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AzTrials

Diabetes Mellitus, Type 2Phase 4NCT01897532

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

A Phase 4 study testing Linagliptin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 649 sites in 27 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Linagliptin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
6,991 participants
Where
649 sitesin 27 countries
Study dates
10 Jul 2013to 18 Jan 2018
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented diagnosis of T2DM before visit 1(screening).
  • 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.
  • 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.
  • HbA1c of => 6.5% and <= 10.0% at Visit 1 (screening)
  • Age => 18 years at Visit 1(screening). For Japan only: Age => 20 years at Visit 1
  • Body Mass Index (BMI) <= 45 kg/m2 at Visit 1 (screening)
  • 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
  • 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)

Who cannot join

  • Type 1 diabetes mellitus.
  • 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.
  • 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.
  • 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.
  • Any previous (or planned within next 12 months) bariatric surgery (open or laparoscopic) or intervention (gastric sleeve).
  • Pre-planned coronary artery re-vascularisation (PCI, CABG) or any previous PCI and/or CABG <= 2 months prior informed consent.
Show all 13Show fewer
  • Known hypersensitivity or allergy to the investigational products or its excipients.
  • Any previous or current alcohol or drug abuse that would interfere with trial participation in the opinion of the investigator.
  • Participation in another trial with an investigational drug ongoing or within 2 months prior to visit 1 (screening).
  • 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.
  • 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.
  • Acute coronary syndrome (ACS), diagnosed <= 2 months prior to visit 1 (screening).
  • Stroke or Transient Ischemic Attack (TIA) <= 3 months prior to visit 1 (screening).

Trial locations and contacts

649 sites in 27 countries.

649 sites in 27 countries

United States197 sites

  • Summa Health System

    Akron, Ohio, 44304

  • New Mexico Clinical Research and Osteoporosis Center, Inc.

    Albuquerque, New Mexico, 87106

  • Endeavor Medical Research

    Alpena, Michigan, 49707

  • Blair Medical Associates

    Altoona, Pennsylvania, 16602

  • Clinical Research Associates of Central Pennsylvania

    Altoona, Pennsylvania, 16602

  • University of Michigan Health System

    Ann Arbor, Michigan, 48105

  • Western Nephrology & Metabolic

    Arvada, Colorado, 80002

  • Emory University

    Atlanta, Georgia, 30303

  • Laureate Clinical Research Group, LLC

    Atlanta, Georgia, 30308

  • DCT- AACT, LLC dba Discovery Clinical Trials

    Austin, Texas, 78758

  • American Health Network

    Avon, Indiana, 46123

  • Bainbridge Medical Associates

    Bainbridge, Georgia, 39819

  • Maryland Cardiovascular Specialists

    Baltimore, Maryland, 21229

  • Overlea Personal Physicians

    Baltimore, Maryland, 21236

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • Rockwood Medical Clinic

    Bedford, Texas, 76022

  • Belleville Family Medical Associates, Ltd

    Belleville, Illinois, 62220

  • Kaiser Permanente - San Diego, Bonita

    Bonita, California, 91902

  • Helix Biomedics LLC

    Boynton Beach, Florida, 33435

  • Orthopedic Research Institute

    Boynton Beach, Florida, 33437

  • Nova Clinical Research, LLC

    Bradenton, Florida, 34209

  • PAB Clinical Research

    Brandon, Florida, 33511

  • Holston Medical Group

    Bristol, Tennessee, 37620

  • Life Medi-Research and Management

    Brooklyn, New York, 11206

  • Meridien Research

    Brooksville, Florida, 34601

  • Burke Internal Medicine and Research

    Burke, Virginia, 22015

  • Kernodle Clinic West

    Burlington, North Carolina, 27215

  • Main Street Physicians Care

    Calabash, North Carolina, 28467

  • Medical Frontiers, LLC

    Carlisle, Ohio, 45005

  • Mississippi Medical Research, LLC

    Carriere, Mississippi, 39426

  • Clinical Trials of South Carolina

    Charleston, South Carolina, 29406

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Box Arthritis & Rheumatology of the Carolinas

    Charlotte, North Carolina, 28210

  • Cedar-Crosse Research Center

    Chicago, Illinois, 60607

  • Chicago Clinical Research Institute, Inc.

    Chicago, Illinois, 60607

  • Southeast Clinical Research, LLC

    Chiefland, Florida, 32626

  • BayCare Medical Group

    Clearwater, Florida, 33756

  • Ericksen Research & Development, LLC

    Clinton, Utah, 84015

  • John Muir Physician Network Clinical Research Center

    Concord, California, 94520

  • The Corvallis Clinic, PC

    Corvallis, Oregon, 97330

  • Atlanta Heart Specialists, LLC

    Cumming, Georgia, 30041

  • Texas Health Physicians Group

    Dallas, Texas, 75218

  • Research Institute of Dallas

    Dallas, Texas, 75231

  • Dayton VA Medical Center

    Dayton, Ohio, 45428

  • McGarity, Jr., William C.

    Decatur, Georgia, 30035-4000

  • Cohen Medical Research Associates, LLC

    Delray Beach, Florida, 33446

  • South Denver Nephrology

    Denver, Colorado, 80210

  • Innovation Medical Research Center, Inc

    Doral, Florida, 33166

  • Central Bucks Cardiology

    Doylestown, Pennsylvania, 18901

  • Doylestown Health Cardiology

    Doylestown, Pennsylvania, 18901

  • Focus Clinical Research

    Draper, Utah, 84020

  • Associates in Endocrinology, Incorporated

    Elgin, Illinois, 60124

  • USMA Clin. Research/Union Square Med. Associates

    Elizabeth, New Jersey, 07201

  • Aa Mrc Llc

    Flint, Michigan, 48504

  • Integrative Research Associates

    Fort Lauderdale, Florida, 33312

  • Jellinger and Lerman, MD, PA dba The Center for Diabetes and Endocrine Care

    Fort Lauderdale, Florida, 33312

  • American Health Network of Indiana, LLC

    Franklin, Indiana, 46131

  • Valley Research

    Fresno, California, 93720

  • Spectrum Medical Research, LLC

    Gaffney, South Carolina, 29341

  • Clinical Research of Gastonia

    Gastonia, North Carolina, 28054

  • Arrowhead Health Centers

    Glendale, Arizona, 85306

  • Colorado Center for Bone Research, P.C.

    Golden, Colorado, 80401

  • American Health Network of Indiana, LLC

    Greenfield, Indiana, 46140

  • Medication Management, LLC

    Greensboro, North Carolina, 27408

  • VitaLink Research

    Greenville, South Carolina, 29615

  • Mountain View Clinical Research

    Greer, South Carolina, 29651

  • Harrisburg Family Medical Center

    Harrisburg, Arkansas, 72432

  • Nova Health Management & Research Group, PC

    Herndon, Virginia, 20170

  • Direct Helpers Medical Center, Inc

    Hialeah, Florida, 33012

  • Universal Clinical Research

    Hialeah, Florida, 33012

  • PMG Research of Bristol, LLC

    Hickory, North Carolina, 28601

  • Homestead Associates in Research

    Homestead, Florida, 33032

  • Ben Taub General Hospital

    Houston, Texas, 77030

  • Southwest Clinical Trials

    Houston, Texas, 77074

  • The Endocrine Center

    Houston, Texas, 77079

  • Texas Family Geriatrics Clinic

    Houston, Texas, 77082

  • Memorial Clinical Associates Research

    Houston, Texas, 77084

  • Longwood Research

    Huntsville, Alabama, 35801

  • Break Through Medical Research

    Irving, Texas, 75039

  • Medical & Surgical Clinic

    Irving, Texas, 75061

  • St. Vincent's Cardiology

    Jacksonville, Florida, 32216

  • Care Partners Clinical Research LLC

    Jacksonville, Florida, 32277

  • Lycoming Internal Medicine, Inc

    Jersey Shore, Pennsylvania, 17740

  • United Medical Associates

    Johnson City, New York, 13901

  • State of Franklin Healthcare Associates, PLLC

    Johnson City, Tennessee, 37604

  • Kidney Care Center, Nephrology

    Joliet, Illinois, 60435

  • Glacier View Cardiology, PC

    Kalispell, Montana, 59901

  • Truman Medical Centers, Inc.

    Kansas City, Missouri, 64108

  • Kansas City Veterans Administration Medical Center

    Kansas City, Missouri, 64128

  • West Memorial Family Practice

    Katy, Texas, 77450

  • Altus Research, Inc.

    Lake Clarke Shores, Florida, 33406

  • Meridien Research

    Lakeland, Florida, 33805

  • Alas Science Clinical Research

    Las Vegas, Nevada, 89120

  • The Research Group of Lexington, LLC

    Lexington, Kentucky, 40503

  • Mount Sinai - PRIME

    Linden, New Jersey, 07036

  • Cardiology and Medicine Clinic

    Little Rock, Arkansas, 72204

  • Little Rock Diagnostic Clinic

    Little Rock, Arkansas, 72205

  • VA Loma Linda Healthcare System

    Loma Linda, California, 92357

  • Long Beach Center for Clinical Research

    Long Beach, California, 90807

  • Clearview Medical Research, LLC

    Los Angeles, California, 90019

  • National Research Institute

    Los Angeles, California, 90057

  • Office of Dr. Richard S. Cherlin

    Los Gatos, California, 95032

  • Coastal Medical Research Group

    Los Osos, California, 93402

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110

  • Diabetes and Metabolism Associates APMC

    Metairie, Louisiana, 70006

  • Clinical Research of Miami

    Miami, Florida, 33126

  • Prestige Clinical Research Center, Inc.

    Miami, Florida, 33133

  • Jesscan Medical Research, Internal Medicine

    Miami, Florida, 33134

  • Clintex Research Group, Inc. Research

    Miami, Florida, 33135

  • University of Miami

    Miami, Florida, 33136

  • Florida Medical Center & Research Inc

    Miami, Florida, 33142

  • A+ Research Incorporated

    Miami, Florida, 33144

  • Unlimited Medical Research, LLC

    Miami, Florida, 33144

  • Regenerate Clinical Trials

    Miami, Florida, 33155

  • Sanitas Research

    Miami, Florida, 33155

  • Future Care Solution, LLC

    Miami, Florida, 33165

  • Research Institute of South Florida Inc

    Miami, Florida, 33173

  • Tellus Clinical Research, Incorporated

    Miami, Florida, 33173

  • New Horizon Research Center

    Miami, Florida, 33175

  • Kendall South Medical Center, Inc

    Miami, Florida, 33185

  • Coral Research Clinic Corp

    Miami, Florida, 33186

  • Precision Research Organization

    Miami Lakes, Florida, 33016

  • Zablocki VA Medical Center

    Milwaukee, Wisconsin, 53295

  • Novo Research, Incorporated

    Modesto, California, 95350

  • Novant Health Southern Piedmont Primary Care

    Monroe, North Carolina, 28110

  • Research Institute of the Carolinas, PLC

    Mooresville, North Carolina, 28117

  • Down East Medical Associates

    Morehead City, North Carolina, 28557

  • Burke Primary Care

    Morganton, North Carolina, 28655

  • American Health Network of Indiana, LLC

    Muncie, Indiana, 47304

  • Hill Country Medical Associates

    New Braunfels, Texas, 78130

  • Tulane University Hospital and Clinic

    New Orleans, Louisiana, 70112

  • Providence Clinical Research

    North Hollywood, California, 91606

  • School of Clinical Research

    North Miami Beach, Florida, 33144

  • Harmony Clinical Research, Incorporated

    North Miami Beach, Florida, 33162

  • Platte River Nephrology

    North Platte, Nebraska, 69101

  • Northridge Clinical Research Inc.

    Northridge, California, 91324

  • Norton Community Care

    Norton, Ohio, 44203

  • Magnolia Research Group

    Ocala, Florida, 34471

  • Carr Cardiology

    Oceanside, California, 92056

  • Permian Research Foundation

    Odessa, Texas, 79761

  • Advanced Research Institute

    Ogden, Utah, 84405

  • Paramount Medical Care

    Ogden, Utah, 84405

  • COR Clinical Research, LLC

    Oklahoma City, Oklahoma, 73103

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Omaha Veterans Affairs Medical Center

    Omaha, Nebraska, 68131

  • Family Medical Center

    Orlando, Florida, 32806

  • Peninsula Research, Inc.

    Ormond Beach, Florida, 32174

  • Methodist Hospital Research Institute, Internal Medicine

    Pearland, Texas, 77584

  • McLaren Northern Michigan Hospital

    Petoskey, Michigan, 49770

  • Precision Trials, LLC

    Phoenix, Arizona, 85032

  • Infinity Clinical Research, LLC

    Plantation, Florida, 33317

  • Sound Medical Research

    Port Orchard, Washington, 98366

  • Health Concepts

    Rapid City, South Dakota, 57702

  • Dominion Medical Associates, Inc.

    Richmond, Virginia, 23219

  • Hunter Holmes McGuire Veterans Administration Medical Center

    Richmond, Virginia, 23249

  • Roanoke Heart Institute PLC

    Roanoke, Virginia, 24014

  • Remedica LLC

    Rochester, Michigan, 48307

  • Vita Link Research- Rock Hill

    Rock Hill, South Carolina, 29732

  • Center for Clinical Trials of Sacramento, Incorporated

    Sacramento, California, 95823

  • HealthEast St. Joseph's Hospital

    Saint Paul, Minnesota, 55102

  • Salem Veterans Affairs Medical Center

    Salem, Virginia, 24153

  • Delmarva Heart Research Foundation, Inc

    Salisbury, Maryland, 21804

  • PMG Research of Salisbury, LLC

    Salisbury, North Carolina, 28144

  • Health Texas Research Institute

    San Antonio, Texas, 78228-6205

  • Covenant Clinical Research, PA

    San Antonio, Texas, 78229

  • DM Clinical Research

    San Antonio, Texas, 78249

  • DCT-Stone Oak, LLC dba Discovery Clinical Trials

    San Antonio, Texas, 78258

  • North America Research Institute

    San Dimas, California, 91773

  • Trinitas Research, Incorporated

    San Jose, California, 95116

  • Intercoastal Medical Group, Endocrinology

    Sarasota, Florida, 34232

  • Saratoga Clinical Research, LLC

    Saratoga Springs, New York, 12866

  • Scottsboro Quick Care Clinic

    Scottsboro, Alabama, 35768

  • Sealy Urgent Care Center and Medical Clinic

    Sealy, Texas, 77474

  • Montgomery Medical Incorporated

    Smithfield, Pennsylvania, 15478

  • Apex Medical Research, AMR, Incorporated

    Springfield, Ohio, 45505

  • Meridien Research

    St. Petersburg, Florida, 33709

  • Professional Health Care of Pinellas, Inc.

    St. Petersburg, Florida, 33713

  • Tri-County Research, Inc

    Sterling Heights, Michigan, 48310-3503

  • Pioneer Research Solutions, Inc.

    Sugar Land, Texas, 77479

  • Meridien Research

    Tampa, Florida, 33634

  • Metabolic Institute of America

    Tarzana, California, 91356

  • Jacobi Medical Center

    The Bronx, New York, 10461

  • ProMedica Health Education & Research Corp.

    Toledo, Ohio, 43606

  • DM Clinical Research

    Tomball, Texas, 77375

  • Cotton-O'Neil Clinical Research Center

    Topeka, Kansas, 66606

  • Oakland Medical Research Center

    Troy, Michigan, 48085

  • Atlanta Heart Specialists, LLC

    Tucker, Georgia, 30084

  • Office of Dr. Terence T. Hart MD

    Tuscumbia, Alabama, 35674

  • Buynak Clinical Research

    Valparaiso, Indiana, 46383

  • Crossroads Clinical Research, LLC

    Victoria, Texas, 77901

  • Northeast Iowa Medical Education Foundation

    Waterloo, Iowa, 50702

  • Center for Clinical Trials of San Gabriel

    West Covina, California, 91790

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa, 50265

  • Metabolic Research Institute

    West Palm Beach, Florida, 33401

  • Professional Research Network of Kansas, LLC

    Wichita, Kansas, 67203

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67205

  • Natalie A Doyle, M.D., P.A.

    Wilson, North Carolina, 27893

Other trials in United States

Argentina55 sites

  • Instituto Médico Adrogué

    Adrogué, B1846DSK

  • Hospital Interzonal General de Agudos Dr Jose Penna

    Bahía Blanca, 8000

  • Inst de Inv Clinicas-Bahia Blanca

    Bahía Blanca, B8000FTD

  • Hospital Italiano Regional del Sur, Bahia Blanca

    Bahía Blanca, B8001HXM

  • Hospital Sirio-Libanés

    Caba, C1419GEP

  • Centro de Investigaciones Metabólicas

    Ciudad Autonoma Buenos Aires, C1056ABJ

  • CIPREC

    Ciudad Autonoma Buenos Aires, C1119ACN

  • Hospital Italiano

    Ciudad Autonoma Buenos Aires, C1181ACH

  • Consultorios Asociados de Endocrinología e Invest Clínica

    Ciudad Autonoma Buenos Aires, C1425AGC

  • CEDIC - Centro de Investigacion Clinica

    Ciudad Autonoma Buenos Aires, C1425DES

  • Instituto Cardiovascular de Buenos Aires

    Ciudad Autonoma Buenos Aires, C1428ART

  • CCBR - Buenos Aires - AR

    Ciudad Autonoma Buenos Aires, C1430CKE

  • Centro Médico Viamonte

    Ciudad Autonoma de Bs As, C1120AAC

  • Centro Médico Colon

    Córdoba, 5000

  • CEMAIC - Centro Medico Especializado

    Córdoba, 5008

  • Inst. Privado de Inv. Clínicas de Córdoba

    Córdoba, X5000AAW

  • Sanatorio Allende S.A.

    Córdoba, X5000JHQ

  • Clínica Colombo

    Córdoba, X5002AOQ

  • Instituto DAMIC - Fundacion Rusculleda

    Córdoba, X5003DCE

  • Hospital Cordoba

    Córdoba, X5004CDT

  • IPAC - Clínica Privada Caraffa SRL

    Córdoba, X5008KKF

  • Clinica Privada del Prado

    Córdoba, X5020AAA

  • Centro Universitario de Investigacion Corrientes

    Corrientes, W3400

  • CIPADI

    Godoy Cruz, 5501

  • Centro Medico Dr. Javier Marino

    Haedo, B1706CZA

  • Hospital Italiano de La Plata

    La Plata, B1900AXI

  • Unidad de Cardiologia Clinica

    Mar del Plata, B7600FEN

  • Hospital Privado de Comunidad

    Mar del Plata, B7602CBM

  • Hospital Central de Mendoza, Mendoza

    Mendoza, 5500

  • Hospital San Martin

    Paraná, E3100BBJ

  • Sanatorio San Martin S.A., Venado Tuerto

    Pellegrini, S2600KUE

  • CER Instituto Médico

    Quilmes, B1878DVB

  • Instituto de Investigaciones Clínicas de Quilmes

    Quilmes, B1878GEG

  • Instituto de Investigaciones Clinicas de Rosario

    Rosario, 2000

  • Instituto Medico de la Fundacion Estudios Clinicos, Rosario

    Rosario, 2000

  • Instituto Medico Fundación Grupo Colaborativo Rosario

    Rosario, 2000

  • Sanatorio Británico

    Rosario, 2000

  • Sanatorio Norte

    Rosario, 2000

  • Instituto de Hematologia y Medicina Clinica Ruben Davoli

    Rosario, CP2000

  • Sanatorio Delta

    Rosario, S2000BIF

  • Centro Medico CIR

    Rosario, S2000DEJ

  • CEDyN

    Rosario, S2000DNM

  • Instituto CAICI

    Rosario, S2000PBJ

  • Instituto Medico CENICLAR-C de Investigaciones Clinicas

    Rosario, S2000QID

  • Centro Cardiovascular Salta

    Salta, 4406

  • CORDIS S.A., Salta

    Salta, A4400ANW

  • Prevencion Cardiovascular Salta, Salta

    Salta, A4400CRC

  • Investigaciones Clinicas Tucuman

    San Miguel de Tucumán, T4000ICL

  • CCBR Tucuman

    San Miguel de Tucumán, T4000

  • Instituto de Investigaciones Clinicas San Nicolas

    San Nicolás, B2900DMH

  • Centro Medico Luquez

    San Vicente, X5006CBI

  • Hospital "Dr. José Maria Cullen "

    Santa Fe, S3000EOZ

  • Centro de Investigaciones Clínicas del Litoral

    Santa Fe, S3000FWO

  • Clinica Privada Fusavim SRL

    Villa María, X5900JKA

  • Instituto de Investigaciones Clínicas Zárate

    Zárate, 2800

Other trials in Argentina

Brazil39 sites

  • Hospital Universitário João de Barros Barreto

    Belém, 66073-000

  • Hospital Felício Rocho

    Belo Horizonte, 30110-060

  • Hospital Lifecenter

    Belo Horizonte, 30110-921

  • Hospital Vera Cruz

    Belo Horizonte, 30140-062

  • Hospital Angelina Caron

    Campina Grande do Sul, 83430-000

  • HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas

    Campinas, 13060-904

  • CAEP - Centro Avançado de Estudos e Pesquisas Ltda.,Campinas

    Campinas, 13087-567

  • Hospital Universitário

    Canoas, 92425-900

  • Universidade de Caxias do Sul - IPCEM - Inst. de Pesq.clilni

    Caxias do Sul, 95070-560

  • Hospital de Caridade Santa Casa de Misericordia de Curitiba

    Curitiba, 80010-030

  • HC UFPR

    Curitiba, 80030-110

  • Cruz Vermelha Brasileira - Filial do Estado do Paraná

    Curitiba, 80030-480

  • Centro de Estudos em Diabetes e Hipertensão

    Fortaleza, 60115-282

  • Centro de Pesquisas em Diabetes e Doenças

    Fortaleza, 60430-350

  • ICE-HUWC - Instituto Cearense de Endocrinologia

    Fortaleza, 60430-370

  • Via Médica

    Goiânia, 74223-130

  • Hospital Bruno Born

    Lajeado, 95900-000

  • ICM - Instituto do Coração de Marília

    Marília, 17515-000

  • Hospital São Vicente de Paulo

    Passo Fundo, 99010-080

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, 90035-074

  • Centro de Pesquisas em Diabetes

    Porto Alegre, 90035-170

  • Instituto de Cardiologia Rio Grande do Sul

    Porto Alegre, 90620-001

  • Centro de Pesquisas Médicas Básica e Clínica Ltda

    Recife, 52020-010

  • CCBR - Rio de Janeiro - BR

    Rio de Janeiro, 22271-100

  • Centro de Pesquisa Clínica Santa Maria

    Santa Maria, 97015-530

  • CCBR Brasil - São Paulo

    Santo André, 09190510

  • Instituto Domingo Braile

    São José do Rio Preto, 15015-750

  • Fundacao Faculdade Regional de Medicina, Sao Jose

    São José do Rio Preto, 15090-000

  • Cpquali Pesquisa Clinica Ltda

    São Paulo, 01228-000

  • Centro de Pesquisa Clinica - CPCLIN

    São Paulo, 01244-030

  • Hospital Alemao Oswaldo Cruz

    São Paulo, 01323-903

  • FGM Clínica Paulista de Doenças Cardiovasculares LTDA

    São Paulo, 01327-010

  • Hospital Sao Paulo - UNIFESP

    São Paulo, 04022-001

  • Hospital do Servidor Público Estadual

    São Paulo, 04039-901

  • Dr. Consulta

    São Paulo, 04254-020

  • Hospital das Clinicas da FMUSP

    São Paulo, 05403-000

  • Incor - Instituto do Coração - HCFMUSP

    São Paulo, 05403-000

  • IMC - Instituto de Moléstias Cardiovasculares Tatuí

    Tatuí, 18270-170

  • ICT - Instituto do Coração do Triângulo

    Uberlândia, 38400-368

Other trials in Brazil

Poland32 sites

  • B_Serwis Popenda Sp.Jawna

    Chorzów, 41-500

  • Poradnia Kardiologiczna Jaroslaw Jurowiecki

    Gdansk, 80-286

  • University Clinical Center, Gdansk

    Gdansk, 80-952

  • Indywidualna Specjalistyczna Praktyka Lekarska

    Gdynia, 81-157

  • MCBK Iwona Czajkowska Anna Podrazka- Szczepaniak S.C.

    Grodzisk Mazowiecki, 05-825

  • Centrum Medyczne Pratia Katowice II

    Katowice, 40-084

  • Polimedica Centrum Bada?, Profilaktyki I Leczenia

    Kielce, 25-364

  • NZOZ Centrum Medyczne ProMiMed Sp. z o.o., Sp.k., Krakow

    Krakow, 31-637

  • Centrum Terapii Wspolczesnej J.M.

    Lodz, 90-242

  • CCBR - Lodz - PL, Lodz

    Lodz, 90-368

  • Individual Specialized Practice

    Lodz, 94-255

  • Centrum Medyczne "Luxmed" Sp. z o.o.

    Lublin, 20-109

  • KO-MED Centra Kliniczne Lublin II

    Lublin, 20-362

  • NZOZ Specialized Ambulance "MEDICA"

    Lublin, 20-538

  • RCMed- Regionalne Centrum Medyczne

    Nowy Duninów, 09-505

  • Medicome Sp. z o.o.

    Oświęcim, 32-600

  • Prywatny Gabinet Lekarski Lech Lazuka

    Parczew, 21-200

  • Clin.Hosp.Med.Univ.Marcinkowski in Poznan

    Poznan, 60-569

  • Praktyka Lekarska Ewa Krzyzagorska

    Poznan, 61-655

  • KOMED Marek Konieczny

    Puławy, 24-100

  • Indywidualna Specjalistyczna Praktyka Lekarska Dr N Med Andrzej Wittek

    Ruda Śląska, 41-709

  • Centrum Medyczne Medyk

    Rzeszów, 35-055

  • RCMed- Regionalne Centrum Medyczne

    Sochaczew, 96-500

  • NSZOZ Medicus

    Środa Wielkopolska, 63-000

  • KO-MED Centra Kliniczne Staszow

    Staszów, 28-200

  • Lecznice Citomed Sp. z o.o.

    Torun, 87-100

  • NZOZ Nasz Lekarz

    Torun, 87-100

  • NBR Polska

    Warsaw, 00-465

  • CCBR/Somed - Warszaw - PL

    Warsaw, 04-730

  • Regionalna Poradnia Diabetoloiczna Zytkiewicz-Jaruga

    Wroclaw, 50-127

  • KO-MED Centra Kliniczne Zamosc

    Zamość, 22-400

  • Polimedica Centrum Bada?, Profilaktyki I Leczenia

    Zgierz, 95-100

Other trials in Poland

Canada28 sites

  • LMC Endocrinology Centres (Barrie) Ltd.

    Barrie, Ontario, L4N 7L3

  • ViaCar Recherche Clinique Inc

    Brossard, Quebec, J4Z 2K9

  • JBN Medical Diagnostic Services Inc.

    Burlington, Ontario, L7M 4Y1

  • Dr. Ronald Collette

    Burnaby, British Columbia, V5G 1T4

  • ALTA Clinical Research Inc.

    Edmonton, Alberta, T5A 4L8

  • LMC Endocrinology Centres (Etobicoke) Ltd.

    Etobicoke, Ontario, M9R 4E1

  • Medicor Research

    Greater Sudbury, Ontario, P3E 1H5

  • Sudbury Cardiac Research

    Greater Sudbury, Ontario, P3E 2N8

  • Dr. R. Labonte Prof. Med. Corp

    Greater Sudbury, Ontario, P3E 3B8

  • Hopital Charles - LeMoyne

    Greenfield Park, Quebec, J4V 2G9

  • True North Clinical Research Halifax, Inc.

    Halifax, Nova Scotia, B3S 1M7

  • Centre De Recherche Clinique

    Laval, Quebec, H7T 2P5

  • Recherche Invascor Inc.

    Longueuil, Quebec, J4N 1C2

  • LMC Endocrinology Centres (Markham) Ltd.

    Markham, Ontario, L6B 0P9

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec, H2X 0A9

  • McGill University Health Centre (MUHC)

    Montreal, Quebec, H4A 3J1

  • SKDS Research Incorporated

    Newmarket, Ontario, L3Y 5G8

  • The Medical Arts Health Research Group

    Penticton, British Columbia, V2A5G8

  • Recherche Clinique Sigma Inc.

    Québec, G1G 3Y8

  • Clinique des maladies Lipidiques de Quebec

    Québec, G1V 4M6

  • The Bailey Clinic

    Red Deer, Alberta, T4N 6V7

  • St Jerome Medical Research Inc.

    Saint-Jérôme, Quebec, J7Z 5T3

  • LMC Endocrinology Centres (Montreal)

    Saint-Laurent, Quebec, H4T 1Z9

  • LMC Clinical Research dba Manna Research Inc. Vancouver

    Vancouver, British Columbia, V6J 1S3

  • Fraser Clinical Trials Inc.

    Victoria, British Columbia, V8R 4R2

  • Discovery Clinical Services Ltd.

    Victoria, British Columbia, V8T 5G4

  • CookMed Research

    Victoria, British Columbia, V8V 4A1

  • Winnipeg Regional Health Authority, Winnipeg

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

South Africa23 sites

  • Cardiology Clinical Research

    Alberton, 1449

  • Iatros International

    Bloemfontein, 9301

  • Limaro Research

    Bloemfontein, 9301

  • Dr JM Engelbrecht Practice

    Cape Town, 7129

  • Dr Dawood, Mohamed and Pillay

    Cape Town, 7405

  • TREAD Research

    Cape Town, 7500

  • Langeberg Clinical Trials

    Cape Town, 7570

  • Cape Town Medical Research Centre

    Cape Town, 7580

  • Ismail, SM

    Cape Town, 7764

  • Groote Schuur Hospital

    Cape Town, 7925

  • Latiff, GHVM

    Durban, 4001

  • Londisizwe Research Centre, Durban

    Durban, 4001

  • Diabetes Care Centre

    Johannesburg, 1501

  • Wits Clinical Research Chris Hani Baragwanath Hospital

    Johannesburg, 2013

  • WCR CMJAH Clinical Trial Site

    Johannesburg, 2193

  • DJW Navorsing

    Krugersdorp, 1739

  • Emmed Research

    Pretoria, 0002

  • University of Pretoria

    Pretoria, 0002

  • Syzygy Clinical Research Services

    Pretoria, 0087

  • Into Research

    Pretoria, 181

  • Seeber, M

    Pretoria, 2

  • Dr M Duki Research and Trial Site, Verulam

    Verulam, 4339

  • Clinical Projects Research

    Worcester, 6850

Other trials in South Africa

Ukraine23 sites

  • Chernivtsi Regional Endocrinology Dispensary

    Chernivtsi, 58022

  • Regional CH Dept of Endocrinology SHEI Ivano-Frankivsk NMU

    Ivano-Frankivsk, 76008

  • CI Ivano-Frankivsk Reg Cl Card Center

    Ivano-Frankivsk, 76018

  • L.T. Malaya Institute of Therapy AMS of Ukraine

    Kharkiv, 61039

  • CIPH Prof. O.I. Meshchaninov Kharkiv CCH of A&E

    Kharkiv, 61103

  • CI of Healthcare Kharkiv CCH #8, Kharkiv

    Kharkiv, 61176

  • KCCC of Endocr Dept of General Endocrine Pathology

    Kyiv, 01004

  • City Clinical Hospital No. 1, Kiev

    Kyiv, 02091

  • V.P. Komisarenko Inst. of Endocrinology and Metabolism

    Kyiv, 04114

  • Kjiv City Oleksandrivska Clinical Hospital

    Kyiv, 1601

  • LLC Treatment and Diagnostic Center Adonis Plus, Kyiv

    Kyiv, 2002

  • SI National Scientific Centre of Radiation Medicine of NAMSU

    Kyiv, 3115

  • P.L. Shupyk NMA of PGE Ch of D H for S-ts of NASU

    Kyiv, 4050

  • SI V.P.Komisarenko Institute of Endocrinology and Metabolism

    Kyiv, 4114

  • Lviv Regional Endocrinology Dispensary

    Lviv, 79010

  • M.V. Sklifosovskyi Poltava RCH, Poltava

    Poltava, 36011

  • CI Sumy City Clinical Hospital #1 Dept of Therapy Sumy SU

    Sumy, 40021

  • CI of TRC Ternopil UH

    Ternopli, 46002

  • Private Small Enterprise Medical Center Pulse

    Vinnytsia, 21001

  • Vinnytsia RC Highly Special.Endocr.Center Dept of Therapy

    Vinnytsia, 21010

  • M.I. Pyrogov VRCH, Vinnytsia

    Vinnytsia, 21018

  • CCH #1 M.I. Pyrogov VNMU Ch of Propaedeutics of IM

    Vinnytsia, 21021

  • CI Zapor CCH#10 SI ZMA PGE Ch of therapy clin pharmacol & endocrin

    Zaporizhzhya, 69001

Other trials in Ukraine

Russia22 sites

  • SBEI HPE Altay State Medical University of MoH and SD

    Barnaul, 656038

  • Res.Inst.-Compl.Iss.Cardi.Dis.

    Kemerovo, 650002

  • NSIH "Departmental Hospital on Station Kemerovo of OJSC "Russian Railways"

    Kemerovo, 650055

  • First Moscow State Medical University n.a. I.M. Sechenov

    Moscow, 119435

  • Moscow 1st State Med.Univ.n.a.I.M.Sechenov

    Moscow, 119992

  • SBEI HPE "Moscow State Medical and Dentistry University

    Moscow, 127473

  • Moscow State Medical Dentistry University

    Moscow, 129301

  • SBIH of Novosibirsk Region "Clinical Emergency Hospital #2"

    Novosibirsk, 630008

  • Novosibirsk Regional Clinical Cardiological Dispansary

    Novosibirsk, 630047

  • FSBSI "Scientific Research Institute", Novosibirsk

    Novosibirsk, 630089

  • FSBSI "Scientific and Research Institute of Physiology and Basic Medicine"

    Novosibirsk, 630117

  • BIH of OR "City Hospital # 2", Omsk

    Omsk, 644021

  • SBIH of Perm territory " City Clinical Hospital # 2 n.a.

    Perm, 614068

  • SBI of Ryazan region "Regional Clinical Cardiological Dis.

    Ryazan, 390026

  • FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov"

    Saint Petersburg, 194044

  • Medical Research Institute LLC, St. Petersburg

    Saint Petersburg, 196084

  • 1stPavlov St.Med.Univ.St.-Petersburg Res.Inst.

    Saint Petersburg, 197022

  • Federal North-West Medical Research Centre

    Saint Petersburg, 197341

  • SPb SBHI "City Policlinic #74"

    Saint Petersburg, 197762

  • SPb SBIH "City Pokrovskaya Hospital"

    Saint Petersburg, 199106

  • GUZ "City Clinical Hospital #40, 197706 Saint-Petersburg

    Sestroretsk, 197706

  • FSBI "Research Institute for Cardiology"

    Tomsk, 634012

Other trials in Russia

Mexico21 sites

  • Investigación en Salud y Metabolismo S.C.

    Chihuahua City, 31237

  • Phylasis Clinicas Research S de RL de CV

    Cuautitlán Izcalli, 54769

  • Centro para el Desarrollo de la Medicina y de Asist Med Espe

    Culiacán, CP80020

  • Centro de Investigacion Biomedica y Farmaceutica, S.C.

    Distrito Federal, 03100

  • Servicios Medicos de la Pena SC

    Guadalajara, 44690

  • Medical Care & Research SA de CV

    Mérida, 97070

  • Sociedad de Cirugia Vascular Plastica Reconstructiva

    Mérida, 97129

  • Phytomedicamenta S.A. de C.V.

    México, 03100

  • Comite Mexicano Para la Prevencion de Osteoporosis AC

    México, 06100

  • Centro de Atención e Investigación en Factores de Riesgo

    México, 06700

  • Clinstile S.A. de C.V.

    México, 06700

  • Ultimate Medica SA de CV

    México, 11850

  • Health Pharma Professional Research S.A. de C.V.

    México, 3810

  • Centro de Estudios Clinicos y Especialidades Medicas, S.C.

    Monterrey, 64620

  • AVIX Investigación Clínica S.C

    Monterrey, 64710

  • Global Trial Research Center S.A. de C.V.

    Monterrey, 64718

  • Centro de Investigacion Clinica Chapultepec S. A. de C. V.

    Morelia, 58260

  • Centro de Estudios Clínicos de Queretaro S.C., CECLIQ

    Querétaro, 76000

  • Centro de Investigacion Cardiovascular y Metabolica

    Tijuana, 22500

  • Centro de Investigación Médica de Ocidente, S.C.

    Zapopan, 45116

  • Hospital Dr Angel Leano

    Zapopan, 45200

Other trials in Mexico

Romania21 sites

  • SC Diana Barbonta SRL, Alba Iulia

    Alba Iulia, 510053

  • Spitalul Universitar de Urgenta, Bucuresti

    Bucharest, 010825

  • I.N.D.N.B.M. "Prof. Dr. N.C. Paulescu" - Sediul Central

    Bucharest, 011234

  • I.N.D.N.B.M. "Prof. Dr. N.C. Paulescu" - Sediul Central

    Bucharest, 020475

  • CMI Dr. Stolea T. Violeta

    Bucharest, 061072

  • Clinica Medicala Data Plus SRL

    Bucharest, 10192

  • I.N.D.N.B.M. "Prof. Dr. N.C. Paulescu" - Sediul "I.L. Caragiale"

    Bucharest, 20045

  • S.C Centrul Medical "Sanatatea Ta" S.R.L

    Bucharest, 20614

  • S.C. Policlinica CCBR SRL, Bucuresti

    Bucharest, 30463

  • Medcon SRL

    Buzău, 120203

  • Spitalul Clinic Judetean de Urgenta ¿Sf. Apostol Andrei¿

    Galati, 800578

  • Spitalul Clinic, Iasi

    Iași, 700503

  • Consultmed SRL, Iasi

    Iași, 700547

  • SC Diaconu-Sotropa Michaela, Cabinet de Diabet

    Iași, 700613

  • S.C Grandmed S.R.L, Oradea

    Oradea, 410159

  • Pelican Impex SRL, Cabinet Nr. 15

    Oradea, 410469

  • S.C Anamed S.R.L

    Oradea, 410491

  • S.C. Diabmed Dr. Popescu Alexandrina S.R.L

    Ploieşti, 100163

  • Gensan SRL

    Sibiu, 550371

  • Mediab SRL

    Târgu Mureş, 540142

  • Centrul Medical Dr Negrisanu SRL

    Timișoara, 300456

Other trials in Romania

Hungary19 sites

  • Lausmed Kft. Outpatient Unit of Internal Medicine

    Baja, 6500

  • Dr. Kenessey Albert Kórház-Rendelõintézet, Balassagyarmat

    Balassagyarmat, 2660

  • DRC Gyogyszervizsgalo Kozpont Kft., Balatonfured

    Balatonfüred, 8230

  • Clinexpert Kft.

    Budapest, 1033

  • Obudai Egeszsegugyi Centrum

    Budapest, 1036

  • QUALICLINIC Kft

    Budapest, 1036

  • Semmelweis Egyetem, Budapest

    Budapest, 1083

  • Semmelweis Egyetem, Budapest

    Budapest, 1088

  • Semmelweis Egyetem, Budapest

    Budapest, 1125

  • University Debrecen Hospital

    Debrecen, 4032

  • Markhot Ferenc Hospital, Eger

    Eger, 3300

  • Csongrad Megyei Eu. Ellato Kozp. Hodmezovasarhely-Mako

    Hódmezővásárhely, 6800

  • Somogy Megyei Kaposi Mor Oktato Korhaz, Kaposvar

    Kaposvár, 7400

  • Selye Janos Hospital Komarom

    Komárom, 2900

  • Ermellek Egeszsegcentrum

    Létavértes, 4281

  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

    Miskolc, 3526

  • Pecsi Tudomanyegyetem

    Pécs, 7624

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klin. Kozpont

    Szeged, 6725

  • Zala Megyei Szent Rafael Korhaz

    Zalaegerszeg, 8900

Other trials in Hungary

Czechia17 sites

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 656 91

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 65691

  • Revmatologie Bruntal, s.r.o.

    Bruntál, 792 01

  • Poliklinika Chocen, a.s.

    Choceň, 56501

  • Aesculap Ambulance Sro

    Dolní Břežany, 252 41

  • OKELI s.r.o.

    Hodonín, 695 01

  • Nemocnice Jindrichuv Hradec a.s.

    Jindřichův Hradec, 377 01

  • Regional Hospital Liberec

    Liberec, 460 63

  • InterKardioML s.r.o.

    Mariánské Lázně, 353 01

  • Interna a diabetologicka ordinace s.r.o.

    Náchod, 547 01

  • PreventaMed, s.r.o.

    Olomouc, 77900

  • Univ. Hospital Kralovske Vinohrady

    Prague, 100 34

  • Vseobecna fakultni nemocnice V Praze

    Prague, 128 08

  • ResTrial s.r.o.

    Prague, 181 00

  • Thomayer Hospital

    Praha 4 - Krc, 140 59

  • Hospital Slany, Internal Department

    Slaný, 274 01

  • Krajska zdravotni, a.s. - Nemocnice Teplice, o.z.

    Teplice, 41501

Other trials in Czechia

Colombia15 sites

  • CEQUIN

    Armenia, 55860

  • Corazon IPS S.A.S.

    Barranquilla, 0000

  • Clínica de la Costa Ltda.

    Barranquilla, 0

  • IPS Centro Cientifico Asistencia

    Barranquilla, 80020

  • Centro de Atencion e Investigacion Medica S.A. - CAIMED

    Bogotá, 0

  • CAFESALUD Medicina Prepagada S.A.

    Bogotá, 110221

  • Dexa Diabetes Servicios Médicos Ltda

    Bogotá, 110221

  • Solano y Terront Servicios Médicos Ltda.

    Bogotá, 110221

  • Fundacion Reina Isabel

    Cali, 0

  • IPS Centro Medico Julián Coronel S.A.

    Cali, 0

  • Fundación Centro de Investigaciones Biomédicas Riescard

    Espinal, 0

  • Centro de Investigacion Clínica Avanzada

    Medellín, 0

  • Fundacion Centro de Investigacion Clinica CIC, Medellin

    Medellín, 50021

  • Fundacion Centro de Obesidad y Metabolismo - COMETA

    Pasto, 52002

  • Healthy Medical CenterS.A.S, Zipaquirá

    Zipaquirá, 0

Other trials in Colombia

Spain15 sites

  • Hospital Virgen del Mar

    Almería, 04120

  • Hospital de la Ribera

    Alzira, 46600

  • Hospital Germans Trias i Pujol

    Badalona, 08916

  • Specialist

    Barcelona, 08006

  • CAP Sarria

    Barcelona, 08017

  • Hospital Quiron. I.C.U.

    Barcelona, 08023

  • EBA Centelles

    Centelles, 08540

  • Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Regional Universitario de Málaga

    Málaga, 29010

  • Hospital General de Segovia

    Segovia, 40002

  • Hospital Quironsalud Infanta Luisa

    Seville, 41010

  • Hospital Virgen Macarena

    Seville, 41071

  • Hospital General Universitario de Valencia

    Valencia, 46014

  • Hospital Dr. Peset

    Valencia, 46017

  • Hospital Virgen de las Montañas, Villamartin

    Villamartín, 11650

Other trials in Spain

United Kingdom13 sites

  • University Hospital Monklands

    Airdrie, ML6 0JS

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH

  • Bradford on Avon Health Centre

    Bradford on Avon, BA15 1DQ

  • Ashgate Medical Practice

    Chesterfield, S40 4AA

  • Dumfries and Galloway Royal Infirmary

    Dumfries, DG1 4AP

  • Ninewells Hospital & Medical School

    Dundee, DD1 9SY

  • Royal Devon and Exeter Hospital

    Exeter, EX2 5DW

  • Glasgow Royal Infirmary

    Glasgow, G4 0SF

  • Leicester General Hospital

    Leicester, LE5 4PW

  • Barts and The London School of Medicine and Dentistry

    London, EC1M 6BQ

  • Morriston Hospital

    Swansea, SA6 6NL

  • Queen Elizabeth II Hospital

    Welwyn Garden City, AL7 4HQ

  • New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

South Korea12 sites

  • Hallym University Sacred Heart Hospital

    Anyang-si, 431-070

  • Inje University Busan Paik Hospital

    Busan, 47392

  • Dong-A University Hospital

    Busan, 602-715

  • Pusan National Univ. Hosp

    Busan, 602-739

  • Myongji Hospital

    Goyang-si, 412-270

  • Gachon University Gil Medical Center

    Incheon, 21565

  • The Catholic University of Korea, Seoul St.Mary's Hospital

    Seoul, 06591

  • Seoul National University Hospital

    Seoul, 110744

  • Asan Medical Center

    Seoul, 138736

  • Korea University Anam Hospital

    Seoul, 2841

  • Korea University Guro Hospital

    Seoul, 8308

  • Wonju Severance Christian Hosp

    Wŏnju, 26426

Other trials in South Korea

Bulgaria10 sites

  • MHAT - Blagoevgrad, EOOD

    Blagoevgrad, 2700

  • MHAT "Yuliya Vrevska" EOOD, Byala

    Byala, 7100

  • MHAT "Dr.Stambolski", Cardiology&Intensiv Care Dept,Kazanlak

    Kazanlak, 6100

  • UMHAT "Kaspela", EOOD, Plovdiv

    Plovdiv, 4002

  • DCC 1 - Ruse, EOOD

    Rousse, 7002

  • Fifth MHAT - Sofia EAD, Sofia

    Sofia, 1233

  • MHAT Lyulin

    Sofia, 1336

  • MHAT 'Tokuda Hospital Sofia', EAD

    Sofia, 1407

  • USHATE Hospital 'Academy Ivan Penchev', Sofia

    Sofia, 1431

  • DCC "Equita" EOOD

    Varna, 9000

Other trials in Bulgaria

Israel10 sites

  • Haemek Medical Center

    Afula, 18101

  • Bnei Zion Medical Center, Haifa

    Haifa, 31048

  • Rambam Medical Center

    Haifa, 3109601

  • Herzliya Medical Center

    Herzliya, 4685107

  • Wolfson Medical Center

    Holon, 58100

  • Hadassah Medical Center, Ein-Karem

    Jerusalem, 9112001

  • Meir Medical Center

    Kfar Saba, 4428164

  • Galilee Medical Center

    Nahariya, 2210001

  • Ziv Medical Center

    Safed, 13100

  • Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Japan10 sites

  • Daishinkai Medical Corporation Ookuma Hospital

    Aichi, Nagoya, 462-0825

  • Seikeikai New Tokyo Heart Clinic

    Chiba, Matsudo, 271-0077

  • Saiseikai Matsuyama Hospital

    Ehime, Matsuyama, 791-8026

  • Aso Co.,Ltd Iizuka Hospital

    Fukuoka, Iizuka, 820-8505

  • Kitakyushubyoin Kitakyushu General Hospital

    Fukuoka, Kitakyushu, 800-0295

  • The Veritas Hospital

    Hyogo, Kawanishi, 666-0125

  • Ibaraki Seinan Medical Center Hospital

    Ibaraki, Sashima-gun, 306-0433

  • Kokan Clinic

    Kanagawa, Kawasaki, 210-0852

  • Nagano Red Cross Hospital

    Nagano, Nagano, 380-8582

  • Josuikai Olive Takamatsu Medical Clinic

    Takamatsu, 760-0076

Other trials in Japan

Malaysia10 sites

  • Hospital Sultanah Bahiyah

    Alor Star, 5460

  • Hospital Tengku Ampuan Rahimah

    Klang, 41200

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

  • Hospital Tengku Ampuan Afzan

    Kuantan, 25100

  • Monash University(Sunway Campus)

    Petaling Jaya, 46150

  • Hospital Pulau Pinang

    Pulau Pinang, 10450

  • Universiti Putra Malaysia

    Serdang, 43400

  • Hospital Seri Manjung

    Seri Manjung, 32040

  • Hospital Taiping

    Taiping, 34000

  • Klinik Kesihatan Tampin

    Tampin, 73009

Other trials in Malaysia

Netherlands10 sites

  • Rijnstate Hospital

    Arnhem, 6815 AD

  • Albert SchweitzerZiekenhuis

    Dordrecht, 3318 AT

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

  • Martini Ziekenhuis

    Groningen, 9728 NT

  • Bethesda Cardiology Group, Hoogeveen

    Hoogeveen, 7909 AA

  • Maastricht Universitair Medisch Centrum

    Maastricht, 6229 HX

  • Rotterdam Research Institute

    Rotterdam, 3039 BD

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX

  • TweeSteden Ziekenhuis

    Waalwijk, 5141 BM

  • Gelre Ziekenhuis Zutphen

    Zutphen, 7207 BA

Other trials in Netherlands

Chile9 sites

  • Hospital Regional de Punta Arenas Dr. Lautaro Navarro Avaria

    Punta Arenas, 6200000

  • Hospital El Pino

    Santiago, 0

  • Sociedad Medica Cardiologica El Llano

    Santiago, 0

  • Hospital Militar de Santiago

    Santiago, 7850000

  • Hospital Sotero del Rio

    Santiago, 8150000

  • CeCim - Centro de Estudios Clinicos e Investigacion Medica

    Santiago, 8331143

  • Hospital Padre Alberto Hurtado

    Santiago, 8880465

  • Hospital Base Valdivia

    Valdivia, 5090000

  • Hospital Naval Almirante Nef

    Viña del Mar, 2520000

Other trials in Chile

China8 sites

  • Beijing Jishuitan Hospital

    Beijing, 100035

  • Third Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510150

  • Zhejiang University School of Medicine SIR RUN RUN SHAW Hospital

    Hangzhou, 310016

  • Center Hospital of Jinan

    Jinan, 250013

  • People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, 530021

  • Tongji Hospital, Tongji University

    Shanghai, 200065

  • First Affiliated Hospital of Xi'an JiaoTong University

    Xi'an, 710061

  • General Hospital of Ningxia Medical University

    Yinchuan, 750004

Other trials in China

Germany8 sites

  • Studienzentrum Aschaffenburg

    Aschaffenburg, 63739

  • Zentrum für klinische Forschung Dr. med. Irma Schöll & Kollegen

    Bad Homburg, 61348

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 1307

  • ClinPhenomics GmbH & Co KG, Frankfurt

    Frankfurt, 60594

  • IKF Pneumologie GmbH & Co. KG

    Frankfurt am Main, 60596

  • Diabetologische Schwerpunktpraxis, Hohenmölsen

    Hohenmölsen, 6679

  • EUGASTRO GmbH, Leipzig

    Leipzig, 4103

  • Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut, Leipzig

    Leipzig, 4249

Other trials in Germany

Taiwan8 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362

  • Far Eastern Memorial Hospital

    New Taipei City, 220

  • China Medical University Hospital

    Taichung, 404

  • NCKUH

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100

  • Taipe Veterans General Hospital

    Taipei, 11217

  • Chang-Gung Memorial Hospital, Linkou

    Taoyuan County, 333

Other trials in Taiwan

Croatia7 sites

  • General Hospital Karlovac

    Karlovac, 47000

  • Hospital for Medical Rehabilitation, Krapinske Toplice

    Krapinske Toplice, 49217

  • General Hospital Slavonski Brod

    Slavonski Brod, 35000

  • General Hospital Varazdin

    Varaždin, 42000

  • General Hosp. Zadar, Dept. of Internal Medicine-Pulmonology

    Zadar, 23000

  • Clinical Hospital Sveti Duh

    Zagreb, 10000

  • University hospital center Zagreb

    Zagreb, 10000

Other trials in Croatia

Portugal7 sites

  • Hospital de Braga-Escala Braga

    Braga, 4710-243

  • CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

    Coimbra, 3000-075

  • APDP - Associação Protectora dos Diabéticos de Portugal

    Lisbon, 1250-203

  • CHLO, EPE - Hospital S. Francisco Xavier

    Lisbon, 1449-005

  • Hospital da Luz

    Lisbon, 1500-650

  • Hospital CUF Porto

    Porto, 4100-180

  • Centro Hospitalar de Vila Nova de Gaia

    V. N. Gaia, 4434-502

Other trials in Portugal

About this study

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

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.

Being tested
Placebo, Linagliptin
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    placebo matching tablets

  • LinagliptinDrug

Study groups in NCT01897532
Study groupRoleWhat they receive
LinagliptinExperimentalNot described
Receives: Drug: Linagliptin
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From randomization to individual end of observation; up to 4.3 years

Secondary outcomes (1)

  1. 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.

    Measured: From randomization to individual end of observation; up to 4.3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2013 (estimated)
  2. Study start10 Jul 2013
  3. Primary completion18 Jan 2018
  4. Study completion18 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
6,991 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01897532
Sponsor's protocol ID
1218.22
Other IDs
2011-004148-23
Status last verified
Mar 2019
First submitted
9 Jul 2013
Last updated
4 Apr 2019

Publications

  • Marx N, Kolkailah AA, Rosenstock J, Johansen OE, Cooper ME, Alexander JH, Toto RD, Wanner C, Espeland MA, Mattheus M, Schnaidt S, Perkovic V, Gollop ND, McGuire DK. Hypoglycemia and Cardiovascular Outcomes in the CARMELINA and CAROLINA Trials of Linagliptin: A Secondary Analysis of Randomized Clinical Trials. JAMA Cardiol. 2024 Feb 1;9(2):134-143. doi: 10.1001/jamacardio.2023.4602.

    PubMed 38170502

  • Balasubramanian P, Kernan WN, Sheth KN, Ofstad AP, Rosenstock J, Wanner C, Zinman B, Mattheus M, Marx N, Inzucchi SE. Baseline Cardiovascular Risk Factor Control in Patients With Type 2 Diabetes and Coronary Disease Versus Stroke: Secondary Analysis of Cardiovascular Outcome Trials. Stroke. 2023 Aug;54(8):2013-2021. doi: 10.1161/STROKEAHA.122.042053. Epub 2023 Jul 14.

    PubMed 37449424

  • Dar MS, Wanner C, Marx N, Ofstad AP, Mattheus M, Kaspers S, Beg SA. Cardiovascular outcomes trial data from EMPA-REG OUTCOME, CAROLINA and CARMELINA: Assessment of a novel staging system for type 2 diabetes. Diabetes Obes Metab. 2023 May;25(5):1372-1384. doi: 10.1111/dom.14989. Epub 2023 Mar 6.

    PubMed 36700391

  • Verhagen C, Janssen J, Minderhoud CA, van den Berg E, Wanner C, Passera A, Johansen OE, Biessels GJ. Chronic kidney disease and cognitive decline in patients with type 2 diabetes at elevated cardiovascular risk. J Diabetes Complications. 2022 Oct;36(10):108303. doi: 10.1016/j.jdiacomp.2022.108303. Epub 2022 Aug 31.

    PubMed 36116359

  • Verhagen C, Janssen J, Exalto LG, van den Berg E, Johansen OE, Biessels GJ. Diabetes-specific dementia risk score (DSDRS) predicts cognitive performance in patients with type 2 diabetes at high cardio-renal risk. J Diabetes Complications. 2020 Oct;34(10):107674. doi: 10.1016/j.jdiacomp.2020.107674. Epub 2020 Jul 16.

    PubMed 32723590

  • Perkovic V, Toto R, Cooper ME, Mann JFE, Rosenstock J, McGuire DK, Kahn SE, Marx N, Alexander JH, Zinman B, Pfarr E, Schnaidt S, Meinicke T, von Eynatten M, George JT, Johansen OE, Wanner C; CARMELINA investigators. Effects of Linagliptin on Cardiovascular and Kidney Outcomes in People With Normal and Reduced Kidney Function: Secondary Analysis of the CARMELINA Randomized Trial. Diabetes Care. 2020 Aug;43(8):1803-1812. doi: 10.2337/dc20-0279. Epub 2020 May 22.

    PubMed 32444457

  • Biessels GJ, Verhagen C, Janssen J, van den Berg E, Zinman B, Rosenstock J, George JT, Passera A, Schnaidt S, Johansen OE; CARMELINA Investigators. Effect of Linagliptin on Cognitive Performance in Patients With Type 2 Diabetes and Cardiorenal Comorbidities: The CARMELINA Randomized Trial. Diabetes Care. 2019 Oct;42(10):1930-1938. doi: 10.2337/dc19-0783. Epub 2019 Aug 9.

    PubMed 31399442

  • McGuire DK, Alexander JH, Johansen OE, Perkovic V, Rosenstock J, Cooper ME, Wanner C, Kahn SE, Toto RD, Zinman B, Baanstra D, Pfarr E, Schnaidt S, Meinicke T, George JT, von Eynatten M, Marx N; CARMELINA Investigators. Linagliptin Effects on Heart Failure and Related Outcomes in Individuals With Type 2 Diabetes Mellitus at High Cardiovascular and Renal Risk in CARMELINA. Circulation. 2019 Jan 15;139(3):351-361. doi: 10.1161/CIRCULATIONAHA.118.038352.

    PubMed 30586723

  • Rosenstock J, Perkovic V, Johansen OE, Cooper ME, Kahn SE, Marx N, Alexander JH, Pencina M, Toto RD, Wanner C, Zinman B, Woerle HJ, Baanstra D, Pfarr E, Schnaidt S, Meinicke T, George JT, von Eynatten M, McGuire DK; CARMELINA Investigators. Effect of Linagliptin vs Placebo on Major Cardiovascular Events in Adults With Type 2 Diabetes and High Cardiovascular and Renal Risk: The CARMELINA Randomized Clinical Trial. JAMA. 2019 Jan 1;321(1):69-79. doi: 10.1001/jama.2018.18269.

    PubMed 30418475

  • Rosenstock J, Perkovic V, Alexander JH, Cooper ME, Marx N, Pencina MJ, Toto RD, Wanner C, Zinman B, Baanstra D, Pfarr E, Mattheus M, Broedl UC, Woerle HJ, George JT, von Eynatten M, McGuire DK; CARMELINA(R) investigators. Rationale, design, and baseline characteristics of the CArdiovascular safety and Renal Microvascular outcomE study with LINAgliptin (CARMELINA(R)): a randomized, double-blind, placebo-controlled clinical trial in patients with type 2 diabetes and high cardio-renal risk. Cardiovasc Diabetol. 2018 Mar 14;17(1):39. doi: 10.1186/s12933-018-0682-3.

    PubMed 29540217

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Linagliptin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 649 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 649 sites in United States, Argentina, Brazil, Poland, Canada and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 frame: From randomization to individual end of observation; up to 4.3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01897532, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.

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