapporo-shi | Sapporo-shi |
| Suruga Clinic | Yamauchi Akira | Japan | Shizuoka | Shizuoka |
| Shunan City Shinnanyo Hospital | Matsutani Akira | Japan | Shunan-shi | Shunan-shi |
| Takamatsu Red Cross Hospital | ISHIKO Tamayo | Japan | Takamatsu | Takamatsu |
| Takatsuki Red Cross Hospital | Kaneko Shizuka | Japan | Takatsuki-shi | Takatsuki-shi |
| Tamana Central Hospital | Matsuda Hirofumi | Japan | Tamana-shi | Tamana-shi |
| Tokushima University Hospital | Matsuhisa Munehide | Japan | Tokushima | Tokushima |
| Tokyo Kamata Medical Center | TAKEMOTO Ikutake | Japan | Tokyo | Tokyo |
| National Center for Global Health and Medicine Hospital | TSUJIMOTO Tetsuro | Japan | Tokyo | Tokyo |
| MAKITA General Hospital | Kosuge Keiichiro | Japan | Tokyo | Tokyo |
| The Institute for Adult Diseases | Onishi Yukiko | Japan | Tokyo | Tokyo |
| Tokyo-Eki Center-Building Clinic | Kiyosue Arihiro | Japan | Tokyo | Tokyo |
| JA Toride Medical Center | Maeda Yoshitaka | Japan | Toride-shi | Toride-shi |
| Toyota Memorial Hospital | Shinoda Junji | Japan | Toyota-shi | Toyota-shi |
| Mie Central Medical Center | Tanaka Tsuyoshi | Japan | Tsu | Tsu |
| Fujii Clinic | Fujii Shinya | Japan | Ube | Ube |
| National Hospital Organization Shinshu Ueda Medical Center | Tanaka Yukio | Japan | Ueda | Ueda |
| Urasoe Sogo Hospital | Ishikawa Kazuo | Japan | Urasoe-shi | Urasoe-shi |
| Okamoto Internal Medicine Office | Imura Mitsuo | Japan | Yaizu | Yaizu |
| National Hospital Organization Yokohama Medical Center | Ujihara Makoto | Japan | Yokohama-shi | Yokohama-shi |
| Tokui Internal Medicine Clinic | Tokui Mikiya | Japan | Yokohama-shi | Yokohama-shi |
| Nakajima Naika Clinic | MUKASA Koji | Japan | Yokosuka-shi | Yokosuka-shi |
| Korea University Ansan Hospital | Kim Nan Hee | Korea, Republic Of | Ansan | Ansan |
| Korea University Ansan Hospital | Cha Dae-Ryong | Korea, Republic Of | Ansan | Ansan |
| Soonchunhayng University Bucheon Hospital | Mok Ji Oh | Korea, Republic Of | Bucheon-si | Bucheon-si |
| Dong-A University Hospital | Suh Sung | Korea, Republic Of | Busan | Busan |
| Inje University Busan Paik Hospital | Park Jeong Hyun | Korea, Republic Of | Busan | Busan |
| Chungbuk National University Hospital | Oh Tae Keun | Korea, Republic Of | Cheongju-si | Cheongju-si |
| Chuncheon Sacred Heart Hospital | Choi Moon-Gi | Korea, Republic Of | Chuncheon | Chuncheon |
| Kyungpook National University Hospital | Lee In-Kyu | Korea, Republic Of | Daegu | Daegu |
| Daegu Catholic University Medical Center | Shon Ho Sang | Korea, Republic Of | Daegu | Daegu |
| Keimyung University Dongsan Hospital | Cho Ho Chan | Korea, Republic Of | Daegu | Daegu |
| Yeungnam University Medical Center | Lee Hyoung Woo | Korea, Republic Of | Daegu | Daegu |
| Chungnam National University Hospital | Lee Kang-Wook | Korea, Republic Of | Daejeon | Daejeon |
| Myongji Hospital | Lee Jae Hyuk | Korea, Republic Of | Goyang | Goyang |
| Hanyang University Guri Hospital | Yi, Joo Hark | Korea, Republic Of | Guri | Guri |
| Chosun University Hospital | Kim Sang Yong | Korea, Republic Of | Gwangju | Gwangju |
| Wonkwang University School Of Medicine & Hospital | Cho, Chung Gu | Korea, Republic Of | Iksan | Iksan |
| Gachon University Gil Hospital | Kim Byung-Joon | Korea, Republic Of | Incheon | Incheon |
| Jeju National University Hospital | Lee Sang Ah | Korea, Republic Of | Jeju-si | Jeju-si |
| Chonbuk National University Hospital | Park Tae-Sun | Korea, Republic Of | Jeonju | Jeonju |
| Pusan National University Hospital | Kim In-Joo | Korea, Republic Of | Pusan | Pusan |
| Seoul National University Bundang Hospital | Jang Hak-Chul | Korea, Republic Of | Seongnam | Seongnam |
| Bundang Cha Hospital | Cho Yong-Wook | Korea, Republic Of | Seongnam | Seongnam |
| Gangnam Severance Hospital | Ahn Chul Woo | Korea, Republic Of | Seoul | Seoul |
| Hallym University Kangdong Sacred Heart Hospital | Kim Doo-Man | Korea, Republic Of | Seoul | Seoul |
| Samsung Medical Center | Lee Moon-Kyu | Korea, Republic Of | Seoul | Seoul |
| Seoul National University Hospital | Park Kyong-Soo | Korea, Republic Of | Seoul | Seoul |
| Gangdong Kyunghee University Hospital | Ahn Kyu Jeung | Korea, Republic Of | Seoul | Seoul |
| Kyunghee University Medical Center | Woo Jeong-Taek | Korea, Republic Of | Seoul | Seoul |
| The Catholic Univ. of Korea Seoul, St. Mary's Hospital | Yoon Kun-Ho | Korea, Republic Of | Seoul | Seoul |
| Korea Universtiy Guro Hospital | Choi Kyung | Korea, Republic Of | Seoul | Seoul |
| Korea University Anam Hospital | Kim Sin-Gon | Korea, Republic Of | Seoul | Seoul |
| The Catholic University of Korea St. Paul's Hospital | Kim Byung Soo | Korea, Republic Of | Seoul | Seoul |
| Asan Medical Center | Kim Min Seon | Korea, Republic Of | Seoul | Seoul |
| Severance Hospital | Kim Beom Seok | Korea, Republic Of | Seoul | Seoul |
| Ajou University Hospital | Lee Kwan-Woo | Korea, Republic Of | Suwon | Suwon |
| Uijeongbu St. Mary's Hospital | Yoon Sun Ae | Korea, Republic Of | Uijeongbu | Uijeongbu |
| Ulsan University Hospital | Nam-Goong II-Seong | Korea, Republic Of | Ulsan | Ulsan |
| Yonsei University Wonju Severance Christian Hospital | Chung Choon Hee | Korea, Republic Of | Wonju | Wonju |
| Hospital Selayang | Wong Hin Seng | Malaysia | Batu Caves | Batu Caves |
| Hospital Serdang | Goh Bak Leong | Malaysia | Kajang | Kajang |
| University Sains Malaysia | Mohamed Mafauzy | Malaysia | Kota Bharu | Kota Bharu |
| Hospital Raja Perempuan Zainab II | Hassen Wan Hasnul Halimi | Malaysia | Kota Bharu | Kota Bharu |
| Hospital Kuala Lumpur | Ahmad Ghazali | Malaysia | Kuala Lumpur | Kuala Lumpur |
| Hospital Universiti Kebangsaan Malaysia | Sukor Norlela | Malaysia | Kuala Lumpur | Kuala Lumpur |
| Hospital Tengku Ampuan Afzan | Nik Ahmad Nik | Malaysia | Kuantan | Kuantan |
| Hospital Melaka | Shalini Vijayasingham | Malaysia | Melaka | Melaka |
| Hospital Pulua Pinang c/o Penang Medical College | Aziz Nor Azizah | Malaysia | Pulau Pinang | Pulau Pinang |
| Hospital Putrajaya | Hussein Zanariah | Malaysia | Putrajaya | Putrajaya |
| Hospital Tuanku Jafaar | Adam Noor | Malaysia | Seremban | Seremban |
| Hospital Taiping | Ramanathan GR | Malaysia | Taiping | Taiping |
| Hospital Taiping | Vaithilingam Indralingan | Malaysia | Taiping | Taiping |
| Centro de Investigacion Clinica del Pacifico | Leguizamo-Dimas Aniceto | Mexico | Acapulco | Acapulco |
| Clinica San Cosme | Chew Wong Alfredo | Mexico | Aguascalientes | Aguascalientes |
| Instituto de Diabetes Obesidad y Nutricion S.C. | Sauque Reyna Leobardo | Mexico | Cuernavaca, Morelos | Cuernavaca, Morelos |
| Investigacion Nefrologica S.C. | Bochicchio-Ricardelli Tomasso | Mexico | Cuernavaca, Morelos | Cuernavaca, Morelos |
| Instituto Jalisciense de Investigacion en Diabetes Obesidad | Gonzalez-Galvez Guillermo | Mexico | Guadalajara | Guadalajara |
| Area Medica SANEFRO | Renoirte Lopez Karina | Mexico | Guadalajara | Guadalajara |
| Instituto Nacioanl de Ciencias Medicas Nutricion S. Zubiran | Nino, Jose Antonio | Mexico | Mexico City | Mexico City |
| Instituto Nacional de Cardiologia | Madero Rovalo Magdalena | Mexico | Mexico City | Mexico City |
| Hospital Universitario Dr. Jose Eleuterio Gonzalez | Gonzalez Gonzalez Jose | Mexico | Monterrey, N.L. | Monterrey, N.L. |
| Hospital y Clinica OCA | Rico Hernandez Raul | Mexico | Monterrey, Nuevo Leon | Monterrey, Nuevo Leon |
| Unidad de Prevencion y Atencion Cardiometabolica (UPAC) | Carranza-Madrigal Jaime | Mexico | Morelia, Michoacan | Morelia, Michoacan |
| Hospital Central Dr. Ignacio Morones Prieto | Chevaile-Ramos Jose | Mexico | San Luis Potosi | San Luis Potosi |
| Universitair Medisch Centrum Groningen | Gansevoort Ron | Netherlands | Groningn | Groningn |
| Albert Schweitzer Ziekenhuis | Smak Gregoor Peter | Netherlands | Dordrecht | Dordrecht |
| Ziekenhuis Groep Twente | Laverman Gozewijn | Netherlands | Almelo | Almelo |
| Gelre Hospital Apeldoorn | Barendregt JNM (Jos) | Netherlands | Apeldoorn | Apeldoorn |
| Meander Medisch Centrum | Luik Peter | Netherlands | Amersfoort | Amersfoort |
| Auckland City Hospital | Pilmore Helen | New Zealand | Auckland | Auckland |
| Dunedin Hospital | Schollum John | New Zealand | Dunedin | Dunedin |
| Waikato Hospital | Rabindranath Kannaiyan | New Zealand | Hamilton | Hamilton |
| Taranaki Base Hospital | Hayat Ashik | New Zealand | New Plymouth | New Plymouth |
| North Shore Hospital | Miller Steven | New Zealand | Takapuna | Takapuna |
| Instituto Endocronolocigo Farfan E.I.R.L | Farfan-Aspilcueta Julio | Peru | Arequipa | Arequipa |
| Exacta Lab SAC | Burga Nunez Jose | Peru | Arequipa | Arequipa |
| Instituto Delgado de Investigacion Medica | Delgado-Butron Cesar | Peru | Arequipa | Arequipa |
| Hospital Nacional Alberto Sabogal Sologuren | Herrada Orue Benjamin | Peru | Callao | Callao |
| Hospital Nacional Adolfo Guevara Velasco Essalud | Zea-Nunez Carlos Antonio | Peru | Cusco | Cusco |
| Centro de Investigacion y Atencion Cardiovascular SAC. | Calderon Ticona Jorge | Peru | Lima | Lima |
| Clinica de Diabetes S.A.C. | Zapata-Rincon Luis | Peru | Lima | Lima |
| Centro Medico Clinica San Judas Tadeo | Dextre Espinoza Augusto | Peru | Lima | Lima |
| Hospital Nacional Arzobispo Loayza | Medina-Santander Boris | Peru | Lima | Lima |
| Clinica Virgen Maria Auxiliadora | Vargas-Gonzales Rolando | Peru | Piura | Piura |
| NZOZ Specjalistyczny Osrodek | Arciszewska Malgorzata | Poland | Bialystok | Bialystok |
| NZOZ Diab Serwis S.C. | Popenda Grazyna | Poland | Chorzow | Chorzow |
| NZOZ SALVIA | Madej Andrzej | Poland | Katowice | Katowice |
| Krakowskie Centrum Medyczne Sp. z o.o. | Kowalczyk-Michalek Martyna | Poland | Krakow | Krakow |
| NZOZ Centrum Medyczne ProMiMed Sp. z o.o., sp.k | Necki Miroslaw | Poland | Krakow | Krakow |
| SPZOZ Uniwersytecki Szpital Kliniczny nr 1 | Nowicki Michal | Poland | Lodz | Lodz |
| NZOZ Przychodnia Specjalistyczna MEDICA | Skokowska Ewa | Poland | Lublin | Lublin |
| Centrum Medyczne Medyk | Mazur Stanislaw | Poland | Rzeszow | Rzeszow |
| Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecini | Ciechanowski Kazimierz | Poland | Szczecin | Szczecin |
| Centrum Uslug Medycznych Dializa | Wruk Michal | Poland | Szczecinek | Szczecinek |
| Medica pro Familia Sp. z o.o. S.K.A | Klodawska Katarzyna | Poland | Warsaw | Warsaw |
| Hospital Curry Cabral,PT | Ferreira Annibal | Portugal | Lisbon | Lisbon |
| Associacao Protectora dos Diabeticos de Portugal | Brine Rita | Portugal | Lisbon | Lisbon |
| Centro Hospitalar do Porto | Cabrita Antonio | Portugal | Porto | Porto |
| Health Preventive Services | Comulada-Rivera Angel | Puerto Rico | Bayamon | Bayamon |
| Instituto Renal del Este | Galindo Ramos Eugenia | Puerto Rico | Caguas | Caguas |
| Caparra Internal Medicine | Matta Fontanet Evelyn | Puerto Rico | Rio Grande | Rio Grande |
| University of Puerto Rico | Burgos-Calderon Rafael | Puerto Rico | Rio Piedras | Rio Piedras |
| PR Renal Health and Research INC. | Calderon-Ortiz, Ricardo | Puerto Rico | Toa Baja | Toa Baja |
| O.D. Medica SRL | Tivadar Simona | Romania | Bucharest | Bucharest |
| Centrul Medical Unirea SRL | Hancu Nicolae | Romania | Cluj-Napoca | Cluj-Napoca |
| Spitalul Clinic Judetean de Urgenta Cluj-Napoca | Duma Livia | Romania | Cluj-Napoca | Cluj-Napoca |
| Spitalul Clinic Judetean de Urgenta Constanta | Tuta Liliana | Romania | Constanta | Constanta |
| Milena Sante SRL | Mistodie Cristina | Romania | Galati | Galati |
| Consultmed SRL | Pintilei Ella | Romania | Iasi | Iasi |
| Municipal Clinical Hospital | Bako Gabriel | Romania | Oradea | Oradea |
| Spitalul Judetean de Urgenta Pitesti | Tutescu Adriana | Romania | Pitesti | Pitesti |
| SC Centrul Medical | Munteanu Mircea | Romania | Timisoara | Timisoara |
| Sptalul Clinic Judetean de Urgenta Timisoara | Petrica Ligia | Romania | Timisoara | Timisoara |
| Sptalul Clinic Judetean de Urgenta Timisoara | Timar Romulus | Romania | Timisoara | Timisoara |
| City Hospital No 6 | Kuzin Anatoly | Russian Federation | Chelyabinsk | Chelyabinsk |
| Gatchina Central District Clinical Hospital | Yavdosyuk Andrey | Russian Federation | Gatchina | Gatchina |
| Irkutsk State Medical Academy of Postgraduate Education | Bardymova Tatiana | Russian Federation | Irkutsk | Irkutsk |
| Kazan State Medical University | Sigitova Olga | Russian Federation | Republic of Tatarstan | Kazan |
| Kazan State Medical University | Maksudova Adelya | Russian Federation | Republic of Tatarstan | Kazan |
| Kirov City Clinical Hospital 1 | Solovev Oleg | Russian Federation | Kirov | Kirov |
| Krasnoyarsk Interdistrict Clinical Emergency Care Hospital | Rechkova Elena | Russian Federation | Krasnoyarsk | Krasnoyarsk |
| Endocrinology Research Center | Shamkhalova Minara | Russian Federation | Moscow | Moscow |
| Moscow - Out-patient Clinic #3 | Pikalova Natalia | Russian Federation | Moscow | Moscow |
| City Hosp 33 of Leninskiy District of City Nizhniy Novgorod | Pichkov Dmitry | Russian Federation | Nizhniy Novgorod | Nizhniy Novgorod |
| Scientific Instituti of Clinical and Experimental Lymphology | Klimontov Vadim | Russian Federation | Novosibirsk | Novosibirsk |
| Orenburg State Medical Academy | Sayfutdinov Rustam | Russian Federation | Orenburg | Orenburg |
| Perm Regional Hospital for War Veterans | Koziolova Natalya | Russian Federation | Perm | Perm |
| Republican Hospital named after V. A. Baranov | Barysheva Olga | Russian Federation | Petrozavodsk | Petrozavodsk |
| City Out-patient Clinic #17 | Lantseva Olga | Russian Federation | Saint-Petersburg | Saint-Petersburg |
| City Clinical Hospital # 38 named after N.A. Semashko | Zrazhevskiy Konstantin | Russian Federation | Saint-Petersburg | Saint-Petersburg |
| St. Petersburg Medical Univ na I.P. Pavlov | Karonova Tatiana | Russian Federation | Saint-Petersburg | Saint-Petersburg |
| City Clinical Hospital # 31 | Essaian Ashot | Russian Federation | Saint-Petersburg | Saint-Petersburg |
| GBOU VPO Saratov State Medical University | Shvarts Yuri | Russian Federation | Saratov | Saratov |
| Smolensk State Medical Academy | Reshedko Galina | Russian Federation | Smolensk | Smolensk |
| Federal State Institution | Sardinov Ruslan | Russian Federation | Republic of Tatarstan | St. Petersburg |
| Siberian State Medical University | Samoylova Yulia | Russian Federation | Tomsk | Tomsk |
| Research Institute for Cardiology | Mordovin Viktor | Russian Federation | Tomsk | Tomsk |
| Regional Clinical Hospital of Yaroslavl Region | Marasaev Vyacheslav | Russian Federation | Republic of Tatarstan | Yaroslavl |
| Tan Tock Seng Hospital | Liew Adrian | Singapore | Singapore | Singapore |
| Khoo Teck Puat Hospital | Yeoh Lee Ying | Singapore | Singapore | Singapore |
| National University Hospital | Teo, Boon Wee | Singapore | Singapore | Singapore |
| Metabolic Center of Dr K.Raslova, ltd | Raslova Katarina | Slovakia | Bratislava | Bratislava |
| Medispektrum, sro | Ilavska Adriana | Slovakia | Bratislava | Bratislava |
| FMC Dialysis Services | Fekete Jozef | Slovakia | Bratislava | Bratislava |
| Slovenska Zdravotnica Univerzita | Oksa Adrian | Slovakia | Bratislava | Bratislava |
| ProVitae-Medical Centre | Zachar Andrej | Slovakia | Bratislava | Bratislava |
| FMC-dialyzacne sluzby, spol.s r.o | Obetkova Ida | Slovakia | Hlohovec | Hlohovec |
| Medikol s.r.o. | Kolesarova Eva | Slovakia | Kosice | Kosice |
| AGTO spol. s.r.o. | Tkac Ivan | Slovakia | Kosice | Kosice |
| FMC Dialyzacne sluzby s.r.o. | Rosenberger Jaroslav | Slovakia | Kosice | Kosice |
| SMOLKO s.r.o. | Smolko Peter | Slovakia | Kosice | Kosice |
| Interna SK s.r.o. | Fulopova Alla | Slovakia | Svidnik | Svidnik |
| Groote Schuur Hospital | Okpechi Ikechi | South Africa | Western Cape | Cape Town |
| Langeberg Clinical Trials | Trokis Julien | South Africa | Western Cape | Cape Town |
| Dr P J Sebastian | Sebastian Peter | South Africa | KwaZulu-Natal | Durban |
| Newkwa Medical Centre | Ramlachan Padaruth | South Africa | KwaZulu-Natal | Durban |
| St. Augustine's Hospital | Naiker Puvanesveri | South Africa | KwaZulu-Natal | Durban |
| Centre for Diabetes and Endocrinology | Distiller Lawrence | South Africa | Gauteng | Johannesburg |
| Makan, Lenasia, SA | Makan Hemant | South Africa | Lenasia | Lenasia |
| Paarl Research Centre | Coetzee Kathleen | South Africa | Western Cape | Paarl |
| Soweto Clinical Trial Centre | Bhorat Asad | South Africa | Soweto | Soweto |
| Clinical Projects Research | van Zyl Louis | South Africa | Western Cape | Worcester |
| Complejo Hospitalario Universitario de A Coruna | Soto Gonzalez Alfonso | Spain | A Coruna | A Coruna |
| Hospital Universitario Germans Trias i Pujol | Bonet Jose | Spain | Badalona - Barcelona | Badalona - Barcelona |
| Hospital Parc de Salut del Mar | Pascual Santos Julio | Spain | Barcelona | Barcelona |
| Hospital Universitario Bellvitge | Grinyo Josep | Spain | Barcelona | Barcelona |
| Hospital Universitario Vall d'Hebron | Seron Daniel | Spain | Barcelona | Barcelona |
| Fundacion Puigvert | Calero Gonzalez Francesca | Spain | Barcelona | Barcelona |
| Hospital Universitario de Basurto | Arrieta Lezarna Javier | Spain | Bilbao | Bilbao |
| Hospital da Costa | Cigarran Guldris Secundino | Spain | Burela | Burela |
| Hospital Universitario Reina Sofia | Santamaria Olmo Rafael | Spain | Cordoba | Cordoba |
| Hospital Universitario de Gran Canarias Dr. Negrin | Rodriguez-Perez Jose | Spain | Las Palmas | Las Palmas |
| Hospital Universitario Arnau de Vilanova | Fernandez Giraldez Elvira | Spain | Lleida | Lleida |
| Hospital Universitario Fundacion Alcorcon | Fernandez Juarez Gema | Spain | Madrid | Madrid |
| Fundacion Jimenez Diaz | Egido Jesus | Spain | Madrid | Madrid |
| Hospital Clinico San Carlos | Herrero Calvo Jose | Spain | Madrid | Madrid |
| Hospital Universitario 12 de Octubre | Praga Terente Manuel | Spain | Madrid | Madrid |
| Hospital Universitarrio Puerta de Hierro Majadahonda | Marques Vidas Maria | Spain | Madrid | Madrid |
| Hospital Universitario Virgen de la Victoria | Valera Cortes Ildefonso | Spain | Malaga | Malaga |
| Hospital Universitario Marques de Valdecilla | Fernandez Fresnedo Gema | Spain | Santander (Cantabria) | Santander (Cantabria) |
| Hospital Universitario Nuestra Senora de Candelaria | Navarro Gonzalez Juan | Spain | Tenerife | Tenerife |
| Hospital General Univ de Valencia | Galan Antonio | Spain | Valencia | Valencia |
| Hospital Universitario Dr. Peset | Gorriz Jose | Spain | Valencia | Valencia |
| Hospital Universitari i Politecnin la Fe | Hernandez-Jaras Julio | Spain | Valencia | Valencia |
| Hospital de Txagorritxu | Minguela Pesquera Jose Ignacio | Spain | Vitoria | Vitoria |
| Orebro Universitetssjukhus | Hellberg Olof | Sweden | Orebro | Orebro |
| Uppsala University Hospital | Fellstrom Bengt | Sweden | Uppsala | Uppsala |
| Hualien Tzu Chi Hospital | Wu Du-An | China | Taiwan | Hualien |
| Far Eastern Memorial Hospital | Jiang Ju-Ying | China | Taiwan | New Taipei |
| Cardinal Tien Hospital | Dee Pei | China | Taiwan | New Taipei |
| China Medical University Hospital | Chen Ching-Chu | China | Taiwan | Taichung |
| Taichung Veterans General Hospital | Sheu Wayne | China | Taiwan | Taichung |
| Chung Shan Medical University | Huang Chien-Ning | China | Taiwan | Taichung |
| Kuang Tien General Hospital | Tseng Shih-Ting | China | Taiwan | Taichung |
| Taichung Hospital | Sheen Yi-Jing | China | Taiwan | Taichung |
| Chi-Mei Medical Center | Tien Kai-Jen | China | Taiwan | Tainan |
| Cathay General Hospital | Lin Ching-Ling | China | Taiwan | Taipei |
| Taipei Medical University Hospital | Wu Mai-Szu | China | Taiwan | Taipei |
| MacKay Memorial Hospital | Chien Ming-Nan | China | Taiwan | Taipei |
| Baskent University School of Medicine | Sezer Siren | Turkey | Ankara | Ankara |
| Akdeniz University School of Medicine | Sari Ramazan | Turkey | Ankara | Ankara |
| Adnan Menderes University | Yenicerioglu Yavuz | Turkey | Aydin | Aydin |
| Istanbul University Medical Faculty | Satman Ilhan | Turkey | Istanbul | Istanbul |
| Istanbul University Medical Faculty | Yildiz Alaattin | Turkey | Istanbul | Istanbul |
| Kocaeli University Medical Faculty | Kalender Gonullu Betul | Turkey | Kocaeli | Kocaeli |
| Chernivtsi Regional Clinical Hospital | Zub Lilia | Ukraine | Chernivtsi | Chernivtsi |
| Ukrainian State Institution of Medical and Social Problems | Panina Svitlana | Ukraine | Dnipropetrovsk | Dnipropetrovsk |
| Ivano-Frankivsk Regional Clinical Hospital | Legun Oleg | Ukraine | Ivano-Frankivsk | Ivano-Frankivsk |
| Kharkiv City Clinical Emergency Hospital | Bilchenko Oleksandr | Ukraine | Kharkiv | Kharkiv |
| Kharkov City Clinical Hospital #27 | Zolotaikina Viktoriia | Ukraine | Kharkiv | Kharkiv |
| SI Institute of Therapy AMS of Ukraine n.a. Mala L.T. | Topchii Ivan | Ukraine | Kharkiv | Kharkiv |
| VP Komissarenko National Academy of Medical Sciences | Korpachev Vadym | Ukraine | Kiev | Kiev |
| Kiev Regional Clinical Hospital | Shen Andriy | Ukraine | Kyiv | Kyiv |
| Polyclinic of Administration of Medical Services | Mankovskyy Borys | Ukraine | Kyiv | Kyiv |
| Communal Institution Odesa Regional Clinical Hospital | Petrosyan Olena | Ukraine | Odesa | Odesa |
| Transcarpathian Regional Clin. Hos. Named after Andriy Novak | Stryzhak Vasyl | Ukraine | Uzhgorod | Uzhgorod |
| Clinic of Scientific Research Institute for Hadicapped | Shevchuk Sergii | Ukraine | Vinnytsya | Vinnytsya |
| Vinnytsya National Medical University n.a. M.I. Pyrogov | Stanislavchuk Mykola | Ukraine | Vinnytsya | Vinnytsya |
| Regional Clinical Hospital of Zhytomyr | Kuskalo Petro | Ukraine | Zhytomyr | Zhytomyr |
| Belfast City Hospital | Maxwell Peter | United Kingdom | Belfast | Belfast |
| Ninewells Hospital | Brennan Geraldine | United Kingdom | Dundee | Dundee |
| South Glasgow Universita Hospi | Mark Patrick | United Kingdom | Glasgow | Glasgow |
| Kings College Hospital | Kon, Sui Phin | United Kingdom | London | London |
| Guy's Hospital | Gnudi Luigi | United Kingdom | London | London |
| The Royal Free Hospital | Patel Dipesh | United Kingdom | London | London |
| North Middlesex Hospital NHS Trust | Tindall Hilary | United Kingdom | London | London |
| Salford Royal NHS Foundation Trust | Kalra Phillip | United Kingdom | Salford | Salford |
| Queen Mary Hospital | Sydney Tang | 中国 | Hong Kong | Hong Kong |
| Prince of Wales Hospital | Risa Ozaki | 中国 | Hong Kong | Hong Kong |
| Queen Mary Hospital | Kathryn Tan | 中国 | Hong Kong | Hong Kong |
| 河北医科大学第二医院 | 傅淑霞 | 中国 | 河北省 | 石家庄 |
| 宁波市第二医院 | 罗群 | 中国 | 浙江省 | 宁波 |
| 郑州大学第一附属医院 | 刘章锁 | 中国 | 河南省 | 郑州 |
伦理委员会信息
| 名称 | 审查结论 | 审查日期 |
|---|---|---|
| 南方医科大学南方医院医学伦理委员会 | 同意 | 2014-10-23 |
试验状态信息
试验状态
主动暂停
目标入组人数
国内: 280 人；
国际: 4148 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: 203 人 ；
国际: 3668 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：2015-02-02；
国际：2013-06-12；
试验终止日期
国内：2017-11-10；
国际：2017-11-10；
临床试验结果摘要
| 版本号 | 版本日期 |
|---|
