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

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

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

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

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

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	1 2型糖尿病 2 筛选时的年龄≥50岁，以及伴有心血管、脑血管或周围血管疾病或慢性肾功能衰竭或慢性心脏衰竭；或者，筛选时年龄≥60岁，以及其他指定的血管疾病危险因素 3 糖化血红蛋白≥7.0％ 4 初始服用抗糖尿病药物或经一个或多个口服抗糖尿病药物（OAD）或人NPH胰岛素或长效胰岛素类似物或预混胰岛素（单独或联合OAD）治疗的受试者
排除标准	1 1型糖尿病 2 筛选前3个月内，使用GLP-1受体激动剂（艾塞那肽，利拉鲁肽或其它）或普兰林肽或任何的二肽基肽酶4（DPP-4）抑制剂 3 筛选前3个月内，使用了除人中性鱼精蛋白（NPH）胰岛素或长效胰岛素类似物或预混胰岛素之外的胰岛素。在受试者并发疾病期间，经研究者同意，可允许短期使用其它胰岛素

试验药	序号 名称 用法 1 中文通用名:利拉鲁肽注射液 用法用量:注射液；6mg/ml，3ml/支；一天一次皮下注射，最大剂量1.8mg。伴随受试者标准治疗。用药时程：18个月的招募期以及最后1名受试者随机入组后的42个月 2 中文通用名:利拉鲁肽注射液 用法用量:注射液；6mg/ml，3ml/支；一天一次皮下注射，最大剂量1.8mg。伴随受试者标准治疗。用药时程：18个月的招募期以及最后1名受试者随机入组后的42个月
对照药	序号 名称 用法 1 中文通用名:安慰剂注射液 用法用量:注射液；6mg/ml，3ml/支；一天一次皮下注射，最大剂量1.8mg。伴随受试者标准治疗。用药时程：18个月的招募期以及最后1名受试者随机入组后的42个月 2 中文通用名:安慰剂注射液 用法用量:注射液；6mg/ml，3ml/支；一天一次皮下注射，最大剂量1.8mg。伴随受试者标准治疗。用药时程：18个月的招募期以及最后1名受试者随机入组后的42个月

主要终点指标及评价时间	序号 指标 评价时间 终点指标选择 1 从随机入组至首次发生心血管死亡、非致死性心血管梗死、非致死性中风（心血管复合终点）的时间 从随机入组至60个月 安全性指标
次要终点指标及评价时间	序号 指标 评价时间 终点指标选择 1 从随机入组至广义的心血管复合终点的时间，该复合终点定义为心血管死亡、非致死性心肌梗死、非致死性中风、血运重建、不稳定型心绞痛或慢性心脏衰竭而导致的住院。 从随机入组至60个月 安全性指标 2 从随机入组至全因死亡 从随机入组至60个月 安全性指标 3 从随机入组至广义心血管复合结局的任何单个成分 从随机入组至60个月 安全性指标

1	姓名	潘长玉	学位	暂无	职称	教授
	电话	010-66887329	Email	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

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	mobiles
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

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

已完成

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 ；

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；