Cardiovascular and Renal Microvascular Outcome Study With Linagliptin in Patients With Type 2 Diabetes Mellitus (CARMELINA)

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

CARMELINA: A Multicenter, International, Randomized, Parallel Group, Double-blind, Placebo-controlled, Cardiovascular Safety and Renal Microvascular Outcome Study With Linagliptin, 5 mg Once Daily in Patients With Type 2 Diabetes Mellitus at High Vascular Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01897532
• Other study ID #: 1218.22
• Secondary ID: 2011-004148-23
• Status: Completed
• Phase: Phase 4
• Start date: July 10, 2013
• Est. completion date: January 18, 2018

Study information

• Verified date: March 2019
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to investigate the longterm impact on cardiovascular morbidity, mortality and renal function of treatment with linagliptin in a selected population of patients with Type 2 diabetes mellitus (T2DM) and to compare outcomes against placebo, on a background of standard of care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6991
• Est. completion date: January 18, 2018
• Est. primary completion date: January 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. Documented diagnosis of T2DM before visit 1(screening).

2. Male or female patients who are drug-naïve or pre-treated with any antidiabetic background medication, excluding treatment with Glucagon-like Peptide 1 (GLP-1) receptor agonists, Dipeptidyl-peptidase 4 (DPP-4) inhibitors or Sodium Glucose Linked Transporter 2 (SGLT-2) inhibitors if => consecutive 7 days.

3. Stable antidiabetic background medication (unchanged daily dose) for at least 8 weeks prior to randomization. If insulin is part of the background therapy, the average daily insulin dose should not have changed by more than 10% within the 8 weeks prior to randomization compared with the daily insulin dose at randomization.

4. HbA1c of => 6.5% and <= 10.0% at Visit 1 (screening)

5. Age => 18 years at Visit 1(screening). For Japan only: Age => 20 years at Visit 1

6. Body Mass Index (BMI) <= 45 kg/m2 at Visit 1 (screening)

7. Signed and dated written informed consent by date of Visit 1(screening) in accordance with Good Clinical Practice (GCP) and local legislation prior to any study related procedure

8. High risk of cardiovascular (CV) events defined by: 1) albuminuria (micro or macro) and previous macrovascular disease and/or 2) impaired renal function with predefined Urine Albumin Creatinine Ratio (UACR)

Exclusion criteria:

1. Type 1 diabetes mellitus.

2. Treatment (=> 7 consecutive days) with GLP-1 receptor agonists, other DPP-4 inhibitors or SGLT-2 inhibitors prior to informed consent. Note: This also includes clinical trials where these antidiabetic drugs have been provided to the patient.

3. Active liver disease or impaired hepatic function, defined by serum levels of either Alanine Transaminase (ALT) (SGPT), Aspartate transaminase (AST) (SGOT), or alkaline phosphatase (AP) => 3 x upper limit of normal (ULN) as determined at Visit 1.

4. Estimated Glomerular filtration Rate (eGFR) <15 ml/min/1.73 m2 (severe renal impairment or End Stage Renal Disease (ESRD), Modification of Diet in Renal Disease (MDRD) formula), as determined during screening at Visit 1 and/or the need for maintenance dialysis.

5. Any previous (or planned within next 12 months) bariatric surgery (open or laparoscopic) or intervention (gastric sleeve).

6. Pre-planned coronary artery re-vascularisation (PCI, CABG) or any previous PCI and/or CABG <= 2 months prior informed consent.

7. Known hypersensitivity or allergy to the investigational products or its excipients.

8. Any previous or current alcohol or drug abuse that would interfere with trial participation in the opinion of the investigator.

9. Participation in another trial with an investigational drug ongoing or within 2 months prior to visit 1 (screening).

10. Pre-menopausal women (last menstruation = 1 year prior to informed consent) who are nursing or pregnant, are of child-bearing potential and are not practicing an acceptable method of birth control (acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence (if allowed by local authorities), double barrier method and vasectomised partner) or do not plan to continue using acceptable method of birth control throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial.

11. Patients considered unreliable by the investigator concerning the requirements for follow up during the study and/or compliance with study drug administration, have a life expectancy less than 5 years for non-CV causes, or have cancer other than non-melanoma skin cancer within last 3 years, or has any other condition than mentioned which in the opinion of the investigator, would not allow safe participation in the study.

12. Acute coronary syndrome (ACS), diagnosed <= 2 months prior to visit 1 (screening).

13. Stroke or Transient Ischemic Attack (TIA) <= 3 months prior to visit 1 (screening).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Placebo
placebo matching tablets
• Linagliptin

Locations

Country	Name	City	State
Argentina	Instituto Médico Adrogué	Adrogue
Argentina	Hospital Interzonal General de Agudos Dr Jose Penna	Bahia Blanca
Argentina	Hospital Italiano Regional del Sur, Bahia Blanca	Bahia Blanca
Argentina	Inst de Inv Clinicas-Bahia Blanca	Bahia Blanca
Argentina	Hospital Sirio-Libanés	Caba
Argentina	CCBR - Buenos Aires - AR	Ciudad Autonoma Buenos Aires
Argentina	CEDIC - Centro de Investigacion Clinica	Ciudad Autonoma Buenos Aires
Argentina	Centro de Investigaciones Metabólicas	Ciudad Autonoma Buenos Aires
Argentina	CIPREC	Ciudad Autonoma Buenos Aires
Argentina	Consultorios Asociados de Endocrinología e Invest Clínica	Ciudad Autonoma Buenos Aires
Argentina	Hospital Italiano	Ciudad Autonoma Buenos Aires
Argentina	Instituto Cardiovascular de Buenos Aires	Ciudad Autonoma Buenos Aires
Argentina	Centro Médico Viamonte	Ciudad Autonoma de Bs As
Argentina	CEMAIC - Centro Medico Especializado	Cordoba
Argentina	Centro Médico Colon	Cordoba
Argentina	Clínica Colombo	Cordoba
Argentina	Clinica Privada del Prado	Cordoba
Argentina	Hospital Cordoba	Cordoba
Argentina	Inst. Privado de Inv. Clínicas de Córdoba	Cordoba
Argentina	Instituto DAMIC - Fundacion Rusculleda	Cordoba
Argentina	IPAC - Clínica Privada Caraffa SRL	Cordoba
Argentina	Sanatorio Allende S.A.	Córdoba
Argentina	Centro Universitario de Investigacion Corrientes	Corrientes
Argentina	CIPADI	Godoy Cruz
Argentina	Centro Medico Dr. Javier Marino	Haedo
Argentina	Hospital Italiano de La Plata	La Plata
Argentina	Hospital Privado de Comunidad	Mar del Plata
Argentina	Unidad de Cardiologia Clinica	Mar del Plata
Argentina	Hospital Central de Mendoza, Mendoza	Mendoza
Argentina	Hospital San Martin	Parana
Argentina	Sanatorio San Martin S.A., Venado Tuerto	Pellegrini 661
Argentina	CER Instituto Médico	Quilmes
Argentina	Instituto de Investigaciones Clínicas de Quilmes	Quilmes
Argentina	CEDyN	Rosario
Argentina	Centro Medico CIR	Rosario
Argentina	Instituto CAICI	Rosario
Argentina	Instituto de Hematologia y Medicina Clinica Ruben Davoli	Rosario
Argentina	Instituto de Investigaciones Clinicas de Rosario	Rosario
Argentina	Instituto Medico CENICLAR-C de Investigaciones Clinicas	Rosario
Argentina	Instituto Medico de la Fundacion Estudios Clinicos, Rosario	Rosario
Argentina	Instituto Medico Fundación Grupo Colaborativo Rosario	Rosario
Argentina	Sanatorio Británico	Rosario
Argentina	Sanatorio Delta	Rosario
Argentina	Sanatorio Norte	Rosario
Argentina	Centro Cardiovascular Salta	Salta
Argentina	CORDIS S.A., Salta	Salta
Argentina	Prevencion Cardiovascular Salta, Salta	Salta
Argentina	CCBR Tucuman	San Miguel de Tucuman
Argentina	Investigaciones Clinicas Tucuman	San Miguel de Tucumán
Argentina	Instituto de Investigaciones Clinicas San Nicolas	San Nicolas
Argentina	Centro Medico Luquez	San Vicente
Argentina	Centro de Investigaciones Clínicas del Litoral	Santa Fe
Argentina	Hospital "Dr. José Maria Cullen "	Santa Fé
Argentina	Clinica Privada Fusavim SRL	Villa Maria
Argentina	Instituto de Investigaciones Clínicas Zárate	Zarate
Brazil	Hospital Universitário João de Barros Barreto	Belém
Brazil	Hospital Felício Rocho	Belo Horizonte
Brazil	Hospital Lifecenter	Belo Horizonte
Brazil	Hospital Vera Cruz	Belo Horizonte
Brazil	Hospital Angelina Caron	Campina Grande do Sul
Brazil	CAEP - Centro Avançado de Estudos e Pesquisas Ltda.,Campinas	Campinas
Brazil	HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas	Campinas
Brazil	Hospital Universitário	Canoas
Brazil	Universidade de Caxias do Sul - IPCEM - Inst. de Pesq.clilni	Caxias do Sul
Brazil	Cruz Vermelha Brasileira - Filial do Estado do Paraná	Curitiba
Brazil	HC UFPR	Curitiba
Brazil	Hospital de Caridade Santa Casa de Misericordia de Curitiba	Curitiba
Brazil	Centro de Estudos em Diabetes e Hipertensão	Fortaleza
Brazil	Centro de Pesquisas em Diabetes e Doenças	Fortaleza
Brazil	ICE-HUWC - Instituto Cearense de Endocrinologia	Fortaleza
Brazil	Via Médica	Goiania
Brazil	Hospital Bruno Born	Lajeado
Brazil	ICM - Instituto do Coração de Marília	Marília
Brazil	Hospital São Vicente de Paulo	Passo Fundo
Brazil	Centro de Pesquisas em Diabetes	Porto Alegre
Brazil	Instituto de Cardiologia Rio Grande do Sul	Porto Alegre
Brazil	Irmandade da Santa Casa de Misericórdia de Porto Alegre	Porto Alegre
Brazil	Centro de Pesquisas Médicas Básica e Clínica Ltda	Recife
Brazil	CCBR - Rio de Janeiro - BR	Rio de Janeiro
Brazil	Centro de Pesquisa Clínica Santa Maria	Santa Maria
Brazil	CCBR Brasil - São Paulo	Santo Andre
Brazil	Fundacao Faculdade Regional de Medicina, Sao Jose	Sao Jose do Rio Preto
Brazil	Instituto Domingo Braile	Sao Jose do Rio Preto
Brazil	Centro de Pesquisa Clinica - CPCLIN	Sao Paulo
Brazil	FGM Clínica Paulista de Doenças Cardiovasculares LTDA	Sao Paulo
Brazil	Hospital Sao Paulo - UNIFESP	Sao Paulo
Brazil	Cpquali Pesquisa Clinica Ltda	São Paulo
Brazil	Dr. Consulta	São Paulo
Brazil	Hospital Alemao Oswaldo Cruz	São Paulo
Brazil	Hospital das Clinicas da FMUSP	São Paulo
Brazil	Hospital do Servidor Público Estadual	São Paulo
Brazil	Incor - Instituto do Coração - HCFMUSP	São Paulo
Brazil	IMC - Instituto de Moléstias Cardiovasculares Tatuí	Tatui
Brazil	ICT - Instituto do Coração do Triângulo	Uberlândia
Bulgaria	MHAT - Blagoevgrad, EOOD	Blagoevgrad
Bulgaria	MHAT "Yuliya Vrevska" EOOD, Byala	Byala
Bulgaria	MHAT "Dr.Stambolski", Cardiology&Intensiv Care Dept,Kazanlak	Kazanlak
Bulgaria	UMHAT "Kaspela", EOOD, Plovdiv	Plovdiv
Bulgaria	DCC 1 - Ruse, EOOD	Ruse
Bulgaria	Fifth MHAT - Sofia EAD, Sofia	Sofia
Bulgaria	MHAT 'Tokuda Hospital Sofia', EAD	Sofia
Bulgaria	MHAT Lyulin	Sofia
Bulgaria	USHATE Hospital 'Academy Ivan Penchev', Sofia	Sofia
Bulgaria	DCC "Equita" EOOD	Varna
Canada	LMC Endocrinology Centres (Barrie) Ltd.	Barrie	Ontario
Canada	ViaCar Recherche Clinique Inc	Brossard	Quebec
Canada	JBN Medical Diagnostic Services Inc.	Burlington	Ontario
Canada	Dr. Ronald Collette	Burnaby	British Columbia
Canada	ALTA Clinical Research Inc.	Edmonton	Alberta
Canada	LMC Endocrinology Centres (Etobicoke) Ltd.	Etobicoke	Ontario
Canada	Hopital Charles - LeMoyne	Greenfield Park	Quebec
Canada	True North Clinical Research Halifax, Inc.	Halifax	Nova Scotia
Canada	Centre De Recherche Clinique	Laval	Quebec
Canada	Recherche Invascor Inc.	Longueuil	Quebec
Canada	LMC Endocrinology Centres (Markham) Ltd.	Markham	Ontario
Canada	Centre Hospitalier de l'Universite de Montreal (CHUM)	Montreal	Quebec
Canada	McGill University Health Centre (MUHC)	Montreal	Quebec
Canada	SKDS Research Incorporated	Newmarket	Ontario
Canada	The Medical Arts Health Research Group	Penticton	British Columbia
Canada	Clinique des maladies Lipidiques de Quebec	Quebec
Canada	Recherche Clinique Sigma Inc.	Quebec
Canada	The Bailey Clinic	Red Deer	Alberta
Canada	St Jerome Medical Research Inc.	St-Jerome	Quebec
Canada	Dr. R. Labonte Prof. Med. Corp	Sudbury	Ontario
Canada	Medicor Research	Sudbury	Ontario
Canada	Sudbury Cardiac Research	Sudbury	Ontario
Canada	LMC Clinical Research dba Manna Research Inc. Vancouver	Vancouver	British Columbia
Canada	CookMed Research	Victoria	British Columbia
Canada	Discovery Clinical Services Ltd.	Victoria	British Columbia
Canada	Fraser Clinical Trials Inc.	Victoria	British Columbia
Canada	LMC Endocrinology Centres (Montreal)	Ville Saint-Laurent	Quebec
Canada	Winnipeg Regional Health Authority, Winnipeg	Winnipeg	Manitoba
Chile	Hospital Regional de Punta Arenas Dr. Lautaro Navarro Avaria	Punta Arenas
Chile	CeCim - Centro de Estudios Clinicos e Investigacion Medica	Santiago
Chile	Hospital El Pino	Santiago
Chile	Hospital Militar de Santiago	Santiago
Chile	Hospital Padre Alberto Hurtado	Santiago
Chile	Hospital Sotero del Rio	Santiago
Chile	Sociedad Medica Cardiologica El Llano	Santiago
Chile	Hospital Base Valdivia	Valdivia
Chile	Hospital Naval Almirante Nef	Viña del Mar
China	Beijing Jishuitan Hospital	Beijing
China	Third Affiliated Hospital of Guangzhou Medical University	Guangzhou
China	Zhejiang University School of Medicine SIR RUN RUN SHAW Hospital	Hangzhou
China	Center Hospital of Jinan	Jinan
China	People's Hospital of Guangxi Zhuang Autonomous Region	Nanning
China	Tongji Hospital, Tongji University	Shanghai
China	First Affiliated Hospital of Xi'an JiaoTong University	Xi'an
China	General Hospital of Ningxia Medical University	Yinchuan
Colombia	CEQUIN	Armenia
Colombia	Clínica de la Costa Ltda.	Barranquilla
Colombia	Corazon IPS S.A.S.	Barranquilla
Colombia	IPS Centro Cientifico Asistencia	Barranquilla
Colombia	CAFESALUD Medicina Prepagada S.A.	Bogota
Colombia	Centro de Atencion e Investigacion Medica S.A. - CAIMED	Bogota
Colombia	Solano y Terront Servicios Médicos Ltda.	Bogota
Colombia	Dexa Diabetes Servicios Médicos Ltda	Bogotá
Colombia	Fundacion Reina Isabel	Cali
Colombia	IPS Centro Medico Julián Coronel S.A.	Cali
Colombia	Fundación Centro de Investigaciones Biomédicas Riescard	Espinal
Colombia	Centro de Investigacion Clínica Avanzada	Medellin
Colombia	Fundacion Centro de Investigacion Clinica CIC, Medellin	Medellin
Colombia	Fundacion Centro de Obesidad y Metabolismo - COMETA	Pasto
Colombia	Healthy Medical CenterS.A.S, Zipaquirá	Zipaquirá
Croatia	General Hospital Karlovac	Karlovac
Croatia	Hospital for Medical Rehabilitation, Krapinske Toplice	Krapinske Toplice
Croatia	General Hospital Slavonski Brod	Slavonski Brod
Croatia	General Hospital Varazdin	Varazdin
Croatia	General Hosp. Zadar, Dept. of Internal Medicine-Pulmonology	Zadar
Croatia	Clinical Hospital Sveti Duh	Zagreb
Croatia	University hospital center Zagreb	Zagreb
Czechia	Fakultni nemocnice u sv. Anny v Brne	Brno
Czechia	Fakultni nemocnice u sv. Anny v Brne	Brno
Czechia	Revmatologie Bruntal, s.r.o.	Bruntal
Czechia	Poliklinika Chocen, a.s.	Chocen
Czechia	Aesculap Ambulance Sro	Dolni Brezany
Czechia	OKELI s.r.o.	Hodonin
Czechia	Nemocnice Jindrichuv Hradec a.s.	Jindrichuv Hradec
Czechia	Regional Hospital Liberec	Liberec
Czechia	InterKardioML s.r.o.	Marianske Lazne
Czechia	Interna a diabetologicka ordinace s.r.o.	Nachod
Czechia	PreventaMed, s.r.o.	Olomouc
Czechia	Univ. Hospital Kralovske Vinohrady	Praha 10
Czechia	Vseobecna fakultni nemocnice V Praze	Praha 2
Czechia	Thomayer Hospital	Praha 4 - Krc
Czechia	ResTrial s.r.o.	Praha 8
Czechia	Hospital Slany, Internal Department	Slany
Czechia	Krajska zdravotni, a.s. - Nemocnice Teplice, o.z.	Teplice
Germany	Studienzentrum Aschaffenburg	Aschaffenburg
Germany	Zentrum für klinische Forschung Dr. med. Irma Schöll & Kollegen	Bad Homburg
Germany	Universitätsklinikum Carl Gustav Carus Dresden	Dresden
Germany	ClinPhenomics GmbH & Co KG, Frankfurt	Frankfurt
Germany	IKF Pneumologie GmbH & Co. KG	Frankfurt am Main
Germany	Diabetologische Schwerpunktpraxis, Hohenmölsen	Hohenmölsen
Germany	EUGASTRO GmbH, Leipzig	Leipzig
Germany	Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut, Leipzig	Leipzig
Hungary	Lausmed Kft. Outpatient Unit of Internal Medicine	Baja
Hungary	Dr. Kenessey Albert Kórház-Rendelõintézet, Balassagyarmat	Balassagyarmat
Hungary	DRC Gyogyszervizsgalo Kozpont Kft., Balatonfured	Balatonfured
Hungary	Clinexpert Kft.	Budapest
Hungary	Obudai Egeszsegugyi Centrum	Budapest
Hungary	QUALICLINIC Kft	Budapest
Hungary	Semmelweis Egyetem, Budapest	Budapest
Hungary	Semmelweis Egyetem, Budapest	Budapest
Hungary	Semmelweis Egyetem, Budapest	Budapest
Hungary	University Debrecen Hospital	Debrecen
Hungary	Markhot Ferenc Hospital, Eger	Eger
Hungary	Csongrad Megyei Eu. Ellato Kozp. Hodmezovasarhely-Mako	Hodmezovasarhely
Hungary	Somogy Megyei Kaposi Mor Oktato Korhaz, Kaposvar	Kaposvar
Hungary	Selye Janos Hospital Komarom	Komarom
Hungary	Ermellek Egeszsegcentrum	Letavertes
Hungary	Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz	Miskolc
Hungary	Pecsi Tudomanyegyetem	Pecs
Hungary	Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klin. Kozpont	Szeged
Hungary	Zala Megyei Szent Rafael Korhaz	Zalaegerszeg
Israel	Haemek Medical Center	Afula
Israel	Bnei Zion Medical Center, Haifa	Haifa
Israel	Rambam Medical Center	Haifa
Israel	Herzliya Medical Center	Herzliya
Israel	Wolfson Medical Center	Holon
Israel	Hadassah Medical Center, Ein-Karem	Jerusalem
Israel	Meir Medical Center	Kfar-Saba
Israel	Galilee Medical Center	Nahariya
Israel	Ziv Medical Center	Safed
Israel	Sourasky Medical Center	Tel Aviv
Japan	Daishinkai Medical Corporation Ookuma Hospital	Aichi, Nagoya
Japan	Seikeikai New Tokyo Heart Clinic	Chiba, Matsudo
Japan	Saiseikai Matsuyama Hospital	Ehime, Matsuyama
Japan	Aso Co.,Ltd Iizuka Hospital	Fukuoka, Iizuka
Japan	Kitakyushubyoin Kitakyushu General Hospital	Fukuoka, Kitakyushu
Japan	The Veritas Hospital	Hyogo, Kawanishi
Japan	Ibaraki Seinan Medical Center Hospital	Ibaraki, Sashima-gun
Japan	Kokan Clinic	Kanagawa, Kawasaki
Japan	Nagano Red Cross Hospital	Nagano, Nagano
Japan	Josuikai Olive Takamatsu Medical Clinic	Takamatsu-shi
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang-si
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Pusan National Univ. Hosp	Busan
Korea, Republic of	Myongji Hospital	Goyang-si
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St.Mary's Hospital	Seoul
Korea, Republic of	Wonju Severance Christian Hosp	Wonju
Malaysia	Hospital Sultanah Bahiyah	Alor Setar
Malaysia	Hospital Tengku Ampuan Rahimah	Klang
Malaysia	University Malaya Medical Centre	Kuala Lumpur
Malaysia	Hospital Tengku Ampuan Afzan	Kuantan
Malaysia	Monash University(Sunway Campus)	Petaling Jaya
Malaysia	Hospital Pulau Pinang	Pulau Pinang
Malaysia	Universiti Putra Malaysia	Serdang
Malaysia	Hospital Seri Manjung	Seri Manjung
Malaysia	Hospital Taiping	Taiping
Malaysia	Klinik Kesihatan Tampin	Tampin
Mexico	Investigación en Salud y Metabolismo S.C.	Chihuahua
Mexico	Phylasis Clinicas Research S de RL de CV	Cuautitlan Izcalli
Mexico	Centro para el Desarrollo de la Medicina y de Asist Med Espe	Culiacan
Mexico	Centro de Investigacion Biomedica y Farmaceutica, S.C.	Distrito Federal
Mexico	Servicios Medicos de la Pena SC	Guadalajara
Mexico	Medical Care & Research SA de CV	Merida
Mexico	Sociedad de Cirugia Vascular Plastica Reconstructiva	Merida
Mexico	Centro de Atención e Investigación en Factores de Riesgo	Mexico
Mexico	Clinstile S.A. de C.V.	Mexico
Mexico	Comite Mexicano Para la Prevencion de Osteoporosis AC	Mexico
Mexico	Health Pharma Professional Research S.A. de C.V.	Mexico
Mexico	Phytomedicamenta S.A. de C.V.	Mexico
Mexico	Ultimate Medica SA de CV	Mexico
Mexico	AVIX Investigación Clínica S.C	Monterrey
Mexico	Centro de Estudios Clinicos y Especialidades Medicas, S.C.	Monterrey
Mexico	Global Trial Research Center S.A. de C.V.	Monterrey
Mexico	Centro de Investigacion Clinica Chapultepec S. A. de C. V.	Morelia
Mexico	Centro de Estudios Clínicos de Queretaro S.C., CECLIQ	Queretaro
Mexico	Centro de Investigacion Cardiovascular y Metabolica	Tijuana
Mexico	Centro de Investigación Médica de Ocidente, S.C.	Zapopan
Mexico	Hospital Dr Angel Leano	Zapopan
Netherlands	Rijnstate Hospital	Arnhem
Netherlands	Albert SchweitzerZiekenhuis	Dordrecht
Netherlands	Martini Ziekenhuis	Groningen
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Netherlands	Bethesda Cardiology Group, Hoogeveen	Hoogeveen
Netherlands	Maastricht Universitair Medisch Centrum	Maastricht
Netherlands	Rotterdam Research Institute	Rotterdam
Netherlands	Universitair Medisch Centrum Utrecht	Utrecht
Netherlands	TweeSteden Ziekenhuis	Waalwijk
Netherlands	Gelre Ziekenhuis Zutphen	Zutphen
Poland	B_Serwis Popenda Sp.Jawna	Chorzow
Poland	Poradnia Kardiologiczna Jaroslaw Jurowiecki	Gdansk
Poland	University Clinical Center, Gdansk	Gdansk
Poland	Indywidualna Specjalistyczna Praktyka Lekarska	Gdynia
Poland	MCBK Iwona Czajkowska Anna Podrazka- Szczepaniak S.C.	Grodzisk Mazowiecki
Poland	Centrum Medyczne Pratia Katowice II	Katowice
Poland	Polimedica Centrum Bada?, Profilaktyki I Leczenia	Kielce
Poland	NZOZ Centrum Medyczne ProMiMed Sp. z o.o., Sp.k., Krakow	Krakow
Poland	CCBR - Lodz - PL, Lodz	Lodz
Poland	Centrum Terapii Wspolczesnej J.M.	Lodz
Poland	Individual Specialized Practice	Lodz
Poland	Centrum Medyczne "Luxmed" Sp. z o.o.	Lublin
Poland	KO-MED Centra Kliniczne Lublin II	Lublin
Poland	NZOZ Specialized Ambulance "MEDICA"	Lublin
Poland	RCMed- Regionalne Centrum Medyczne	Nowy Duninow
Poland	Medicome Sp. z o.o.	Oswiecim
Poland	Prywatny Gabinet Lekarski Lech Lazuka	Parczew
Poland	Clin.Hosp.Med.Univ.Marcinkowski in Poznan	Poznan
Poland	Praktyka Lekarska Ewa Krzyzagorska	Poznan
Poland	KOMED Marek Konieczny	Pulawy
Poland	Indywidualna Specjalistyczna Praktyka Lekarska Dr N Med Andrzej Wittek	Ruda Slaska
Poland	Centrum Medyczne Medyk	Rzeszow
Poland	RCMed- Regionalne Centrum Medyczne	Sochaczew
Poland	NSZOZ Medicus	Sroda Wielkopolska
Poland	KO-MED Centra Kliniczne Staszow	Staszow
Poland	Lecznice Citomed Sp. z o.o.	Torun
Poland	NZOZ Nasz Lekarz	Torun
Poland	NBR Polska	Warsaw
Poland	CCBR/Somed - Warszaw - PL	Warszaw
Poland	Regionalna Poradnia Diabetoloiczna Zytkiewicz-Jaruga	Wroclaw
Poland	KO-MED Centra Kliniczne Zamosc	Zamosc
Poland	Polimedica Centrum Bada?, Profilaktyki I Leczenia	Zgierz
Portugal	Hospital de Braga-Escala Braga	Braga
Portugal	CHUC - Centro Hospitalar e Universitário de Coimbra, EPE	Coimbra
Portugal	APDP - Associação Protectora dos Diabéticos de Portugal	Lisboa
Portugal	CHLO, EPE - Hospital S. Francisco Xavier	Lisboa
Portugal	Hospital da Luz	Lisboa
Portugal	Hospital CUF Porto	Porto
Portugal	Centro Hospitalar de Vila Nova de Gaia	V. N. Gaia
Romania	SC Diana Barbonta SRL, Alba Iulia	Alba Iulia
Romania	Clinica Medicala Data Plus SRL	Bucuresti
Romania	CMI Dr. Stolea T. Violeta	Bucuresti
Romania	I.N.D.N.B.M. "Prof. Dr. N.C. Paulescu" - Sediul "I.L. Caragiale"	Bucuresti
Romania	I.N.D.N.B.M. "Prof. Dr. N.C. Paulescu" - Sediul Central	Bucuresti
Romania	I.N.D.N.B.M. "Prof. Dr. N.C. Paulescu" - Sediul Central	Bucuresti
Romania	S.C Centrul Medical "Sanatatea Ta" S.R.L	Bucuresti
Romania	S.C. Policlinica CCBR SRL, Bucuresti	Bucuresti
Romania	Spitalul Universitar de Urgenta, Bucuresti	Bucuresti
Romania	Medcon SRL	Buzau
Romania	Spitalul Clinic Judetean de Urgenta ¿Sf. Apostol Andrei¿	Galati
Romania	Consultmed SRL, Iasi	Iasi
Romania	SC Diaconu-Sotropa Michaela, Cabinet de Diabet	Iasi
Romania	Spitalul Clinic, Iasi	Iasi
Romania	Pelican Impex SRL, Cabinet Nr. 15	Oradea
Romania	S.C Anamed S.R.L	Oradea
Romania	S.C Grandmed S.R.L, Oradea	Oradea
Romania	S.C. Diabmed Dr. Popescu Alexandrina S.R.L	Ploiesti
Romania	Gensan SRL	Sibiu
Romania	Centrul Medical Dr Negrisanu SRL	Timisoara
Romania	Mediab SRL	Tirgu Mures
Russian Federation	SBEI HPE Altay State Medical University of MoH and SD	Barnaul
Russian Federation	NSIH "Departmental Hospital on Station Kemerovo of OJSC "Russian Railways"	Kemerovo
Russian Federation	Res.Inst.-Compl.Iss.Cardi.Dis.	Kemerovo
Russian Federation	First Moscow State Medical University n.a. I.M. Sechenov	Moscow
Russian Federation	Moscow 1st State Med.Univ.n.a.I.M.Sechenov	Moscow
Russian Federation	Moscow State Medical Dentistry University	Moscow
Russian Federation	SBEI HPE "Moscow State Medical and Dentistry University	Moscow
Russian Federation	FSBSI "Scientific and Research Institute of Physiology and Basic Medicine"	Novosibirsk
Russian Federation	FSBSI "Scientific Research Institute", Novosibirsk	Novosibirsk
Russian Federation	Novosibirsk Regional Clinical Cardiological Dispansary	Novosibirsk
Russian Federation	SBIH of Novosibirsk Region "Clinical Emergency Hospital #2"	Novosibirsk
Russian Federation	BIH of OR "City Hospital # 2", Omsk	Omsk
Russian Federation	SBIH of Perm territory " City Clinical Hospital # 2 n.a.	Perm
Russian Federation	SBI of Ryazan region "Regional Clinical Cardiological Dis.	Ryazan
Russian Federation	1stPavlov St.Med.Univ.St.-Petersburg Res.Inst.	Saint-Petersburg
Russian Federation	Federal North-West Medical Research Centre	Saint-Petersburg
Russian Federation	FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov"	Saint-Petersburg
Russian Federation	SPb SBHI "City Policlinic #74"	Saint-Petersburg
Russian Federation	SPb SBIH "City Pokrovskaya Hospital"	Saint-Petersburg
Russian Federation	GUZ "City Clinical Hospital #40, 197706 Saint-Petersburg	Sestroretsk
Russian Federation	Medical Research Institute LLC, St. Petersburg	St. Petersburg
Russian Federation	FSBI "Research Institute for Cardiology"	Tomsk
South Africa	Cardiology Clinical Research	Alberton
South Africa	Iatros International	Bloemfontein
South Africa	Limaro Research	Bloemfontein
South Africa	Cape Town Medical Research Centre	Cape Town
South Africa	Dr Dawood, Mohamed and Pillay	Cape Town
South Africa	Dr JM Engelbrecht Practice	Cape Town
South Africa	Groote Schuur Hospital	Cape Town
South Africa	Ismail, SM	Cape Town
South Africa	Langeberg Clinical Trials	Cape Town
South Africa	TREAD Research	Cape Town
South Africa	Latiff, GHVM	Durban
South Africa	Londisizwe Research Centre, Durban	Durban
South Africa	Diabetes Care Centre	Johannesburg
South Africa	WCR CMJAH Clinical Trial Site	Johannesburg
South Africa	Wits Clinical Research Chris Hani Baragwanath Hospital	Johannesburg
South Africa	DJW Navorsing	Krugersdorp
South Africa	Emmed Research	Pretoria
South Africa	Into Research	Pretoria
South Africa	Seeber, M	Pretoria
South Africa	Syzygy Clinical Research Services	Pretoria
South Africa	University of Pretoria	Pretoria
South Africa	Dr M Duki Research and Trial Site, Verulam	Verulam
South Africa	Clinical Projects Research	Worcester
Spain	Hospital Virgen del Mar	Almeria
Spain	Hospital de la Ribera	Alzira
Spain	Hospital Germans Trias i Pujol	Badalona
Spain	CAP Sarria	Barcelona
Spain	Hospital Quiron. I.C.U.	Barcelona
Spain	Specialist	Barcelona
Spain	EBA Centelles	Centelles
Spain	Fundación Jiménez Díaz	Madrid
Spain	Hospital Regional Universitario de Málaga	Malaga
Spain	Hospital General de Segovia	Segovia
Spain	Hospital Quironsalud Infanta Luisa	Sevilla
Spain	Hospital Virgen Macarena	Sevilla
Spain	Hospital Dr. Peset	Valencia
Spain	Hospital General Universitario de Valencia	Valencia
Spain	Hospital Virgen de las Montañas, Villamartin	Villamartin
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung
Taiwan	Far Eastern Memorial Hospital	New Taipei City
Taiwan	China Medical University Hospital	Taichung
Taiwan	NCKUH	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipe Veterans General Hospital	Taipei
Taiwan	Chang-Gung Memorial Hospital, Linkou	Taoyuan County
Ukraine	Chernivtsi Regional Endocrinology Dispensary	Chernivtsi
Ukraine	CI Ivano-Frankivsk Reg Cl Card Center	Ivano-Frankivsk
Ukraine	Regional CH Dept of Endocrinology SHEI Ivano-Frankivsk NMU	Ivano-Frankivsk
Ukraine	CI of Healthcare Kharkiv CCH #8, Kharkiv	Kharkiv
Ukraine	CIPH Prof. O.I. Meshchaninov Kharkiv CCH of A&E	Kharkiv
Ukraine	L.T. Malaya Institute of Therapy AMS of Ukraine	Kharkiv
Ukraine	City Clinical Hospital No. 1, Kiev	Kyiv
Ukraine	KCCC of Endocr Dept of General Endocrine Pathology	Kyiv
Ukraine	Kjiv City Oleksandrivska Clinical Hospital	Kyiv
Ukraine	LLC Treatment and Diagnostic Center Adonis Plus, Kyiv	Kyiv
Ukraine	P.L. Shupyk NMA of PGE Ch of D H for S-ts of NASU	Kyiv
Ukraine	SI National Scientific Centre of Radiation Medicine of NAMSU	Kyiv
Ukraine	SI V.P.Komisarenko Institute of Endocrinology and Metabolism	Kyiv
Ukraine	V.P. Komisarenko Inst. of Endocrinology and Metabolism	Kyiv
Ukraine	Lviv Regional Endocrinology Dispensary	Lviv
Ukraine	M.V. Sklifosovskyi Poltava RCH, Poltava	Poltava
Ukraine	CI Sumy City Clinical Hospital #1 Dept of Therapy Sumy SU	Sumy
Ukraine	CI of TRC Ternopil UH	Ternopli
Ukraine	CCH #1 M.I. Pyrogov VNMU Ch of Propaedeutics of IM	Vinnytsia
Ukraine	M.I. Pyrogov VRCH, Vinnytsia	Vinnytsia
Ukraine	Private Small Enterprise Medical Center Pulse	Vinnytsia
Ukraine	Vinnytsia RC Highly Special.Endocr.Center Dept of Therapy	Vinnytsia
Ukraine	CI Zapor CCH#10 SI ZMA PGE Ch of therapy clin pharmacol & endocrin	Zaporizhzhia
United Kingdom	University Hospital Monklands	Airdrie
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	Bradford on Avon Health Centre	Bradford on Avon
United Kingdom	Ashgate Medical Practice	Chesterfield
United Kingdom	Dumfries and Galloway Royal Infirmary	Dumfries
United Kingdom	Ninewells Hospital & Medical School	Dundee
United Kingdom	Royal Devon and Exeter Hospital	Exeter
United Kingdom	Glasgow Royal Infirmary	Glasgow
United Kingdom	Leicester General Hospital	Leicester
United Kingdom	Barts and The London School of Medicine and Dentistry	London
United Kingdom	Morriston Hospital	Swansea
United Kingdom	Queen Elizabeth II Hospital	Welwyn Garden City
United Kingdom	New Cross Hospital	Wolverhampton
United States	Summa Health System	Akron	Ohio
United States	New Mexico Clinical Research and Osteoporosis Center, Inc.	Albuquerque	New Mexico
United States	Endeavor Medical Research	Alpena	Michigan
United States	Blair Medical Associates	Altoona	Pennsylvania
United States	Clinical Research Associates of Central Pennsylvania	Altoona	Pennsylvania
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Western Nephrology & Metabolic	Arvada	Colorado
United States	Emory University	Atlanta	Georgia
United States	Laureate Clinical Research Group, LLC	Atlanta	Georgia
United States	DCT- AACT, LLC dba Discovery Clinical Trials	Austin	Texas
United States	American Health Network	Avon	Indiana
United States	Bainbridge Medical Associates	Bainbridge	Georgia
United States	Johns Hopkins University	Baltimore	Maryland
United States	Maryland Cardiovascular Specialists	Baltimore	Maryland
United States	Overlea Personal Physicians	Baltimore	Maryland
United States	Rockwood Medical Clinic	Bedford	Texas
United States	Belleville Family Medical Associates, Ltd	Belleville	Illinois
United States	Kaiser Permanente - San Diego, Bonita	Bonita	California
United States	Helix Biomedics LLC	Boynton Beach	Florida
United States	Orthopedic Research Institute	Boynton Beach	Florida
United States	Nova Clinical Research, LLC	Bradenton	Florida
United States	PAB Clinical Research	Brandon	Florida
United States	Holston Medical Group	Bristol	Tennessee
United States	Jacobi Medical Center	Bronx	New York
United States	Life Medi-Research and Management	Brooklyn	New York
United States	Meridien Research	Brooksville	Florida
United States	Burke Internal Medicine and Research	Burke	Virginia
United States	Kernodle Clinic West	Burlington	North Carolina
United States	Main Street Physicians Care	Calabash	North Carolina
United States	Medical Frontiers, LLC	Carlisle	Ohio
United States	Mississippi Medical Research, LLC	Carriere	Mississippi
United States	Clinical Trials of South Carolina	Charleston	South Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Box Arthritis & Rheumatology of the Carolinas	Charlotte	North Carolina
United States	Cedar-Crosse Research Center	Chicago	Illinois
United States	Chicago Clinical Research Institute, Inc.	Chicago	Illinois
United States	Southeast Clinical Research, LLC	Chiefland	Florida
United States	BayCare Medical Group	Clearwater	Florida
United States	Ericksen Research & Development, LLC	Clinton	Utah
United States	John Muir Physician Network Clinical Research Center	Concord	California
United States	The Corvallis Clinic, PC	Corvallis	Oregon
United States	Atlanta Heart Specialists, LLC	Cumming	Georgia
United States	Research Institute of Dallas	Dallas	Texas
United States	Texas Health Physicians Group	Dallas	Texas
United States	Dayton VA Medical Center	Dayton	Ohio
United States	McGarity, Jr., William C.	Decatur	Georgia
United States	Cohen Medical Research Associates, LLC	Delray Beach	Florida
United States	South Denver Nephrology	Denver	Colorado
United States	Innovation Medical Research Center, Inc	Doral	Florida
United States	Central Bucks Cardiology	Doylestown	Pennsylvania
United States	Doylestown Health Cardiology	Doylestown	Pennsylvania
United States	Focus Clinical Research	Draper	Utah
United States	Associates in Endocrinology, Incorporated	Elgin	Illinois
United States	USMA Clin. Research/Union Square Med. Associates	Elizabeth	New Jersey
United States	Aa Mrc Llc	Flint	Michigan
United States	Integrative Research Associates	Fort Lauderdale	Florida
United States	Jellinger and Lerman, MD, PA dba The Center for Diabetes and Endocrine Care	Fort Lauderdale	Florida
United States	American Health Network of Indiana, LLC	Franklin	Indiana
United States	Valley Research	Fresno	California
United States	Spectrum Medical Research, LLC	Gaffney	South Carolina
United States	Clinical Research of Gastonia	Gastonia	North Carolina
United States	Arrowhead Health Centers	Glendale	Arizona
United States	Colorado Center for Bone Research, P.C.	Golden	Colorado
United States	American Health Network of Indiana, LLC	Greenfield	Indiana
United States	Medication Management, LLC	Greensboro	North Carolina
United States	VitaLink Research	Greenville	South Carolina
United States	Mountain View Clinical Research	Greer	South Carolina
United States	Harrisburg Family Medical Center	Harrisburg	Arkansas
United States	Nova Health Management & Research Group, PC	Herndon	Virginia
United States	Direct Helpers Medical Center, Inc	Hialeah	Florida
United States	Universal Clinical Research	Hialeah	Florida
United States	PMG Research of Bristol, LLC	Hickory	North Carolina
United States	Homestead Associates in Research	Homestead	Florida
United States	Ben Taub General Hospital	Houston	Texas
United States	Memorial Clinical Associates Research	Houston	Texas
United States	Southwest Clinical Trials	Houston	Texas
United States	Texas Family Geriatrics Clinic	Houston	Texas
United States	The Endocrine Center	Houston	Texas
United States	Longwood Research	Huntsville	Alabama
United States	Break Through Medical Research	Irving	Texas
United States	Medical & Surgical Clinic	Irving	Texas
United States	Care Partners Clinical Research LLC	Jacksonville	Florida
United States	St. Vincent's Cardiology	Jacksonville	Florida
United States	Lycoming Internal Medicine, Inc	Jersey Shore	Pennsylvania
United States	State of Franklin Healthcare Associates, PLLC	Johnson City	Tennessee
United States	United Medical Associates	Johnson City	New York
United States	Kidney Care Center, Nephrology	Joliet	Illinois
United States	Glacier View Cardiology, PC	Kalispell	Montana
United States	Kansas City Veterans Administration Medical Center	Kansas City	Missouri
United States	Truman Medical Centers, Inc.	Kansas City	Missouri
United States	West Memorial Family Practice	Katy	Texas
United States	Altus Research, Inc.	Lake Clarke Shores	Florida
United States	Meridien Research	Lakeland	Florida
United States	Alas Science Clinical Research	Las Vegas	Nevada
United States	The Research Group of Lexington, LLC	Lexington	Kentucky
United States	Mount Sinai - PRIME	Linden	New Jersey
United States	Cardiology and Medicine Clinic	Little Rock	Arkansas
United States	Little Rock Diagnostic Clinic	Little Rock	Arkansas
United States	VA Loma Linda Healthcare System	Loma Linda	California
United States	Long Beach Center for Clinical Research	Long Beach	California
United States	Clearview Medical Research, LLC	Los Angeles	California
United States	National Research Institute	Los Angeles	California
United States	Office of Dr. Richard S. Cherlin	Los Gatos	California
United States	Coastal Medical Research Group	Los Osos	California
United States	Manassas Clinical Research Center	Manassas	Virginia
United States	Diabetes and Metabolism Associates APMC	Metairie	Louisiana
United States	A+ Research Incorporated	Miami	Florida
United States	Clinical Research of Miami	Miami	Florida
United States	Clintex Research Group, Inc. Research	Miami	Florida
United States	Coral Research Clinic Corp	Miami	Florida
United States	Florida Medical Center & Research Inc	Miami	Florida
United States	Future Care Solution, LLC	Miami	Florida
United States	Jesscan Medical Research, Internal Medicine	Miami	Florida
United States	Kendall South Medical Center, Inc	Miami	Florida
United States	New Horizon Research Center	Miami	Florida
United States	Prestige Clinical Research Center, Inc.	Miami	Florida
United States	Regenerate Clinical Trials	Miami	Florida
United States	Research Institute of South Florida Inc	Miami	Florida
United States	Sanitas Research	Miami	Florida
United States	Tellus Clinical Research, Incorporated	Miami	Florida
United States	University of Miami	Miami	Florida
United States	Unlimited Medical Research, LLC	Miami	Florida
United States	Precision Research Organization	Miami Lakes	Florida
United States	Zablocki VA Medical Center	Milwaukee	Wisconsin
United States	Novo Research, Incorporated	Modesto	California
United States	Novant Health Southern Piedmont Primary Care	Monroe	North Carolina
United States	Research Institute of the Carolinas, PLC	Mooresville	North Carolina
United States	Down East Medical Associates	Morehead City	North Carolina
United States	Burke Primary Care	Morganton	North Carolina
United States	American Health Network of Indiana, LLC	Muncie	Indiana
United States	Hill Country Medical Associates	New Braunfels	Texas
United States	Tulane University Hospital and Clinic	New Orleans	Louisiana
United States	Providence Clinical Research	North Hollywood	California
United States	Harmony Clinical Research, Incorporated	North Miami Beach	Florida
United States	School of Clinical Research	North Miami Beach	Florida
United States	Platte River Nephrology	North Platte	Nebraska
United States	Northridge Clinical Research Inc.	Northridge	California
United States	Norton Community Care	Norton	Ohio
United States	Magnolia Research Group	Ocala	Florida
United States	Carr Cardiology	Oceanside	California
United States	Permian Research Foundation	Odessa	Texas
United States	Advanced Research Institute	Ogden	Utah
United States	Paramount Medical Care	Ogden	Utah
United States	COR Clinical Research, LLC	Oklahoma City	Oklahoma
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Omaha Veterans Affairs Medical Center	Omaha	Nebraska
United States	Family Medical Center	Orlando	Florida
United States	Peninsula Research, Inc.	Ormond Beach	Florida
United States	Methodist Hospital Research Institute, Internal Medicine	Pearland	Texas
United States	McLaren Northern Michigan Hospital	Petoskey	Michigan
United States	Precision Trials, LLC	Phoenix	Arizona
United States	Infinity Clinical Research, LLC	Plantation	Florida
United States	Sound Medical Research	Port Orchard	Washington
United States	Health Concepts	Rapid City	South Dakota
United States	Dominion Medical Associates, Inc.	Richmond	Virginia
United States	Hunter Holmes McGuire Veterans Administration Medical Center	Richmond	Virginia
United States	Roanoke Heart Institute PLC	Roanoke	Virginia
United States	Remedica LLC	Rochester	Michigan
United States	Vita Link Research- Rock Hill	Rock Hill	South Carolina
United States	Center for Clinical Trials of Sacramento, Incorporated	Sacramento	California
United States	HealthEast St. Joseph's Hospital	Saint Paul	Minnesota
United States	Meridien Research	Saint Petersburg	Florida
United States	Professional Health Care of Pinellas, Inc.	Saint Petersburg	Florida
United States	Salem Veterans Affairs Medical Center	Salem	Virginia
United States	Delmarva Heart Research Foundation, Inc	Salisbury	Maryland
United States	PMG Research of Salisbury, LLC	Salisbury	North Carolina
United States	Covenant Clinical Research, PA	San Antonio	Texas
United States	DCT-Stone Oak, LLC dba Discovery Clinical Trials	San Antonio	Texas
United States	DM Clinical Research	San Antonio	Texas
United States	Health Texas Research Institute	San Antonio	Texas
United States	North America Research Institute	San Dimas	California
United States	Trinitas Research, Incorporated	San Jose	California
United States	Intercoastal Medical Group, Endocrinology	Sarasota	Florida
United States	Saratoga Clinical Research, LLC	Saratoga Springs	New York
United States	Scottsboro Quick Care Clinic	Scottsboro	Alabama
United States	Sealy Urgent Care Center and Medical Clinic	Sealy	Texas
United States	Montgomery Medical Incorporated	Smithfield	Pennsylvania
United States	Apex Medical Research, AMR, Incorporated	Springfield	Ohio
United States	Tri-County Research, Inc	Sterling Heights	Michigan
United States	Pioneer Research Solutions, Inc.	Sugar Land	Texas
United States	Meridien Research	Tampa	Florida
United States	Metabolic Institute of America	Tarzana	California
United States	ProMedica Health Education & Research Corp.	Toledo	Ohio
United States	DM Clinical Research	Tomball	Texas
United States	Cotton-O'Neil Clinical Research Center	Topeka	Kansas
United States	Oakland Medical Research Center	Troy	Michigan
United States	Atlanta Heart Specialists, LLC	Tucker	Georgia
United States	Office of Dr. Terence T. Hart MD	Tuscumbia	Alabama
United States	Buynak Clinical Research	Valparaiso	Indiana
United States	Crossroads Clinical Research, LLC	Victoria	Texas
United States	Northeast Iowa Medical Education Foundation	Waterloo	Iowa
United States	Center for Clinical Trials of San Gabriel	West Covina	California
United States	Iowa Diabetes and Endocrinology Research Center	West Des Moines	Iowa
United States	Metabolic Research Institute	West Palm Beach	Florida
United States	Heartland Research Associates, LLC	Wichita	Kansas
United States	Professional Research Network of Kansas, LLC	Wichita	Kansas
United States	Natalie A Doyle, M.D., P.A.	Wilson	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Boehringer Ingelheim	Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Colombia,  Croatia,  Czechia,  Germany,  Hungary,  Israel,  Japan,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  Poland,  Portugal,  Romania,  Russian Federation,  South Africa,  Spain,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to the First Occurrence of Any of the Following Adjudication-confirmed Components of the Primary Composite Endpoint 3-point Major Adverse Cardiovascular (CV) Events (3-point MACE): CV Death, Non-fatal Myocardial Infarction (MI) or Non-fatal Stroke.	Time to event analysis of patients with first occurrence of any of the following adjudication-confirmed components of the primary composite endpoint (3-point MACE): CV death, non-fatal MI or non-fatal stroke. The percentage of observed patients with first occurrence of any of the following adjudication-confirmed components of the primary composite endpoint (3-point MACE) was reported.	From randomization to individual end of observation; up to 4.3 years
Secondary	Time to the First Occurrence of Any of the Following Adjudication-confirmed Components: Renal Death, Sustained End Stage Renal Disease (ESRD), or Sustained Decrease of 40% or More in Estimated Glomerular Filtration Rate (eGFR).	Time to the first occurrence of any of the following adjudication-confirmed components: renal death, sustained ESRD, or sustained decrease of 40% or more in eGFR.; The percentage of observed patients with first occurrence of any of the following adjudication-confirmed components: renal death, sustained ESRD, or sustained decrease of 40% or more in eGFR was reported.	From randomization to individual end of observation; up to 4.3 years

External Links

•   Link