Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Subjects With Type 2 Diabetes Mellitus
Launched by GLAXOSMITHKLINE · Jun 4, 2015
Trial Information
Current as of July 05, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Men or women at least 40 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy.
- • Diagnosis of type 2 diabetes.
- • Established cardiovascular disease with at least one of the following: coronary artery disease, cerebrovascular disease, or peripheral arterial disease.
- • HbA1c \>7.0% (53 mmol/mol) (based on the most recent documented laboratory measurement within 6 months).
- • Able and willing to provide informed consent.
- Exclusion Criteria:
- • Severely reduced kidney function: eGFR \<30 ml/min/1.73 m\^2 (based on the last measured and documented laboratory measurement within 6 months) or renal replacement therapy.
- • Use of a GLP-1 receptor agonist at Screening.
- • Severe gastroparesis
- • History of pancreatitis or considered clinically at significant risk of developing pancreatitis during the course of the study.
- • Personal or family history of medullary carcinoma of the thyroid or subject with multiple endocrine neoplasia type 2 (MEN-2). Personal history of pancreatic neuroendocrine tumours.
- • Medical history which might limit the subject's ability to take trial treatments for the duration of the study or to otherwise complete the study.
- • Breastfeeding, pregnancy, or planning a pregnancy during the course of the study. Note: a pregnancy test will be performed on all women of child bearing potential prior to study entry.
- • Known allergy to any GLP-1 receptor agonist or excipients of albiglutide.
- • Use of another investigational product within 30 days or according to local regulations, or currently enrolled in a study of an investigational device.
- • Any other reason the investigator deems the subject to be unsuitable for the study.
About Glaxosmithkline
GlaxoSmithKline (GSK) is a global healthcare company dedicated to improving the quality of human life by enabling people to do more, feel better, and live longer. With a strong focus on research and development, GSK specializes in pharmaceuticals, vaccines, and consumer health products. The company is committed to advancing innovative therapies and preventive measures across various therapeutic areas, including respiratory, oncology, immunology, and infectious diseases. GSK's collaborative approach and rigorous clinical trial processes underscore its dedication to delivering safe and effective healthcare solutions that meet the needs of patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Decatur, Georgia, United States
Dallas, Texas, United States
Milano, Lombardia, Italy
Padova, Veneto, Italy
Barcelona, , Spain
San Antonio, Texas, United States
Napoli, Campania, Italy
Bologna, Emilia Romagna, Italy
Northridge, California, United States
Lexington, Kentucky, United States
Charlotte, North Carolina, United States
Winston Salem, North Carolina, United States
Tacoma, Washington, United States
New Orleans, Louisiana, United States
Leuven, , Belgium
Hamburg, , Germany
Nashville, Tennessee, United States
Torrance, California, United States
Denver, Colorado, United States
Edegem, , Belgium
Miskolc, , Hungary
Heerlen, , Netherlands
Fargo, North Dakota, United States
Memphis, Tennessee, United States
Coral Springs, Florida, United States
Jacksonville, Florida, United States
Bellaire, Texas, United States
Vero Beach, Florida, United States
Tyler, Texas, United States
Mobile, Alabama, United States
San Diego, California, United States
San Ramon, California, United States
Stanford, California, United States
Ocala, Florida, United States
Annapolis, Maryland, United States
Camp Hill, Pennsylvania, United States
Sellersville, Pennsylvania, United States
Myrtle Beach, South Carolina, United States
Córdoba, Córdova, Argentina
Rosario, Santa Fe, Argentina
Freiburg, Baden Wuerttemberg, Germany
Dachau, Bayern, Germany
Leipzig, Sachsen, Germany
Pirna, Sachsen, Germany
Berlin, , Germany
Bari, Puglia, Italy
Badalona, , Spain
Granada, , Spain
Madrid, , Spain
Malaga, , Spain
Sevilla, , Spain
Valencia, , Spain
Kristianstad, , Sweden
Umeå, , Sweden
Edinburgh, Midlothian, United Kingdom
Tempe, Arizona, United States
Truro, Nova Scotia, Canada
Georgetown, Texas, United States
Birmingham, Alabama, United States
Coral Gables, Florida, United States
Inverness, Florida, United States
Camden, New Jersey, United States
Hickory, North Carolina, United States
Bristol, Tennessee, United States
Lakeland, Florida, United States
Littleton, Colorado, United States
Moline, Illinois, United States
Wilmington, North Carolina, United States
Feasterville, Pennsylvania, United States
Penndel, Pennsylvania, United States
Anderson, South Carolina, United States
Kingsport, Tennessee, United States
Chula Vista, California, United States
Lancaster, California, United States
Pittsburgh, Pennsylvania, United States
Wenatchee, Washington, United States
Topeka, Kansas, United States
Omaha, Nebraska, United States
Kingwood, Texas, United States
Moncton, New Brunswick, Canada
Laval, Quebec, Canada
Columbus, Ohio, United States
La Rochelle Cedex 1, , France
Kuenzing, Bayern, Germany
Wallerfing, Bayern, Germany
Falkensee, Brandenburg, Germany
Hildesheim, Niedersachsen, Germany
Koeln, Nordrhein Westfalen, Germany
Parma, Emilia Romagna, Italy
Roeselare, , Belgium
Pontevedra, , Spain
Monterrey, Nuevo León, Mexico
Liège, , Belgium
Tarrasa, Barcelona, , Spain
Halifax, Nova Scotia, Canada
Pawtucket, Rhode Island, United States
Bruxelles, , Belgium
Shatin, , Hong Kong
Barnaul, , Russian Federation
La Coruña, , Spain
Bangkok, , Thailand
Chiangmai, , Thailand
Salisbury, North Carolina, United States
Broglie, , France
Catanzaro, Calabria, Italy
Siena, Toscana, Italy
Alkmaar, , Netherlands
Santiago De Compostela, , Spain
Atlanta, Georgia, United States
Brooklyn, New York, United States
Göteborg, , Sweden
West Des Moines, Iowa, United States
El Paso, Texas, United States
Austin, Texas, United States
Statesville, North Carolina, United States
Seoul, , Korea, Republic Of
Cleveland, Ohio, United States
Santa Fe, , Argentina
Deggingen, Baden Wuerttemberg, Germany
Haag, Bayern, Germany
Mainz, Rheinland Pfalz, Germany
Heraklion, Crete, , Greece
Malmö, , Sweden
Glendale, Arizona, United States
Port Orange, Florida, United States
Louisville, Kentucky, United States
North Massapequa, New York, United States
Witten, Nordrhein Westfalen, Germany
Delitzsch, Sachsen, Germany
Thessaloniki, , Greece
Arenzano (Ge), Liguria, Italy
Saratov, , Russian Federation
Los Angeles, California, United States
Hamilton, Ontario, Canada
Essen, Nordrhein Westfalen, Germany
Brussels, , Belgium
Karlsruhe, Baden Wuerttemberg, Germany
Avon, Indiana, United States
Spokane, Washington, United States
Roma, Lazio, Italy
Songkla, , Thailand
Mendoza, , Argentina
Houston, Texas, United States
Hellerup, , Denmark
Gelnhausen, Hessen, Germany
Oslo, , Norway
Bochum, Nordrhein Westfalen, Germany
Albuquerque, New Mexico, United States
Smiths Falls, Ontario, Canada
Mexico, D.F., , Mexico
Moscow, , Russian Federation
Samara, , Russian Federation
Karlskrona, , Sweden
Plano, Texas, United States
Praha 5, , Czechia
Chemnitz, Sachsen, Germany
Manchester, , United Kingdom
Tucson, Arizona, United States
Toledo, Ohio, United States
Kaohsiung, , Taiwan
Tucker, Georgia, United States
Hong Kong, , Hong Kong
Haddon Heights, New Jersey, United States
Hvidovre, , Denmark
Potsdam, Brandenburg, Germany
Paris, , France
Cordoba, , Argentina
Sofia, , Bulgaria
Cebu City, , Philippines
Praha 2, , Czechia
Rednitzhembach, Bayern, Germany
Aurora, Illinois, United States
Dunwoody, Georgia, United States
Gurnee, Illinois, United States
Arlington, Texas, United States
Federal Way, Washington, United States
Usti Nad Labem, , Czechia
Wangen, Baden Wuerttemberg, Germany
Aschaffenburg, Bayern, Germany
Sagunto/Valencia, , Spain
San Juan (Alicante), , Spain
Santa Coloma De Gramanet (Barcelona), , Spain
Esbjerg, , Denmark
Nikaia Piraeus, , Greece
Dresden, Sachsen, Germany
Eindhoven, , Netherlands
Arkhangelsk, , Russian Federation
Munster, Indiana, United States
Stuttgart, Baden Wuerttemberg, Germany
Lansdale, Pennsylvania, United States
Córdoba, , Spain
Magdeburg, Sachsen Anhalt, Germany
Leipzg, Sachsen, Germany
Hualien, , Taiwan
Searcy, Arkansas, United States
Ostrava, , Czechia
Gueglingen, Baden Wuerttemberg, Germany
Ascoli Piceno, Marche, Italy
Port Charlotte, Florida, United States
St. John's, Newfoundland And Labrador, Canada
Palma De Mallorca, , Spain
Athens, , Greece
Haidari, Athens, , Greece
Wroclaw, , Poland
Kyiv, , Ukraine
Changhua, , Taiwan
Harleysville, Pennsylvania, United States
Gniewkowo, , Poland
Boadilla Del Monte (Madrid), , Spain
Rapid City, South Dakota, United States
Málaga, , Spain
Praha 10, , Czechia
Guadalajara, Jalisco, Mexico
Mérida, Yucatán, Mexico
San Giovanni Rotondo (Fg), Puglia, Italy
Pinelands, , South Africa
Ryazan, , Russian Federation
Cape Town, , South Africa
Bonheiden, , Belgium
Beroun, , Czechia
Monterrey Nl, Nuevo León, Mexico
Zlin, , Czechia
Goodyear, Arizona, United States
Jersey Shore, Pennsylvania, United States
Mar Del Plata, Buenos Aires, Argentina
Aguascalientes, Ags, Aguascalientes, Mexico
Bradenton, Florida, United States
Floersheim, Hessen, Germany
Adrogue, Buenos Aires, Argentina
Krasnodar, , Russian Federation
Tomsk, , Russian Federation
León, , Spain
Lomita, California, United States
Conyers, Georgia, United States
Franklin, Indiana, United States
Greenfield, Indiana, United States
Saint Cloud, Minnesota, United States
Sandusky, Ohio, United States
Bahia Blanca, Buenos Aires, Argentina
Victoria, British Columbia, Canada
Brampton, Ontario, Canada
Levis, Quebec, Canada
Sherbrooke, Quebec, Canada
Strasbourg Cedex, , France
Bad Oeynhausen, Nordrhein Westfalen, Germany
Ioannina, , Greece
Sátoraljaújhely, , Hungary
Novosibirsk, , Russian Federation
Paarl, , South Africa
Umhlanga, , South Africa
Pozuelo De Alarcón/Madrid, , Spain
Odesa, , Ukraine
Snellville, Georgia, United States
Schertz, Texas, United States
Callao, Lima, Peru
Lima, , Peru
Nizhniy Novgorod, , Russian Federation
Alzira/Valencia, , Spain
Ekaterinburg, , Russian Federation
Taipei, , Taiwan
København Nv, , Denmark
Villingen Schwenningen, Baden Wuerttemberg, Germany
Elsterwerda, Brandenburg, Germany
Oschatz, Sachsen, Germany
Aguascalientes, , Mexico
Hoenefoss, , Norway
Laoag City, , Philippines
Kemerovo, , Russian Federation
Nizhny Novgorod, , Russian Federation
Voronezh, , Russian Federation
Lake Worth, Florida, United States
Byala, , Bulgaria
Eger, , Hungary
Rostov On Don, , Russian Federation
Mykolaiv, , Ukraine
Zaporizhzhya, , Ukraine
Bergamo, Lombardia, Italy
örebro, , Sweden
Fleming Island, Florida, United States
Saint Petersburg, Florida, United States
Wellington, Florida, United States
Cumming, Georgia, United States
Lewiston, Maine, United States
Rocky Mount, North Carolina, United States
Madison, Wisconsin, United States
Cambridge, Ontario, Canada
Frederikssund, , Denmark
Hardenberg, , Netherlands
Bloemfontein, Free State, South Africa
Pathumthani, , Thailand
Belle Glade, Florida, United States
Blackpool, , United Kingdom
Stavanger, , Norway
Perm, , Russian Federation
Iloilo City, , Philippines
Ivanovo, , Russian Federation
Houghton, , South Africa
Stara Zagora, , Bulgaria
Borås, , Sweden
Stockholm, , Sweden
Ravenna, Emilia Romagna, Italy
Amiens Cedex 1, , France
Elche, , Spain
Gödöllő, , Hungary
St Charles Borromée, Quebec, Canada
Olomouc, , Czechia
San Marino, California, United States
Simi Valley, California, United States
Miami, Florida, United States
Champaign, Illinois, United States
Huntsville, Texas, United States
Pergamino, Buenos Aires, Argentina
Gabrovo, , Bulgaria
Sevlievo, , Bulgaria
Stuhr, Niedersachsen, Germany
Wardenburg, Niedersachsen, Germany
Riesa, Sachsen, Germany
Budapest, , Hungary
Debrecen, , Hungary
Komarom, , Hungary
Chelyabinsk, , Russian Federation
Saint Petersburg, , Russian Federation
Canet De Mar Barcelona, , Spain
Taichung, , Taiwan
Chernivtsi, , Ukraine
Kherson, , Ukraine
Nantes Cedex 2, , France
Córdoba, , Argentina
Muenster, Nordrhein Westfalen, Germany
Centelles (Barcelona), , Spain
Little Rock, Arkansas, United States
Long Beach, California, United States
Baja, , Hungary
Poltava, , Ukraine
Springfield, Ohio, United States
Pau Cedex, , France
Kangwondo, , Korea, Republic Of
Berazategui, , Argentina
Tainan, , Taiwan
Alicante, , Spain
San Rafael, Mendoza, Argentina
Queretaro, , Mexico
Montana, , Bulgaria
Chandler, Arizona, United States
Cornwall, Ontario, Canada
Kleve, Nordrhein Westfalen, Germany
Suwon, , Korea, Republic Of
Linköping, , Sweden
Corbeil Essonnes, , France
Ludwigshafen Am Rhein, Rheinland Pfalz, Germany
Sankt Ingbert, Saarland, Germany
Gyeonggido, , Korea, Republic Of
Bialystok, , Poland
Kolbjørnsvik, , Norway
Trois Rivieres, Quebec, Canada
Chieti, Abruzzo, Italy
Dortmund, , Germany
Hatvan, , Hungary
Narbonne, , France
Moreno Valley, California, United States
Oakland, California, United States
New Haven, Connecticut, United States
Ponte Vedra, Florida, United States
Muncie, Indiana, United States
Saint Paul, Minnesota, United States
Saint Louis, Missouri, United States
Las Vegas, Nevada, United States
Newport, Pennsylvania, United States
Columbia, South Carolina, United States
Suite 101, Texas, United States
Layton, Utah, United States
Manassas, Virginia, United States
Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Godoy Cruz, Mendoza, Argentina
Buenos Aires, , Argentina
La Plata, , Argentina
Kelowna, British Columbia, Canada
Surrey, British Columbia, Canada
Winnipeg, Manitoba, Canada
Burlington, Ontario, Canada
Corunna, Ontario, Canada
London, Ontario, Canada
Sarnia, Ontario, Canada
Sudbury, Ontario, Canada
Toronto, Ontario, Canada
Brossard, Quebec, Canada
Chicoutimi, Quebec, Canada
Greenfield Park, Quebec, Canada
Montreal, Quebec, Canada
St Lambert, Quebec, Canada
Krnov, , Czechia
Praha 1, , Czechia
Praha 4, , Czechia
Pribram 1, , Czechia
Uherske Hradiste, , Czechia
Copenhagen, , Denmark
Herlev, , Denmark
Holbæk, , Denmark
København S, , Denmark
Roskilde, , Denmark
Pierre Bénite, , France
Vandœuvre Lès Nancy, , France
Ludwigsburg, Baden Wuerttemberg, Germany
Bad Kreuznach, Rheinland Pfalz, Germany
Hohenmoelsen, Sachsen Anhalt, Germany
Jerichow, Sachsen Anhalt, Germany
Schkeuditz, Sachsen, Germany
Mannheim, , Germany
Muenchen, , Germany
Alexandroupolis, , Greece
Athens,, , Greece
Lamia, , Greece
Pireas, , Greece
Vigevano (Pv), Lombardia, Italy
Ancona, Marche, Italy
Olbia (Ot), Sardegna, Italy
S.Andrea Delle Fratte S. Sisto (Pg), Umbria, Italy
Daegu, , Korea, Republic Of
Gyeonggi Do, , Korea, Republic Of
Pusan, , Korea, Republic Of
Suwon, Kyonggi Do, , Korea, Republic Of
Tlaquepaque, Jalisco, Mexico
Queretaro, Querétaro, Mexico
Mazatlán, Sinaloa, Mexico
Amsterdam, , Netherlands
Gouda, , Netherlands
Hoogeveen, , Netherlands
Meppel, , Netherlands
Rotterdam, , Netherlands
Sneek, , Netherlands
Trujillo, La Libertad, Peru
San Martin De Porres, Lima, Peru
Arequipa, , Peru
Piura, , Peru
Bydgoszcz, , Poland
Gdansk, , Poland
Katowice, , Poland
Krakow, , Poland
Lublin, , Poland
Poznan, , Poland
Sopot, , Poland
Warszawa, , Poland
Wierzchoslawice, , Poland
Yaroslavl, , Russian Federation
Tongaat, Kwazulu Natal, South Africa
Kuilsrivier, , South Africa
Almeria, , Spain
Badalona / Barcelona, , Spain
Cangas Del Narcea/Asturias, , Spain
Sanlucar De Barrameda Cádiz, , Spain
Vigo Pontevedra, , Spain
Eksjö, , Sweden
Helsingborg, , Sweden
Härnösand, , Sweden
Ljungby, , Sweden
Rättvik, , Sweden
Uppsala, , Sweden
Dnipropetrovsk, , Ukraine
Kharkiv, , Ukraine
Uzhgorod, , Ukraine
Vinnytsia, , Ukraine
Soham, Cambridgeshire, United Kingdom
Chesterfield, Derbyshire, United Kingdom
Romford, Essex, United Kingdom
Northwood, Middlesex, United Kingdom
Trowbridge, Wiltshire, United Kingdom
Aberdeen, , United Kingdom
Axbridge, Somerset, , United Kingdom
Ayr, , United Kingdom
Bristol, , United Kingdom
Dumfries, , United Kingdom
Dundee, , United Kingdom
Fife, , United Kingdom
Gloucester, , United Kingdom
Lancaster, , United Kingdom
Newport, , United Kingdom
Oxford, , United Kingdom
Rotherham, , United Kingdom
Sidcup, Kent, , United Kingdom
Wigan, , United Kingdom
Monterrey, , Mexico
Mérida, , Mexico
Monterrey Nl, , Mexico
Patients applied
Trial Officials
GSK Clinical Trials
Study Director
GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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