AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 3NCT01243424

CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes

A Phase 3 study testing linagliptin and glimepiride in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 613 sites in 43 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 and mortality, relevant efficacy parameters (e.g., glycaemic parameters) and safety (e.g., weight and hypoglycaemia) of treatment with linagliptin in patients with type 2 diabetes at elevated cardiovascular risk receiving usual… Read more about this study

Who is it for?
Ages 40 to 85 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
linagliptin and glimepiride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
6,103 participants
Where
613 sitesin 43 countries
Study dates
11 Nov 2010to 21 Aug 2018
Phase
Phase 3
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 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Type 2 diabetes
  • Elevated glycosylated haemoglobin (HbA1c): 6.5 - 8.5%, inclusive, if treatment naïve or mono-/dual therapy with metformin and/or an alpha-glucosidase inhibitor; 6.5 - 7.5%, inclusive, if treatment with sulphonylurea/glinide in mono- or dual (with metformin OR an alpha-glucosidase inhibitor) therapy)
  • Pre-existing cardiovascular disease OR specified diabetes end-organ damage OR age => 70 years OR two or more specified cardiovascular risk factor
  • BMI =< 45kg/m²
  • age between >= 40 and =< 85 years
  • signed and dated written International Conference of Harmonisation( ICF)
  • stable anti-diabetic background for at least 8 wks before study start

Who cannot join

  • Type 1 diabetes
  • Treatment with other antidiabetic drugs (e.g. rosiglitazone, pioglitazone, Glucagon-like peptide 1 (GLP-1) analogue/agonists, Dipeptidyl-peptidase IV (DPP-IV) inhibitors or any insulin) prior to informed consent (previous short term use of insulin (up to two weeks) is allowed if taken at least 8 weeks prior informed consent)
  • treatment with any anti-obesity drug less than 3 months before ICF
  • uncontrolled hyperglycemia
  • previous or planned bariatric surgery or intervention
  • current or planned system corticoid treatment
Show all 20Show fewer
  • change in thyroid hormones treatment
  • acute liver disease or impaired hepatic function
  • pre-planned coronary artery revascularization within 6 months of ICF
  • known hypersensitivity to any of the components
  • Inappropriateness of glimepiride treatment for renal safety issues according to local prescribing information
  • congestive heart failure class III or IV
  • acute or chronic metabolic acidosis
  • hereditary galactose intolerance
  • alcohol or drug abuse
  • participation in another trail with IMP given 2 months before Investigational Medicinal/Medical Product (IMP) start
  • pre-menopausal women who are nursing or pregnant or of child-bearing potential and not willing to use acceptable method of birth control
  • patients considered reliable by the investigator
  • acute coronary syndrome =< 6 wks before ICF
  • stroke or Transient Ischemic Attack (TIA) =< 3 months prior to ICF

Trial locations and contacts

613 sites in 43 countries.

613 sites in 43 countries

United States177 sites

  • Community Health Care of Manchester

    Akron, Ohio, 44319

  • Albany Medical Center / Albany Medical College

    Albany, New York, 12206

  • Hartwell Research Group, LLC

    Anderson, South Carolina, 29621

  • KRK Medical Research

    Arlington, Texas, 76012

  • OnSite Clinical Solutions, LLC

    Asheville, North Carolina, 28801

  • Atco Medical Associates, PC

    Atco, New Jersey, 08004

  • North Alabama Research Center, LLC

    Athens, Alabama, 35611

  • PMI Health Research Group

    Atlanta, Georgia, 30312

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30318

  • Austin Center for Clinical Research

    Austin, Texas, 78758

  • Community Medical Associates, LLC

    Austintown, Ohio, 44515

  • American Health Network

    Avon, Indiana, 46123

  • Office of Dr. Stephen R. Smith, MD

    Baltimore, Maryland, 21234

  • Acadia Clinical Research, LLC

    Bangor, Maine, 04401

  • Desert Oasis Healthcare

    Bermuda Dunes, California, 92203

  • The Center for Clinical Trials, Inc.

    Biloxi, Mississippi, 39531

  • Alabama Internal Medicine, PC

    Birmingham, Alabama, 35235

  • Cahaba Research, Inc.

    Birmingham, Alabama, 35242

  • East Coast Medical Associates

    Boca Raton, Florida, 33433

  • Suburban Clinical Research

    Bolingbrook, Illinois, 60490

  • PMG Research of Bristol

    Bristol, Tennessee, 37620

  • Investigators Research Group, LLC

    Brownsburg, Indiana, 46112

  • Burke Internal Medicine and Research

    Burke, Virginia, 22015

  • Kernodle Clinic West

    Burlington, North Carolina, 27215

  • Harrison Community Research Center

    Cadiz, Ohio, 43907

  • ClinSite, LLC

    Canton, Michigan, 48187

  • Medical Frontiers, LLC

    Carlisle, Ohio, 45005

  • Punzi Medical Center

    Carrollton, Texas, 75006

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27517

  • Internal Medicine Research

    Charlotte, North Carolina, 28204

  • Gaffney Health Services

    Charlotte, North Carolina, 28205

  • University Diabetes and Endocrine Consultants

    Chattanooga, Tennessee, 37411

  • Cedar-Crosse Research Center

    Chicago, Illinois, 60607

  • John H. Stroger Jr. Hospital of Cook Country

    Chicago, Illinois, 60612

  • Apex Medical Research

    Chicago, Illinois, 60616

  • Summit Medical Group

    Clifton, New Jersey, 07012

  • Clinical Research Advantage, Inc./Rita B. Chuang, MD, LLC

    Colorado Springs, Colorado, 80909

  • Clinical Research Advantage, Inc./Rita B. Chuang, MD, LLC

    Colorado Springs, Colorado, 80920

  • New England Center for Clinical Research, Inc

    Cranston, Rhode Island, 02920

  • Dallas Diabetes and Endocrine Center

    Dallas, Texas, 75230

  • Baylor Endocrine Center

    Dallas, Texas, 75246

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-8858

  • Todd Kazdan, DO Family Practice

    Davie, Florida, 33314

  • Century Clinical Research, Inc

    Daytona Beach, Florida, 32117

  • Doral Research Center

    Doral, Florida, 33172

  • Albert F. Johary MD, PC

    Dunwoody, Georgia, 30338

  • Durham Internal Medicine Associates

    Durham, North Carolina, 27704

  • Riverside Clinical Research

    Edgewater, Florida, 32132

  • USMA Clinical Research

    Elizabeth, New Jersey, 07201

  • Central Jersey Medical Research

    Elizabeth, New Jersey, 07202

  • Sentara Family Medicine

    Elizabeth City, North Carolina, 27909

  • Ettrick Health Center

    Ettrick, Virginia, 23803

  • Oregon Medical Group

    Eugene, Oregon, 97401

  • Pharmakon Inc

    Evergreen Park, Illinois, 60805

  • Larry D Stonesifer, MD Inc., PS

    Federal Way, Washington, 98003

  • Apex Medical Research, AMR Inc

    Flint, Michigan, 48504

  • MCM Clinical Research, LLC

    Florence, Kentucky, 41042

  • Alan Graff, MD, PA

    Fort Lauderdale, Florida, 33309

  • M & O Clinical Research, LLC

    Fort Lauderdale, Florida, 33316

  • Edinger Medical Group and Research Center

    Fountain Valley, California, 92708

  • American Health Network of Indiana, LLC

    Franklin, Indiana, 46131

  • Clinical Trials of St. Jude Heritage Med. Group

    Fullerton, California, 92835

  • Genoa Medical Center

    Genoa, Ohio, 43430

  • Paris View Family Practice

    Greenville, South Carolina, 29601

  • Mountain View Clinical Research

    Greer, South Carolina, 29651

  • Harleysville Medical Associates

    Harleysville, Pennsylvania, 19438

  • Hayden Lake Family Physicians

    Hayden Lake, Idaho, 83835

  • Clinical Research Advantage, Inc./Rita B. Chuang, MD, LLC

    Henderson, Nevada, 89052

  • Eastern Research

    Hialeah, Florida, 33013

  • Research in Miami Inc

    Hialeah, Florida, 33013

  • Jacon Medical Research Associates, LLC

    Houston, Texas, 77030

  • JVC Family Medicine

    Houston, Texas, 77040

  • Clinical Trial Network

    Houston, Texas, 77074

  • Endocrine and Psychiastry Center

    Houston, Texas, 77095

  • Pioneer Research Solutions, Inc.

    Houston, Texas, 77099

  • Mapleton Medical Center

    Indianapolis, Indiana, 46205

  • American Health Network, LLC

    Indianapolis, Indiana, 46254

  • Jacksonville Impotence Treatment Center

    Jacksonville, Florida, 32223

  • East Coast Institute for Research, LLC

    Jacksonville, Florida, 32258

  • Care Partners Clinical Research LLC

    Jacksonville, Florida, 32277

  • Northeast Arkansas Baptist Clinic

    Jonesboro, Arkansas, 72404

  • Westside Family Medical Center, PC

    Kalamazoo, Michigan, 49009

  • Detweiler Family Medicine & Associates, PC

    Lansdale, Pennsylvania, 19446

  • Clinical Research of South Nevada

    Las Vegas, Nevada, 89121

  • Palm Medical Research Center

    Las Vegas, Nevada, 89148

  • Precision Clinical Research, LLC

    Lauderdale Lakes, Florida, 33319

  • Kentucky Diabetes Endocrinology Center

    Lexington, Kentucky, 40503

  • Medical Investigations, Inc

    Little Rock, Arkansas, 72205

  • Aureus Research, Inc

    Little Rock, Arkansas, 72211

  • Tri City Medical Centers, PC

    Livonia, Michigan, 48152

  • Long Beach Center for Clinical Research

    Long Beach, California, 90807

  • Office of Dr. Richard S. Cherlin

    Los Gatos, California, 95032

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110

  • Office of Dr. Craig S. Thompson, MD, LLC

    Marion, Ohio, 43302

  • RAS Health Limited

    Marion, Ohio, 43302

  • Advanced Medical Research, LLC

    Maumee, Ohio, 43537

  • University of Tennessee

    Memphis, Tennessee, 38163

  • Boise Kidney and Hypertension Institute

    Meridian, Idaho, 83642

  • Clinical Research Advantage, Inc./Rita B. Chuang, MD, LLC

    Mesa, Arizona, 85203

  • Clinical Research Advantage, Inc./Rita B. Chuang, MD, LLC

    Mesa, Arizona, 85213

  • Crescent City Clinical Research

    Metairie, Louisiana, 70006

  • Veritas Research Corporation

    Miami, Florida, 33126

  • APF Research, LLC

    Miami, Florida, 33134

  • Swiss Medical Research

    Miami, Florida, 33135

  • University of Miami

    Miami, Florida, 33136

  • South Miami Clinical Research

    Miami, Florida, 33143

  • Well Pharma Medical Research

    Miami, Florida, 33143

  • Advanced Pharma CR, LLC

    Miami, Florida, 33147

  • AppleMed Research Group, LLC

    Miami, Florida, 33155

  • Kendall South Medical Center, Inc

    Miami, Florida, 33185

  • Midland Clinical Research Center

    Midland, Texas, 79707

  • PHS Clinical Trials

    Midvale, Utah, 84047

  • Park Nicollet Institute

    Minneapolis, Minnesota, 55416

  • McKinley Research, LLC

    Mishawaka, Indiana, 46545

  • Internal Medicine Center, LLC

    Mobile, Alabama, 36608

  • Diagnostic and Medical Clinic

    Mobile, Alabama, 36695

  • Extended Arm Physicians, Inc.

    Montgomery, Alabama, 36106

  • American Health Network of Indiana, LLC

    Muncie, Indiana, 47304

  • Hill Country Medical Associates

    New Braunfels, Texas, 78130

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652

  • Advanced Research Institute, Inc

    New Port Richey, Florida, 34653

  • Tristan Medical Enterprises, PC dba Regeneris

    North Attleboro, Massachusetts, 02760

  • Providence Clinical Research

    North Hollywood, California, 91606

  • Naidu Clinic

    Odessa, Texas, 79761

  • Infinity Research Group, LLC

    Oklahoma City, Oklahoma, 73103

  • Quality Clinical Research

    Omaha, Nebraska, 68114

  • Sunshine Research Center

    Opa-locka, Florida, 33054

  • South Carolina Nephrology and Hypertension Center, Inc

    Orangeburg, South Carolina, 29118

  • Diabetes and Endocrine Center of Orlando

    Orlando, Florida, 32803

  • Four Rivers Clinical Research, Inc

    Paducah, Kentucky, 42003

  • Suncoast Clinical Research

    Palm Harbor, Florida, 34684

  • Misal Khan, MD FRCS, ED, PA

    Panama City, Florida, 32401

  • The Methodist Hospital d/b/a HMRI CCAT at Pearland

    Pearland, Texas, 77584

  • Advanced Clinical Research

    Pell City, Alaska, 35128

  • Iconic Clinical Trials

    Pembroke Pines, Florida, 33024

  • Gulf Region Clinical Research Institute

    Pensacola, Florida, 32514

  • Temple University School of Medicine

    Philadelphia, Pennsylvania, 19140

  • Village Health Partners

    Plano, Texas, 75024

  • Chaparral Medical Group, Inc

    Pomona, California, 91767

  • St. John's Center for Clinical Research

    Ponte Vedra Beach, Florida, 32081

  • PMG Research of Raleigh, LLC

    Raleigh, North Carolina, 27609

  • ARI Clinical Trials, Inc

    Redondo Beach, California, 90277

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23220

  • Richmond Family Practice

    Richmond, Virginia, 23220

  • Endocrine and Metabolic Consultants

    Rockville, Maryland, 20852

  • KMED Research

    Saint Clair Shores, Michigan, 48081

  • Highland Clinical Research

    Salt Lake City, Utah, 84124

  • Sun Research Institute

    San Antonio, Texas, 78215

  • San Diego Sports Medicine and Family Health Center

    San Diego, California, 92120

  • West Coast Research, LLC

    San Ramon, California, 94582

  • Northeast Clinical Research of San Antonio, LLC

    Schertz, Texas, 78154

  • Carolina Research Center, Inc

    Shelby, North Carolina, 28150

  • Endocrine Associates of Long Island, PC

    Smithtown, New York, 11787

  • Georgia Clinical Research, LLC

    Snellville, Georgia, 30078

  • Premier Clinical Research

    Spokane, Washington, 99204

  • Mercy Health Research

    St Louis, Missouri, 63141

  • Piedmont Healthcare

    Statesville, North Carolina, 28625

  • Tri-County Research, Inc

    Sterling Heights, Michigan, 48310

  • Kenneth Otah and Associates

    Sugar Land, Texas, 77478

  • Carolina Diabetes & Kidney Center

    Sumter, South Carolina, 29150

  • University of California Los Angeles

    Sylmar, California, 91342

  • Metabolic Institute of America

    Tarzana, California, 91356

  • Medical Research Associates

    Traverse City, Michigan, 49684

  • Oakland Medical Research Center

    Troy, Michigan, 48085

  • Genova Clinical Research

    Tucson, Arizona, 85704

  • Quality of Life Medical & Research Center

    Tucson, Arizona, 85712

  • Trinity Clinical Research, LLC

    Tullahoma, Tennessee, 37388

  • Castlerock Clinical Research Consultants, LLC

    Tulsa, Oklahoma, 74136

  • Office of Dr. Terence T. Hart MD

    Tuscumbia, Alabama, 35674

  • Matrix Research Institute

    Tustin, California, 92780

  • Orange County Research Center

    Tustin, California, 92780

  • Warminster Medical Associates, PC

    Warminster, Pennsylvania, 18974

  • Metabolic Research Institute

    West Palm Beach, Florida, 33401

  • Southgate Medical Group/ Southgate Medical Park

    West Seneca, New York, 14224

  • Westlake Medical Research

    Westlake Village, California, 91361

  • PMG Research of Wilmington, LLC

    Wilmington, North Carolina, 28401

  • Pharmacotherapy Research Associates, Inc

    Zanesville, Ohio, 43701

Other trials in United States

Germany39 sites

  • Universitätsklinikum Aachen, AöR

    Aachen, 52074

  • Studienzentrum Klausmann

    Aschaffenburg, 63739

  • Gemeinschaftspraxis, Asslar

    Aßlar, 35614

  • Diabetes Schwerpunktpraxis

    Bad Nauheim, 61231

  • Praxis Dr. Naumburger, Berlin

    Berlin, 10409

  • emovis GmbH

    Berlin, 10629

  • Praxis Dr. Rieker, Berlin

    Berlin, 10789

  • IFG Institut für Gesundheitsförderung GmbH

    Berlin, 12621

  • Dünnwaldpraxis, Köln

    Cologne, 51069

  • MVZ DaVita Dormagen GmbH

    Dormagen- Hackenbroich, 41540

  • Praxis Dr. Busch, Dortmund

    Dortmund, 44137

  • GWT-TUD GmbH

    Dresden, 01307

  • Praxis Dr. Schlecht, Eisenach

    Eisenach, 99817

  • ZKS Südbrandenburg GmbH

    Elsterwerda, 04910

  • Praxis Dr. Huptas, Essen

    Essen, 45307

  • Praxis Dr. Schmidt, Flörsheim

    Flörsheim, 65439

  • Institut für Stoffwechselforschung, Frankfurt

    Frankfurt, 60322

  • Praxis Dr. Groeneveld, Furth im Wald

    Furth im Wald, 93437

  • Praxis Dr. Kohlhas, Gebhardshain

    Gebhardshain, 57580

  • Praxis Dr. Samer, Haag

    Haag, 83527

  • Klinische Forschung Management & Services GmbH

    Hamburg, 20253

  • Diabetologische Schwerpunktpraxis

    Hamburg, 21073

  • Praxis Dr. Burkhardt, Hamburg

    Hamburg, 22335

  • Diabeteszentrum Alstertal, Hamburg

    Hamburg, 22391

  • Praxis Dr. Herrmann, Hatten

    Kirchhatten, 26209

  • Praxis Dr. Klein, Künzing

    Künzing, 94550

  • Praxis Dr. Nischik, Leipzig

    Leipzig, 04109

  • Praxis Dr. Kropp, Lübeck

    Lübeck, 23554

  • PFÜTZNER Science & Health Institute GmbH

    Mainz, 55128

  • Diabetologische Schwerpunktpraxis

    Münster, 48153

  • Praxis Dr. Böckmann

    Neumünster, 24534

  • Praxis Dr. Hilgenberg

    Rehburg-Loccum, 31547

  • Praxis Dr. Naudts, Rodgau

    Rodgau/Dudenhofen, 63110

  • Praxis Dr. Hirschhäuser

    Saarbrücken, 66121

  • Praxis Dr. Segner, St. Ingberg

    Saint Ingbert / Oberwürzbach, 66386

  • Praxis Dr. Herrmann

    Schwabenheim, 55270

  • Praxis Dr. Dietlein

    Stadtbergen, 86391

  • Praxis Dr. Sauter

    Wangen, 88239

  • Schwerpunktpraxis Diabetologie

    Zwenkau, 04442

Other trials in Germany

France24 sites

  • CAB Hell M, MG, Behren Les Forbach

    Behren-lès-Forbach, 57460

  • CAB Breton Dr Nicolas

    Béziers, 34500

  • HOP Haut Levèque, Diabéto, Pessac

    Bordeaux, 33075

  • CAB Lemarie B, MG, Bourg des Cptes

    Bourg-des-Comptes, 35890

  • CAB Cadinot Dr D, Broglie

    Broglie, 27270

  • CAB Ferrier R, MG, Cannes

    Cannes, 06400

  • CAB Jordan E, MG, Carbonne

    Carbonne, 31390

  • CAB Merlin P, MG Castets

    Castets, 40260

  • CAB Fonteny R, MG, Chartres

    Chartres, 28000

  • CAB Fournier P, MG, Chartres

    Chartres, 28000

  • CAB Martocq G, MG, Cournonterral

    Cournonterral, 34660

  • HOP, Fort de France, Fort de France

    Fort de France, 97261

  • CAB Le Mouel S, MG, Hinx

    Hinx, 40180

  • CAB Pholsena, MG, La Réunion

    La Réunion, 97410

  • CAB Bismuth M

    Labarthe-sur-Lèze, 31860

  • CAB Zimmermann D

    Louvigne de Bie, 35680

  • CAB Mainetti P, MG, Maintenon

    Maintenon, 28130

  • CAB Barucq F, MG, Orthez

    Orthez, 64300

  • CAB Mostephai M

    Orthez, 64300

  • CAB Cassagnes JL, MG, Palau Del Vidre

    Palau-del-Vidre, 66690

  • CAB Mercey Y, MG, St Genies des Fontaines

    Saint Genies Des Fontaines, 66740

  • Hop St Dié des Vosges, Diabéto, St Dié des Vosges

    Saint-Dié, 88187

  • CAB Bonneau D, MG, Thouars

    Thouars, 79100

  • CAB Morel H, MG, Tilly sur Seulles

    Tilly-sur-Seulles, 14250

Other trials in France

India24 sites

  • Shree Krishna Hospital and Heart Care Centre, Ahmedabad

    Ahmedabad, 380052

  • Diabetes care and research centre

    Bangalore, 560010

  • Manipal Hospital

    Bangalore, 560017

  • Bangalore Diabetes Centre (BDC)- Medisys Clinical Research

    Bangalore, 560043

  • MS Ramaiah Memorial Hospital,

    Bangalore, Karnataka, 560054

  • Belgaum Diabetes Centre, Belgaum

    Belagavi, 590001

  • Swamy Diabetes Centre

    Chennai, 600 028

  • Apollo Hospitals

    Chennai, 600010

  • M V Hospital For Diabetes and Diabetes Research Centre

    Chennai, 600013

  • Dr. Mohans Diabetes Speciality Centre

    Chennai, 600086

  • CIIGMA Institute of Medical Sciences Pvt Ltd

    Chhatrapati Sambhajinagar, 431001

  • Kovai Diabetes Speciality Centre & Hospital

    Coimbatore, 641009

  • TOTALL Diabetes Hormone Institute

    Indore, 452010

  • Diabetes Thyroid and Endocrine Centre

    Jaipur, 302 006

  • Diamed Clinical Research Services Pvt. Ltd.

    Jaipur, 302016

  • Grant Medical Foundation, Ruby Hall Clinic

    Maharashtra, 411001

  • Global Hospital- Superspeciality & Transplant Centre

    Mumbai, 400012

  • RHIDEM

    Mumbai, 400014

  • K.G.N. Diabetes and Endocrine Centre

    Mumbai, Maharastra, 400008

  • Sunil's Diabetes care and Research Centre

    Nagpur, 440 010

  • Jahingir Clinical Development Centre

    Pune, 411001

  • Deshmukh Clinic

    Pune, 411030

  • Diabetes Care Center

    Thiruvananthapuram, 695 010

  • Yalamanchi Hospitals & Research Centres Pvt Ltd.

    Vijayawada, 520 002

Other trials in India

Spain18 sites

  • C.A.P. Sardenya

    Barcelona, 08025

  • CAP Les Corts

    Barcelona, 08028

  • CAP Casanova

    Barcelona, 08036

  • CAP Burjassot 1

    Burjassot, 46100

  • C.S. Natahoyo

    Gijón, 33212

  • Hospital Universitari de Girona Doctor Josep Trueta

    Girona, 17007

  • CAP Florida

    L'Hospitalet de Llobregat, 08905

  • Hospital de Bellvitge

    L'Hospitalet de Llobregat, 08907

  • CAP La Roca

    La Roca Del Vallés (Barcelona), 08430

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • C.S. El Cristo

    Oviedo, 33006

  • C.S. Colloto

    Oviedo, 33010

  • C.S. Vallobin-La Florida

    Oviedo, 33012

  • ABS Pineda de Mar

    Pineda de Mar, 08397

  • Hospital de l'Esperit Sant

    Santa Coloma de Gramanet, 08923

  • CAP Tàrrega

    Tàrrega, 25300

  • CS Ingeniero Joaquin Benlloch

    Valencia, 46006

  • Hospital Clínico de Valencia

    Valencia, 46010

Other trials in Spain

Argentina16 sites

  • Instituto de Investigaciones Clínicas de Bahía Blanca

    Bahía Blanca, B8000FTD

  • CIPREC

    CABA, C1119ACN

  • CENUDIAB

    CABA, C1440AAD

  • Instituto Médico Especializado

    Capital Federal, C1405BCH

  • Consultorios Asociados de Endocrinología e Invest Clínica

    Capital Federal, C1425AGC

  • Ilaim-Ceom

    Córdoba, X5000BNB

  • IPAC - Clínica Privada Caraffa SRL

    Córdoba, X5008KKF

  • Instituto Cardiovascular de Corrientes Juana Francisca Cabra

    Corrientes, W3400AMZ

  • Hospital Italiano de La Plata

    La Plata, B1900AWT

  • CIPADI

    Mendoza, M5500EVJ

  • Instituto de Investigaciones Clinicas de Rosario

    Rosario, S2000CVD

  • Instituto de Hematología y Medicina Clínica Dr. Rubén Davoli

    Rosario, S2000CXP

  • Hospital San Bernardo

    Salta, A4406CLA

  • Investigaciones Clinicas Tucuman

    San Miguel de Tucumán, T4000ICL

  • Instituto de Investigaciones Biomédicas

    Santa Fe, S3000FNF

  • Centro de Investigaciones Clínicas del Litoral

    Santa Fe, S3000SWO

Other trials in Argentina

Netherlands16 sites

  • Huisartspraktijk Emmers

    's-Hertogenbosch, 5235 KG

  • FlevoResearch

    Almere Stad, 1311 RL

  • Academisch Medisch Centrum (AMC)

    Amsterdam, 1105 AZ

  • Rode Kruis Ziekenhuis Beverwijk

    Beverwijk, 1942 LE

  • Andromed Breda

    Breda, 4811 SW

  • Noordwest Ziekenhuisgroep, location Den Helder

    Den Helder, 1782 GZ

  • Andromed Eindhoven

    Eindhoven, 5611 NV

  • Andromed Noord

    Groningen, 9711 SG

  • Vasculair Onderzoek Centrum

    Hoorn, 1624 NP

  • Maastricht Universitair Medisch Centrum

    Maastricht, 6229 HX

  • Andromed Rotterdam

    Rotterdam, 3039 BD

  • Rotterdam Research Institute

    Rotterdam, 3039 BD

  • Ikazia Ziekenhuis

    Rotterdam, 3083 AN

  • Antonius Ziekenhuis

    Sneek, 8601 ZK

  • Andromed Oost

    Velp, 6883 ES

  • Andromed Leiden-Zoetermeer

    Zoetermeer, 2724 EK

Other trials in Netherlands

South Korea15 sites

  • Korea University Ansan Hospital

    Ansan, 15355

  • Inje University Busan Paik Hospital

    Busan, 614-735

  • Keimyung University Dongsan Medical Center

    Daegu, 700-712

  • National Health Insurance Service Ilsan Hospital

    Goyang, 410-719

  • Dongguk University Ilsan Hospital

    Goyang, 410-773

  • Inje University Ilsan Paik Hospital

    Goyang, 411-706

  • Chonbuk National University Hospital

    Jeonju, 561-712

  • Pusan National Univ. Hosp

    Pusan, 602-739

  • Seoul National University Bundang Hospital

    Seongnam, 463-707

  • Korea University Anam Hospital

    Seoul, 02841

  • Korea University Guro Hospital

    Seoul, 08308

  • Kangdong Sacred Heart Hospital

    Seoul, 134-701

  • Ajou University Hospital

    Suwon, 443-380

  • Wonju Severance Christian Hosp

    Wŏnju, 220-701

  • Pusan National University Yangsan Hospital

    Yangsan, 626-770

Other trials in South Korea

Taiwan15 sites

  • Chang-Hua Christian Hospital

    Changhua, 500

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • E-Da Hospital

    Kaohsiung City, 824

  • Far Eastern Memorial Hospital

    New Taipei City, 220

  • China Medical University Hospital

    Taichung, 40447

  • Taichung Veterans General Hospital

    Taichung, 40705

  • NCKUH

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100

  • Shih-Kong Wu Ho-Shu Memorial Hospital

    Taipei, 111

  • Taipe Veterans General Hospital

    Taipei, 11217

  • Cheng Hsin General Hospital

    Taipei, 112

  • Tri-Service General Hospital

    Taipei, 114

  • Cardinal Tien Hospital

    Taipei, 23137

  • Taipei Medical University-Shuang Ho Hospital

    Taipei, 235

  • Mackay Memorial Hospital

    Taipei, 25160

Other trials in Taiwan

Belgium14 sites

  • Blankenberge - PRAC Vileyn, Geert

    Blankenberge, 8370

  • Bonheiden - HOSP Imelda

    Bonheiden, 2820

  • De Pinte - PRAC Hollanders, Geert

    De Pinte, 9840

  • Retie - PRAC De Vos, Axel

    Dessel, 2480

  • Deurne - PRAC Heyvaert, Frank

    Deurne, 2100

  • Deurne - PRAC Verelst, Joost

    Deurne, 2100

  • Genk - PRAC Vernijns, J.

    Genk, 3600

  • Gozée - PRAC De Meulemeester, Marc

    Gozée, 6534

  • Hasselt - PRAC Vantroyen, Daniel

    Hasselt, 3500

  • Herent - PRAC Denolf, Bart

    Herent, 3020

  • Linkebeek - PRAC Maury, Olivier

    Linkebeek, 1630

  • Moorsel - PRAC Van Mulders, N.

    Moorsel, 9310

  • Natoye - PRAC Balthazar, Y.

    Natoye, 5360

  • Tremelo - PRAC Vermeersch, Lode

    Tremelo, 3210

Other trials in Belgium

Japan14 sites

  • Daishinkai Medical Corporation Ookuma Hospital

    Aichi, Nagoya, 462-0825

  • Chibanishi General Hospital

    Chiba, Matsudo, 270-2251

  • New Tokyo Heart Clinic

    Chiba, Matsudo, 271-0077

  • Kashinoki I.M. Clinic, Fukushima, I.M.

    Fukushima, Date, 960-0418

  • Japan Community Health care Organization Nihonmatsu Hospital

    Fukushima, Nihonmatsu, 964-8501

  • Iwase General Hospital

    Fukushima, Sukagawa, 962-8503

  • Iryohojinshadan Sasaki Clinic

    Hyogo, Amagasaki, 660-0827

  • Takasagoseibu Hospital

    Hyogo, Takasago, 676-0812

  • Kanagawa Cardiovascular and Respiratory Center

    Kanagawa, Yokohama, 236-0051

  • Jinnouchi Clinic Diabetes Care Center

    Kumamoto, Kumamoto, 862-0976

  • Kumamoto Rosai Hospital

    Kumamoto, Yatsushiro, 866-8533

  • Koga General Hospital

    Miyazaki, Miyazaki, 880-0041

  • Saitama Medical Cooperative Association Hanyu General Hospital

    Saitama, Hanyu, 348-0045

  • Nihon University Itabashi Hospital

    Tokyo, Itabashi-ku, 173-8610

Other trials in Japan

Brazil12 sites

  • Hospital Universitário João de Barros Barreto

    Belém, 66073-000

  • Universidade Federal do Paraná

    Curitiba, 80060-900

  • Hospital Geral de Goiânia Alberto Rassi

    Goiânia, 74043-110

  • Centro de Pesquisas Clínicas Ltda

    Higienópolis, 01244-030

  • Centro de Estudos em Diabetes e Hipertensão

    Joaquim Távora, 60115-282

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90020-090

  • Centro de Pesquisas em Diabetes

    Porto Alegre, 90035-170

  • Instituto Estadual de Diabetes e Endocrinologia

    Rio de Janeiro, 20211-340

  • Irmandade da Santa Casa de Misericórdia de São Paulo - IPEC - Instituto de Pesquisa Clínica

    Santa Cecília, 01221-020

  • Instituto de Molestias Cardiovasculares - IMC

    São José do Rio Preto, 15015-210

  • Hospital das Clinicas da FMUSP

    São Paulo, 05403-900

  • Hospital do Rim e Hipertensão - UNIFESP

    Vila Clementino, 04025-011

Other trials in Brazil

Canada11 sites

  • Cambridge Cardiac Care Inc.

    Cambridge, Ontario, N1R 6V6

  • Hamilton Medical Research Group

    Hamilton, Ontario, L8M 1K7

  • Kings County Medical Centre

    Montague, Prince Edward Island, C0A 1R0

  • SKDS Research Incorporated

    Newmarket, Ontario, L3Y 5G8

  • Dynamik Research

    Pointe-Claire, Quebec, H9R 3J1

  • IUCPQ (Laval University)

    Québec, Migration Data, G1V 4G5

  • First Line Medical Services Ltd.

    St. John's, Newfoundland and Labrador, A1E 2C2

  • Topsail Road Medical Clinic

    St. John's, Newfoundland and Labrador, A1E 2E2

  • Wilderman Medical Clinic

    Thornhill, Ontario, L4J 1W3

  • St. Michael's Hospital

    Toronto, Ontario, M5C 2T2

  • Albion Finch Medical Centre

    Toronto, Ontario, M9V 4B4

Other trials in Canada

Colombia11 sites

  • BioMelab

    Barranquilla

  • Centro Cientifico Asistencial Jose Luis Accini

    Barranquilla

  • Fundacion del Caribe de Investigacion Biomedica

    Barranquilla

  • Dexa Diabetes Servicios Médicos Ltda

    Bogotá

  • Endocare Research Institute

    Bogotá

  • UNIENDO Unidad Integral de Endocrinologia

    Bogotá

  • Centro cardiovascular Aristides

    Cartagena

  • centro de Diagnostico Cardiologico para la Investigacion Bio

    Cartagena

  • Fundacion Cardiovascular de Colombia

    El Bosque

  • Fundación Oftalmologica de Santander

    El Bosque

  • Fundación Centro de Investigaciones Biomédicas Riescard

    Tolima

Other trials in Colombia

Norway11 sites

  • Medi 3 AS

    Ålesund, N-6002

  • Bodø Legesenter AS, avd. for med. studier

    Bodø, N-8001

  • Medi 3 Innlandet AS, avd Elverum

    Elverum, N-2408

  • Vestre Viken HF, Bærum sykehus

    Gjettum, N-1346

  • M3 Helse AS

    Hamar, N-2317

  • Bylegene SA

    Jessheim, N-2050

  • Heiaklinikken

    Lierskogen, N-3420

  • Rådhuset Spesialistsenter

    Oslo, N-0160

  • Sandvika Spesialistsenter

    Sandvika, N-1337

  • Grålum Legesenter

    Sarpsborg, N-1727

  • Forusakutten - Kolibri Medical, Avd. Stavanger

    Stavanger, N-4005

Other trials in Norway

Georgia10 sites

  • Unimed Ajara LLC, Private Practice

    Batumi, 6004

  • Central Hospital LTD 'Gormedi', Gori

    Gori, 1400

  • L&J Clinic, Kutaisi

    Kutaisi, 4600

  • EC Cardiology Clinic,Tbilisi

    Tbilisi, 0144

  • National Center for Diabetes Research Ltd., Tbilisi

    Tbilisi, 0159

  • National Institute of Endocrinology, Tbilisi

    Tbilisi, 0159

  • Zhordania Institute of Human Reproduction, Tbilisi

    Tbilisi, 0159

  • Medical Centre Medelite Ltd., Tbilisi

    Tbilisi, 0177

  • Chemotherapy & Immunotherapy Clinic 'Medulla', Tbilisi

    Tbilisi, 0186

  • JSC 'Curatio'

    Zugdidi, 2100

Other trials in Georgia

Philippines10 sites

  • Asian Hospital & Medical Center

    City of Muntinlupa, 1781

  • Center for Diabetes Care

    Iloilo City, 5000

  • Mary Mediatrix Medical Center

    Lipa City, Batangas, 4217

  • Philippine General Hospital

    Manila, 1000

  • University of Santo Tomas Hospital

    Manila, 1008

  • Manila Doctors Hospital

    Manila, 1011

  • St. Luke's Medical Center

    Quezon City, 1102

  • Quirino Memorial Medical Center

    Quezon City, 1109

  • Cardinal Santos Medical Center

    San Juan City, 1503

  • Surigao Health Specialists

    Surigao City, 8400

Other trials in Philippines

South Africa10 sites

  • Dr. P. Patel

    Cape Town, 7764

  • Dr. E. L. Janari

    Cape Town, 7965

  • Dr. Vawda

    Durban, 4091

  • Parklands Medical Centre

    Durban, 4091

  • Dr. Jurgens

    Krugersdorp, 1739

  • Dr. H. Makan

    Lenasia, 1827

  • Dr. D. R. Lakha, Johannesburg

    Lenasia, 2033

  • Greenacres Hospital

    Port Elizabeth, 6045

  • Dr. M. Seeber

    Pretoria, 0083

  • Vergelegen Medi-Clinic

    Somerset West, 7130

Other trials in South Africa

Ukraine10 sites

  • Donetsk Regional Clinical Hosp, Therapy Department

    Donetsk, 83003

  • Ivano-Frankivsk City Central Clinical Hospital

    Ivano-Frankivsk, 76000

  • City Clinical Hospital No. 27, Kharkiv

    Kharkiv, 61002

  • City Clinical Hospital No. 17, Kharkov

    Kharkiv, 61037

  • Clinic for Cardiology "Sertse i sudyny", Kiev

    Kiev, 01032

  • City Clinical Hospital No. 1, Kiev

    Kiev, 02091

  • Poliklinika #2, Kyiv

    Kyiv, 02002

  • City Hospital No. 5, Lvov

    Lviv, 73013

  • Odeska zaliznichna likarnya, Odessa

    Odesa, 65039

  • Vinnitsia Regional Endocrinology Dispensary

    Vinnitsa, 21010

Other trials in Ukraine

United Kingdom10 sites

  • Crouch Oak Family Practice

    Addlestone, KT15 2BH

  • Ash Vale Health Centre, Aldershot

    Ash Vale, Aldershot, GU12 5BA

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS

  • Hathaway Medical Centre

    Chippenham, SN14 6GT

  • University Hospital of North Durham

    Durham, DH1 5TW

  • St Mary's Surgery

    Ely, CB7 4HF

  • Gloucestershire Royal Hospital

    Gloucester, GL1 3NN

  • James Paget University Hospital

    Great Yarmouth, NR31 6LA

  • Morriston Hospital

    Swansea, SA6 6NL

  • Royal Cornwall Hospital

    Truro, TR1 3LJ

Other trials in United Kingdom

Hungary9 sites

  • Imre Magyar Hospital, Ajka

    Ajka, 8400

  • Lausmed Kft. Outpatient Unit of Internal Medicine

    Baja, 6500

  • Karolyi Sandor Hospital, Budapest

    Budapest, 1041

  • Bekes County Pandy Kalman Hospital

    Gyula, 5700

  • Erzsebet Hospital, Hodmezövasarhely

    Hódmezövásárhely, 6800

  • Dr. Samuel Diosszilagyi Hospital and Outpatient Clinic, Mako

    Makó, 6900

  • TaNa Med Kft.

    Mosonmagyaróvár, 9200

  • Grof Esterhazy Hospital and Outpatient Clinic

    Pápa, 8500

  • Tolna County Balassa Janos Hospital

    Szekszárd, 7100

Other trials in Hungary

Italy9 sites

  • Ospedale "SS. Trinità"

    Cagliari, 09100

  • Policlinico Universitario Mater Domini, Universita di Catanzaro

    Catanzaro, 88100

  • Policlinico San Martino

    Genova, 16132

  • Ospedale di Guastalla

    Guastalla (RE), 42016

  • A.O.U.Policlinico G.Martino

    Messina, 98125

  • Fondazione Centro San Raffaele del Monte Tabor

    Milan, 20132

  • Ospedale S. Pertini

    Roma, 00100

  • Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza

    Roma, 00189

  • IRCCS Gruppo Multimedica

    Sesto San Giovanni (MI), 20099

Other trials in Italy

Russia9 sites

  • LLC Clinic of new technologies of medicine

    Dzerzhinsky, 140091

  • City Clinical Hospital No. 6 of MoH of Udmurt Republic

    Izhevsk, 436000

  • City Clinical Hospital No. 4, Moscow

    Moscow, 115093

  • City Clinical Hospital No. 13, Moscow

    Moscow, 115280

  • State Institution "Central Clinical Hospital of RAS", Moscow

    Moscow, 117333

  • City Clinical Hospital No. 61, Moscow

    Moscow, 119048

  • State Healthcare Institution, Regional hospital #2

    Rostov-on-Don, 344029

  • Limited Liability Company "CENTER DIABET", Samara

    Samara, 443067

  • MMU City Outpatient Clinic no. 20, Saratov

    Saratov, 410018

Other trials in Russia

Sweden9 sites

  • CTC Sahlgrenska Universitetssjukhuset

    Gothenburg, 413 45

  • Sjukhuset, Härnösand

    Härnösand, 87182

  • Avonova Hälsa AB

    Järfälla, 177 30

  • Skånes universitetssjukhus, Malmö

    Malmö, 20502

  • Dalecarlia Clinical Research Center

    Rättvik, 795 30

  • Södra Dalarnas vårdcentral, Hedemora

    Rättvik, 79530

  • Näsets Läkargrupp

    Skanör, 239 33

  • Vårdcentralen Silentzvägen

    Uddevalla, 451 50

  • S3 Clinical Research Centers

    Vällingby, 162 68

Other trials in Sweden

Czechia8 sites

  • Internal & Diabetology Ambulance, Jablonec nad Nisou

    Jablonec nad Nisou, 466 01

  • Diabetology & Internal Ambulance

    Olomouc-Lazce, 779 00

  • Internal & Diabetology Ambulance Dr. Vrkoc, Ostrava

    Ostrava, 702 00

  • Cardiology ambulance, Plzen

    Pilsen, 301 00

  • Diebetology internal Ambulance

    Prague, 101 00

  • ResTrial s.r.o.

    Prague, 181 00

  • Internal & Diabetology Ambulance, Prostejov

    Prostějov, 796 01

  • Hospital Strakonice, Internal Department

    Strakonice, 386 29

Other trials in Czechia

Greece8 sites

  • General Hospital of Athens Evangelismos

    Athens, 10676

  • General University Hospital "Attikon"

    Haidari, Athens, 12410

  • Univ. Gen. Hosp. of Ioannina

    Ioannina, 45500

  • General Hospital "Amalia Fleming"

    Melissia, Athens, 15127

  • General Hospital of Nikaia

    Nikaia, 18484

  • University General Hospital of Thessaloniki AHEPA

    Thessaloniki, 54636

  • General Hopsital of Thessaloniki "Ippokrateio"

    Thessaloniki, 54642

  • Kliniki Thermi

    Thessaloniki, 57001

Other trials in Greece

Malaysia8 sites

  • Penang Medical College

    George Town, 10450

  • Monash University

    Johor Bahru, Johor, 80100

  • Hospital University Sains Malaysia

    Kota Bharu, 16150

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

  • Hospital Tengku Ampuan Afzan

    Kuantan, 25100

  • Hospital Melaka

    Malacca, 75400

  • Hospital Taiping

    Taiping, 34000

Other trials in Malaysia

Peru8 sites

  • Instituto Delgado de Investigacion Medica

    Arequipa, LIMA 54

  • Clinica San Pedro

    Huacho

  • Hospital Nacional Dos de Mayo

    Lima, 01

  • Clinica Internacional

    Lima, LIMA 1

  • Centro de Investigaciones Médicas METABOLICARE SAC

    Lima, Lima 27

  • Clinica San Gabriel

    Lima, Lima 32

  • Centro De Especialidades Medicas Santa Maria S.A.C

    Piura

  • Clinica San Judas Tadeo

    San Miguel, 32

Other trials in Peru

Portugal8 sites

  • Hospital Fernando Fonseca, EPE

    Amadora, 2700-276

  • CHLO, EPE - Hospital de Santa Cruz

    Carnaxide, 2799-523

  • CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

    Coimbra, 3000-075

  • Centro Hospitalar da Cova da Beira Hospital Pêro da Covilhã

    Covilha, 6200-251

  • Hospital Distrital Figueira da Foz, EPE

    Figueira da Foz Municipality, 3094-001

  • Hospital da Luz

    Lisbon, 1500-650

  • Centro Hospitalar São João,EPE

    Porto, 4202-451

  • Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião

    Santa Maria da Feira, 4520-211

Other trials in Portugal

Finland7 sites

  • Diabetesklinikka, Mehiläinen Töölö

    Helsinki, 00260

  • Lääkärikeskus Ite

    Joensuu, 80100

  • Lääkärikeskus Aava Kerava

    Kerava, 04200

  • Kokkolan Lääkärikeskus

    Kokkola, 67100

  • IteLasaretti

    Kuopio, FI-70100

  • Terveystalo Oulu, Diapolis

    Oulu, FI-90100

  • TYKS

    Turku, FI-20520

Other trials in Finland

Israel7 sites

  • Barzilai Medical Center

    Ashkelon, 78278

  • Rambam Medical Center

    Haifa, 31096

  • Edith Wolfson Medical Center, Diabetic Unit, Holon

    Holon, 58100

  • Hadassah Medical Center, Ein-Karem

    Jerusalem, 91120

  • Western Galilee Hospital

    Nahariya, 22100

  • Sourasky Medical Center

    Tel Aviv, 64239

  • The Chaim Sheba Medical Center Tel Hashomer

    Tel HaShomer, 52621

Other trials in Israel

Slovakia7 sites

  • DIASTYLE s.r.o., Diabetology Outpatient Department

    Banská Bystrica, 974 01

  • ENDIAMED s.r.o., Dolny Kubin

    Dolný Kubín, 026 01

  • CELL B s.r.o.

    Levice, 934 01

  • DIA-KONTROL s.r.o.

    Levice, 934 01

  • Funkystuff s.r.o., Nove Zamky

    Nové Zámky, 940 01

  • Diabetologicka ambulancia MUDr. Lucia Gajdosikova s.r.o.

    Považská Bystrica, 017 01

  • MEDIVASA s.r.o., Outpatient Clinic, Zilina

    Žilina, 010 01

Other trials in Slovakia

Romania6 sites

  • SC Diabol SRL, Brasov

    Brasov, 500365

  • Nicodiab SRL, Bucharest

    Bucharest, 010507

  • SC Medical Centre "Sanatatea Ta" SRL, Bucharest

    Bucharest, 020614

  • Consultmed SRL, Iasi

    Iași, 700547

  • Emergency County Clinical Hospital, Sibiu

    Sibiu, 550245

  • Private Practice Dr. Remus Gagiu

    Targoviste, 130083

Other trials in Romania

Australia5 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Eastern Clinical Research Unit

    East Ringwood, Victoria, 3135

  • Royal Brisbane & Women's Hospital-Endocrinology

    Herston, Queensland, 4029

  • Logan Hospital

    Meadowbrook, Queensland, 4131

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

Other trials in Australia

Bulgaria5 sites

  • Univ.Multiprofile Hospital "Dr. Georgy Stranski" EAD, Pleven

    Pleven, 5800

  • Multiprofile Hospital for Active Treatment

    Sofia, 1431

  • Multiprofile Hospital for Active Treatment "Zaritza Johanna"

    Sofia, 1527

  • Military Medical Academy, Clin. Endocrinology & Metab. Dis.

    Sofia, 1606

  • MHAT Prof Stoyan Kirkovich AD

    Stara Zagora, 6000

Other trials in Bulgaria

Mexico5 sites

  • Hospital General de Acapulco

    Acapulco, 39570

  • Centro de Investigacion Cardiometabolica de Aguascalientes

    Aguascalientes, 20234

  • Instituto Nacional de Cardiologia Ignacio Chavez

    Distrito Federal, 14080

  • Unidad de Investigacion Clinica Cardiometabolica de Occident

    Guadalajara, 44150

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Monterrey, 64460

Other trials in Mexico

Serbia5 sites

  • Clinical Medical Center Zvezdara, Belgrade

    Belgrade, 11000

  • Clinical Centre Nis

    Niš, 18000

  • General Hospital Pancevo

    Pančevo, 26000

  • General Hospital Subotica, Internal Medicine

    Subotica, 24000

  • Clinical Hospital Center Zemun

    Zemun, 11080

Other trials in Serbia

Chile4 sites

  • Consulta Privada Maria Loreto Aguirre Coveña

    Providencia, 7500010

  • Hospital de Servicios Médicos Godoy Ltda

    Providencia

  • Centro Medico Antulawen

    Temuco

  • Hospital Naval Almirante Nef

    Viña del Mar

Other trials in Chile

Ireland4 sites

  • The Red House Family Practice

    Co. Cork, CORK

  • Connolly Hospital Blanchardstown

    Dublin, 15

  • The Palms GP Surgery

    Gorey, Wexford

  • Fethard-on-Sea Medical Practice

    Wexford, Wexford

Other trials in Ireland

New Zealand4 sites

  • Christchurch Hospital

    Christchurch, 4710

  • RMC Medical Research Ltd

    Dunedin, 9012

  • P3 Research, Wellington

    Newtown Wellington NZ, 6021

  • P3 Research, Promed House

    Tauranga, 3110

Other trials in New Zealand

Switzerland4 sites

  • Allgemeine Medizin

    Basel, 4057

  • FMH endocrinologia diabetologia

    Bellinzona, 6500

  • Inselspital Bern

    Bern, 3010

  • Dr. Pietro Gerber

    Lugano, 6900

Other trials in Switzerland

Tunisia4 sites

  • HOP Fattouma Bourguiba, Mint, Monastir

    Monastir, 5000

  • HOP Hédi Chaker, Endo, Sfax

    Sfax, 3029

  • HOP Farhat Hached, Mint, Sousse

    Sousse, 4000

  • HOP Habib Thameur, Mint, Tunis

    Tunis, 1008

Other trials in Tunisia

Hong Kong3 sites

  • Alice Ho Miu Ling Nethersole Hospital

    Hong Kong

  • Prince of Wales Hospital

    Hong Kong

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

About this study

Official title: A Multicentre, International, Randomised, Parallel Group, Double Blind Study to Evaluate Cardiovascular Safety of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes Mellitus at High Cardiovascular Risk.

The aim of the study is to investigate the longterm impact on cardiovascular morbidity and mortality, relevant efficacy parameters (e.g., glycaemic parameters) and safety (e.g., weight and hypoglycaemia) of treatment with linagliptin in patients with type 2 diabetes at elevated cardiovascular risk receiving usual care, and compare outcome against glimepiride.

Being tested
linagliptin, glimepiride, linagliptin placebo, glimepiride placebo
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.

  • linagliptinDrug

    linagliptin tablets 5mg QD

  • glimepirideDrug

    glimepiride over-encapsulated tablet 1-4 mg QD

  • linagliptin placeboDrug

    linagliptin placebo

  • glimepiride placeboDrug

    glimepiride placebo

Study groups in NCT01243424
Study groupRoleWhat they receive
linagliptinExperimentalpatient to receive linagliptin or glimepiride placebo over encapsulated tablet Quaque die (QD)
Receives: Drug: linagliptin; Drug: glimepiride placebo
glimepiride 1-4 mg QDActive comparatorpatient to receive glimepiride 1-4 mg or linagliptin placebo tablet Quaque die (QD)
Receives: Drug: glimepiride; Drug: linagliptin placebo

What is being measured

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

  1. The First 3-point Major Adverse Cardiovascular Events (3P-MACE)

    The first occurrence of any of the following Clinical Event Committee (CEC) confirmed adjudicated components of the primary composite endpoint: CV death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI (excluding silent MI), or nonfatal stroke is presented.

    Measured: From randomization until individual day of trial completion, up to 432 weeks

Secondary outcomes (19)

  1. The First 4-point (4P)- MACE

    The first key secondary endpoint was time to first occurrence of any of the following adjudicated components of the composite endpoint: CV death (including fatal stroke and fatal MI), non-fatal stroke, non-fatal MI (excluding silent MI), or hospitalisation for unstable angina pectoris.

    Measured: From randomization until individual day of trial completion, up to 432 weeks

  2. Percentage of Participants Taking Trial Medication at Trial End, Maintained Glycaemic Control (HbA1c ≤7.0%) Without Need for Rescue Medication, Without >2% Weight Gain, and Without Moderate/Severe Hypoglycaemic Episodes During Maintenance Phase

    The second key secondary endpoint was a composite endpoint of treatment sustainability, defined as the percentage of patients taking trial medication at trial end, maintained glycaemic control (HbA1c ≤7.0%) without need for rescue medication, without >2% weight gain, and without moderate/severe hypoglycaemic episodes during maintenance phase.

    Measured: From Visit 6 (Week 16) to Final visit (Week 432) (Maintenance Phase)

  3. Percentage of Participants Who Were on Trial Medication at Trial End, Maintained Glycaemic Control (HbA1c ≤7.0%) Without Need for Rescue Medication, and Without >2% Weight Gain During Maintenance Phase

    The third key secondary endpoint was a composite endpoint of treatment sustainability, defined as percentage of patients who were on trial medication at trial end, maintained glycaemic control (HbA1c ≤7.0%) without need for rescue medication, and without >2% weight gain during maintenance phase.

    Measured: From Visit 6 (Week 16) to Final visit (Week 432) (Maintenance Phase)

  4. Percentage of Participants With the Occurrence of at Least One Event of 3P-MACE

    Percentage of participants occurrence of at least one of the following adjudicated components of CV death (including fatal stroke and fatal MI), non-fatal MI (excluding silent MI) and non-fatal stroke is presented as secondary CV endpoint.

    Measured: From randomization until individual day of trial completion, up to 432 weeks

  5. Percentage of Participants With the Occurrence of at Least One Event of 4P -MACE

    Percentage of participants occurrence of at least one of the following adjudicated components of CV death (including fatal stroke and fatal MI), non-fatal MI (excluding silent MI), non-fatal stroke, and hospitalisation for unstable angina pectoris is presented as secondary CV endpoint.

    Measured: From randomization until individual day of trial completion, up to 432 weeks

  6. Percentage of Participants With Occurrence of Any of the Components of the Composite Endpoint of All Adjudication-confirmed Events

    Percentage of participants with occurrence of any of the following components of the composite endpoint of all adjudication-confirmed events of:

    • CV death (including fatal stroke and fatal MI)
    • non-fatal MI
    • non-fatal stroke
    • hospitalisation for unstable angina pectoris
    • TIA
    • hospitalisation for heart failure
    • hospitalisation for coronary revascularisation procedures (CABG, PCI)

    Measured: From start of the treatment until 7 days after the end of treatment, up to 433 weeks

  7. Time to First Occurrence of Any of the Components of the Composite Endpoint of All Adjudication-confirmed Events

    Time to first occurrence of any of the following components of the composite endpoint of all adjudication-confirmed events of:

    • CV death (including fatal stroke and fatal MI)
    • non-fatal MI
    • non-fatal stroke
    • hospitalisation for unstable angina pectoris
    • Transient ischaemic attack (TIA)
    • hospitalisation for heart failure
    • hospitalisation for coronary revascularisation procedures (CABG, PCI)

    Measured: From start of the treatment until 7 days after the end of treatment, up to 433 weeks

  8. Change From Baseline to Final Visit in Hemoglobin A1c (HbA1c)

    Change from baseline to final visit in HbA1c is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.

    Measured: Baseline and week 432

  9. Change From Baseline to Final Visit in Fasting Plasma Glucose (FPG)

    Change from baseline to final visit in fasting plasma glucose (FPG) is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.

    Measured: Baseline and week 432

  10. Change From Baseline to Final Visit Fasting Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol and High-density Lipoprotein (HDL) Cholesterol

    Change from baseline to final visit in total cholesterol, low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.

    Measured: Baseline and week 432

  11. Change From Baseline to Final Visit in Triglycerides

    Change from baseline to final visit in triglycerides is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.

    Measured: Baseline and week 432

  12. Change From Baseline to Final Visit in Creatinine

    Change from baseline to final visit in creatinine is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.

    Measured: Baseline and week 432

  13. Change From Baseline to Final Visit in Estimated Glomerular Filtration Rate (eGFR)

    Change from baseline to final visit in eGFR is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.

    Measured: Baseline and week 432

  14. Change From Baseline to Final Visit in Urine Albumin Creatinine Ratio (UACR)

    Change from baseline to final visit in UACR is presented as secondary diabetes-related endpoint. Least square mean is adjusted geometric mean (gMean) ratio. The Final Visit value referred to the last value obtained on-treatment.

    Measured: Baseline and week 432

  15. Percentage of Participants With Transition in Albuminuria Classes

    Percentage of patients with transition in albuminuria classes is presented as secondary endpoint. Data for last value on treatment (LVOT) to baseline (base) is presented.

    Measured: Baseline and week 432

  16. Change From Baseline of Insulin Secretion Rate (ISR) at Fixed Glucose Concentration at 208 Weeks

    The endpoint change from baseline of ISR at fixed glucose concentration at 208 weeks as derived from a 3-hour meal tolerance test is Beta-cell function sub-study endpoint.

    Measured: Baseline and week 208

  17. Percentage of Participants With Occurrence of Accelerated Cognitive Decline at End of Follow-up

    Occurrence of accelerated cognitive decline based on regression based index (RBI) score at end of follow-up (a dichotomous outcome measure; presence or absence of accelerated cognitive decline) is Cognition sub-study endpoint.

    Measured: 433 weeks

  18. Continuous Glucose Monitoring (CGM) Sub-study: Change From Baseline in the Inter-quartile Range of Diurnal Glucose Variability (Milligrams/ Deciliter) to End of Study

    Baseline data for the continuous glucose monitoring sub-study was collected and analyzed. However, the participant number was far less than original planned. The study was stopped early around week 64 (V9) due to recruitment issues and data were not pre-specified to be analyzed and reported at week 64 time point as target was with an estimated time point of 432 weeks for primary or secondary end points. Thus this endpoint was not analysed and only the baseline data collected were analysed and the results are reported in this CGM substudy endpoint.

    Measured: Baseline

  19. CGM Sub-study : Change From Baseline in the Inter-quartile Range of Diurnal Glucose Variability (Millimoles/ Litre) to End of Study

    Baseline data for the continuous glucose monitoring sub-study was collected and analyzed. However, the participant number was far less than original planned. The study was stopped early around week 64 (V9) due to recruitment issues and data were not pre-specified to be analyzed and reported at week 64 time point as target was with an estimated time point of 432 weeks for primary or secondary end points. Thus this endpoint was not analysed and only the baseline data collected were analysed and the results are reported in this CGM substudy endpoint.

    Measured: Baseline

Timeline

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

  1. First posted18 Nov 2010 (estimated)
  2. Study start11 Nov 2010
  3. Primary completion21 Aug 2018
  4. Study completion21 Aug 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
6,103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01243424
Sponsor's protocol ID
1218.74
Other IDs
2009-013157-15, 2009
Status last verified
Dec 2019
First submitted
17 Nov 2010
Last updated
7 Jan 2020

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, Biessels GJ, Johansen OE, Exalto LG. Females with type 2 diabetes are at higher risk for accelerated cognitive decline than males: CAROLINA-COGNITION study. Nutr Metab Cardiovasc Dis. 2022 Feb;32(2):355-364. doi: 10.1016/j.numecd.2021.10.013. Epub 2021 Oct 27.

    PubMed 34895804

  • Biessels GJ, Verhagen C, Janssen J, van den Berg E, Wallenstein G, Zinman B, Espeland MA, Johansen OE. Effects of linagliptin vs glimepiride on cognitive performance in type 2 diabetes: results of the randomised double-blind, active-controlled CAROLINA-COGNITION study. Diabetologia. 2021 Jun;64(6):1235-1245. doi: 10.1007/s00125-021-05393-8. Epub 2021 Feb 9.

    PubMed 33559704

  • Rosenstock J, Kahn SE, Johansen OE, Zinman B, Espeland MA, Woerle HJ, Pfarr E, Keller A, Mattheus M, Baanstra D, Meinicke T, George JT, von Eynatten M, McGuire DK, Marx N; CAROLINA Investigators. Effect of Linagliptin vs Glimepiride on Major Adverse Cardiovascular Outcomes in Patients With Type 2 Diabetes: The CAROLINA Randomized Clinical Trial. JAMA. 2019 Sep 24;322(12):1155-1166. doi: 10.1001/jama.2019.13772.

    PubMed 31536101

  • Janssen J, van den Berg E, Zinman B, Espeland MA, Geijselaers SLC, Mattheus M, Johansen OE, Biessels GJ. HbA1c, Insulin Resistance, and beta-Cell Function in Relation to Cognitive Function in Type 2 Diabetes: The CAROLINA Cognition Substudy. Diabetes Care. 2019 Jan;42(1):e1-e3. doi: 10.2337/DC18-0914. No abstract available.

    PubMed 30811335

  • Chilton R. Linagliptin versus glimepiride add-on for the long-term treatment of Type 2 diabetes mellitus. Expert Rev Endocrinol Metab. 2013 Jul;8(4):345-349. doi: 10.1586/17446651.2013.811849.

    PubMed 30736150

  • Biessels GJ, Janssen J, van den Berg E, Zinman B, Espeland MA, Mattheus M, Johansen OE; CAROLINA(R) investigators. Rationale and design of the CAROLINA(R) - cognition substudy: a randomised controlled trial on cognitive outcomes of linagliptin versus glimepiride in patients with type 2 diabetes mellitus. BMC Neurol. 2018 Jan 15;18(1):7. doi: 10.1186/s12883-018-1014-7.

    PubMed 29334906

  • Marx N, Rosenstock J, Kahn SE, Zinman B, Kastelein JJ, Lachin JM, Espeland MA, Bluhmki E, Mattheus M, Ryckaert B, Patel S, Johansen OE, Woerle HJ. Design and baseline characteristics of the CARdiovascular Outcome Trial of LINAgliptin Versus Glimepiride in Type 2 Diabetes (CAROLINA(R)). Diab Vasc Dis Res. 2015 May;12(3):164-74. doi: 10.1177/1479164115570301. Epub 2015 Mar 15.

    PubMed 25780262

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing linagliptin and glimepiride in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 613 sites in 43 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 7 inclusion and 20 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 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 613 sites in United States, Germany, France, India, Spain and 38 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 7 Jan 2020). 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?

The First 3-point Major Adverse Cardiovascular Events (3P-MACE) (time frame: From randomization until individual day of trial completion, up to 432 weeks). 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 NCT01243424, which also lists 11 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 7 Jan 2020.

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