Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Subjects With Type 2 Diabetes Mellitus
NCT ID: NCT02465515
Last Updated: 2019-03-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
9463 participants
INTERVENTIONAL
2015-07-01
2018-03-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Albiglutide
Albiglutide once weekly by subcutaneous injection. Starting dose 30 mg may be increased to 50 mg if needed. Albiglutide will be administered in addition to standard therapy for diabetes and cardiovascular health.
Albiglutide 30 mg
Once weekly subcutaneous injection. Starting dose 30 mg may be increased to 50 mg if needed.
Albiglutide 50 mg
Once weekly subcutaneous injection. Starting dose 30 mg may be increased to 50 mg if needed.
Placebo
Placebo once weekly by subcutaneous injection. Placebo will be administered in addition to standard therapy for diabetes and cardiovascular health.
Albiglutide matching placebo
Once weekly subcutaneous injection. Matched to 30 mg and 50 mg albiglutide.
Interventions
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Albiglutide 30 mg
Once weekly subcutaneous injection. Starting dose 30 mg may be increased to 50 mg if needed.
Albiglutide 50 mg
Once weekly subcutaneous injection. Starting dose 30 mg may be increased to 50 mg if needed.
Albiglutide matching placebo
Once weekly subcutaneous injection. Matched to 30 mg and 50 mg albiglutide.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
ALL
No
Sponsors
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Duke Clinical Research Institute
OTHER
GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
Locations
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GSK Investigational Site
Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Chandler, Arizona, United States
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Glendale, Arizona, United States
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Goodyear, Arizona, United States
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Tempe, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Searcy, Arkansas, United States
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Chula Vista, California, United States
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Lancaster, California, United States
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Lomita, California, United States
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Long Beach, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Moreno Valley, California, United States
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Northridge, California, United States
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Oakland, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Marino, California, United States
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San Ramon, California, United States
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Simi Valley, California, United States
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Stanford, California, United States
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Torrance, California, United States
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Denver, Colorado, United States
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Littleton, Colorado, United States
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Littleton, Colorado, United States
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New Haven, Connecticut, United States
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Belle Glade, Florida, United States
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Bradenton, Florida, United States
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Bradenton, Florida, United States
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Coral Gables, Florida, United States
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Coral Springs, Florida, United States
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Fleming Island, Florida, United States
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Inverness, Florida, United States
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Jacksonville, Florida, United States
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Lake Worth, Florida, United States
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Lakeland, Florida, United States
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Miami, Florida, United States
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Ocala, Florida, United States
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Ponte Vedra, Florida, United States
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Port Charlotte, Florida, United States
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Port Orange, Florida, United States
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St. Petersburg, Florida, United States
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Wellington, Florida, United States
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Atlanta, Georgia, United States
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Conyers, Georgia, United States
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Cumming, Georgia, United States
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Decatur, Georgia, United States
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Dunwoody, Georgia, United States
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Snellville, Georgia, United States
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Tucker, Georgia, United States
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Aurora, Illinois, United States
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Louisville, Kentucky, United States
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Córdoba, Córdoba Province, Argentina
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Godoy Cruz, Mendoza Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Santa Fe, , Argentina
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Bonheiden, , Belgium
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Stara Zagora, , Bulgaria
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Kelowna, British Columbia, Canada
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Surrey, British Columbia, Canada
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Victoria, British Columbia, Canada
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Victoria, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Moncton, New Brunswick, Canada
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St. John's, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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Truro, Nova Scotia, Canada
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Brampton, Ontario, Canada
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Burlington, Ontario, Canada
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Cornwall, Ontario, Canada
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Corunna, Ontario, Canada
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Greater Sudbury, Ontario, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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London, Ontario, Canada
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Sarnia, Ontario, Canada
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Smiths Falls, Ontario, Canada
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Toronto, Ontario, Canada
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Brossard, Quebec, Canada
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Chicoutimi, Quebec, Canada
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Greenfield Park, Quebec, Canada
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Greenfield Park, Quebec, Canada
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Laval, Quebec, Canada
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Lévis, Quebec, Canada
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Montreal, Quebec, Canada
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Saint-Charles-Borromée, Quebec, Canada
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Saint-Lambert, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Beroun, , Czechia
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Krnov, , Czechia
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Olomouc, , Czechia
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Ostrava, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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PÅ™Ãbram, , Czechia
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Uherské Hradiště, , Czechia
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Ústà nad Labem, , Czechia
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ZlÃn, , Czechia
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Copenhagen, , Denmark
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Esbjerg, , Denmark
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Frederikssund, , Denmark
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Hellerup, , Denmark
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Herlev, , Denmark
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Holbæk, , Denmark
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Hvidovre, , Denmark
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København NV, , Denmark
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København S, , Denmark
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Roskilde, , Denmark
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Amiens, , France
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Broglie, , France
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Corbeil-Essonnes, , France
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La Rochelle, , France
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Nantes, , France
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Narbonne, , France
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Paris, , France
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Pau, , France
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Pierre-Bénite, , France
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Strasbourg, , France
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Vandœuvre-lès-Nancy, , France
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Deggingen, Baden-Wurttemberg, Germany
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Freiburg im Breisgau, Baden-Wurttemberg, Germany
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Güglingen, Baden-Wurttemberg, Germany
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Karlsruhe, Baden-Wurttemberg, Germany
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Ludwigsburg, Baden-Wurttemberg, Germany
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Stuttgart, Baden-Wurttemberg, Germany
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Stuttgart, Baden-Wurttemberg, Germany
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Villingen-Schwenningen, Baden-Wurttemberg, Germany
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Wangen, Baden-Wurttemberg, Germany
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Aschaffenburg, Bavaria, Germany
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Dachau, Bavaria, Germany
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Haag, Bavaria, Germany
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Künzing, Bavaria, Germany
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Rednitzhembach, Bavaria, Germany
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Wallerfing, Bavaria, Germany
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Elsterwerda, Brandenburg, Germany
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Falkensee, Brandenburg, Germany
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Potsdam, Brandenburg, Germany
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Flörsheim, Hesse, Germany
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Gelnhausen, Hesse, Germany
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Hildesheim, Lower Saxony, Germany
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Stuhr, Lower Saxony, Germany
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Wardenburg, Lower Saxony, Germany
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Bad Oeynhausen, North Rhine-Westphalia, Germany
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Bochum, North Rhine-Westphalia, Germany
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Cologne, North Rhine-Westphalia, Germany
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Essen, North Rhine-Westphalia, Germany
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Essen, North Rhine-Westphalia, Germany
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Kleve, North Rhine-Westphalia, Germany
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Münster, North Rhine-Westphalia, Germany
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Chemnitz, Saxony, Germany
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Dresden, Saxony, Germany
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Leipzig, Saxony, Germany
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Leipzig, Saxony, Germany
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Oschatz, Saxony, Germany
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Pirna, Saxony, Germany
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Alkmaar, , Netherlands
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San MartÃn de Porres, Lima region, Peru
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Callao, Lima, Peru
GSK Investigational Site
Arequipa, , Peru
GSK Investigational Site
Lima, , Peru
GSK Investigational Site
Lima, , Peru
GSK Investigational Site
Lima, , Peru
GSK Investigational Site
Lima, , Peru
GSK Investigational Site
Lima, , Peru
GSK Investigational Site
Piura, , Peru
GSK Investigational Site
Cebu City, , Philippines
GSK Investigational Site
Iloilo City, , Philippines
GSK Investigational Site
Laoag, , Philippines
GSK Investigational Site
Bialystok, , Poland
GSK Investigational Site
Bydgoszcz, , Poland
GSK Investigational Site
Bydgoszcz, , Poland
GSK Investigational Site
Gdansk, , Poland
GSK Investigational Site
Gniewkowo, , Poland
GSK Investigational Site
Katowice, , Poland
GSK Investigational Site
Katowice, , Poland
GSK Investigational Site
Krakow, , Poland
GSK Investigational Site
Krakow, , Poland
GSK Investigational Site
Krakow, , Poland
GSK Investigational Site
Lublin, , Poland
GSK Investigational Site
Poznan, , Poland
GSK Investigational Site
Poznan, , Poland
GSK Investigational Site
Sopot, , Poland
GSK Investigational Site
Warsaw, , Poland
GSK Investigational Site
Wierzchosławice, , Poland
GSK Investigational Site
Wroclaw, , Poland
GSK Investigational Site
Wroclaw, , Poland
GSK Investigational Site
Wroclaw, , Poland
GSK Investigational Site
Arkhangelsk, , Russia
GSK Investigational Site
Barnaul, , Russia
GSK Investigational Site
Chelyabinsk, , Russia
GSK Investigational Site
Chelyabinsk, , Russia
GSK Investigational Site
Ivanovo, , Russia
GSK Investigational Site
Kemerovo, , Russia
GSK Investigational Site
Kemerovo, , Russia
GSK Investigational Site
Krasnodar, , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Nizhny Novgorod, , Russia
GSK Investigational Site
Nizhny Novgorod, , Russia
GSK Investigational Site
Novosibirsk, , Russia
GSK Investigational Site
Novosibirsk, , Russia
GSK Investigational Site
Perm, , Russia
GSK Investigational Site
Rostov-on-Don, , Russia
GSK Investigational Site
Ryazan, , Russia
GSK Investigational Site
Saint Petersburg, , Russia
GSK Investigational Site
Samara, , Russia
GSK Investigational Site
Saratov, , Russia
GSK Investigational Site
Tomsk, , Russia
GSK Investigational Site
Tomsk, , Russia
GSK Investigational Site
Tomsk, , Russia
GSK Investigational Site
Voronezh, , Russia
GSK Investigational Site
Yaroslavl, , Russia
GSK Investigational Site
Yaroslavl, , Russia
GSK Investigational Site
Yaroslavl, , Russia
GSK Investigational Site
Yaroslavl, , Russia
GSK Investigational Site
Yekaterinburg, , Russia
GSK Investigational Site
Yekaterinburg, , Russia
GSK Investigational Site
Bloemfontein, Free State, South Africa
GSK Investigational Site
Tongaat, KwaZulu-Natal, South Africa
GSK Investigational Site
Bloemfontein, , South Africa
GSK Investigational Site
Cape Town, , South Africa
GSK Investigational Site
Houghton Estate, , South Africa
GSK Investigational Site
Kuilsrivier, , South Africa
GSK Investigational Site
Paarl, , South Africa
GSK Investigational Site
Pinelands, , South Africa
GSK Investigational Site
Umhlanga, , South Africa
GSK Investigational Site
Daegu, , South Korea
GSK Investigational Site
Daegu, , South Korea
GSK Investigational Site
Gyeonggi-do, , South Korea
GSK Investigational Site
Gyeonggido, , South Korea
GSK Investigational Site
Kangwondo, , South Korea
GSK Investigational Site
Pusan, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Suwon, , South Korea
GSK Investigational Site
Suwon, Kyonggi-do, , South Korea
GSK Investigational Site
A Coruña, , Spain
GSK Investigational Site
Alicante, , Spain
GSK Investigational Site
AlmerÃa, , Spain
GSK Investigational Site
Alzira/Valencia, , Spain
GSK Investigational Site
Badalona, , Spain
GSK Investigational Site
Badalona / Barcelona, , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Boadilla Del Monte (Madrid), , Spain
GSK Investigational Site
Canet de Mar - Barcelona, , Spain
GSK Investigational Site
Cangas Del Narcea/Asturias, , Spain
GSK Investigational Site
Centelles (Barcelona), , Spain
GSK Investigational Site
Córdoba, , Spain
GSK Investigational Site
Elche, , Spain
GSK Investigational Site
Granada, , Spain
GSK Investigational Site
León, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Málaga, , Spain
GSK Investigational Site
Palma de Mallorca, , Spain
GSK Investigational Site
Palma de Mallorca, , Spain
GSK Investigational Site
Pontevedra, , Spain
GSK Investigational Site
Pozuelo de Alarcón/Madrid, , Spain
GSK Investigational Site
Sagunto/Valencia, , Spain
GSK Investigational Site
San Juan (Alicante), , Spain
GSK Investigational Site
Sanlucar de Barrameda - Cádiz, , Spain
GSK Investigational Site
Santa Coloma de Gramanet (Barcelona), , Spain
GSK Investigational Site
Santiago de Compostela, , Spain
GSK Investigational Site
Seville, , Spain
GSK Investigational Site
Tarrasa, Barcelona, , Spain
GSK Investigational Site
Valencia, , Spain
GSK Investigational Site
Valencia, , Spain
GSK Investigational Site
Valencia, , Spain
GSK Investigational Site
Vigo-Pontevedra, , Spain
GSK Investigational Site
Borås, , Sweden
GSK Investigational Site
Eksjö, , Sweden
GSK Investigational Site
Gothenburg, , Sweden
GSK Investigational Site
Härnösand, , Sweden
GSK Investigational Site
Helsingborg, , Sweden
GSK Investigational Site
Karlskrona, , Sweden
GSK Investigational Site
Kristianstad, , Sweden
GSK Investigational Site
Linköping, , Sweden
GSK Investigational Site
Ljungby, , Sweden
GSK Investigational Site
Malmo, , Sweden
GSK Investigational Site
Örebro, , Sweden
GSK Investigational Site
Rättvik, , Sweden
GSK Investigational Site
Stockholm, , Sweden
GSK Investigational Site
Stockholm, , Sweden
GSK Investigational Site
Stockholm, , Sweden
GSK Investigational Site
Umeå, , Sweden
GSK Investigational Site
Uppsala, , Sweden
GSK Investigational Site
Changhua, , Taiwan
GSK Investigational Site
Hualien City, , Taiwan
GSK Investigational Site
Kaohsiung City, , Taiwan
GSK Investigational Site
Taichung, , Taiwan
GSK Investigational Site
Tainan City, , Taiwan
GSK Investigational Site
Taipei, , Taiwan
GSK Investigational Site
Taipei, , Taiwan
GSK Investigational Site
Bangkok, , Thailand
GSK Investigational Site
Bangkok, , Thailand
GSK Investigational Site
Chiang Mai, , Thailand
GSK Investigational Site
Pathum Thani, , Thailand
GSK Investigational Site
Songkhla, , Thailand
GSK Investigational Site
Chernivtsi, , Ukraine
GSK Investigational Site
Dnipropetrovsk, , Ukraine
GSK Investigational Site
Kharkiv, , Ukraine
GSK Investigational Site
Kharkiv, , Ukraine
GSK Investigational Site
Kherson, , Ukraine
GSK Investigational Site
Kyiv, , Ukraine
GSK Investigational Site
Kyiv, , Ukraine
GSK Investigational Site
Kyiv, , Ukraine
GSK Investigational Site
Kyiv, , Ukraine
GSK Investigational Site
Kyiv, , Ukraine
GSK Investigational Site
Kyiv, , Ukraine
GSK Investigational Site
Mykolaiv, , Ukraine
GSK Investigational Site
Odesa, , Ukraine
GSK Investigational Site
Poltava, , Ukraine
GSK Investigational Site
Uzhhorod, , Ukraine
GSK Investigational Site
Vinnytsia, , Ukraine
GSK Investigational Site
Zaporizhzhya, , Ukraine
GSK Investigational Site
Soham, Cambridgeshire, United Kingdom
GSK Investigational Site
Chesterfield, Derbyshire, United Kingdom
GSK Investigational Site
Romford, Essex, United Kingdom
GSK Investigational Site
Northwood, Middlesex, United Kingdom
GSK Investigational Site
Edinburgh, Midlothian, United Kingdom
GSK Investigational Site
Trowbridge, Wiltshire, United Kingdom
GSK Investigational Site
Aberdeen, , United Kingdom
GSK Investigational Site
Axbridge, Somerset, , United Kingdom
GSK Investigational Site
Ayr, , United Kingdom
GSK Investigational Site
Blackpool, , United Kingdom
GSK Investigational Site
Bristol, , United Kingdom
GSK Investigational Site
Dumfries, , United Kingdom
GSK Investigational Site
Dundee, , United Kingdom
GSK Investigational Site
Dundee, , United Kingdom
GSK Investigational Site
Dundee, , United Kingdom
GSK Investigational Site
Fife, , United Kingdom
GSK Investigational Site
Fife, , United Kingdom
GSK Investigational Site
Gloucester, , United Kingdom
GSK Investigational Site
Lancaster, , United Kingdom
GSK Investigational Site
Manchester, , United Kingdom
GSK Investigational Site
Newport, , United Kingdom
GSK Investigational Site
Oxford, , United Kingdom
GSK Investigational Site
Rotherham, , United Kingdom
GSK Investigational Site
Sidcup, Kent, , United Kingdom
GSK Investigational Site
Trowbridge, , United Kingdom
GSK Investigational Site
Wigan, , United Kingdom
Countries
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References
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John McMurray, Stefano Del Prato, Adrian Hernandez, Larry Leiter, Chris Granger, Ralph D'Agostino, Jennifer Green, Kristina Sigmon, Anne Rosenberg Nigel Jones, Karl Thorpe, Matt Somerville, Salim Janmohamed. Albiglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes and Cardiovascular Disease. Lancet. 2018
Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.
Gilbert MP, Skelly J, Hernandez AF, Green JB, Krychtiuk KA, Granger CB, Leiter LA, McMurray JJV, Del Prato S, Pratley RE. Effect of albiglutide on cardiovascular outcomes in older adults: A post hoc analysis of a randomized controlled trial. Diabetes Obes Metab. 2024 May;26(5):1714-1722. doi: 10.1111/dom.15479. Epub 2024 Feb 6.
O'Brien EC, Raman SR, Ellis A, Hammill BG, Berdan LG, Rorick T, Janmohamed S, Lampron Z, Hernandez AF, Curtis LH. The use of electronic health records for recruitment in clinical trials: a mixed methods analysis of the Harmony Outcomes Electronic Health Record Ancillary Study. Trials. 2021 Jul 19;22(1):465. doi: 10.1186/s13063-021-05397-0.
Hernandez AF, Green JB, Janmohamed S, D'Agostino RB Sr, Granger CB, Jones NP, Leiter LA, Rosenberg AE, Sigmon KN, Somerville MC, Thorpe KM, McMurray JJV, Del Prato S; Harmony Outcomes committees and investigators. Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial. Lancet. 2018 Oct 27;392(10157):1519-1529. doi: 10.1016/S0140-6736(18)32261-X. Epub 2018 Oct 2.
Green JB, Hernandez AF, D'Agostino RB, Granger CB, Janmohamed S, Jones NP, Leiter LA, Noronha D, Russell R, Sigmon K, Del Prato S, McMurray JJV. Harmony Outcomes: A randomized, double-blind, placebo-controlled trial of the effect of albiglutide on major cardiovascular events in patients with type 2 diabetes mellitus-Rationale, design, and baseline characteristics. Am Heart J. 2018 Sep;203:30-38. doi: 10.1016/j.ahj.2018.03.030. Epub 2018 Jun 12.
Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Am J Manag Care. 2018 Apr;24(8 Suppl):S146-S155.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2014-001824-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
116174
Identifier Type: -
Identifier Source: org_study_id
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