AzTrials
AzTrials

Diabetes MellitusPhase 4NCT02465515

Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Subjects With Type 2 Diabetes Mellitus

A Phase 4 study testing Albiglutide 30 mg and Albiglutide 50 mg in people with Diabetes Mellitus, run by GlaxoSmithKline at 607 sites in 28 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

Albiglutide is an analogue of glucagon-like peptide-1 (GLP-1), used to treat type 2 diabetes This study will test whether albiglutide affects the occurrence of major cardiovascular events such as heart attacks or strokes and other important medical outcomes in persons with type 2 diabetes, when used alone or added to… Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Diabetes Mellitus
What is being tested?
Albiglutide 30 mg and Albiglutide 50 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
9,463 participants
Where
607 sitesin 28 countries
Study dates
1 Jul 2015to 14 Mar 2018
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

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

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

607 sites in 28 countries.

607 sites in 28 countries

United States146 sites

  • GSK Investigational Site

    Albuquerque, New Mexico, 87102

  • GSK Investigational Site

    Anderson, South Carolina, 29621

  • GSK Investigational Site

    Annapolis, Maryland, 21401

  • GSK Investigational Site

    Arlington, Texas, 76014

  • GSK Investigational Site

    Atlanta, Georgia, 30318

  • GSK Investigational Site

    Atlanta, Georgia, 30342

  • GSK Investigational Site

    Aurora, Illinois, 60504

  • GSK Investigational Site

    Austin, Texas, 78731

  • GSK Investigational Site

    Avon, Indiana, 46123

  • GSK Investigational Site

    Bellaire, Texas, 77401

  • GSK Investigational Site

    Belle Glade, Florida, 33430

  • GSK Investigational Site

    Birmingham, Alabama, 35211

  • GSK Investigational Site

    Birmingham, Alabama, 35235

  • GSK Investigational Site

    Bradenton, Florida, 34201

  • GSK Investigational Site

    Bradenton, Florida, 34209

  • GSK Investigational Site

    Bristol, Tennessee, 37620

  • GSK Investigational Site

    Brooklyn, New York, 11215

  • GSK Investigational Site

    Camden, New Jersey, 08103

  • GSK Investigational Site

    Camp Hill, Pennsylvania, 17011

  • GSK Investigational Site

    Champaign, Illinois, 61820

  • GSK Investigational Site

    Chandler, Arizona, 85284

  • GSK Investigational Site

    Charlotte, North Carolina, 28207

  • GSK Investigational Site

    Charlotte, North Carolina, 28209

  • GSK Investigational Site

    Charlotte, North Carolina, 28277

  • GSK Investigational Site

    Chula Vista, California, 91910

  • GSK Investigational Site

    Cleveland, Ohio, 44122

  • GSK Investigational Site

    Columbia, South Carolina, 29223

  • GSK Investigational Site

    Columbus, Ohio, 43210

  • GSK Investigational Site

    Conyers, Georgia, 30094

  • GSK Investigational Site

    Coral Gables, Florida, 33134

  • GSK Investigational Site

    Coral Springs, Florida, 33065

  • GSK Investigational Site

    Cumming, Georgia, 30041

  • GSK Investigational Site

    Dallas, Texas, 75216

  • GSK Investigational Site

    Dallas, Texas, 75231

  • GSK Investigational Site

    Dallas, Texas, 75234

  • GSK Investigational Site

    Dallas, Texas

  • GSK Investigational Site

    Decatur, Georgia, 30033

  • GSK Investigational Site

    Denver, Colorado, 80220

  • GSK Investigational Site

    Dunwoody, Georgia, 30338

  • GSK Investigational Site

    El Paso, Texas, 79925

  • GSK Investigational Site

    Fargo, North Dakota, 58103

  • GSK Investigational Site

    Feasterville, Pennsylvania, 19053

  • GSK Investigational Site

    Federal Way, Washington, 98003

  • GSK Investigational Site

    Fleming Island, Florida, 32003

  • GSK Investigational Site

    Franklin, Indiana, 46131

  • GSK Investigational Site

    Georgetown, Texas, 78626

  • GSK Investigational Site

    Glendale, Arizona, 85308

  • GSK Investigational Site

    Goodyear, Arizona, 85395

  • GSK Investigational Site

    Greenfield, Indiana, 46140

  • GSK Investigational Site

    Gurnee, Illinois, 60031

  • GSK Investigational Site

    Haddon Heights, New Jersey, 08035

  • GSK Investigational Site

    Harleysville, Pennsylvania, 19438

  • GSK Investigational Site

    Hickory, North Carolina, 28601

  • GSK Investigational Site

    Houston, Texas, 77070

  • GSK Investigational Site

    Huntsville, Texas, 77340

  • GSK Investigational Site

    Inverness, Florida, 34452

  • GSK Investigational Site

    Jacksonville, Florida, 32216

  • GSK Investigational Site

    Jersey Shore, Pennsylvania, 17740

  • GSK Investigational Site

    Kingsport, Tennessee, 37660

  • GSK Investigational Site

    Kingwood, Texas, 77339

  • GSK Investigational Site

    Lake Worth, Florida, 33467

  • GSK Investigational Site

    Lakeland, Florida, 33805

  • GSK Investigational Site

    Lancaster, California, 93534

  • GSK Investigational Site

    Lansdale, Pennsylvania, 19446

  • GSK Investigational Site

    Las Vegas, Nevada, 89086

  • GSK Investigational Site

    Layton, Utah, 84401

  • GSK Investigational Site

    Lewiston, Maine, 04240

  • GSK Investigational Site

    Lexington, Kentucky, 40503

  • GSK Investigational Site

    Little Rock, Arkansas, 72209

  • GSK Investigational Site

    Littleton, Colorado, 80120

  • GSK Investigational Site

    Littleton, Colorado, 80127

  • GSK Investigational Site

    Lomita, California, 90717

  • GSK Investigational Site

    Long Beach, California, 90807

  • GSK Investigational Site

    Long Beach, California, 90822

  • GSK Investigational Site

    Los Angeles, California, 90017

  • GSK Investigational Site

    Los Angeles, California, 90073

  • GSK Investigational Site

    Louisville, Kentucky, 40213

  • GSK Investigational Site

    Madison, Wisconsin, 53713

  • GSK Investigational Site

    Manassas, Virginia, 20109

  • GSK Investigational Site

    Memphis, Tennessee, 38104

  • GSK Investigational Site

    Memphis, Tennessee, 38119

  • GSK Investigational Site

    Miami, Florida, 33174

  • GSK Investigational Site

    Mobile, Alabama, 36608

  • GSK Investigational Site

    Moline, Illinois, 61265

  • GSK Investigational Site

    Moreno Valley, California, 92555

  • GSK Investigational Site

    Muncie, Indiana, 47304-

  • GSK Investigational Site

    Munster, Indiana, 46321

  • GSK Investigational Site

    Myrtle Beach, South Carolina, 29572

  • GSK Investigational Site

    Nashville, Tennessee, 37203

  • GSK Investigational Site

    Nashville, Tennessee, 37212

  • GSK Investigational Site

    New Haven, Connecticut, 06511

  • GSK Investigational Site

    New Orleans, Louisiana, 70115

  • GSK Investigational Site

    Newport, Pennsylvania, 17074

  • GSK Investigational Site

    North Massapequa, New York, 11758

  • GSK Investigational Site

    Northridge, California, 91325

  • GSK Investigational Site

    Oakland, California, 94607

  • GSK Investigational Site

    Ocala, Florida, 34471

  • GSK Investigational Site

    Omaha, Nebraska, 68124

  • GSK Investigational Site

    Pawtucket, Rhode Island, 02860

  • GSK Investigational Site

    Penndel, Pennsylvania, 19047

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15212

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15240

  • GSK Investigational Site

    Plano, Texas, 75093

  • GSK Investigational Site

    Ponte Vedra, Florida, 32081

  • GSK Investigational Site

    Port Charlotte, Florida, 33952

  • GSK Investigational Site

    Port Orange, Florida, 32127

  • GSK Investigational Site

    Rapid City, South Dakota, 57701

  • GSK Investigational Site

    Rapid City, South Dakota, 57702

  • GSK Investigational Site

    Rocky Mount, North Carolina, 27804

  • GSK Investigational Site

    Saint Cloud, Minnesota, 56303

  • GSK Investigational Site

    Saint Paul, Minnesota, 55102

  • GSK Investigational Site

    Salisbury, North Carolina, 28144

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Antonio, Texas, 78258

  • GSK Investigational Site

    San Diego, California, 92103

  • GSK Investigational Site

    San Diego, California, 92117

  • GSK Investigational Site

    San Marino, California, 91108

  • GSK Investigational Site

    San Ramon, California, 94583

  • GSK Investigational Site

    Sandusky, Ohio, 44870

  • GSK Investigational Site

    Schertz, Texas, 78154

  • GSK Investigational Site

    Searcy, Arkansas, 72143

  • GSK Investigational Site

    Sellersville, Pennsylvania, 18960

  • GSK Investigational Site

    Simi Valley, California, 93065

  • GSK Investigational Site

    Snellville, Georgia, 30078

  • GSK Investigational Site

    Spokane, Washington, 99208

  • GSK Investigational Site

    Springfield, Ohio, 45504

  • GSK Investigational Site

    St Louis, Missouri, 63136

  • GSK Investigational Site

    St. Petersburg, Florida, 33713

  • GSK Investigational Site

    Stanford, California, 94305

  • GSK Investigational Site

    Statesville, North Carolina, 28625

  • GSK Investigational Site

    Suite 101, Texas, 76132

  • GSK Investigational Site

    Tacoma, Washington, 98405

  • GSK Investigational Site

    Tempe, Arizona, 85283

  • GSK Investigational Site

    Toledo, Ohio, 43614

  • GSK Investigational Site

    Topeka, Kansas, 66606

  • GSK Investigational Site

    Torrance, California, 90502

  • GSK Investigational Site

    Tucker, Georgia, 30084

  • GSK Investigational Site

    Tucson, Arizona, 85741

  • GSK Investigational Site

    Tucson, Arizona, 85745

  • GSK Investigational Site

    Tyler, Texas, 75708

  • GSK Investigational Site

    Vero Beach, Florida, 32960

  • GSK Investigational Site

    Wellington, Florida, 33449

  • GSK Investigational Site

    Wenatchee, Washington, 98801

  • GSK Investigational Site

    West Des Moines, Iowa, 50265

  • GSK Investigational Site

    Wilmington, North Carolina, 28401

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27157

Other trials in United States

Germany64 sites

  • GSK Investigational Site

    Aschaffenburg, Bavaria, 63739

  • GSK Investigational Site

    Bad Kreuznach, Rhineland-Palatinate, 55545

  • GSK Investigational Site

    Bad Oeynhausen, North Rhine-Westphalia, 32545

  • GSK Investigational Site

    Berlin, 10117

  • GSK Investigational Site

    Berlin, 10409

  • GSK Investigational Site

    Berlin, 10789

  • GSK Investigational Site

    Berlin, 12157

  • GSK Investigational Site

    Berlin, 13405

  • GSK Investigational Site

    Bochum, North Rhine-Westphalia, 44791

  • GSK Investigational Site

    Bochum, North Rhine-Westphalia, 44869

  • GSK Investigational Site

    Chemnitz, Saxony, 09113

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 51069

  • GSK Investigational Site

    Dachau, Bavaria, 85221

  • GSK Investigational Site

    Deggingen, Baden-Wurttemberg, 73326

  • GSK Investigational Site

    Delitzsch, Saxony, 04509

  • GSK Investigational Site

    Dortmund, 44137

  • GSK Investigational Site

    Dresden, Saxony, 01069

  • GSK Investigational Site

    Dresden, Saxony, 01219

  • GSK Investigational Site

    Dresden, Saxony, 01279

  • GSK Investigational Site

    Dresden, Saxony, 01307

  • GSK Investigational Site

    Elsterwerda, Brandenburg, 04910

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45136

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45329

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45359

  • GSK Investigational Site

    Falkensee, Brandenburg, 14612

  • GSK Investigational Site

    Flörsheim, Hesse, 65439

  • GSK Investigational Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • GSK Investigational Site

    Gelnhausen, Hesse, 63571

  • GSK Investigational Site

    Güglingen, Baden-Wurttemberg, 74363

  • GSK Investigational Site

    Haag, Bavaria, 83527

  • GSK Investigational Site

    Hamburg, 20099

  • GSK Investigational Site

    Hamburg, 21073

  • GSK Investigational Site

    Hamburg, 22041

  • GSK Investigational Site

    Hildesheim, Lower Saxony, 31139

  • GSK Investigational Site

    Hohenmölsen, Saxony-Anhalt, 06679

  • GSK Investigational Site

    Jerichow, Saxony-Anhalt, 39319

  • GSK Investigational Site

    Karlsruhe, Baden-Wurttemberg, 76199

  • GSK Investigational Site

    Kleve, North Rhine-Westphalia, 47533

  • GSK Investigational Site

    Künzing, Bavaria, 94550

  • GSK Investigational Site

    Leipzg, Saxony, 04109

  • GSK Investigational Site

    Leipzig, Saxony, 04109

  • GSK Investigational Site

    Leipzig, Saxony, 04249

  • GSK Investigational Site

    Ludwigsburg, Baden-Wurttemberg, 71640

  • GSK Investigational Site

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67059

  • GSK Investigational Site

    Magdeburg, Saxony-Anhalt, 39112

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55116

  • GSK Investigational Site

    Mannheim, 68163

  • GSK Investigational Site

    München, 80809

  • GSK Investigational Site

    Münster, North Rhine-Westphalia, 48145

  • GSK Investigational Site

    Oschatz, Saxony, 04758

  • GSK Investigational Site

    Pirna, Saxony, 01796

  • GSK Investigational Site

    Potsdam, Brandenburg, 14469

  • GSK Investigational Site

    Rednitzhembach, Bavaria, 91126

  • GSK Investigational Site

    Riesa, Saxony, 01587

  • GSK Investigational Site

    Sankt Ingbert, Saarland, 66386

  • GSK Investigational Site

    Schkeuditz, Saxony, 04435

  • GSK Investigational Site

    Stuhr, Lower Saxony, 28816

  • GSK Investigational Site

    Stuttgart, Baden-Wurttemberg, 70199

  • GSK Investigational Site

    Stuttgart, Baden-Wurttemberg, 70378

  • GSK Investigational Site

    Villingen-Schwenningen, Baden-Wurttemberg, 78048

  • GSK Investigational Site

    Wallerfing, Bavaria, 94574

  • GSK Investigational Site

    Wangen, Baden-Wurttemberg, 88239

  • GSK Investigational Site

    Wardenburg, Lower Saxony, 26203

  • GSK Investigational Site

    Witten, North Rhine-Westphalia, 58455

Other trials in Germany

Spain39 sites

  • GSK Investigational Site

    A Coruña, 15006

  • GSK Investigational Site

    Alicante, 03004

  • GSK Investigational Site

    Almería, 4001

  • GSK Investigational Site

    Alzira/Valencia, 46600

  • GSK Investigational Site

    Badalona, 08916

  • GSK Investigational Site

    Badalona / Barcelona, 08917

  • GSK Investigational Site

    Barcelona, 08003

  • GSK Investigational Site

    Barcelona, 08006

  • GSK Investigational Site

    Barcelona, 08026

  • GSK Investigational Site

    Barcelona, 08907

  • GSK Investigational Site

    Boadilla Del Monte (Madrid), 28660

  • GSK Investigational Site

    Canet de Mar - Barcelona, 08360

  • GSK Investigational Site

    Cangas Del Narcea/Asturias, 33800

  • GSK Investigational Site

    Centelles (Barcelona), 08540

  • GSK Investigational Site

    Córdoba, 14004

  • GSK Investigational Site

    Elche, 03293

  • GSK Investigational Site

    Granada, 18012

  • GSK Investigational Site

    León, 24071

  • GSK Investigational Site

    Madrid, 28006

  • GSK Investigational Site

    Madrid, 28034

  • GSK Investigational Site

    Madrid, 28040

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Madrid, 28050

  • GSK Investigational Site

    Málaga, 29010

  • GSK Investigational Site

    Palma de Mallorca, 07010

  • GSK Investigational Site

    Palma de Mallorca, 07198

  • GSK Investigational Site

    Pontevedra, 36071

  • GSK Investigational Site

    Pozuelo de Alarcón/Madrid, 28223

  • GSK Investigational Site

    Sagunto/Valencia, 46520

  • GSK Investigational Site

    San Juan (Alicante), 03550

  • GSK Investigational Site

    Sanlucar de Barrameda - Cádiz, 11540

  • GSK Investigational Site

    Santa Coloma de Gramanet (Barcelona), 08923

  • GSK Investigational Site

    Santiago de Compostela, 15706

  • GSK Investigational Site

    Seville, 41014

  • GSK Investigational Site

    Tarrasa, Barcelona, 08221

  • GSK Investigational Site

    Valencia, 46010

  • GSK Investigational Site

    Valencia, 46017

  • GSK Investigational Site

    Valencia, 46026

  • GSK Investigational Site

    Vigo-Pontevedra, 36312

Other trials in Spain

Russia35 sites

  • GSK Investigational Site

    Arkhangelsk, 163045

  • GSK Investigational Site

    Barnaul, 656 045

  • GSK Investigational Site

    Chelyabinsk, 454021

  • GSK Investigational Site

    Chelyabinsk, 454047

  • GSK Investigational Site

    Ivanovo, 153005

  • GSK Investigational Site

    Kemerovo, 650000

  • GSK Investigational Site

    Kemerovo, 650002

  • GSK Investigational Site

    Krasnodar, 350086

  • GSK Investigational Site

    Moscow, 117 036

  • GSK Investigational Site

    Moscow, 117 03

  • GSK Investigational Site

    Moscow, 117292

  • GSK Investigational Site

    Moscow, 119435

  • GSK Investigational Site

    Moscow, 119992

  • GSK Investigational Site

    Moscow, 127411

  • GSK Investigational Site

    Moscow, 129110

  • GSK Investigational Site

    Nizhny Novgorod, 603003

  • GSK Investigational Site

    Nizhny Novgorod, 603126

  • GSK Investigational Site

    Novosibirsk, 630047

  • GSK Investigational Site

    Novosibirsk, 630091

  • GSK Investigational Site

    Perm, 614097

  • GSK Investigational Site

    Rostov-on-Don, 344022

  • GSK Investigational Site

    Ryazan, 390039

  • GSK Investigational Site

    Saint Petersburg, 195257

  • GSK Investigational Site

    Samara, 443067

  • GSK Investigational Site

    Saratov, 410053

  • GSK Investigational Site

    Tomsk, 634012

  • GSK Investigational Site

    Tomsk, 634041

  • GSK Investigational Site

    Tomsk, 634050

  • GSK Investigational Site

    Voronezh, 394018

  • GSK Investigational Site

    Yaroslavl, 150000

  • GSK Investigational Site

    Yaroslavl, 150003

  • GSK Investigational Site

    Yaroslavl, 150010

  • GSK Investigational Site

    Yaroslavl, 150030

  • GSK Investigational Site

    Yekaterinburg, 620039

  • GSK Investigational Site

    Yekaterinburg, 620149

Other trials in Russia

Canada32 sites

  • GSK Investigational Site

    Brampton, Ontario, L6Z 4N5

  • GSK Investigational Site

    Brossard, Quebec, J4Z 2K

  • GSK Investigational Site

    Burlington, Ontario, L7M 4Y

  • GSK Investigational Site

    Cambridge, Ontario, N1R 7R1

  • GSK Investigational Site

    Chicoutimi, Quebec, G7H 7K9

  • GSK Investigational Site

    Cornwall, Ontario, K6H4M4

  • GSK Investigational Site

    Corunna, Ontario, N0N 1G

  • GSK Investigational Site

    Greater Sudbury, Ontario, P3A 5H

  • GSK Investigational Site

    Greenfield Park, Quebec, J4V 2G

  • GSK Investigational Site

    Greenfield Park, Quebec, J4V 2H1

  • GSK Investigational Site

    Halifax, Nova Scotia, B3H 1V7

  • GSK Investigational Site

    Hamilton, Ontario, L8L 2X2

  • GSK Investigational Site

    Kelowna, British Columbia, V1Y 1V6

  • GSK Investigational Site

    Laval, Quebec, H7T 2P5

  • GSK Investigational Site

    Lévis, Quebec, G6V 4Z5

  • GSK Investigational Site

    London, Ontario, N5W 6A

  • GSK Investigational Site

    London, Ontario, N6A 4V2

  • GSK Investigational Site

    Moncton, New Brunswick, E1G 1A7

  • GSK Investigational Site

    Montreal, Quebec, H4N 2W

  • GSK Investigational Site

    Saint-Charles-Borromée, Quebec, J6E 6J2

  • GSK Investigational Site

    Saint-Lambert, Quebec, J4P 2J

  • GSK Investigational Site

    Sarnia, Ontario, N7T 4X

  • GSK Investigational Site

    Sherbrooke, Quebec, J1J 2E3

  • GSK Investigational Site

    Smiths Falls, Ontario, K7A 4W8

  • GSK Investigational Site

    St. John's, Newfoundland and Labrador, A1B 3V6

  • GSK Investigational Site

    Surrey, British Columbia, V3V 0C6

  • GSK Investigational Site

    Toronto, Ontario, M9V 4B

  • GSK Investigational Site

    Trois-Rivières, Quebec, G8T 7A1

  • GSK Investigational Site

    Truro, Nova Scotia, B2N 1L2

  • GSK Investigational Site

    Victoria, British Columbia, V8R 4R2

  • GSK Investigational Site

    Victoria, British Columbia, V8V 4A

  • GSK Investigational Site

    Winnipeg, Manitoba, 3P

Other trials in Canada

Argentina31 sites

  • GSK Investigational Site

    Adrogué, Buenos Aires, B1846DSK

  • GSK Investigational Site

    Bahía Blanca, Buenos Aires, B8000FTD

  • GSK Investigational Site

    Berazategui, 1886

  • GSK Investigational Site

    Buenos Aires, 1093

  • GSK Investigational Site

    Buenos Aires, 1407

  • GSK Investigational Site

    Buenos Aires, C1056ABJ

  • GSK Investigational Site

    Buenos Aires, C1061ABD

  • GSK Investigational Site

    Buenos Aires, C1128A

  • GSK Investigational Site

    Buenos Aires, C1180A

  • GSK Investigational Site

    Buenos Aires, C1406BOA

  • GSK Investigational Site

    Buenos Aires, C1425AGC

  • GSK Investigational Site

    Buenos Aires, C1426A

  • GSK Investigational Site

    Buenos Aires, C1428D

  • GSK Investigational Site

    Buenos Aires

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, 1205

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1179AAB

  • GSK Investigational Site

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C141AH

  • GSK Investigational Site

    Córdoba, Córdoba Province, 5000

  • GSK Investigational Site

    Córdoba, 5016

  • GSK Investigational Site

    Godoy Cruz, Mendoza Province, M5501ARP

  • GSK Investigational Site

    La Plata, B1902C

  • GSK Investigational Site

    Mar del Plata, Buenos Aires, B7600FZN

  • GSK Investigational Site

    Mar del Plata, Buenos Aires

  • GSK Investigational Site

    Mendoza, 5500

  • GSK Investigational Site

    Mendoza, M5500CCE

  • GSK Investigational Site

    Mendoza, M5500C

  • GSK Investigational Site

    Pergamino, Buenos Aires, B2700CPM

  • GSK Investigational Site

    Rosario, Santa Fe Province, 2000

  • GSK Investigational Site

    Rosario, Santa Fe Province, S2000C

  • GSK Investigational Site

    San Rafael, Mendoza Province, 5600

  • GSK Investigational Site

    Santa Fe, 3000

Other trials in Argentina

United Kingdom26 sites

  • GSK Investigational Site

    Aberdeen, AB25 2

  • GSK Investigational Site

    Axbridge, Somerset, BS26 2

  • GSK Investigational Site

    Ayr, KA6 6D

  • GSK Investigational Site

    Blackpool, FY3 8NR

  • GSK Investigational Site

    Bristol, BS10 5

  • GSK Investigational Site

    Chesterfield, Derbyshire, S40 4AAA

  • GSK Investigational Site

    Dumfries, DG1 4AP

  • GSK Investigational Site

    Dundee, DD1 9S

  • GSK Investigational Site

    Dundee, DD4 6Q

  • GSK Investigational Site

    Dundee, DD5 4LX

  • GSK Investigational Site

    Edinburgh, Midlothian, EH4 2XU

  • GSK Investigational Site

    Fife, KY14 7AW

  • GSK Investigational Site

    Fife, KY2 5A

  • GSK Investigational Site

    Gloucester, GL1 3N

  • GSK Investigational Site

    Lancaster, LA1 4R

  • GSK Investigational Site

    Manchester, M23 9LT

  • GSK Investigational Site

    Newport, PO30 5

  • GSK Investigational Site

    Northwood, Middlesex, HA6 2R

  • GSK Investigational Site

    Oxford, OX3 7L

  • GSK Investigational Site

    Romford, Essex, RM1 3P

  • GSK Investigational Site

    Rotherham, S60 2UD

  • GSK Investigational Site

    Sidcup, Kent, DA14 6

  • GSK Investigational Site

    Soham, Cambridgeshire, CB7 5J

  • GSK Investigational Site

    Trowbridge, Wiltshire, BA14 8

  • GSK Investigational Site

    Trowbridge, BA14 9

  • GSK Investigational Site

    Wigan, WN1 2NN

Other trials in United Kingdom

Italy24 sites

  • GSK Investigational Site

    Ancona, The Marches, 60131

  • GSK Investigational Site

    Arenzano (GE), Liguria, 16011

  • GSK Investigational Site

    Ascoli Piceno, The Marches, 63100

  • GSK Investigational Site

    Bari, Apulia, 70124

  • GSK Investigational Site

    Bergamo, Lombardy, 24127

  • GSK Investigational Site

    Bologna, Emilia-Romagna, 40138

  • GSK Investigational Site

    Catanzaro, Calabria, 88100

  • GSK Investigational Site

    Chieti, Abruzzo, 66100

  • GSK Investigational Site

    Milan, Lombardy, 20122

  • GSK Investigational Site

    Milan, Lombardy, 20132

  • GSK Investigational Site

    Milan, Lombardy, 20142

  • GSK Investigational Site

    Naples, Campania, 80131

  • GSK Investigational Site

    Naples, Campania, 80138

  • GSK Investigational Site

    Olbia (OT), Sardinia, 07026

  • GSK Investigational Site

    Padova, Veneto, 35128

  • GSK Investigational Site

    Parma, Emilia-Romagna, 43100

  • GSK Investigational Site

    Ravenna, Emilia-Romagna, 48121

  • GSK Investigational Site

    Rome, Lazio, 00133

  • GSK Investigational Site

    Rome, Lazio, 00168

  • GSK Investigational Site

    Rome, Lazio, 00186

  • GSK Investigational Site

    S.Andrea Delle Fratte - S. Sisto (PG), Umbria, 06132

  • GSK Investigational Site

    San Giovanni Rotondo (FG), Apulia, 71013

  • GSK Investigational Site

    Siena, Tuscany, 53100

  • GSK Investigational Site

    Vigevano (PV), Lombardy, 27029

Other trials in Italy

Poland19 sites

  • GSK Investigational Site

    Bialystok, 15-435

  • GSK Investigational Site

    Bydgoszcz, 85-231

  • GSK Investigational Site

    Bydgoszcz, 85-863

  • GSK Investigational Site

    Gdansk, 80-858

  • GSK Investigational Site

    Gniewkowo, 88-140

  • GSK Investigational Site

    Katowice, 40-081

  • GSK Investigational Site

    Katowice, 40-772

  • GSK Investigational Site

    Krakow, 30-539

  • GSK Investigational Site

    Krakow, 31-261

  • GSK Investigational Site

    Krakow, 31-530

  • GSK Investigational Site

    Lublin, 20-538

  • GSK Investigational Site

    Poznan, 60-111

  • GSK Investigational Site

    Poznan, 61-655

  • GSK Investigational Site

    Sopot, 81- 71

  • GSK Investigational Site

    Warsaw, 00-465

  • GSK Investigational Site

    Wierzchosławice, 33-122

  • GSK Investigational Site

    Wroclaw, 50-127

  • GSK Investigational Site

    Wroclaw, 50-981

  • GSK Investigational Site

    Wroclaw, 54-239

Other trials in Poland

South Korea17 sites

  • GSK Investigational Site

    Daegu, 42415

  • GSK Investigational Site

    Daegu, 700-71

  • GSK Investigational Site

    Gyeonggi-do, 463-70

  • GSK Investigational Site

    Gyeonggido, 420-717

  • GSK Investigational Site

    Kangwondo, 220-701

  • GSK Investigational Site

    Pusan, 602-73

  • GSK Investigational Site

    Seoul, 110-744

  • GSK Investigational Site

    Seoul, 120-752

  • GSK Investigational Site

    Seoul, 134-72

  • GSK Investigational Site

    Seoul, 135-71

  • GSK Investigational Site

    Seoul, 135-72

  • GSK Investigational Site

    Seoul, 137-70

  • GSK Investigational Site

    Seoul, 150-95

  • GSK Investigational Site

    Seoul, 152-703

  • GSK Investigational Site

    Seoul, 411-70

  • GSK Investigational Site

    Suwon, 442-723

  • GSK Investigational Site

    Suwon, Kyonggi-do, 443-72

Other trials in South Korea

Sweden17 sites

  • GSK Investigational Site

    Borås, SE-506

  • GSK Investigational Site

    Eksjö, SE-575 35

  • GSK Investigational Site

    Gothenburg, SE-413 45

  • GSK Investigational Site

    Härnösand, SE-871

  • GSK Investigational Site

    Helsingborg, SE-252

  • GSK Investigational Site

    Karlskrona, SE-371 41

  • GSK Investigational Site

    Kristianstad, SE-291 85

  • GSK Investigational Site

    Linköping, SE-587 58

  • GSK Investigational Site

    Ljungby, SE-341

  • GSK Investigational Site

    Malmö, SE-205 02

  • GSK Investigational Site

    Örebro, SE-703 62

  • GSK Investigational Site

    Rättvik, SE-795 30

  • GSK Investigational Site

    Stockholm, SE-111

  • GSK Investigational Site

    Stockholm, SE-113 61

  • GSK Investigational Site

    Stockholm, SE-182 88

  • GSK Investigational Site

    Umeå, SE-901 85

  • GSK Investigational Site

    Uppsala, SE-752

Other trials in Sweden

Ukraine17 sites

  • GSK Investigational Site

    Chernivtsi, 58022

  • GSK Investigational Site

    Dnipropetrovsk, 49038

  • GSK Investigational Site

    Kharkiv, 61058

  • GSK Investigational Site

    Kharkiv, 61070

  • GSK Investigational Site

    Kherson, 73000

  • GSK Investigational Site

    Kyiv, 01004

  • GSK Investigational Site

    Kyiv, 01021

  • GSK Investigational Site

    Kyiv, 02091

  • GSK Investigational Site

    Kyiv, 03049

  • GSK Investigational Site

    Kyiv, 04050

  • GSK Investigational Site

    Kyiv, 04114

  • GSK Investigational Site

    Mykolaiv, 54003

  • GSK Investigational Site

    Odesa, 65025

  • GSK Investigational Site

    Poltava, 36011

  • GSK Investigational Site

    Uzhhorod, 88000

  • GSK Investigational Site

    Vinnytsia, 21010

  • GSK Investigational Site

    Zaporizhzhya, 69001

Other trials in Ukraine

Greece16 sites

  • GSK Investigational Site

    Alexandroupoli, 68 100

  • GSK Investigational Site

    Athens, 11 527

  • GSK Investigational Site

    Athens, 11521

  • GSK Investigational Site

    Athens, 11528

  • GSK Investigational Site

    Haidari, Athens, 12462

  • GSK Investigational Site

    Heraklion, Crete, 71409

  • GSK Investigational Site

    Ioannina, 45500

  • GSK Investigational Site

    Lamia, 35100

  • GSK Investigational Site

    Nikaia Piraeus, 184 54

  • GSK Investigational Site

    Piraeus, 18536

  • GSK Investigational Site

    Thessaloniki, 546 36

  • GSK Investigational Site

    Thessaloniki, 546 42

  • GSK Investigational Site

    Thessaloniki, 54642

  • GSK Investigational Site

    Thessaloniki, 564 29

  • GSK Investigational Site

    Thessaloniki, 570 01

  • GSK Investigational Site

    Thessaloniki, 570 10

Other trials in Greece

Czechia13 sites

  • GSK Investigational Site

    Beroun, 266 01

  • GSK Investigational Site

    Krnov, 794 01

  • GSK Investigational Site

    Olomouc, 772 00

  • GSK Investigational Site

    Ostrava, 702 00

  • GSK Investigational Site

    Prague, 100 00

  • GSK Investigational Site

    Prague, 116 94

  • GSK Investigational Site

    Prague, 128 08

  • GSK Investigational Site

    Prague, 149 00

  • GSK Investigational Site

    Prague, 150 00

  • GSK Investigational Site

    Příbram, 261 01

  • GSK Investigational Site

    Uherské Hradiště, 686 01

  • GSK Investigational Site

    Ústí nad Labem, 401 13

  • GSK Investigational Site

    Zlín, 760 01

Other trials in Czechia

Mexico13 sites

  • GSK Investigational Site

    Aguascalientes, 20230

  • GSK Investigational Site

    Aguascalientes, Ags, Aguascalientes, 20127

  • GSK Investigational Site

    Guadalajara, Jalisco, 44150

  • GSK Investigational Site

    Guadalajara, Jalisco, 44600

  • GSK Investigational Site

    Guadalajara, Jalisco, 45116

  • GSK Investigational Site

    Mazatlán, Sinaloa, 82126

  • GSK Investigational Site

    Mazatlán, Sinaloa

  • GSK Investigational Site

    Mérida, Yucatán, 97129

  • GSK Investigational Site

    Mexico City, 11650

  • GSK Investigational Site

    Monterrey, Nuevo León, 64460

  • GSK Investigational Site

    Monterrey NL, Nuevo León, 64718

  • GSK Investigational Site

    Querétaro City, Querétaro, 76000

  • GSK Investigational Site

    Tlaquepaque, Jalisco, 45510

Other trials in Mexico

France11 sites

  • GSK Investigational Site

    Amiens, 80054

  • GSK Investigational Site

    Broglie, 27270

  • GSK Investigational Site

    Corbeil-Essonnes, 91106

  • GSK Investigational Site

    La Rochelle, 17019

  • GSK Investigational Site

    Nantes, 44277

  • GSK Investigational Site

    Narbonne, 11100

  • GSK Investigational Site

    Paris, 75010

  • GSK Investigational Site

    Pau, 64046

  • GSK Investigational Site

    Pierre-Bénite, 69310

  • GSK Investigational Site

    Strasbourg, 67091

  • GSK Investigational Site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Hungary11 sites

  • GSK Investigational Site

    Baja, 6500

  • GSK Investigational Site

    Budapest, 1036

  • GSK Investigational Site

    Budapest, 1135

  • GSK Investigational Site

    Debrecen, 4026

  • GSK Investigational Site

    Debrecen, 4031

  • GSK Investigational Site

    Eger, 3300

  • GSK Investigational Site

    Gödöllő, 2100

  • GSK Investigational Site

    Hatvan, 3000

  • GSK Investigational Site

    Komárom, 2900

  • GSK Investigational Site

    Miskolc, 3529

  • GSK Investigational Site

    Sátoraljaújhely, 3980

Other trials in Hungary

Denmark10 sites

  • GSK Investigational Site

    Copenhagen, 2100

  • GSK Investigational Site

    Esbjerg, 6700

  • GSK Investigational Site

    Frederikssund, DK-3600

  • GSK Investigational Site

    Hellerup, 2900

  • GSK Investigational Site

    Herlev, DK-273

  • GSK Investigational Site

    Holbæk, DK-430

  • GSK Investigational Site

    Hvidovre, 2650

  • GSK Investigational Site

    København NV, 2400

  • GSK Investigational Site

    København S, DK-230

  • GSK Investigational Site

    Roskilde, DK-400

Other trials in Denmark

Netherlands10 sites

  • GSK Investigational Site

    Alkmaar, 1815 JD

  • GSK Investigational Site

    Amsterdam, 1061 A

  • GSK Investigational Site

    Eindhoven, 5631 BM

  • GSK Investigational Site

    Gouda, 2803 H

  • GSK Investigational Site

    Hardenberg, 7772 SE

  • GSK Investigational Site

    Heerlen, 6419 PC

  • GSK Investigational Site

    Hoogeveen, 7909 A

  • GSK Investigational Site

    Meppel, 7943 K

  • GSK Investigational Site

    Rotterdam, 3051 G

  • GSK Investigational Site

    Sneek, 8601 Z

Other trials in Netherlands

Peru10 sites

  • GSK Investigational Site

    Arequipa

  • GSK Investigational Site

    Callao, Lima, Callao 2

  • GSK Investigational Site

    Lima, 01

  • GSK Investigational Site

    Lima, 17

  • GSK Investigational Site

    Lima, Lima 14

  • GSK Investigational Site

    Lima, Lima 29

  • GSK Investigational Site

    Lima, Lima 32

  • GSK Investigational Site

    Piura, 20001

  • GSK Investigational Site

    San Martín de Porres, Lima region, Lima 33

  • GSK Investigational Site

    Trujillo, La Libertad, 13001

Other trials in Peru

South Africa9 sites

  • GSK Investigational Site

    Bloemfontein, Free State, 9301

  • GSK Investigational Site

    Bloemfontein, 9301

  • GSK Investigational Site

    Cape Town, 7500

  • GSK Investigational Site

    Houghton Estate, 2198

  • GSK Investigational Site

    Kuilsrivier, 7580

  • GSK Investigational Site

    Paarl, 7646

  • GSK Investigational Site

    Pinelands, 7405

  • GSK Investigational Site

    Tongaat, KwaZulu-Natal, 4400

  • GSK Investigational Site

    Umhlanga, 4319

Other trials in South Africa

Bulgaria8 sites

  • GSK Investigational Site

    Byala, 7100

  • GSK Investigational Site

    Gabrovo, 5300

  • GSK Investigational Site

    Montana

  • GSK Investigational Site

    Sevlievo, 5400

  • GSK Investigational Site

    Sofia, 1202

  • GSK Investigational Site

    Sofia, 1407

  • GSK Investigational Site

    Sofia, 1632

  • GSK Investigational Site

    Stara Zagora, 6000

Other trials in Bulgaria

Belgium7 sites

  • GSK Investigational Site

    Bonheiden, 2820

  • GSK Investigational Site

    Brussels, 1070

  • GSK Investigational Site

    Brussels, 1090

  • GSK Investigational Site

    Edegem, 2650

  • GSK Investigational Site

    Leuven, 3000

  • GSK Investigational Site

    Liège, 4000

  • GSK Investigational Site

    Roeselare, 8800

Other trials in Belgium

Taiwan7 sites

  • GSK Investigational Site

    Changhua, 500

  • GSK Investigational Site

    Hualien City, 970

  • GSK Investigational Site

    Kaohsiung City, 833

  • GSK Investigational Site

    Taichung, 433

  • GSK Investigational Site

    Tainan, 71004

  • GSK Investigational Site

    Taipei, 10002

  • GSK Investigational Site

    Taipei, 112

Other trials in Taiwan

Norway5 sites

  • GSK Investigational Site

    Hoenefoss, 3513

  • GSK Investigational Site

    Kolbjørnsvik, 4816

  • GSK Investigational Site

    Oslo, 0319

  • GSK Investigational Site

    Oslo, 0586

  • GSK Investigational Site

    Stavanger, 4011

Other trials in Norway

Thailand5 sites

  • GSK Investigational Site

    Bangkok, 10330

  • GSK Investigational Site

    Bangkok, 10400

  • GSK Investigational Site

    Chiang Mai, 50200

  • GSK Investigational Site

    Pathum Thani, 12120

  • GSK Investigational Site

    Songkhla, 90110

Other trials in Thailand

Philippines3 sites

  • GSK Investigational Site

    Cebu City, 6000

  • GSK Investigational Site

    Iloilo City, 5000

  • GSK Investigational Site

    Laoag, 2900

Other trials in Philippines

Hong Kong2 sites

  • GSK Investigational Site

    Hong Kong

  • GSK Investigational Site

    Shatin

Other trials in Hong Kong

About this study

Official title: A Long Term, Randomised, Double Blind, Placebo-controlled Study to Determine the Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Patients With Type 2 Diabetes Mellitus

Albiglutide is an analogue of glucagon-like peptide-1 (GLP-1), used to treat type 2 diabetes This study will test whether albiglutide affects the occurrence of major cardiovascular events such as heart attacks or strokes and other important medical outcomes in persons with type 2 diabetes, when used alone or added to other diabetes treatments.

Being tested
Albiglutide 30 mg, Albiglutide 50 mg, Albiglutide matching placebo
Keywords
cardiovascular events /outcomes, Type 2 diabetes mellitus, albiglutide, glucagon-like peptide-1 receptor agonist
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

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

  • Albiglutide 30 mgBiological

    Once weekly subcutaneous injection. Starting dose 30 mg may be increased to 50 mg if needed.

  • Albiglutide 50 mgBiological

    Once weekly subcutaneous injection. Starting dose 30 mg may be increased to 50 mg if needed.

  • Albiglutide matching placeboBiological

    Once weekly subcutaneous injection. Matched to 30 mg and 50 mg albiglutide.

Study groups in NCT02465515
Study groupRoleWhat they receive
AlbiglutideExperimentalAlbiglutide 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.
Receives: Biological: Albiglutide 30 mg; Biological: Albiglutide 50 mg
PlaceboPlacebo comparatorPlacebo once weekly by subcutaneous injection. Placebo will be administered in addition to standard therapy for diabetes and cardiovascular health.
Receives: Biological: Albiglutide matching placebo

What is being measured

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

  1. Time to First Occurrence of Major Adverse Cardiovascular Events (MACE) During Cardiovascular (CV) Follow-up Time Period

    Time to MACE defined as the time to first occurrence of Cardiovascular Endpoint Committee (CEC)-adjudicated MACE (CV death, myocardial infarction [MI] or stroke) was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. The analysis was performed on the Intent to Treat (ITT) Population which comprised of all randomized participants excluding participants who did not provide consent.

    Measured: Median of 1.65 person years for CV follow-up time period

Secondary outcomes (20)

  1. Time to First Occurrence of MACE or Urgent Revascularization for Unstable Angina

    Time to first occurrence of CEC-adjudicated MACE (CV death, MI or stroke) or urgent revascularization for unstable angina was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

    Measured: Median of 1.65 person years for CV follow-up time period

  2. Time to Adjudicated CV Death

    Time to adjudicated CV death was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

    Measured: Median of 1.65 person years for the CV follow-up time period

  3. Time to First Occurrence of Adjudicated MI

    Time to first occurrence of adjudicated MI was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

    Measured: Median of 1.65 person years for CV follow-up time period

  4. Time to First Occurrence of Adjudicated Stroke

    Time to first occurrence of adjudicated stroke was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

    Measured: Median of 1.65 person years for CV follow-up time period

  5. Time to First Occurrence of Adjudicated CV Death or Hospitalization for Heart Failure (HF)

    Time to first occurrence of adjudicated CV death or hospitalization for HF was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.

    Measured: Median of 1.65 person years for CV follow-up time period

  6. Time to Initiation of Insulin of More Than 3 Months Duration for Those Participants Not Treated With Insulin at Study Start

    Time to initiation of insulin of more than 3 months duration in participants not treated with insulin at study start was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the on-therapy and post-therapy AE time period. The analysis was performed on Non-Insulin Population which comprised of participants in the ITT Population who were not on insulin at Baseline.

    Measured: Up to 2.7 years

  7. Time to Initiation of Prandial Insulin in Those Participants on Basal Insulin at Study Start

    Time to initiation of prandial insulin in those participants on basal insulin at study start was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the on-therapy and post-therapy AE time period. The analysis was performed on Basal Insulin Population which comprised of participants in the ITT Population who were on basal insulin but not on other insulin at Baseline (i.e., will not include a participant on a mixed insulin or on a prandial-only insulin).

    Measured: Up to 2.7 years

  8. Percentage of Participants Achieving Composite Metabolic Endpoint

    Percentage of participants achieving composite metabolic endpoint defined as the percentage of participants achieving glycemic control (glycated hemoglobin [HbA1c] <=7% ) with no severe hypoglycemic incidents and weight gain < 5%. Final Assessment is the latest post-Baseline assessment of both HbA1c and weight.

    Measured: Months 8, 16, 24 and final assessment (up to 2.7 years)

  9. Time to First Occurrence of a Clinically Important Microvascular Event

    Clinically important microvascular events were defined as the following: need for renal transplant or dialysis, new diabetes-related blindness, and procedures (laser photocoagulation or anti-vascular endothelial growth factor treatment or vitrectomy for diabetic retinopathy/eye disease). Time to first occurrence of a clinically important microvascular event was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the on-therapy and post-therapy AE time period.

    Measured: Up to 2.7 years

  10. Change From Baseline in HbA1c

    Change from Baseline in HbA1c was analyzed using mixed model repeated measures (MMRM) including observed case data (does not impute any missing data). Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value. Change from Baseline in HbA1c using Baseline data from Local or Central Laboratory, and post-Baseline Central Laboratory data is presented.

    Measured: Baseline and Months 8 and 16

  11. Change From Baseline in Body Weight

    Change from Baseline in body weight was analyzed using mixed model repeated measures including observed case data (does not impute any missing data). Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value.

    Measured: Baseline and Months 8 and 16

  12. Change From Baseline in Treatment Related Impact Measures-Diabetes (TRIM-D) Total Score

    The TRIM-D is a 28 item treatment satisfaction measure with 5 domains assessing Treatment Burden, Daily Life, Diabetes Management, Compliance and Psychological Health. The raw score ranges for each subscale were: treatment burden (6 to 30), daily life (5 to 25), diabetes management (5 to 25), compliance (4 to 20) and psychological health (8 to 40), higher scores indicating better health state. Total raw score was determined by summing the raw scores for each of the subscales and the total score (transformed) was determined as [(raw score minus lowest possible raw score)/possible raw score range] x100. The possible total (transformed) score range is 0-100, where higher scores indicated better health state. Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value.

    Measured: Baseline and Months 8 and 16

  13. Change From Baseline in EuroQol- 5 Dimension (EQ-5D) Visual Analogue Scale (VAS) Score

    The EQ-5D is a standardized instrument used to evaluate generic health-related quality of life, comprising 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It provides a simple descriptive profile and a single index value for health status. The EQ-5D self-reported questionnaire includes a visual analog scale (VAS), which records the respondent's self-rated health status on a graduated (0-100) scale, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value.

    Measured: Baseline and Months 8 and 16

  14. Time to Death

    Time to death was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants who died/endpoint person-years) is presented along with 95% confidence interval. Endpoint person-years=(cumulative total time to event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the Vital Status follow-up time period.

    Measured: Median of 1.73 years for the Vital Status follow-up time period

  15. Number of Participants With Non-fatal Serious Adverse Events (SAEs)

    SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before; is associated with liver injury and impaired liver function. Number of participants with on-therapy non-fatal SAEs are presented. Safety Population comprised of all randomized participants who received at least one dose of study treatment.

    Measured: Up to 2.7 years

  16. Number of Participants With Adverse Events (AEs) Leading to Discontinuation of Investigational Product (AELD)

    The number of participants with on-therapy AEs leading to discontinuation of investigational product is reported.

    Measured: Up to 2.7 years

  17. Number of Participants With AEs of Special Interest

    The protocol defined AEs of special interest included: development of thyroid cancer; hematologic malignancy; pancreatic cancer; pancreatitis (investigator reported and pancreatitis positively adjudicated by the Pancreatic Adjudication Committee [PAC]); investigational product injection site reactions; immunological reactions; severe hypoglycemic events; hepatic events; hepatic enzyme elevations (including gamma glutamyl transferase [GGT]); serious gastrointestinal (GI) events; appendicitis; atrial fibrillation/flutter; pneumonia; worsening renal function and diabetic retinopathy. The number of participants with on-therapy AEs of special interest is reported.

    Measured: Up to 2.7 years

  18. Change in Estimated Glomerular Filtration Rate (eGFR) Calculated Using Modification of Diet in Renal Disease (MDRD) Formula

    Blood samples were collected for the measurement of serum creatinine. Serum creatinine values were used to calculate eGFR using the MDRD formula, eGFR=175 x (serum creatinine)^-1.154 x (Age)^-0.203 x (0.742 if female) x (1.212 if African American). Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value. Change from Baseline in eGFR using Baseline data from Local or Central Laboratory, and post-Baseline Central Laboratory data for the on-treatment time period is presented.

    Measured: Baseline and Months 8 and 16

  19. Change From Baseline in Blood Pressure

    Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were taken with the participant in a semi-recumbent or seated position after at least a 5-minute rest period. Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value.

    Measured: Baseline and Months 8,16,24 and end of study (up to 2.7 years)

  20. Change From Baseline in Heart Rate

    Heart rate was measured with the participant in a semi-recumbent or seated position after at least a 5-minute rest period. Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value.

    Measured: Baseline and Months 8, 16, 24 and end of study (up to 2.7 years)

Timeline

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

  1. First posted8 Jun 2015 (estimated)
  2. Study start1 Jul 2015
  3. Primary completion20 Feb 2018
  4. Study completion14 Mar 2018

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
9,463 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02465515
Sponsor's protocol ID
116174
Other IDs
2014-001824-32, 2014
Status last verified
Feb 2019
First submitted
4 Jun 2015
Last updated
6 Mar 2019
Data monitoring committee
Yes

Publications

  • 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

  • Umapathysivam MM, Araldi E, Hastoy B, Dawed AY, Vatandaslar H, Mayrhofer JE, Lindquist P, Silva PN, Goga A, Trullinger GO, Godbersen S, Sengupta S, Kaufmann A, Thomsen SK, Hartmann B, Chen YC, Jonsson AE, Kabakci H, Thaman S, Grarup N, Have CT, Pallo LP, Faerch K, Gjesing AP, Nawaz S, Cheeseman J, Neville MJ, Pedersen O, Walker M, Sun H, Jennison C, Hattersley AT, Rehfeld JF, Holman RR, Verchere BC, Hansen T, Karpe F, Holst JJ, Rosenkilde MM, Jones AG, Ristow M, McCarthy MI, Pearson ER, Stoffel M, Gloyn AL. Type 2 diabetes risk alleles in peptidyl-glycine alpha-amidating monooxygenase influence GLP-1 levels and response to GLP-1 receptor agonists. Genome Med. 2026 Mar 29;18(1):40. doi: 10.1186/s13073-026-01630-0.

    PubMed 41906117

  • 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.

    PubMed 39963952

  • 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.

    PubMed 38317618

  • 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.

    PubMed 34281607

  • 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.

    PubMed 30291013

  • 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.

    PubMed 30015066

  • 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.

    PubMed 29693361

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Albiglutide 30 mg and Albiglutide 50 mg in people with Diabetes Mellitus, run by GlaxoSmithKline at 607 sites in 28 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 5 inclusion and 10 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 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 607 sites in United States, Germany, Spain, Russia, Canada and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

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

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

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

What does the primary outcome measure?

Time to First Occurrence of Major Adverse Cardiovascular Events (MACE) During Cardiovascular (CV) Follow-up Time Period (time frame: Median of 1.65 person years for CV follow-up time period). 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 NCT02465515, which also lists 8 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 6 Mar 2019.

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