CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes
Launched by BOEHRINGER INGELHEIM · Nov 17, 2010
Trial Information
Current as of May 14, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion criteria:
- • 1. Type 2 diabetes
- • 2. 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)
- • 3. Pre-existing cardiovascular disease OR specified diabetes end-organ damage OR age =\> 70 years OR two or more specified cardiovascular risk factor
- • 4. BMI =\< 45kg/m²
- • 5. age between \>= 40 and =\< 85 years
- • 6. signed and dated written International Conference of Harmonisation( ICF)
- • 7. stable anti-diabetic background for at least 8 wks before study start
- Exclusion criteria:
- • 1. Type 1 diabetes
- • 2. 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)
- • 3. treatment with any anti-obesity drug less than 3 months before ICF
- • 4. uncontrolled hyperglycemia
- • 5. previous or planned bariatric surgery or intervention
- • 6. current or planned system corticoid treatment
- • 7. change in thyroid hormones treatment
- • 8. acute liver disease or impaired hepatic function
- • 9. pre-planned coronary artery revascularization within 6 months of ICF
- • 10. known hypersensitivity to any of the components
- • 11. Inappropriateness of glimepiride treatment for renal safety issues according to local prescribing information
- • 12. congestive heart failure class III or IV
- • 13. acute or chronic metabolic acidosis
- • 14. hereditary galactose intolerance
- • 15. alcohol or drug abuse
- • 16. participation in another trail with IMP given 2 months before Investigational Medicinal/Medical Product (IMP) start
- • 17. pre-menopausal women who are nursing or pregnant or of child-bearing potential and not willing to use acceptable method of birth control
- • 18. patients considered reliable by the investigator
- • 19. acute coronary syndrome =\< 6 wks before ICF
- • 20. stroke or Transient Ischemic Attack (TIA) =\< 3 months prior to ICF
About Boehringer Ingelheim
Boehringer Ingelheim is a global, research-driven pharmaceutical company dedicated to improving health and quality of life through innovative therapies. Established in 1885 and headquartered in Ingelheim, Germany, the company focuses on the development of prescription medicines in key therapeutic areas, including respiratory diseases, cardiovascular health, oncology, and immunology. Boehringer Ingelheim is committed to advancing medical science through rigorous clinical trials and collaborative research, striving to bring novel treatments to patients while upholding the highest standards of safety and efficacy. With a strong emphasis on sustainability and corporate responsibility, the company aims to make a meaningful impact on global health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Haifa, , Israel
Adelaide, South Australia, Australia
Parkville, Victoria, Australia
Hong Kong, , Hong Kong
Bern, , Switzerland
Miami, Florida, United States
Memphis, Tennessee, United States
Dallas, Texas, United States
Philadelphia, Pennsylvania, United States
West Palm Beach, Florida, United States
Dallas, Texas, United States
Harleysville, Pennsylvania, United States
Westlake Village, California, United States
Minneapolis, Minnesota, United States
Chicago, Illinois, United States
Taipei, , Taiwan
Greer, South Carolina, United States
Truro, , United Kingdom
Groningen, , Netherlands
Hamburg, , Germany
Oklahoma City, Oklahoma, United States
Manila, , Philippines
Salta, , Argentina
Avon, Indiana, United States
Toronto, Ontario, Canada
Kuala Lumpur, , Malaysia
L'hospitalet De Llobregat, , Spain
Nis, , Serbia
Valencia, , Spain
Christchurch, , New Zealand
Madrid, , Spain
Hong Kong, , Hong Kong
Somerset West, , South Africa
Taipei, , Taiwan
Durban, , South Africa
Tel Aviv, , Israel
Sneek, , Netherlands
Kuala Lumpur, , Malaysia
New Port Richey, Florida, United States
Tustin, California, United States
Carrollton, Texas, United States
Taichung, , Taiwan
Rotterdam, , Netherlands
Bangor, Maine, United States
Melaka, , Malaysia
Hialeah, Florida, United States
Gloucester, , United Kingdom
Nahariya, , Israel
Bangalore, , India
Kaohsiung, , Taiwan
Berlin, , Germany
Milano, , Italy
Dallas, Texas, United States
San Diego, California, United States
Tucson, Arizona, United States
Houston, Texas, United States
Velp, , Netherlands
New Braunfels, Texas, United States
Manassas, Virginia, United States
North Hollywood, California, United States
Edgewater, Florida, United States
Franklin, Indiana, United States
Troy, Michigan, United States
Henderson, Nevada, United States
Raleigh, North Carolina, United States
Greenville, South Carolina, United States
Bristol, Tennessee, United States
Midland, Texas, United States
San Antonio, Texas, United States
St. John's, Newfoundland And Labrador, Canada
Quezon City, , Philippines
Traverse City, Michigan, United States
Birmingham, Alabama, United States
Tulsa, Oklahoma, United States
Girona, , Spain
Birmingham, Alabama, United States
Tainan, , Taiwan
Monterrey, , Mexico
Manila, , Philippines
Hamilton, Ontario, Canada
Lexington, Kentucky, United States
Cranston, Rhode Island, United States
Swansea, , United Kingdom
Goyang, , Korea, Republic Of
Jeonju, , Korea, Republic Of
Birmingham, , United Kingdom
Omaha, Nebraska, United States
Pointe Claire, Quebec, Canada
Seongnam, , Korea, Republic Of
Eugene, Oregon, United States
Zanesville, Ohio, United States
Palm Harbor, Florida, United States
Ashkelon, , Israel
Elizabeth, New Jersey, United States
Carlisle, Ohio, United States
Great Yarmouth, , United Kingdom
Wilmington, North Carolina, United States
Paducah, Kentucky, United States
Salt Lake City, Utah, United States
Spokane, Washington, United States
Atlanta, Georgia, United States
Saint Clair Shores, Michigan, United States
Warminster, Pennsylvania, United States
Tucson, Arizona, United States
Jacksonville, Florida, United States
Akron, Ohio, United States
Busan, , Korea, Republic Of
Saint Louis, Missouri, United States
Meridian, Idaho, United States
Pleven, , Bulgaria
Tbilisi, , Georgia
Jerusalem, , Israel
Tel Hashomer, , Israel
Chippenham, , United Kingdom
Bolingbrook, Illinois, United States
Las Vegas, Nevada, United States
Anderson, South Carolina, United States
Odessa, Texas, United States
Genoa, Ohio, United States
Daegu, , Korea, Republic Of
Sumter, South Carolina, United States
Fountain Valley, California, United States
Opa Locka, Florida, United States
Miami, Florida, United States
Roma, , Italy
Kanagawa, Yokohama, , Japan
Lima, , Peru
Vällingby, , Sweden
Port Elizabeth, , South Africa
Seoul, , Korea, Republic Of
Hong Kong, , Hong Kong
Suwon, , Korea, Republic Of
Amsterdam, , Netherlands
Barranquilla, , Colombia
Seoul, , Korea, Republic Of
Athens, Alabama, United States
Aachen, , Germany
Taipei, , Taiwan
Brownsburg, Indiana, United States
Burke, Virginia, United States
Maastricht, , Netherlands
Taipei, , Taiwan
Porto, , Portugal
Mishawaka, Indiana, United States
Atco, New Jersey, United States
Atlanta, Georgia, United States
Plano, Texas, United States
Mobile, Alabama, United States
Mobile, Alabama, United States
Montgomery, Alabama, United States
Tuscumbia, Alabama, United States
Pell City, Alaska, United States
Mesa, Arizona, United States
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
Little Rock, Arkansas, United States
Bermuda Dunes, California, United States
Fullerton, California, United States
Long Beach, California, United States
Los Gatos, California, United States
Pomona, California, United States
Redondo Beach, California, United States
San Ramon, California, United States
Sylmar, California, United States
Tarzana, California, United States
Tustin, California, United States
Colorado Springs, Colorado, United States
Boca Raton, Florida, United States
Davie, Florida, United States
Daytona Beach, Florida, United States
Doral, Florida, United States
Fort Lauderdale, Florida, United States
Fort Lauderdale, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Lauderdale Lakes, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
Orlando, Florida, United States
Panama City, Florida, United States
Pembroke Pines, Florida, United States
Pensacola, Florida, United States
Ponte Vedra Beach, Florida, United States
Dunwoody, Georgia, United States
Snellville, Georgia, United States
Hayden Lake, Idaho, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Evergreen Park, Illinois, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Muncie, Indiana, United States
Florence, Kentucky, United States
Metairie, Louisiana, United States
Baltimore, Maryland, United States
Rockville, Maryland, United States
North Attleboro, Massachusetts, United States
Canton, Michigan, United States
Flint, Michigan, United States
Kalamazoo, Michigan, United States
Livonia, Michigan, United States
Sterling Heights, Michigan, United States
Biloxi, Mississippi, United States
Las Vegas, Nevada, United States
Clifton, New Jersey, United States
Elizabeth, New Jersey, United States
Albany, New York, United States
Smithtown, New York, United States
West Seneca, New York, United States
Asheville, North Carolina, United States
Burlington, North Carolina, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Elizabeth City, North Carolina, United States
Shelby, North Carolina, United States
Statesville, North Carolina, United States
Austintown, Ohio, United States
Cadiz, Ohio, United States
Marion, Ohio, United States
Marion, Ohio, United States
Maumee, Ohio, United States
Lansdale, Pennsylvania, United States
Orangeburg, South Carolina, United States
Chattanooga, Tennessee, United States
Tullahoma, Tennessee, United States
Arlington, Texas, United States
Austin, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Pearland, Texas, United States
Schertz, Texas, United States
Sugar Land, Texas, United States
Midvale, Utah, United States
Ettrick, Virginia, United States
Richmond, Virginia, United States
Richmond, Virginia, United States
Federal Way, Washington, United States
Bahía Blanca, , Argentina
Caba, , Argentina
Caba, , Argentina
Capital Federal, , Argentina
Capital Federal, , Argentina
Cordoba, , Argentina
Corrientes, , Argentina
Córdoba, , Argentina
La Plata, , Argentina
Mendoza, , Argentina
Rosario, , Argentina
Rosario, , Argentina
San Miguel De Tucumán, , Argentina
Santa Fe, , Argentina
Santa Fe, , Argentina
Herston, Queensland, Australia
Meadowbrook, Queensland, Australia
East Ringwood, Victoria, Australia
Blankenberge, , Belgium
Bonheiden, , Belgium
De Pinte, , Belgium
Dessel, , Belgium
Deurne, , Belgium
Deurne, , Belgium
Genk, , Belgium
Gozée, , Belgium
Hasselt, , Belgium
Herent, , Belgium
Linkebeek, , Belgium
Moorsel, , Belgium
Natoye, , Belgium
Tremelo, , Belgium
Belém, , Brazil
Curitiba, , Brazil
Goiânia, , Brazil
Higienópolis, , Brazil
Joaquim Távora, , Brazil
Porto Alegre, , Brazil
Porto Alegre, , Brazil
Río De Janeiro, , Brazil
Santa Cecília, , Brazil
São José Do Rio Preto, , Brazil
São Paulo, , Brazil
Vila Clementino, , Brazil
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Quebec, Migration Data, Canada
St. John's, Newfoundland And Labrador, Canada
Cambridge, Ontario, Canada
Newmarket, Ontario, Canada
Thornhill, Ontario, Canada
Toronto, Ontario, Canada
Montague, Prince Edward Island, Canada
Providencia, , Chile
Providencia, , Chile
Temuco, , Chile
Viña Del Mar, , Chile
Barranquilla, , Colombia
Barranquilla, , Colombia
Bogota, , Colombia
Bogotá, , Colombia
Bogotá, , Colombia
Cartagena, , Colombia
Cartagena, , Colombia
El Bosque, , Colombia
El Bosque, , Colombia
Tolima, , Colombia
Jablonec Nad Nisou, , Czechia
Olomouc Lazce, , Czechia
Ostrava, , Czechia
Plzen, , Czechia
Praha 8, , Czechia
Praha, , Czechia
Prostejov, , Czechia
Strakonice, , Czechia
Helsinki, , Finland
Joensuu, , Finland
Kerava, , Finland
Kokkola, , Finland
Kuopio, , Finland
Oulu, , Finland
Turku, , Finland
Behren Les Forbach, , France
Bordeaux, , France
Bourg Des Comptes, , France
Broglie, , France
Béziers, , France
Cannes, , France
Carbonne, , France
Castets, , France
Chartres, , France
Chartres, , France
Cournonterral, , France
Fort De France, , France
Hinx, , France
La Reunion, , France
Labarthe Sur Leze, , France
Louvigne De Bie, , France
Maintenon, , France
Orthez, , France
Orthez, , France
Palau Del Vidre, , France
Saint Genies Des Fontaines, , France
St Dié Des Vosges Cedex, , France
Thouars, , France
Tilly Sur Seulles, , France
Batumi, , Georgia
Gori, , Georgia
Kutaisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Zugdidi, , Georgia
Aschaffenburg, , Germany
Asslar, , Germany
Bad Nauheim, , Germany
Berlin, , Germany
Berlin, , Germany
Berlin, , Germany
Dormagen Hackenbroich, , Germany
Dortmund, , Germany
Dresden, , Germany
Eisenach, , Germany
Elsterwerda, , Germany
Essen, , Germany
Flörsheim, , Germany
Frankfurt, , Germany
Furth Im Wald, , Germany
Gebhardshain, , Germany
Haag, , Germany
Hamburg, , Germany
Hamburg, , Germany
Hamburg, , Germany
Kirchhatten, , Germany
Köln, , Germany
Künzing, , Germany
Leipzig, , Germany
Lübeck, , Germany
Mainz, , Germany
Münster, , Germany
Neumünster, , Germany
Rehburg Loccum, , Germany
Rodgau/Dudenhofen, , Germany
Saarbrücken, , Germany
Saint Ingbert / Oberwürzbach, , Germany
Schwabenheim, , Germany
Stadtbergen, , Germany
Wangen, , Germany
Zwenkau, , Germany
Athens, , Greece
Haidari, Athens, , Greece
Ioannina, , Greece
Melissia, Athens, , Greece
Nikaia, , Greece
Thessaloniki, , Greece
Thessaloniki, , Greece
Thessaloniki, , Greece
Ajka, , Hungary
Baja, , Hungary
Budapest, , Hungary
Gyula, , Hungary
Hódmezövásárhely, , Hungary
Mako, , Hungary
Mosonmagyarovar, , Hungary
Papa, , Hungary
Szekszard, , Hungary
Ahmedabad, , India
Aurangabad, , India
Bangalore, Karnataka, , India
Bangalore, , India
Bangalore, , India
Belgaum, , India
Chennai, , India
Chennai, , India
Chennai, , India
Chennai, , India
Coimbatore, , India
Indore, , India
Jaipur, , India
Jaipur, , India
Maharashtra, , India
Mumbai, Maharastra, , India
Mumbai, , India
Mumbai, , India
Nagpur, , India
Pune, , India
Pune, , India
Thiruvananthapuram, , India
Vijayawada, , India
Co. Cork, , Ireland
Dublin, , Ireland
Gorey, , Ireland
Wexford, , Ireland
Holon, , Israel
Cagliari, , Italy
Catanzaro, , Italy
Genova, , Italy
Guastalla (Re), , Italy
Messina, , Italy
Roma, , Italy
Sesto San Giovanni (Mi), , Italy
Aichi, Nagoya, , Japan
Chiba, Matsudo, , Japan
Chiba, Matsudo, , Japan
Fukushima, Date, , Japan
Fukushima, Nihonmatsu, , Japan
Fukushima, Sukagawa, , Japan
Hyogo, Amagasaki, , Japan
Hyogo, Takasago, , Japan
Kumamoto, Kumamoto, , Japan
Kumamoto, Yatsushiro, , Japan
Miyazaki, Miyazaki, , Japan
Saitama, Hanyu, , Japan
Tokyo, Itabashi Ku, , Japan
Ansan, , Korea, Republic Of
Goyang, , Korea, Republic Of
Goyang, , Korea, Republic Of
Pusan, , Korea, Republic Of
Seoul, , Korea, Republic Of
Wonju, , Korea, Republic Of
Yangsan, , Korea, Republic Of
Johor Bahru, Johor, , Malaysia
Kota Bharu, , Malaysia
Kuantan, , Malaysia
Penang, , Malaysia
Taiping, , Malaysia
Acapulco, , Mexico
Aguascalientes, , Mexico
Distrito Federal, , Mexico
Guadalajara, , Mexico
'S Hertogenbosch, , Netherlands
Almere, , Netherlands
Beverwijk, , Netherlands
Breda, , Netherlands
Den Helder, , Netherlands
Eindhoven, , Netherlands
Hoorn, , Netherlands
Rotterdam, , Netherlands
Rotterdam, , Netherlands
Zoetermeer, , Netherlands
Dunedin, , New Zealand
Newtown Wellington Nz, , New Zealand
Tauranga, , New Zealand
Bodø, , Norway
Elverum, , Norway
Gjettum, , Norway
Hamar, , Norway
Jessheim, , Norway
Lierskogen, , Norway
Oslo, , Norway
Sandvika, , Norway
Sarpsborg, , Norway
Stavanger, , Norway
ålesund, , Norway
Arequipa, , Peru
Huacho, , Peru
Lima, , Peru
Lima, , Peru
Lima, , Peru
Piura, , Peru
San Miguel, , Peru
Iloilo, , Philippines
Lipa City, Batangas, , Philippines
Manila, , Philippines
Muntinlupa, , Philippines
Quezon City, , Philippines
San Juan, , Philippines
Surigao, , Philippines
Amadora, , Portugal
Carnaxide, , Portugal
Coimbra, , Portugal
Covilhã, , Portugal
Figueira Da Foz, , Portugal
Lisboa, , Portugal
Santa Maria Da Feira, , Portugal
Brasov, , Romania
Bucharest, , Romania
Bucharest, , Romania
Iasi, , Romania
Sibiu, , Romania
Tirgoviste, , Romania
Dzerzhinsky, , Russian Federation
Izhevsk, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Rostov Na Donu, , Russian Federation
Samara, , Russian Federation
Saratov, , Russian Federation
Belgrade, , Serbia
Pancevo, , Serbia
Subotica, , Serbia
Zemun, , Serbia
Banska Bystrica, , Slovakia
Dolny Kubin, , Slovakia
Levice, , Slovakia
Levice, , Slovakia
Nove Zamky, , Slovakia
Povazska Bystrica, , Slovakia
Zilina, , Slovakia
Cape Town, , South Africa
Cape Town, , South Africa
Durban, , South Africa
Krugersdorp, , South Africa
Lenasia, , South Africa
Lenasia, , South Africa
Pretoria, , South Africa
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Burjassot, , Spain
Gijon, , Spain
L'hospitalet De Llobregat, , Spain
La Roca Del Vallés (Barcelona), , Spain
Oviedo, , Spain
Oviedo, , Spain
Oviedo, , Spain
Pineda De Mar, , Spain
Santa Coloma De Gramanet, , Spain
Tàrrega, , Spain
Valencia, , Spain
Göteborg, , Sweden
Härnösand, , Sweden
Järfälla, , Sweden
Malmö, , Sweden
Rättvik, , Sweden
Rättvik, , Sweden
Skanör, , Sweden
Uddevalla, , Sweden
Basel, , Switzerland
Bellinzona, , Switzerland
Lugano, , Switzerland
Changhua, , Taiwan
Kaohsiung, , Taiwan
New Taipei City, , Taiwan
Taichung,, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Monastir, , Tunisia
Sfax, , Tunisia
Sousse, , Tunisia
Tunis, , Tunisia
Donetsk, , Ukraine
Ivano Frankivsk, , Ukraine
Kharkiv, , Ukraine
Kharkov, , Ukraine
Kiev, , Ukraine
Kiev, , Ukraine
Kyiv, , Ukraine
Lvov, , Ukraine
Odesa, , Ukraine
Vinnitsa, , Ukraine
Addlestone, , United Kingdom
Ash Vale, Aldershot, , United Kingdom
Durham, , United Kingdom
Ely, , United Kingdom
Patients applied
Trial Officials
Boehringer Ingelheim
Study Chair
Boehringer Ingelheim
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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