登记号
CTR20150180
相关登记号
CTR20150744
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
2型糖尿病，已有或者有心血管事件的高度风险
试验通俗题目
在2 型糖尿病成人患者中评估Canagliflozin 对肾脏终点影响
试验专业题目
在2 型糖尿病成人患者中评估Canagliflozin 对肾脏终点影响的随机、多中心、双盲、平行、安慰剂对照研究
试验方案编号
28431754DIA4003-INT4
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
许可见
联系人座机
010-58218490
联系人手机号
联系人Email
kxu1@its.jnj.com
联系人邮政地址
北京市朝阳区建国路77号华贸中心2座6层西安杨森制药有限公司
联系人邮编
100025
临床试验信息
试验分类
安全性和有效性
试验分期
IV期
试验目的
在接受标准治疗但血糖未得到充分控制，发生心血管（CV）事件风险较高的T2DM 受试者中与安慰剂相比评canagliflozin 对白蛋白尿进展产生的影响。并同时评估canagliflozin 对白蛋白尿逆转，eGFR 从基线至研究药物停药后约30天测得的最后一个非治疗值的变化，以及尿白蛋白/肌酐比的影响
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
30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
- 必须确诊为T2DM
- 目前的血糖水平没有得到足够的控制，即在筛选时，HbA1c 水平≥7.0%至≤10.5%
- 已有或者有心血管事件的高度风险
- 目前没有接受AHA 治疗或接受AHA 单药治疗或AHA 与任何获准药物联合治疗，如，磺脲类、二甲双胍、吡格列酮、α-葡萄糖苷酶抑制剂、GLP-1 类似物、DPP-4 抑制剂或胰岛素
- 男性或女性，确诊为T2DM，HbA1c水平≥7.0%至≤10.5%，且（1）目前没有接受AHA治疗或（2）接受AHA单药治疗或AHA与任何获准药物联合治疗，如，磺脲类、二甲双胍、吡格列酮、α-葡萄糖苷酶抑制剂、GLP-1类似物、DPP-4抑制剂或胰岛素
- 据下列一种，定义已有或者有心血管事件的高度风险： 2.1 年龄>30岁，既往有症状性动脉粥样硬化性心血管事件，包括：心肌梗死、卒中、因不稳定性心绞痛住院、冠状动脉旁路搭桥术、经皮冠状动脉介入治疗（植入或未植入支架）、外周血管重建（血管成形术或外科手术）、有症状且血流动力学有明显改变的颈动脉或外周血管疾病，或因血管疾病引起的截肢 2.2 年龄≥50岁，筛选访视时有以下2个或多个风险因素：T2DM患病时间10年或以上，受试者至少接受一种降压治疗的情况下筛选访视中记录的收缩压>140mmHg（3次读数的平均值），目前每天吸烟，记录证明筛选前1年内有微量或大量白蛋白尿（相关定义请参见第3.2节，研究设计原理）或者记录证明筛选前1年内HDL-C<1mmol/L（<39mg/dL） 注：将执行CV病史（第一类）：风险因素（第二类）大约70%：30%的总体目标比值（第二类最多可达到大约40%）。上述目标是作为全球比值，各地区之间可以存在差异。将集中监测这些类别的受试者比例。
- 女性必须符合下列要求： 3.1 绝经后定义为： a. 45岁以上，已闭经至少18个月或 b. 45岁以上，已闭经至少6个月但不到18个月，已知血清促卵泡生成素水平（FSH）大于40 IU/L，或 3.2 手术绝育（接受了子宫切除术或双侧卵巢切除术、输卵管阻塞）或其他原因导致无妊娠能力，或 3.3 如果性活跃，应采取高度有效的避孕方法，例如口服激素避孕药、注射避孕针、避孕贴片、子宫环、双屏障法（例如，避孕套、子宫帽或宫颈帽联用杀精皂、乳膏或凝胶），受试者随机分组前男性伴侣绝育以及，必须同意在研究过程中继续采取有效地避孕方法，应按当地监管机构的许可行事，或 3.4 禁欲 注：筛选时禁欲的受试者必须同意，如果他们在参加研究期间开始有活跃的性生活，应采用非常有效的避孕方法。 3.5 育龄妇女（即不符合前文中绝经后定义的受试者，不论其年龄如何）基线时以及如果当地法规要求，筛选时（第1天）尿妊娠试验结果必须呈阴性（注：如果当地法规要求，可以使用血清妊娠试验代替尿液妊娠试验）
- 愿意且能够遵守方案规定的禁止和限制事项
- 受试者必须签署知情同意文件，提示他们理解研究的目的和研究要求的程序，愿意参与这项研究，遵守方案规定的限制
排除标准
- 有糖尿病酮症酸中毒病史，T1DM，胰腺或β 细胞移植，或继发于胰腺炎或胰腺切除的糖尿病史
- 筛选前6 个月内有一次以上严重低血糖发作的病史
- 遗传性葡萄糖-半乳糖吸收不良或原发性肾性糖尿的病史
- 仍然持续存在，未得到充分控制的甲状腺疾病
- 需要免疫抑制剂治疗的肾病，或有慢性透析或肾移植病史
- 筛选前3 个月内有心肌梗死、不稳定性心绞痛、血管再建术或脑血管意外，或计划行血管再建手术
- 糖尿病相关性/代谢性: 糖尿病酮症酸中毒病史，T1DM，胰腺或β细胞移植，或继发于胰腺炎或胰腺切除的糖尿病
- 筛选前6个月内有一次以上严重低血糖发作的病史 :注：严重低血糖是指需要他人帮助的低血糖事件。
- 遗传性葡萄糖-半乳糖吸收不良或原发性肾性糖尿的病史
- 仍然持续存在，未得到充分控制的甲状腺疾病 注：接受甲状腺素替代疗法的受试者在第1天之前必须已经接受稳定剂量至少6周。
- 需要免疫抑制剂治疗的肾病，或有慢性透析或肾移植病史。注：有儿童期接受过治疗的肾病病史、无后遗症的受试者可参加
- 筛选前3个月内有心肌梗死、不稳定性心绞痛、血管再建术或脑血管意外，或计划行血管再建手术，或临床诊断为纽约心脏病协会（NYHA）IV级心衰 （纽约心脏病协会标准委员会）
- 筛选前3个月内需要紧急诊断评价或干预的已知ECG结果（如，新发生的有临床重要性的心律失常或传导障碍）
- 胃肠道
- 乙肝表面抗原或丙肝抗体阳性的已知病史（除非已知与持久稳定/正常的天冬氨酸氨基转移酶[AST]和丙氨酸氨基转移酶[ALT]水平相关），或其他临床活动性肝病
- 有减肥手术史或计划做减肥手术
- 实验室: 筛选访视时eGFR <30mL/min/1.73m2 ;？ ALT>2.0倍正常上限（ULN）或总胆红素>1.5倍ULN，除非研究者认为且与申办方的医学专员达成一致，否则认为这些检查所见提示Gilbert病
- 其他情况:筛选前5年内有恶性肿瘤病史（皮肤鳞状和基底细胞癌和原位宫颈癌除外，或研究者认为且与申办方的医学专员达成一致，认为恶性肿瘤已经被治愈，复发的可能性很小）
- 人类免疫缺陷病毒（HIV）抗体阳性史
- 受试者目前患具临床重要性的血液系统疾病（如，有症状的贫血，增生性骨髓疾病，血小板减少症）
- 研究者认为受试者的预期寿命不到1年，或研究者认为可导致参加研究不符合受试者的最佳利益或可能阻止、限制或混淆方案规定的安全性或有效性评估的任何情况
- 筛选访视前3个月内曾有大手术（即，需要全麻），或受试者参加研究期间计划接受任何手术（小手术除外，即局麻下进行的门诊手术）
- 据研究者认为可能损害受试者的健康或导致受试者无法满足或执行研究要求的任何情况
- 药物/治疗 : 当前或既往使用一种 SGL T2抑制剂
- 既往或当前参加另一项canagliflozin研究
- 已知对canagliflozin或其赋形剂过敏、超敏或不耐受（参考14.1节，研究药物的物理描述）
- 目前使用糖皮质激素或免疫抑制剂，或可能需要使用糖皮质激素（持续时间不到2周）或免疫抑制剂。注：使用吸入、鼻腔内给药、关节内注射或外用糖皮质激素，或治疗置换剂量糖皮质激素的受试者可参加研究
- 第1天/基线前3个月内接受过活性研究性药物（包括疫苗）或使用研究性医疗器械
- 一般事项 :筛选前3年内有药物或酒精滥用史
- 正妊娠或哺乳，或研究期间计划妊娠或哺乳
- 研究者或研究中心的员工（与提议的研究或该研究者/研究中心领导的其他研究有直接关系）以及员工或研究者的家人 注：研究者应确保受试者满足所有入选标准，并确定受试者自筛选后其临床状态没有任何改变。随机分组前，临床状态在筛选后发生改变、导致满足某一排除标准的受试者，应被排除
试验分组
试验药
| 名称 | 用法 |
|---|---|
|
中文通用名:卡格列净片（100mg)
|
用法用量:胶囊；规格100mg；首餐前口服，一天一次，每次100mg，用药过程：基线第一天持续到试验结束（最多服药至第156周），13周时根据研究者判断可能提高至300mg
|
|
中文通用名:卡格列净片（300mg)
|
用法用量:胶囊；规格300mg；首餐前口服，一天一次，每次300mg，用药过程：13周根据研究者判断提高至300mg持续到试验结束（最多服药至第156周），期间根据研究者判断剂量可能降至100mg
|
对照药
| 名称 | 用法 |
|---|---|
|
中文通用名:安慰剂(100mg)
|
用法用量:胶囊；规格100 mg；
首餐前口服，一天一次，每次100mg，用药过程：初始筛选后持续到随机，如果随机到安慰机组，则服用到试验结束（最多服药至第156周），13周时根据研究者判断可能提高至300mg。安慰剂组。
|
|
中文通用名:安慰剂（300mg)
|
用法用量:胶囊；规格300 mg；
首餐前口服，一天一次，每次300mg，用药过程：初始筛选后持续到随机，如果随机到安慰机组则服用到试验结束（最多服药至第156周），13周时根据研究者判断可能提高至300mg，试验过程中也可能会下调至100mg。安慰剂组。
|
终点指标
主要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| 白蛋白尿进展的受试者人数 | 基线，26、52、78、104和156周末 | 有效性指标 |
次要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| 1.白蛋白尿逆转的受试者人数； 2. eGFR 从基线至最后一个停止治疗后数值的变化； 3.尿白蛋白/肌酐比 | 1. 基线，26、52、78、104和156周末 2. 研究药物停药后大约30 天 3. 末次治疗访视 | 有效性指标 |
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 | |
|---|---|---|---|---|---|---|---|
| 纪立农 | 主任医师 | 13910978815 | jiln@bjmu.edu.cn | 北京大学人民医院内分泌科 北京市西城区西直门南大街11号 | 100044 | 北京大学人民医院 |
各参加机构信息
| 机构名称 | （主要）研究者 | 国家 | 地区 | 城市 |
|---|---|---|---|---|
| 北京大学人民医院 | 纪立农 | 中国 | 北京 | 北京 |
| 济南市中心医院 | 逄曙光 | 中国 | 山东 | 济南 |
| 首都医科大学附属北京安贞医院 | 马长生 | 中国 | 北京 | 北京 |
| 浙江医院 | 严静 | 中国 | 浙江 | 杭州 |
| 包头市中心医院 | 赵瑞平 | 中国 | 内蒙古 | 包头 |
| 无锡市人民医院 | 卜瑞芳 | 中国 | 江苏 | 无锡 |
| 辽宁省人民医院 | 李占全 | 中国 | 辽宁 | 沈阳 |
| CIAD Moron | HERMIDA SONIA | Argentina | Buenos Aires | Moron |
| CEMAIC - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinical | Nardone Lucrecia | Argentina | Cordoba | Cordoba |
| Consultorios Asociados de Endocrinología e Investigación Clínica Aplicada | Maffei Laura | Argentina | Buenos Aires | Ciudad de Buenos Aires |
| Canberra Hospital and Health Services | Nolan Christopher | Australia | ACT | Woden |
| Royal North Shore Hospital | Hocking Samantha | Australia | NSW | St Leonards |
| Repatriation General Hospital | Stranks Stephen | Australia | SA | Adelaide |
| Imelda ziekenhuis | VERCAMMEN CHRIS | Belgium | N/A | BONHEIDEN |
| UZA | VAN GAAL LUC | Belgium | N/A | EDEGEM |
| UZ LEUVEN | MATHIEU Chantal | Belgium | N/A | Leuven |
| CHR La Citadelle | Warling Xavier | Belgium | N/A | Liège |
| Canadian Centre for Clinical Trials | Wilderman Igor | Canada | ON | Thornhill |
| HEALTH SCIENCES CENTRE | WOO VINCENT | Canada | MB | Winnipeg |
| Sanatorio Guemes | FARIAS JAVIER | Argentina | Buenos Aires | Buenos Aires |
| CEDIC Centro de Investigaciones Clinicas | GELERSZTEIN ELIZABETH | Argentina | Buenos Aires | Buenos Aires |
| Instituto de Investigaciones Clinicas Rosario | LAGRUTTA MARIANA | Argentina | N/A | Rosario |
| Clinica de Fracturas y Ortopedia | Alvarisqueta Andres | Argentina | N/A | Buenos Aires |
| Instituto de Investigaciones Clinicas Mar del Plata | SPOSETTI GEORGINA | Argentina | N/A | Mar del Plata |
| Clinica Privada DIM | VISCO VIRGINIA | Argentina | N/A | Buenos Aires |
| Grupo Colaborativo Rosario Diabetes y Enfermedades Metabolicas | FELDMAN RODOLFO | Argentina | Santa Fe | Rosario |
| IMOBA | ORIO SILVIA | Argentina | N/A | Buenos Aires |
| Buenos Aires | Cooke Duncan | Australia | TAS | Launceston |
| Trialworks Clinical Reseach Services | de Looze Ferdinandus | Australia | Queensland | Sherwood |
| Freemantle General Hospital | DAVIS TIMOTHY | Australia | N/A | Freemantle |
| Princess Alexandra Hospital | Russell Anthony | Australia | QLD | Wolloongabba |
| Diabetes Clinical Stream, Hunter New England Local Health District | Shamasunder Acharya | Australia | NSW | Newcastle |
| Eastern Health Research | Gerstman Murray | Australia | VIC | East Ringwood |
| St Vincents Hospital Melbourne | MacIsaac Richard | Australia | VIC | Fitzroy |
| Testumed | Behets Jan | Belgium | N/A | Tessenderlo |
| Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman | Scheen Andre | Belgium | N/A | Liege |
| Algemeen Ziekenhuis Jan Palfijn - Merksem | Verhaegen Ann | Belgium | N/A | MERKSEM |
| Centre Multidisciplinaire du Pied de Ransart - Centre du Pied | Dumont Isabelle | Belgium | N/A | Ransart |
| Algemeen Ziekenhuis (AZ) Sint-Jan AV | Taes Youri | Belgium | N/A | Brugge |
| AZ Delta | Duyck Francis | Belgium | N/A | Roeselare |
| Manna Research Inc. | Blouin Francois | Canada | N/A | Lévis |
| Clinique Médicale St Marc des Carrières | Filteau Pierre | Canada | QC | Saint Marc des Carrieres |
| Applied Medical Informatics Research | Tsoukas George | Canada | QC | Westmont |
| Hydrostone Medical Centre | Archibald John | Canada | NS | Halifax |
| Acadia Medical Centre | DATTANI DAN | Canada | SK | Saskatoon |
| Centre de recherché en endocrinologie | Godin Chantal | Canada | Quebec | Sherbrooke |
| London Road Diagnostic Clinic/Medical Centre | OMAHONY MICHAEL | Canada | ON | Sarnia |
| GAIN MEDICAL CENTRE | Shu DANIEL | Canada | BRITISH COLUMBIA | COQUITLAM |
| Alpha Recherche Clinique | Belle-Isle Jasmin | Canada | Quebec | Quebec City |
| Dawson Road Family Health Team | Friars Douglas | Canada | Ontario | Guelph |
| Albion Finch Medical Centre | GUPTA ANIL | Canada | ON | Toronto |
| Lakeridge Health Oshawa | Steele Andrew | Canada | ONTARIO | OSHAWA |
| Apple Hills Medical Associates | Nemtean Ted | Canada | Ontario | Mississauga |
| ambulance diabetologa | Spousta Tomas | Czech Republic | N/A | Praha 10 |
| Clintrial s.r.o. | Souckova Tatana | Czech Republic | N/A | Praha 10 |
| Diabetologicka a interni ambulance, Diabet2 s.r.o | Bartaskova Dagmar | Czech Republic | N/A | Praha 11 |
| Dieko, s.r.o. | Kyselova Pavlina | Czech Republic | N/A | PLZEN |
| Medicentrum Beroun, spol. s.r.o. | Raclavska Lea | Czech Republic | N/A | Beroun |
| Milan Kvapil, s.r.o. | Kvapil Milan | Czech Republic | N/A | Praha 8 |
| MUDr. Jana Havellkova, s.r.o. | Havelkova Jana | Czech Republic | N/A | Znojmo |
| CHU Grenoble | ZAOUI Philippe | France | N/A | GRENOBLE CEDEX 9 |
| Centre hospitalier Saint Louis | GOUET Didier | France | N/A | La Rochelle Cedex 1 |
| CH DE NARBONNE | COURREGES Jean-Pierre | France | N/A | Narbonne |
| CHU d'Amiens | FENDRI Salha | France | N/A | AMIENS Cedex 1 |
| CHU DE POITIERS | HADJADJ Samy | France | N/A | Poitiers |
| Hopital du Bocage | VERGES Bruno | France | N/A | DIJON |
| Hopital Hotel Dieu | CLAVEL Sylvaine | France | N/A | Le Creusot |
| Hopital georges pompidou | Altman Jean-Jacques | France | N/A | Paris |
| Groupe Hospitalier Pitie Salpetriere | HARTEMANN Agnes | France | N/A | Paris Cedex 13 |
| Hopital de Bois-Guillaume | Prevost Gaétan | France | N/A | Rouen |
| Leicester General Hospital | DAVIES MELANIE | Great Britain | N/A | Leicester |
| Musgrove Park Hospital | ANDREWS ROB | Great Britain | N/A | Taunton |
| Albany House Medical Centre | Annamalai Narayan | Great Britain | N/A | Welllingborough |
| Royal Victoria Hospital | BELL PATRICK | Great Britain | N/A | Belfast |
| Birmingham Heartlands Hospital | Bellary Srikanth | Great Britain | N/A | Birmingham |
| Ashgate Medical Practice | BLAGDEN MARK | Great Britain | DERBYSHIRE | Chesterfield |
| West Suffolk Hospital NHS Trust | Clark John | Great Britain | Suffolk | Bury St Edmunds |
| Royal Cornwall Hospital | Creely Steven | Great Britain | N/A | Truro |
| Queen Elizabeth II Hospital | Darzy Ken | Great Britain | N/A | WelwynGarden City |
| Royal Derby Hospital | Idris Iskandar | Great Britain | Derbyshire | Derby |
| SOUTH AXHOLME PRACTICE | FALK RICHARD | Great Britain | N/A | Doncaster |
| Salford Royal NHS Foundation Trust | SUMMERS LUCINDA | Great Britain | N/A | Manchester |
| The Crouch Oak Family Practice | Harvey Peter | Great Britain | N/A | Addlestone |
| Southmead Hospital | Johnson Andrew | Great Britain | N/A | Bristol |
| Barlow Medical Centre | KWOK SEE | Great Britain | N/A | Manchester |
| Royal Blackburn Hospital | RAMTOOLA SHENAZ | Great Britain | N/A | Blackburn |
| The Ipswich Hospital | Rayman Gerry | Great Britain | SUFFOLK | Ipswich |
| Torbay Hospital-Devon | Smith Jamie | Great Britain | Devon | Torquay |
| Aintree University Hospital NHS Trust | WILDING JOHN | Great Britain | N/A | Liverpool |
| Markusovszky Egyetemi Oktatókórház | Baranyai Marietta | Hungary | N/A | SZOMBATHELY |
| CRU Hungary Kft. | CSOMOS KATALIN | Hungary | N/A | Szikszó |
| Bács-Kiskun Megyei Onkormányzat Kórháza | GURZO MIHALY | Hungary | N/A | KECSKEMéT |
| Markhot Ferenc Oktatókórház és Rendelointézet | Harcsa Eleonóra | Hungary | N/A | Eger |
| UNO MEDICAL TRIALS LTD. | KANAKARIDISZ NIKOSZ | Hungary | N/A | Budapest |
| Kanizsai Dorottya Korhaz | Késmárki Nóra | Hungary | N/A | Nagykanizsa |
| Zala Megyei Kórház | OROSZLAN TAMAS | Hungary | N/A | Zalaegerszeg |
| Szent Pantaleon Kórház-Rendelointézet Dunaújváros | Pátkay József | Hungary | N/A | Dunaújváros |
| DRC Gyogyszervizsgalo Kozpont Kft | Peterfai Eva | Hungary | N/A | Balatonfured |
| Multimedica Diabetes and Metabolic Diseases Unit | GENOVESE Stefano | Italy | N/A | Sesto San Giovanni (Milano) |
| Policlinico seconda Università | GIUGLIANO DARIO | Italy | N/A | Napoli N/a |
| POLICLINICO UNIVERSITARIO | CUCINOTTA Domenico | Italy | N/A | Messina |
| Azienda Ospedaliera Mater Domini | SESTI Giorgio | Italy | N/A | Catanzaro |
| Azienda Ospedaliera Sant Andrea | PUGLIESE Giuseppe | Italy | N/A | Roma |
| Policlinico S. Orsola Malpighi Dept. Clinical Dietetics | MARCHESINI REGGIANI Giulio | Italy | N/A | Bologna |
| Libera Università - Campus Biomedico | POZZILLI Paolo | Italy | N/A | Roma |
| Department of Medical Sciences, University of Milan, Endocrinology and Diabetology Unit, IRCCS Ca' G | Orsi Emanuela | Italy | N/A | Milano |
| SC Diabetologia e M Metaboliche ASL TO 5 Chieri | GIORDA Carlo | Italy | N/A | Chieri (Torino) |
| Diabetes Clinic AUSL Provincia di Ravenna | DI BARTOLO PAOLO | Italy | N/A | RAVENNA |
| Centre de Recherch Clinique de Laval | Dumas Richard | Canada | QC | Laval |
| Chonbuk National Univ. Hospital | Park TaeSun | Korea | Jeollabuk-do | Jeonju-si |
| Yonsei University Wonju Severance Christian Hospital | Chung Choon Hee | Korea | N/A | Wonju-Si |
| Korea University Anam Hospital | Choi DongSeop | Korea | N/A | Seoul |
| Korea University Ansan Hospital | Kim NanHee | Korea | Gyeonggi-do | Ansan |
| Korea University Guro Hospital | Choi KyungMook | Korea | N/A | Seoul |
| Kyung Hee University Hospital at Gangdong | Ahn Kyu-Jeung | Korea | Seoul Teugbyeolsi | Seoul |
| Soonchunhyang University Bucheon Hospital | Mok JiOh | Korea | Gyeonggi-do | Bucheon |
| Gachon University Gil Medical Center | Kim Byung-Joon | Korea | N/A | Incheon |
| Hallym University Sacred Heart Hospital | Kim Doo-Man | Korea | N/A | Seoul |
| Hospital Universiti Sains Malaysia - 2nd Floor Clinical Trial Unit | Mohamed Mafauzy | Malaysia | Kelantan | Kota Bharu |
| Klinik Kesihatan Greentown | Paranthaman Vengadasalam | Malaysia | N/A | Ipoh |
| University Malaya Medical Centre - CIC, 13th Floor, Menara Utama | Tan Alexander | Malaysia | N/A | Kuala Lumpur |
| Hospital Universiti Sains Malaysia - 2nd Floor Clinical Trial Unit | Wan Mohamed Wan Mohd Izani | Malaysia | N/A | Kota Bharu |
| Gleneagles Medical Centre | Shah Rajesh P. | Malaysia | Penang | Georgetown |
| Universiti Teknologi MARA, Selayang Campus | YUSOFF KHALID | Malaysia | Selangor | Shah Alam |
| Penang Medical College | Mohd Khir Amir Sharifuddin | Malaysia | N/A | Pulau Pinang |
| Hospital Umum Sarawak | Tan Florence | Malaysia | Sarawak | Kuching |
| HOSPITAL RAJA PEREMPUAN ZAINAB II | Yahya Mansor | Malaysia | Kelantan | Kota Bharu |
| CENTRO DE ESTUDIOS DE INVESTIGACION METABOLICOS Y CARDIOVASCULARES S.C. | VIOLANTE RAFAEL | Mexico | N/A | Tampico |
| Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C. | De los Rios Manuel Odin | Mexico | Sinaloa | Culiacan |
| Instituto del Corazon de Queretaro | Alcocer Marco | Mexico | N/A | Queretaro |
| Centro de Especialidades Médicas de Celaya | Rosas Juan | Mexico | Guanajuato | Celaya |
| CONSULTORIO MEDICO | Vargas Armando | Mexico | Jalisco | Guadalajara |
| Instituto de Terapeutica Experimental y Clínica (INTEC) | González Manuel | Mexico | Jalisco | Guadalajara |
| Instituto de Terapeutica Experimental y Clínica (INTEC) | MARTINEZ ESPERANZA | Mexico | Jalisco | Guadalajara |
| PARACELSUS S.A. DE C.V. | Aldrete Jorge Antonio | Mexico | Distrito Federal | Mexico |
| Instituto Jalicience de Investigacion en diabetes y obesidad S.C. | Gonzalez Guillermo | Mexico | Jalisco | Guadalajara |
| Investigacion Biomedica Aplicada de Hidalgo | Mustieles Rocha Cynthia | Mexico | Hidalgo | Pachuca |
| Instituto de Diabetes, Obesidad y Nutrición, S.C. | Sauque Leobardo | Mexico | Morales | Cuernavaca |
| Unidad de Investigación Médica | Frenk Paul | Mexico | Distrito Federal | Mexico |
| Centro de Atención e Investigación Cardiovascular del Potosí, S.C. | Arenas José Luis | Mexico | San Luis Potosi | San Luis Potosi |
| Quality Care Research | Tichelaar Peter | Netherlands | Overijssel | Kloosterhaar |
| Bethesda Diabetes Research Center | Kooy A. | Netherlands | N/A | Hoogeveen |
| Meander Medisch Centrum | Van de Wiel Albert | Netherlands | 3818 ES | Amersfoort |
| Medisch Centrum Gorecht | Lochorn Gerben | Netherlands | N/A | Hoogezand |
| Andromed Rotterdam | VAN KEMPEN WOUTER | Netherlands | ZUID-HOLLAND | Rotterdam |
| Emotional Brain | Alhakim Mazin | Netherlands | N/A | Almere |
| TweeSteden Ziekenhuis, locatie waalwijk | Imholz Ben | Netherlands | N/A | waalwijk |
| Albert Schweitzer Ziekenhuis Zwijndrecht | van leendert Ruud | Netherlands | ZUID-HOLLAND | Zwijndrecht |
| Albert Schweitzer Ziekenhuis | Smak Gregoor Peter | Netherlands | N/A | Dordrecht |
| Praktijk Poortvliet | Brussen Joop | Netherlands | N/A | poortvliet |
| LUMC | Pijl Hanno | Netherlands | N/A | Leiden |
| Sint Franciscus Gasthuis | Castro Cabezas Manuel | Netherlands | N/A | ROTTERDAM |
| Saxenburgh Groep | Gonkel F. | Netherlands | N/A | Hardenberg |
| Maasstad Ziekenhuis | Smits P. | Netherlands | Zuid-Holland | Rotterdam |
| Huisarts Lansdorp | Lansdorp Daan | Netherlands | N/A | Wamel |
| Andromed Breda | KOSE VICDAN | Netherlands | NOORD-BRABANT | Breda |
| Andromed Eindhoven | Kentgens Susanne | Netherlands | N/A | Eindhoven |
| Andromed Noord | Voors-Pette Christine | Netherlands | N/A | Groningen |
| Andromed Zoetermeer | Rojas Gloria | Netherlands | Zuid-Holland | Zoetermeer |
| Andromed Oost | Hoogendijk Jacqueline | Netherlands | N/A | Velp |
| Andromed Amsterdam | Schipperen Stefanie | Netherlands | NOORD-BRABANT | Breda |
| Andromed Utrecht | Wittekoek Janneke | Netherlands | N/A | Utrecht |
| Emotional Brain Utrecht | Veenendaal Aletha | Netherlands | N/A | UTRECHT |
| Southern Clinical Trials - Waitemata | Richmond John | Netherlands | New Zealand | Christchurch |
| Lipid & Diabetes Research Group | Scott Russell | New Zealand | Canterbury | Christchurch |
| Lakeland Clinical Trials | WILLIAMS MIKE | New Zealand | N/A | Rotorua |
| P3 RESEARCH WELLINGTON | QUINN DEAN | New Zealand | Wellington | Wellington |
| Wellington Hospital, Endocrine, Diabetes & Research Centre, Capital & Coast District Health Board | Krebs Jeremy | New Zealand | Wellington | Wellington |
| Middlemore Hospital Clinical Research Centre | Baker John | New Zealand | N/A | Auckland |
| Palmerston North Hospital | Chaudhri Owais | New Zealand | Manawatu | Palmerston North |
| P3 Research Ltd. | Young Calum | New Zealand | N/A | Tauranga |
| NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny | Arciszewska Malgorzata | Poland | N/A | Bialystok |
| Centralny Szpital Kliniczny MSWiA; Klinika Chorob Wewnetrzanych, Endokrynologii i Diabetologii | Jedynasty Krystyna | Poland | N/A | Warszawa |
| Wojewódzki Zespól Specjalistycznej Opieki Zdrowotnej, Poradnia Diabetologiczna | Sowinski Dariusz | Poland | N/A | Wroclaw |
| NZOZ CenterMed Lublin Sp. z o.o. | zyprowska Ewa | Poland | N/A | Lublin N/a |
| NZOZ | MADEJ ANDRZEJ | Poland | N/A | Katowice |
| Bydgoskie Centrum Diabetologii i Endokrynologii | Polaszewska-Muszynska Miroslawa | Poland | N/A | Bydgoszcz |
| NZOZ Regionalna Poradnia Diabetologiczna | Zytkiewicz-Jaruga Danuta | Poland | N/A | Wroclaw |
| Niepubliczny Zaklad Opieki Zdrowotnej OSTEO-MEDIC s.c. Artur Racewicz i Jerzy Supronik | Wasilewska Katarzyna | Poland | N/A | Bialystok |
| NZOZ Gdanska Poradnia Cukrzycowa | Romanczuk Piotr | Poland | N/A | Gdansk |
| Nasz Lekarz, Niepubliczny Zaktad Opieki Zdrowotnej, Praktyka Grupowa Lekarzy Rodzinnych z Przychodn | Ocicka-Kozakiewicz Anna | Poland | N/A | Torun |
| NZOZ T-MED s.c. | Marcisz Czeslaw | Poland | N/A | Tychy |
| NZOZ TERAPIA - OPTIMA | Okopien Boguslaw | Poland | N/A | Katowice |
| CENTRUM BADAWCZE WSPOLCZESNEJ TERAPII | Bochenek Anna | Poland | N/A | Warszawa |
| NZOZ Lecznice Citomed Sp. z o.o., Poradnia Diabetologiczna | Wojnowski Lukasz | Poland | N/A | Toruń |
| MAZOWIECKIE CENTRUM BADAN KLINICZNYCH SC (MCBK S.C.) | Sliwinska Teresa | Poland | N/A | Grodzisk Mazowiecki |
| NZOZ | Sokolowska Barbara | Poland | N/A | Kraków |
| MEDICOME sp z o.o.Oswiecimskie Centrum Badań Klinicznych | Zmuda Witold | Poland | N/A | Oswiecim |
| NBR Polska | Klodawska Katarzyna | Poland | N/A | Warsaw |
| NZOZ Przychodnia Specjalistyczna Medica | Skokowska Ewa | Poland | N/A | Lublin |
| Przychodnia Srodmiescie SP. z o.o. | Fabisiak Jacek | Poland | N/A | Bydgoszcz |
| Regional Clinical Hospital for War Veterans | Raskina Tatiana | Russia | N/A | Kemerovo |
| Cardiovascular Pathology Research Institute of Siberian Branch of RAMS | Barbarash Olga | Russia | N/A | Kemerovo |
| Penza City Clinical Hospital #4 | Bartosh Leonid | Russia | N/A | Penza |
| HEALTHCARE INSTITUTION OF NIZHNY NOVGOROD REGION CITY CLINICAL HOSPITAL #33 | Motylev Igor | Russia | N/A | Nizhny Novgorod |
| City Clinical Hospital #6 | Kuzin A | Russia | N/A | Chelyabinsk |
| Regional Hospital of War Veterans | Reshetko Olga | Russia | N/A | Saratov |
| North State Medical University | Zykova Tatyana | Russia | N/A | Arkhangelsk |
| Clinical Emergency Hospital n.a. N.V. Solovyev | Ershova Olga | Russia | N/A | Yaroslavl |
| Saint-Petersburg Clinical Hospital of Russian Academy of Sciences | BALYZEK MARINA | Russia | N/A | Saint-Petersburg |
| Smolensk Regional Clinical Hospital | RAFALSKY VLADIMIR | Russia | N/A | Smolensk |
| Rostov State Medical University | Volkova Natalya | Russia | N/A | Rostov-On-Don |
| City Out-patient clinic #34 | Nosova Nina | Russia | N/A | St-Petersburg |
| Consultative Diagnostic Center and Outpatient Clinic of RF President Management Department | Burova Natalia | Russia | N/A | Saint-Petersburg |
| City Multiple-Discipline Hospital # 2 | ZALEVSKAYA ALSU | Russia | N/A | SAINT-PETERSBURG |
| Smolensk State Medical Academy of Roszdrav | RESHEDKO GALINA | Russia | N/A | Smolensk |
| State Institution of Health | SHILKINA NATALIA | Russia | N/A | Yaroslavl |
| Clinical Hospital named after N. A. Semashko | CHIZHOV PETR | Russia | N/A | Yaroslavl |
| Medical Exercises Dispensary of Krasnogvardeiskiy district in St-Petersburg | SHERENKOV ALEXANDER | Russia | N/A | SHERENKOV ALEXANDER |
| City Clinical Hospital # 26 | Simanenkov Vladimir | Russia | N/A | St. Petersburg |
| City Hospital #5 | LYSENKO TATIANA | Russia | N/A | BARNAUL |
| Consultative and Diagnostic Centre | IPATKO IRINA | Russia | N/A | SYKTYVKAR |
| Institute of Medical Research | Boyarkin Mikhail | Russia | N/A | Saint Petersburg |
| Rostov State Medical University | Vorobyev Sergey | Russia | N/A | Rostov-On-Don |
| Tyumen Cardiology Center | GAPON LYUDMILA | Russia | N/A | Tyumen |
| International Medical Centre SOGAZ | OBREZAN ANDREY | Russia | N/A | Saint-Petersburg |
| St. Petersburg State Healthcare Institution Diagnostic Centre #85 | Esip Valeria | Russia | N/A | Saint-Petersburg |
| Krestovsky Island Medical Institute | Paltsman Zhanna | Russia | N/A | Saint-Petersburg |
| Center Diabetes | Verbovoy Andrey | Russia | N/A | Samara |
| Vsevolzhsk Central Regional Hospital | Khetagurova Fatima | Russia | N/A | Vsevolzhsk |
| POLICLINICA VILADECANS-FUNDACION PRIVADA HAYGE | ALVAREZ-GARCIA PERE | Spain | Barcelona | Viladecans |
| HOSPITAL ARQUITECTO MARCIDE | MARTINEZ DEBEN FRANCISCO | Spain | N/A | Ferrol |
| Hospital Ciudad Sanitaria y Universitaria de Bellvitge | Grinyo Josep M | Spain | Barcelona | Barcelona |
| H. Clinico Universitario de Santiago de Compostela | Calvo Carlos | Spain | N/A | Santiago de Compostela |
| Hospital Universitario de La Princesa | Suarez Carmen | Spain | Madrid | Madrid |
| HOSPITAL SAGUNTO | Pascual JM | Spain | Valencia | Puerto Sagunto |
| H. UNIV. SAN JUAN DE ALICANTE | Dominguez Jose | Spain | Alicante | Alicante |
| Hospital del Mar | Oliveras Anna | Spain | Barcelona | Barcelona |
| Hospital de Figueres | Grau Armand | Spain | Gerona | Figueres |
| Hospital General Segovia | Gómez Peralta Fernando | Spain | Segovia | Segovia |
| HOSPITAL GREGORIO MARANON | Alvarez-Sala Luis | Spain | MADRID | MADRID |
| Hospital Infanta Leonor | Francisco Canizo | Spain | Madrid | Madrid |
| HOSPITAL INFANTA SOFIA | Gómez Cerezo Jorge | Spain | Madrid | San Sebastián de los Reyes |
| Hospital La Paz | GARCIA PUIG JUAN | Spain | N/A | Madrid |
| Hospital La Ribera de Alzira | Trescolí Carlos | Spain | VALENCIA | Alzira |
| H. REINA SOFIA | Fuentes Jimenez Francisco Jose | Spain | N/A | Cordoba |
| HOSPITAL SON DURETA (SON ESPASES) | Tofé Santiago | Spain | Baleares | Palma de Mallorca |
| Hospital Universitario Canarias | López Judith | Spain | Santa Cruz de Tenerife | LA LAGUNA |
| Hospital Universitario de Ciudad Real | Nieto Iglesias Javier | Spain | CIUDAD REAL | CIUDAD REAL |
| Hospital Universitario de Móstoles | Vigil Luis | Spain | Madrid | Mostoles |
| Hosp. Unv. de Valme | Duran Garcia Santiago | Spain | Sevilla | Sevilla |
| Hospital Universitario Dr. Peset | Gorriz Jose Luis | Spain | Valencia | Valencia |
| Hospital Universitario Príncipe de Asturias | Saavedra Vallejo Pilar | Spain | N/A | Alcala de Henares |
| Hospital Universitario Virgen de la Victoria | Tinahones Madueno Francisco | Spain | Málaga | Málaga |
| Hospital Virgen del Mar | Blanco Coronado Jose Luis | Spain | Almeria | Almeria |
| COMPLEJO HOSPITALIARIO UNIVERSITARIO DE A CORUNA | Soto Alfonso | Spain | A Coruna | A Coruna |
| Instituto de Ciencias Medicas | De Teresa Luis | Spain | Alicante | Alicante |
| CSU Parc Taulí | Gonzalez Jose Miguel | Spain | Barcelona | Sabadell |
| Hospital Infanta Luisa | RODRIGUEZ BOTARO ANTONIO | Spain | Sevilla | Sevilla |
| Nuevas Tecnologías en Diabetes, Endocrinología y Nutrición | Cuesta Carmina | Spain | Sevilla | Sevilla |
| Medect Clinical Trials | Bragée Bjorn | Sweden | N/A | Stockholm |
| City Diabetes | TENGMARK BENGT-OLOV | Sweden | N/A | Stockholm |
| Silentzvagens Vardcentral | JUL-NIELSEN Hans | Sweden | N/A | UDDEVALLA |
| Karolinska Trial Alliance, KTA prim | Crisby Militia | Sweden | N/A | Stockholm |
| Uppsala Akademiska Sjukhus | HUSS FREDRIK | Sweden | N/A | Uppsala |
| CTC AB | Jennersjo Par | Sweden | N/A | Linkoping |
| Ladulaaskliniken | Berndtsson–Blom Katarina | Sweden | N/A | Skene |
| S3 Clinical Research Centers | Liu Bo | Sweden | N/A | Vallingby |
| Clinical Trial Center | STENLOF KAJ | Sweden | N/A | Goteborg |
| Capio Citykliniken | Lindholm Carl-Johan | Sweden | N/A | Lund |
| Endokrin- och diabetescentrum | Jendle Johan | Sweden | N/A | Karlstad |
| Pharmasite | Koskinen Pekka | Sweden | Skane Lan | Malmo |
| PTC | STENLOF KAJ | Sweden | N/A | Goteborg |
| Taichung veterans general hospital | Shue Wayne H-H | 中国 | N/A | Taichung |
| Taipei Veterans General Hospital | Chiang Chern-En | 中国 | N/A | TAIPEI |
| China Medical University Hospital | Chen Ching-Chu | 中国 | Taiwan | Taichung |
| Taichung Hospital | Sheen Yi-Jing | 中国 | N/A | Taichung |
| Kyiv Oleksandrivska Clinical Hospita | Reshotko Dmytro | Ukraine | N/A | Kyiv |
| Uzhgorod National University, Department of Hospital Therapy | Rishko Nikolay | Ukraine | N/A | Uzhgorod |
| National Research Centre of Radiation Medicine National Academy of medical science of Ukraine | SAMOYLOV OLEXANDER | Ukraine | N/A | Kiev |
| Vinnytsya National Medical University named after M.I.Pirogov | SERKOVA VALENTINA | Ukraine | N/A | Vinnitsa |
| Municipal Healthcare Institution | SMIRNOV IVAN | Ukraine | N/A | Kharkiv |
| SI V.P. Komisarenko Institute of Endocrinology and Metabolism of NAMS of Ukraine | SOKOLOVA LIUBOV | Ukraine | N/A | Kyiv |
| Kharkov Medical Academy of Postgraduate Education, Dept. of Cardiology and Functional Diagnostics | TSELUYKO VIRA | Ukraine | N/A | Kharkov |
| Zaporizhzhya State Medical University | Vizir Vadym | Ukraine | Zaporiz'ka Oblast' | Zaporizhzhya |
| Kyiv Municipal Clinical Hospital #1 | Zlova Tetiana | Ukraine | N/A | Kyiv |
| Bukovinian State Medical University | Maslyanko Vitaliy | Ukraine | N/A | Chernivtsy |
| Clinic of Ukrainian Scientific-Practical Center of Endocrine Surgery-MoHU, Endocrinology Dept. | LARIN OLEKSANDR | Ukraine | N/A | Kiev N/a |
| Odessa National Medical University | Valentina Velichko | Ukraine | N/A | Odessa |
| Sumy State University | PRYSTUPA LYUDMILA | Ukraine | N/A | Sumy |
| Ternopil State Medical University named after I.Y. Gorbachevskogo | Yarema Nadiya | Ukraine | N/A | Ternopil |
| State Institution Railway clinical Hospital #2 | MISHANICH GALINA | Ukraine | N/A | Kyiv |
| Municipal Institution | Bondarets Iryna | Ukraine | N/A | Cherkasy |
| Ivano-Frankivsk National Medical University, Dept. of Therapy | VIRSTYUK NATALIYA | Ukraine | N/A | Ivano-Frankivsk |
| Dep. of Endocrinology - and Clinical Pharmacology - Medical University | SERHIYENKO OLEXANDER | Ukraine | N/A | Lviv |
| LVIV REGIONAL STATE CLINICAL TREATMENT AND DIAGNOSTIC CARDIOLOGY CENTER | PAVLYK STEPAN | Ukraine | N/A | Lviv |
| SI | LEVCHENKO OLENA | Ukraine | N/A | Odesa |
| Danylo Halytsky Lviv National Medical University | Abrahamovych Orest | Ukraine | N/A | Lviv |
| Ivano-Frankivsk National Medical University | BOTSURKO VOLODYMYR | Ukraine | N/A | Ivano-Frankovsk |
| P.L.Shupik National Medical Academy of Post-Graduate Education | DOLZHENKO MARYNA | Ukraine | N/A | Kyiv |
| Communal Institution of Zaporizhzhya Regional Council “Regional Clinical Endocrinology Dispensary | CHERNIKOVA VICTORIA | Ukraine | N/A | Zaporizhzhia |
| Donetsk National Medical University named after M.Gorkiy | Dorofeyev Andriy | Ukraine | N/A | Donetsk |
| State Institution | Karachentsev Yuriy | Ukraine | N/A | Kharkiv |
| Ukrainian Medical Stomatological Academy | KATERENCHUK VITALIY | Ukraine | N/A | Poltava |
| SI V.P. Komisarenko Institute of Endocrinology and Metabolism of NAMS of Ukraine | Korpachov Vadym | Ukraine | N/A | Kyiv |
| Municipal institution “Regional medical center of cardiology diseases” Zaporizhzhya Regional Rada | Malynovsky Yaroslav | Ukraine | N/A | Zaporizhzhya |
| P.L. Shupik National Medical Academy of Post-Graduate Education | Mankovsky Boris | Ukraine | N/A | Kiev |
| Vinnitsa National Medical University named after M.I.Pirogov | MOSTOVOY YURIY | Ukraine | N/A | VINNITSA |
| Kharkiv City Clinical Hospital | PERERVA LARISA | Ukraine | N/A | Kharkov |
| State Institution “Dnipropetrovsk Medical Academy of Ministry of Health of Ukraine” | PERTSEVA NATALIYA | Ukraine | N/A | Dnipropetrovsk |
| Hillcrest Clinical Research | Conrad Vicki | USA | OK | Oklahoma City |
| Family Medical Assoc | Fox Kenneth | USA | N/A | Levittown |
| St. Luke's Hospital - Lipid & Diabetes Research | Forker Alan | USA | N/A | Kansas City |
| Lonepeak Family Medicine | Jack David | USA | N/A | Draper |
| Buynak Clinical Research | Buynak Robert | USA | IN | Valparaiso |
| Clinical NeuroScience Solutions, Inc | Dever Michael | USA | FL | Orlando |
| PMG Research | Kirby John | USA | TN | Jefferson City |
| Lynn Institute | Parmar Paramjit | USA | CO | Denver |
| Baptist Health Center for Clinical Research | Wijewardane Priyantha | USA | AR | Little Rock |
| Elias Research | Taslimi Jalal | USA | FL | Miami |
| Arroyo Medical Group, Inc. | Guthrie Roger | USA | CA | Pismo Beach |
| Sierra Clinical Research | Reddy Jakkidi | USA | N/A | Roseville |
| Highland Clinical Research | Muse Derek | USA | N/A | Salt Lake City |
| Cotton-O'Neil Clinical Research Center | Wynne Alan | USA | N/A | Topeka |
| L-MARC RESEARCH CENTER | Bays Harold | USA | KY | Louisville |
| Advanced Clinical Research | Kirstein Judith | USA | N/A | West Jordan |
| Apex Medical Research | Arif Ahmed | USA | MI | Flint |
| Diabetes & Endocrine Associates Research Center | Baker Claire | USA | NE | Omaha |
| Southeast Clinical Research LLC | Barbel-Johnson Kim | USA | N/A | Jacksonville |
| Ponce School of Medicine | Barranco Santana Elizabeth | USA | PR | Ponce |
| Prestige Clinical Reseaerch | Bedel Gary | USA | OH | Franklin |
| Sunshine Research Center | Blemur Pierre | USA | FL | Opa Locka |
| International Research Associates, LLC | Breton Christian | USA | FL | Miami |
| John Muir Physician Network Clin. Research Center | Chang Anna | USA | N/A | Concord |
| Clinical Trials Management, LLC | Naccari Brian | USA | LA | Metairie |
| Certified Clinical Research | Coburn Nancy Jo | USA | CA | Carmichael |
| Suncoast Clinical Research | Cohen Lisa | USA | N/A | New Port Richey |
| Integris Physicians Services | Dedeke Eric | USA | OK | Yukon |
| Banksville Medical PC | Diederich Charles | USA | PA | Pittsburgh |
| Unifour Medical Research | Earl John | USA | NC | Hickory |
| Seven Corners Medical Research Center | George Anu | USA | VA | Falls Church |
| Premier Clinical Research | Gleason Gary | USA | WA | Spokane |
| Tidewater Integrated Medical Research | Haase Gregory | USA | VA | Virginia Beach |
| Community Health Care | Ison Rodney | USA | N/A | Barberton |
| The Methodist Hospital System | Jain Mahendra | USA | TX | Pearland |
| Advanced Healthcare SC | Jain Rajeev | USA | WI | Milwaukee |
| Austin Center for Clinical Research | Laurent Aziz | USA | TX | Austin |
| Center Diabetes/Endocrine Care | Lerman Sam | USA | FL | Hollywood |
| Tipton Medical and Diagnostic Center | Levinson Lawrence | USA | PA | Tipton |
| Clinical Research of West Florida | Lynn Lon D. | USA | N/A | Tampa |
| Heritage Valley Medical Group, Inc. | Oliver Michael | USA | PA | Beaver |
| Clinical Trials Managements, LLC | Kusnick Barry | USA | LA | Metairie |
| Pearl Clinical Research Inc. | Pearlstein Robert | USA | PA | Norristown |
| Suncoast Clinical Research | Plevin Sanford | USA | FL | Palm Harbor |
| Nevada Alliance Against Diabetes | Saavedra Rubin | USA | NV | Las Vegas |
| Mercy Health Research | Smith Timothy | USA | N/A | St Louis |
| Uptown Research Institute, LLC | Jutovsky Michael | USA | IL | Chicago |
| Progressive Clinical Research | Wade Ralph | USA | N/A | Bountiful |
| Palmetto Clinical Research, L.L.C. | Wallace James | USA | SC | Greer |
| Albert J. Weisbrot and Assoicates Inc. | Weisbrot Albert | USA | N/A | Mason |
| Clinical Research Associates of Tidewater | Wombolt Duane | USA | VA | Norfolk |
| Instituto de Investigaciones Clínicas Zarate | VICO MARISA | Argentina | Buenos Aires | Zarate, Buenos Aires |
| Azienda Ospedaliera Universitaria Integrata Verona | BONORA Enzo | 意大利 | N/A | Verona |
| Restrial, s.r.o. | Petra,Horanska | 新西兰 | NA | Praha 8 |
| Academisch Medisch Centrum, Kamer L01-109 | Max,Nieuwdorp | 荷兰 | NA | AMSTERDAM |
| "Diabet" Centrum Medyczne s.c. | Leszek,Romanowski | 波兰 | NA | Chrzanow |
| PharmaSite | Pekka,Koskinen | 瑞典 | NA | Malmo |
| San Miguel Medical | Elba,Perez Vargas | 美国 | PR | Trujillo Alto |
| Westlake Medical Research Clinical Trials | Krista,Preston | 美国 | CA | Thousand Oaks |
伦理委员会信息
| 名称 | 审查结论 | 审查日期 |
|---|---|---|
| 北京大学人民医院医学伦理委员会 | 修改后同意 | 2015-02-10 |
| 北京大学人民医院医学伦理委员会 | 同意 | 2015-03-18 |
| 北京大学人民医院医学伦理委员会 | 同意 | 2015-06-08 |
| 北京大学人民医院医学伦理委员会 | 同意 | 2015-09-09 |
| 北京大学人民医院医学伦理委员会 | 同意 | 2015-12-05 |
| 北京大学人民医院医学伦理委员会 | 同意 | 2016-04-26 |
| 北京大学人民医院医学伦理委员会 | 同意 | 2016-06-22 |
| 北京大学人民医院医学伦理委员会 | 同意 | 2016-11-18 |
试验状态信息
试验状态
已完成
目标入组人数
国内: 100 人；
国际: 5700 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: 5886 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：2015-04-15；
国际：2014-01-17；
试验终止日期
国内：2017-01-05；
国际：2017-02-23；
临床试验结果摘要
| 版本号 | 版本日期 |
|---|
