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

February 11, 2019 updated by: GlaxoSmithKline

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.

Study Overview

Status

Completed

Conditions

Diabetes Mellitus

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9463

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Berazategui, Argentina, 1886
    - GSK Investigational Site
  - Buenos Aires, Argentina, C1061ABD
    - GSK Investigational Site
  - Buenos Aires, Argentina, C1425AGC
    - GSK Investigational Site
  - Buenos Aires, Argentina, 1093
    - GSK Investigational Site
  - Buenos Aires, Argentina, 1407
    - GSK Investigational Site
  - Buenos Aires, Argentina, C1180A
    - GSK Investigational Site
  - Buenos Aires, Argentina
    - GSK Investigational Site
  - Ciudad Autonoma de Buenos Aires, Argentina, C1056ABJ
    - GSK Investigational Site
  - Ciudad Autonoma de Buenos Aires, Argentina, C1406BOA
    - GSK Investigational Site
  - Ciudad Autonoma de Buenos Aires, Argentina, C1428D
    - GSK Investigational Site
  - Ciudad Autónoma de Buenos Aires, Argentina, C1128A
    - GSK Investigational Site
  - Ciudad Autónoma de Buenos Aires, Argentina, C1426A
    - GSK Investigational Site
  - Cordoba, Argentina, 5016
    - GSK Investigational Site
  - La Plata, Argentina, B1902C
    - GSK Investigational Site
  - Mendoza, Argentina, 5500
    - GSK Investigational Site
  - Mendoza, Argentina, M5500CCE
    - GSK Investigational Site
  - Mendoza, Argentina, M5500C
    - GSK Investigational Site
  - Santa Fe, Argentina, 3000
    - GSK Investigational Site
- Buenos Aires
  - Adrogue, Buenos Aires, Argentina, B1846DSK
    - GSK Investigational Site
  - Bahia Blanca, Buenos Aires, Argentina, B8000FTD
    - GSK Investigational Site
  - Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1179AAB
    - GSK Investigational Site
  - Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1205
    - GSK Investigational Site
  - Ciudad autónoma de Buenos Aires, Buenos Aires, Argentina, C141AH
    - GSK Investigational Site
  - Mar del Plata, Buenos Aires, Argentina, B7600FZN
    - GSK Investigational Site
  - Mar del Plata, Buenos Aires, Argentina
    - GSK Investigational Site
  - Pergamino, Buenos Aires, Argentina, B2700CPM
    - GSK Investigational Site
- Córdova
  - Córdoba, Córdova, Argentina, 5000
    - GSK Investigational Site
- Mendoza
  - Godoy Cruz, Mendoza, Argentina, M5501ARP
    - GSK Investigational Site
  - San Rafael, Mendoza, Argentina, 5600
    - GSK Investigational Site
- Santa Fe
  - Rosario, Santa Fe, Argentina, 2000
    - GSK Investigational Site
  - Rosario, Santa Fe, Argentina, S2000C
    - GSK Investigational Site
Belgium
- - Bonheiden, Belgium, 2820
    - GSK Investigational Site
  - Brussels, Belgium, 1090
    - GSK Investigational Site
  - Bruxelles, Belgium, 1070
    - GSK Investigational Site
  - Edegem, Belgium, 2650
    - GSK Investigational Site
  - Leuven, Belgium, 3000
    - GSK Investigational Site
  - Liège, Belgium, 4000
    - GSK Investigational Site
  - Roeselare, Belgium, 8800
    - GSK Investigational Site
Bulgaria
- - Byala, Bulgaria, 7100
    - GSK Investigational Site
  - Gabrovo, Bulgaria, 5300
    - GSK Investigational Site
  - Montana, Bulgaria
    - GSK Investigational Site
  - Sevlievo, Bulgaria, 5400
    - GSK Investigational Site
  - Sofia, Bulgaria, 1407
    - GSK Investigational Site
  - Sofia, Bulgaria, 1202
    - GSK Investigational Site
  - Sofia, Bulgaria, 1632
    - GSK Investigational Site
  - Stara Zagora, Bulgaria, 6000
    - GSK Investigational Site
Canada
- British Columbia
  - Kelowna, British Columbia, Canada, V1Y 1V6
    - GSK Investigational Site
  - Surrey, British Columbia, Canada, V3V 0C6
    - GSK Investigational Site
  - Victoria, British Columbia, Canada, V8R 4R2
    - GSK Investigational Site
  - Victoria, British Columbia, Canada, V8V 4A
    - GSK Investigational Site
- Manitoba
  - Winnipeg, Manitoba, Canada, 3P
    - GSK Investigational Site
- New Brunswick
  - Moncton, New Brunswick, Canada, E1G 1A7
    - GSK Investigational Site
- Newfoundland and Labrador
  - St. John's, Newfoundland and Labrador, Canada, A1B 3V6
    - GSK Investigational Site
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 1V7
    - GSK Investigational Site
  - Truro, Nova Scotia, Canada, B2N 1L2
    - GSK Investigational Site
- Ontario
  - Brampton, Ontario, Canada, L6Z 4N5
    - GSK Investigational Site
  - Burlington, Ontario, Canada, L7M 4Y
    - GSK Investigational Site
  - Cambridge, Ontario, Canada, N1R 7R1
    - GSK Investigational Site
  - Cornwall, Ontario, Canada, K6H4M4
    - GSK Investigational Site
  - Corunna, Ontario, Canada, N0N 1G
    - GSK Investigational Site
  - Hamilton, Ontario, Canada, L8L 2X2
    - GSK Investigational Site
  - London, Ontario, Canada, N6A 4V2
    - GSK Investigational Site
  - London, Ontario, Canada, N5W 6A
    - GSK Investigational Site
  - Sarnia, Ontario, Canada, N7T 4X
    - GSK Investigational Site
  - Smiths Falls, Ontario, Canada, K7A 4W8
    - GSK Investigational Site
  - Sudbury, Ontario, Canada, P3A 5H
    - GSK Investigational Site
  - Toronto, Ontario, Canada, M9V 4B
    - GSK Investigational Site
- Quebec
  - Brossard, Quebec, Canada, J4Z 2K
    - GSK Investigational Site
  - Chicoutimi, Quebec, Canada, G7H 7K9
    - GSK Investigational Site
  - Greenfield Park, Quebec, Canada, J4V 2H1
    - GSK Investigational Site
  - Greenfield Park, Quebec, Canada, J4V 2G
    - GSK Investigational Site
  - Laval, Quebec, Canada, H7T 2P5
    - GSK Investigational Site
  - Levis, Quebec, Canada, G6V 4Z5
    - GSK Investigational Site
  - Montreal, Quebec, Canada, H4N 2W
    - GSK Investigational Site
  - Sherbrooke, Quebec, Canada, J1J 2E3
    - GSK Investigational Site
  - St-Charles-Borromée, Quebec, Canada, J6E 6J2
    - GSK Investigational Site
  - St-Lambert, Quebec, Canada, J4P 2J
    - GSK Investigational Site
  - Trois-Rivieres, Quebec, Canada, G8T 7A1
    - GSK Investigational Site
Czechia
- - Beroun, Czechia, 266 01
    - GSK Investigational Site
  - Krnov, Czechia, 794 01
    - GSK Investigational Site
  - Olomouc, Czechia, 772 00
    - GSK Investigational Site
  - Ostrava, Czechia, 702 00
    - GSK Investigational Site
  - Praha 1, Czechia, 116 94
    - GSK Investigational Site
  - Praha 10, Czechia, 100 00
    - GSK Investigational Site
  - Praha 2, Czechia, 128 08
    - GSK Investigational Site
  - Praha 4, Czechia, 149 00
    - GSK Investigational Site
  - Praha 5, Czechia, 150 00
    - GSK Investigational Site
  - Pribram 1, Czechia, 261 01
    - GSK Investigational Site
  - Uherske Hradiste, Czechia, 686 01
    - GSK Investigational Site
  - Usti nad Labem, Czechia, 401 13
    - GSK Investigational Site
  - Zlin, Czechia, 760 01
    - GSK Investigational Site
Denmark
- - Copenhagen, Denmark, 2100
    - GSK Investigational Site
  - Esbjerg, Denmark, 6700
    - GSK Investigational Site
  - Frederikssund, Denmark, DK-3600
    - GSK Investigational Site
  - Hellerup, Denmark, 2900
    - GSK Investigational Site
  - Herlev, Denmark, DK-273
    - GSK Investigational Site
  - Holbæk, Denmark, DK-430
    - GSK Investigational Site
  - Hvidovre, Denmark, 2650
    - GSK Investigational Site
  - København NV, Denmark, 2400
    - GSK Investigational Site
  - København S, Denmark, DK-230
    - GSK Investigational Site
  - Roskilde, Denmark, DK-400
    - GSK Investigational Site
France
- - Amiens Cedex 1, France, 80054
    - GSK Investigational Site
  - Broglie, France, 27270
    - GSK Investigational Site
  - Corbeil-Essonnes, France, 91106
    - GSK Investigational Site
  - La Rochelle Cedex 1, France, 17019
    - GSK Investigational Site
  - Nantes cedex 2, France, 44277
    - GSK Investigational Site
  - Narbonne, France, 11100
    - GSK Investigational Site
  - Paris, France, 75010
    - GSK Investigational Site
  - Pau Cedex, France, 64046
    - GSK Investigational Site
  - Pierre-Bénite, France, 69310
    - GSK Investigational Site
  - Strasbourg cedex, France, 67091
    - GSK Investigational Site
  - Vandœuvre-lès-Nancy, France, 54511
    - GSK Investigational Site
Germany
- - Berlin, Germany, 10117
    - GSK Investigational Site
  - Berlin, Germany, 10789
    - GSK Investigational Site
  - Berlin, Germany, 12157
    - GSK Investigational Site
  - Berlin, Germany, 10409
    - GSK Investigational Site
  - Berlin, Germany, 13405
    - GSK Investigational Site
  - Dortmund, Germany, 44137
    - GSK Investigational Site
  - Hamburg, Germany, 20099
    - GSK Investigational Site
  - Hamburg, Germany, 22041
    - GSK Investigational Site
  - Hamburg, Germany, 21073
    - GSK Investigational Site
  - Mannheim, Germany, 68163
    - GSK Investigational Site
  - Muenchen, Germany, 80809
    - GSK Investigational Site
- Baden-Wuerttemberg
  - Deggingen, Baden-Wuerttemberg, Germany, 73326
    - GSK Investigational Site
  - Freiburg, Baden-Wuerttemberg, Germany, 79106
    - GSK Investigational Site
  - Gueglingen, Baden-Wuerttemberg, Germany, 74363
    - GSK Investigational Site
  - Karlsruhe, Baden-Wuerttemberg, Germany, 76199
    - GSK Investigational Site
  - Ludwigsburg, Baden-Wuerttemberg, Germany, 71640
    - GSK Investigational Site
  - Stuttgart, Baden-Wuerttemberg, Germany, 70378
    - GSK Investigational Site
  - Stuttgart, Baden-Wuerttemberg, Germany, 70199
    - GSK Investigational Site
  - Villingen-Schwenningen, Baden-Wuerttemberg, Germany, 78048
    - GSK Investigational Site
  - Wangen, Baden-Wuerttemberg, Germany, 88239
    - GSK Investigational Site
- Bayern
  - Aschaffenburg, Bayern, Germany, 63739
    - GSK Investigational Site
  - Dachau, Bayern, Germany, 85221
    - GSK Investigational Site
  - Haag, Bayern, Germany, 83527
    - GSK Investigational Site
  - Kuenzing, Bayern, Germany, 94550
    - GSK Investigational Site
  - Rednitzhembach, Bayern, Germany, 91126
    - GSK Investigational Site
  - Wallerfing, Bayern, Germany, 94574
    - GSK Investigational Site
- Brandenburg
  - Elsterwerda, Brandenburg, Germany, 04910
    - GSK Investigational Site
  - Falkensee, Brandenburg, Germany, 14612
    - GSK Investigational Site
  - Potsdam, Brandenburg, Germany, 14469
    - GSK Investigational Site
- Hessen
  - Floersheim, Hessen, Germany, 65439
    - GSK Investigational Site
  - Gelnhausen, Hessen, Germany, 63571
    - GSK Investigational Site
- Niedersachsen
  - Hildesheim, Niedersachsen, Germany, 31139
    - GSK Investigational Site
  - Stuhr, Niedersachsen, Germany, 28816
    - GSK Investigational Site
  - Wardenburg, Niedersachsen, Germany, 26203
    - GSK Investigational Site
- Nordrhein-Westfalen
  - Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32545
    - GSK Investigational Site
  - Bochum, Nordrhein-Westfalen, Germany, 44791
    - GSK Investigational Site
  - Bochum, Nordrhein-Westfalen, Germany, 44869
    - GSK Investigational Site
  - Essen, Nordrhein-Westfalen, Germany, 45359
    - GSK Investigational Site
  - Essen, Nordrhein-Westfalen, Germany, 45136
    - GSK Investigational Site
  - Essen, Nordrhein-Westfalen, Germany, 45329
    - GSK Investigational Site
  - Kleve, Nordrhein-Westfalen, Germany, 47533
    - GSK Investigational Site
  - Koeln, Nordrhein-Westfalen, Germany, 51069
    - GSK Investigational Site
  - Muenster, Nordrhein-Westfalen, Germany, 48145
    - GSK Investigational Site
  - Witten, Nordrhein-Westfalen, Germany, 58455
    - GSK Investigational Site
- Rheinland-Pfalz
  - Bad Kreuznach, Rheinland-Pfalz, Germany, 55545
    - GSK Investigational Site
  - Ludwigshafen am Rhein, Rheinland-Pfalz, Germany, 67059
    - GSK Investigational Site
  - Mainz, Rheinland-Pfalz, Germany, 55116
    - GSK Investigational Site
- Saarland
  - Sankt Ingbert, Saarland, Germany, 66386
    - GSK Investigational Site
- Sachsen
  - Chemnitz, Sachsen, Germany, 09113
    - GSK Investigational Site
  - Delitzsch, Sachsen, Germany, 04509
    - GSK Investigational Site
  - Dresden, Sachsen, Germany, 01307
    - GSK Investigational Site
  - Dresden, Sachsen, Germany, 01069
    - GSK Investigational Site
  - Dresden, Sachsen, Germany, 01279
    - GSK Investigational Site
  - Dresden, Sachsen, Germany, 01219
    - GSK Investigational Site
  - Leipzg, Sachsen, Germany, 04109
    - GSK Investigational Site
  - Leipzig, Sachsen, Germany, 04109
    - GSK Investigational Site
  - Leipzig, Sachsen, Germany, 04249
    - GSK Investigational Site
  - Oschatz, Sachsen, Germany, 04758
    - GSK Investigational Site
  - Pirna, Sachsen, Germany, 01796
    - GSK Investigational Site
  - Riesa, Sachsen, Germany, 01587
    - GSK Investigational Site
  - Schkeuditz, Sachsen, Germany, 04435
    - GSK Investigational Site
- Sachsen-Anhalt
  - Hohenmoelsen, Sachsen-Anhalt, Germany, 06679
    - GSK Investigational Site
  - Jerichow, Sachsen-Anhalt, Germany, 39319
    - GSK Investigational Site
  - Magdeburg, Sachsen-Anhalt, Germany, 39112
    - GSK Investigational Site
Greece
- - Alexandroupolis, Greece, 68 100
    - GSK Investigational Site
  - Athens, Greece, 11528
    - GSK Investigational Site
  - Athens, Greece, 11521
    - GSK Investigational Site
  - Athens,, Greece, 11 527
    - GSK Investigational Site
  - Haidari, Athens, Greece, 12462
    - GSK Investigational Site
  - Heraklion, Crete, Greece, 71409
    - GSK Investigational Site
  - Ioannina, Greece, 45500
    - GSK Investigational Site
  - Lamia, Greece, 35100
    - GSK Investigational Site
  - Nikaia Piraeus, Greece, 184 54
    - GSK Investigational Site
  - Pireas, Greece, 18536
    - GSK Investigational Site
  - Thessaloniki, Greece, 546 36
    - GSK Investigational Site
  - Thessaloniki, Greece, 54642
    - GSK Investigational Site
  - Thessaloniki, Greece, 564 29
    - GSK Investigational Site
  - Thessaloniki, Greece, 546 42
    - GSK Investigational Site
  - Thessaloniki, Greece, 570 10
    - GSK Investigational Site
  - Thessaloniki, Greece, 570 01
    - GSK Investigational Site
Hong Kong
- - Hong Kong, Hong Kong
    - GSK Investigational Site
  - Shatin, Hong Kong
    - GSK Investigational Site
Hungary
- - Baja, Hungary, 6500
    - GSK Investigational Site
  - Budapest, Hungary, 1036
    - GSK Investigational Site
  - Budapest, Hungary, 1135
    - GSK Investigational Site
  - Debrecen, Hungary, 4031
    - GSK Investigational Site
  - Debrecen, Hungary, 4026
    - GSK Investigational Site
  - Eger, Hungary, 3300
    - GSK Investigational Site
  - Gödöllő, Hungary, 2100
    - GSK Investigational Site
  - Hatvan, Hungary, 3000
    - GSK Investigational Site
  - Komarom, Hungary, 2900
    - GSK Investigational Site
  - Miskolc, Hungary, 3529
    - GSK Investigational Site
  - Sátoraljaújhely, Hungary, 3980
    - GSK Investigational Site
Italy
- Abruzzo
  - Chieti, Abruzzo, Italy, 66100
    - GSK Investigational Site
- Calabria
  - Catanzaro, Calabria, Italy, 88100
    - GSK Investigational Site
- Campania
  - Napoli, Campania, Italy, 80131
    - GSK Investigational Site
  - Napoli, Campania, Italy, 80138
    - GSK Investigational Site
- Emilia-Romagna
  - Bologna, Emilia-Romagna, Italy, 40138
    - GSK Investigational Site
  - Parma, Emilia-Romagna, Italy, 43100
    - GSK Investigational Site
  - Ravenna, Emilia-Romagna, Italy, 48121
    - GSK Investigational Site
- Lazio
  - Roma, Lazio, Italy, 00186
    - GSK Investigational Site
  - Roma, Lazio, Italy, 00168
    - GSK Investigational Site
  - Roma, Lazio, Italy, 00133
    - GSK Investigational Site
- Liguria
  - Arenzano (GE), Liguria, Italy, 16011
    - GSK Investigational Site
- Lombardia
  - Bergamo, Lombardia, Italy, 24127
    - GSK Investigational Site
  - Milano, Lombardia, Italy, 20132
    - GSK Investigational Site
  - Milano, Lombardia, Italy, 20122
    - GSK Investigational Site
  - Milano, Lombardia, Italy, 20142
    - GSK Investigational Site
  - Vigevano (PV), Lombardia, Italy, 27029
    - GSK Investigational Site
- Marche
  - Ancona, Marche, Italy, 60131
    - GSK Investigational Site
  - Ascoli Piceno, Marche, Italy, 63100
    - GSK Investigational Site
- Puglia
  - Bari, Puglia, Italy, 70124
    - GSK Investigational Site
  - San Giovanni Rotondo (FG), Puglia, Italy, 71013
    - GSK Investigational Site
- Sardegna
  - Olbia (OT), Sardegna, Italy, 07026
    - GSK Investigational Site
- Toscana
  - Siena, Toscana, Italy, 53100
    - GSK Investigational Site
- Umbria
  - S.Andrea Delle Fratte - S. Sisto (PG), Umbria, Italy, 06132
    - GSK Investigational Site
- Veneto
  - Padova, Veneto, Italy, 35128
    - GSK Investigational Site
Korea, Republic of
- - Daegu, Korea, Republic of, 42415
    - GSK Investigational Site
  - Daegu, Korea, Republic of, 700-71
    - GSK Investigational Site
  - Gyeonggi-do, Korea, Republic of, 463-70
    - GSK Investigational Site
  - Gyeonggido, Korea, Republic of, 420-717
    - GSK Investigational Site
  - Kangwondo, Korea, Republic of, 220-701
    - GSK Investigational Site
  - Pusan, Korea, Republic of, 602-73
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 120-752
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 110-744
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 152-703
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 135-71
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 150-95
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 134-72
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 135-72
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 137-70
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 411-70
    - GSK Investigational Site
  - Suwon, Korea, Republic of, 442-723
    - GSK Investigational Site
  - Suwon, Kyonggi-do, Korea, Republic of, 443-72
    - GSK Investigational Site
Mexico
- - Aguascalientes, Mexico, 20230
    - GSK Investigational Site
  - Mexico, D.F., Mexico, 11650
    - GSK Investigational Site
- Aguascalientes
  - Aguascalientes, Ags, Aguascalientes, Mexico, 20127
    - GSK Investigational Site
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44600
    - GSK Investigational Site
  - Guadalajara, Jalisco, Mexico, 44150
    - GSK Investigational Site
  - Guadalajara, Jalisco, Mexico, 45116
    - GSK Investigational Site
  - Tlaquepaque, Jalisco, Mexico, 45510
    - GSK Investigational Site
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64460
    - GSK Investigational Site
  - Monterrey NL, Nuevo León, Mexico, 64718
    - GSK Investigational Site
- Querétaro
  - Queretaro, Querétaro, Mexico, 76000
    - GSK Investigational Site
- Sinaloa
  - Mazatlán, Sinaloa, Mexico, 82126
    - GSK Investigational Site
  - Mazatlán, Sinaloa, Mexico
    - GSK Investigational Site
- Yucatán
  - Mérida, Yucatán, Mexico, 97129
    - GSK Investigational Site
Netherlands
- - Alkmaar, Netherlands, 1815 JD
    - GSK Investigational Site
  - Amsterdam, Netherlands, 1061 A
    - GSK Investigational Site
  - Eindhoven, Netherlands, 5631 BM
    - GSK Investigational Site
  - Gouda, Netherlands, 2803 H
    - GSK Investigational Site
  - Hardenberg, Netherlands, 7772 SE
    - GSK Investigational Site
  - Heerlen, Netherlands, 6419 PC
    - GSK Investigational Site
  - Hoogeveen, Netherlands, 7909 A
    - GSK Investigational Site
  - Meppel, Netherlands, 7943 K
    - GSK Investigational Site
  - Rotterdam, Netherlands, 3051 G
    - GSK Investigational Site
  - Sneek, Netherlands, 8601 Z
    - GSK Investigational Site
Norway
- - Hoenefoss, Norway, 3513
    - GSK Investigational Site
  - Kolbjørnsvik, Norway, 4816
    - GSK Investigational Site
  - Oslo, Norway, 0319
    - GSK Investigational Site
  - Oslo, Norway, 0586
    - GSK Investigational Site
  - Stavanger, Norway, 4011
    - GSK Investigational Site
Peru
- - Arequipa, Peru
    - GSK Investigational Site
  - Lima, Peru, 01
    - GSK Investigational Site
  - Lima, Peru, 17
    - GSK Investigational Site
  - Lima, Peru, Lima 32
    - GSK Investigational Site
  - Lima, Peru, Lima 14
    - GSK Investigational Site
  - Lima, Peru, Lima 29
    - GSK Investigational Site
  - Piura, Peru, 20001
    - GSK Investigational Site
- La Libertad
  - Trujillo, La Libertad, Peru, 13001
    - GSK Investigational Site
- Lima
  - Callao, Lima, Peru, Callao 2
    - GSK Investigational Site
  - San Martin de Porres, Lima, Peru, Lima 33
    - GSK Investigational Site
Philippines
- - Cebu City, Philippines, 6000
    - GSK Investigational Site
  - Iloilo City, Philippines, 5000
    - GSK Investigational Site
  - Laoag City, Philippines, 2900
    - GSK Investigational Site
Poland
- - Bialystok, Poland, 15-435
    - GSK Investigational Site
  - Bydgoszcz, Poland, 85-863
    - GSK Investigational Site
  - Bydgoszcz, Poland, 85-231
    - GSK Investigational Site
  - Gdansk, Poland, 80-858
    - GSK Investigational Site
  - Gniewkowo, Poland, 88-140
    - GSK Investigational Site
  - Katowice, Poland, 40-081
    - GSK Investigational Site
  - Katowice, Poland, 40-772
    - GSK Investigational Site
  - Krakow, Poland, 31-530
    - GSK Investigational Site
  - Krakow, Poland, 30-539
    - GSK Investigational Site
  - Krakow, Poland, 31-261
    - GSK Investigational Site
  - Lublin, Poland, 20-538
    - GSK Investigational Site
  - Poznan, Poland, 60-111
    - GSK Investigational Site
  - Poznan, Poland, 61-655
    - GSK Investigational Site
  - Sopot, Poland, 81- 71
    - GSK Investigational Site
  - Warszawa, Poland, 00-465
    - GSK Investigational Site
  - Wierzchoslawice, Poland, 33-122
    - GSK Investigational Site
  - Wroclaw, Poland, 54-239
    - GSK Investigational Site
  - Wroclaw, Poland, 50-127
    - GSK Investigational Site
  - Wroclaw, Poland, 50-981
    - GSK Investigational Site
Russian Federation
- - Arkhangelsk, Russian Federation, 163045
    - GSK Investigational Site
  - Barnaul, Russian Federation, 656 045
    - GSK Investigational Site
  - Chelyabinsk, Russian Federation, 454021
    - GSK Investigational Site
  - Chelyabinsk, Russian Federation, 454047
    - GSK Investigational Site
  - Ekaterinburg, Russian Federation, 620039
    - GSK Investigational Site
  - Ekaterinburg, Russian Federation, 620149
    - GSK Investigational Site
  - Ivanovo, Russian Federation, 153005
    - GSK Investigational Site
  - Kemerovo, Russian Federation, 650000
    - GSK Investigational Site
  - Kemerovo, Russian Federation, 650002
    - GSK Investigational Site
  - Krasnodar, Russian Federation, 350086
    - GSK Investigational Site
  - Moscow, Russian Federation, 117292
    - GSK Investigational Site
  - Moscow, Russian Federation, 129110
    - GSK Investigational Site
  - Moscow, Russian Federation, 119992
    - GSK Investigational Site
  - Moscow, Russian Federation, 119435
    - GSK Investigational Site
  - Moscow, Russian Federation, 117 036
    - GSK Investigational Site
  - Moscow, Russian Federation, 117 03
    - GSK Investigational Site
  - Moscow, Russian Federation, 127411
    - GSK Investigational Site
  - Nizhniy Novgorod, Russian Federation, 603126
    - GSK Investigational Site
  - Nizhny Novgorod, Russian Federation, 603003
    - GSK Investigational Site
  - Novosibirsk, Russian Federation, 630091
    - GSK Investigational Site
  - Novosibirsk, Russian Federation, 630047
    - GSK Investigational Site
  - Perm, Russian Federation, 614097
    - GSK Investigational Site
  - Rostov-on-Don, Russian Federation, 344022
    - GSK Investigational Site
  - Ryazan, Russian Federation, 390039
    - GSK Investigational Site
  - Saint Petersburg, Russian Federation, 195257
    - GSK Investigational Site
  - Samara, Russian Federation, 443067
    - GSK Investigational Site
  - Saratov, Russian Federation, 410053
    - GSK Investigational Site
  - Tomsk, Russian Federation, 634050
    - GSK Investigational Site
  - Tomsk, Russian Federation, 634012
    - GSK Investigational Site
  - Tomsk, Russian Federation, 634041
    - GSK Investigational Site
  - Voronezh, Russian Federation, 394018
    - GSK Investigational Site
  - Yaroslavl, Russian Federation, 150003
    - GSK Investigational Site
  - Yaroslavl, Russian Federation, 150000
    - GSK Investigational Site
  - Yaroslavl, Russian Federation, 150030
    - GSK Investigational Site
  - Yaroslavl, Russian Federation, 150010
    - GSK Investigational Site
South Africa
- - Bloemfontein, South Africa, 9301
    - GSK Investigational Site
  - Cape Town, South Africa, 7500
    - GSK Investigational Site
  - Houghton, South Africa, 2198
    - GSK Investigational Site
  - Kuilsrivier, South Africa, 7580
    - GSK Investigational Site
  - Paarl, South Africa, 7646
    - GSK Investigational Site
  - Pinelands, South Africa, 7405
    - GSK Investigational Site
  - Umhlanga, South Africa, 4319
    - GSK Investigational Site
- Free State
  - Bloemfontein, Free State, South Africa, 9301
    - GSK Investigational Site
- KwaZulu- Natal
  - Tongaat, KwaZulu- Natal, South Africa, 4400
    - GSK Investigational Site
Spain
- - Alicante, Spain, 03004
    - GSK Investigational Site
  - Almeria, Spain, 4001
    - GSK Investigational Site
  - Alzira/Valencia, Spain, 46600
    - GSK Investigational Site
  - Badalona, Spain, 08916
    - GSK Investigational Site
  - Badalona / Barcelona, Spain, 08917
    - GSK Investigational Site
  - Barcelona, Spain, 08003
    - GSK Investigational Site
  - Barcelona, Spain, 08907
    - GSK Investigational Site
  - Barcelona, Spain, 08006
    - GSK Investigational Site
  - Barcelona, Spain, 08026
    - GSK Investigational Site
  - Boadilla Del Monte (Madrid), Spain, 28660
    - GSK Investigational Site
  - Canet De Mar - Barcelona, Spain, 08360
    - GSK Investigational Site
  - Cangas Del Narcea/Asturias, Spain, 33800
    - GSK Investigational Site
  - Centelles (Barcelona), Spain, 08540
    - GSK Investigational Site
  - Córdoba, Spain, 14004
    - GSK Investigational Site
  - Elche, Spain, 03293
    - GSK Investigational Site
  - Granada, Spain, 18012
    - GSK Investigational Site
  - La Coruña, Spain, 15006
    - GSK Investigational Site
  - León, Spain, 24071
    - GSK Investigational Site
  - Madrid, Spain, 28006
    - GSK Investigational Site
  - Madrid, Spain, 28040
    - GSK Investigational Site
  - Madrid, Spain, 28046
    - GSK Investigational Site
  - Madrid, Spain, 28034
    - GSK Investigational Site
  - Madrid, Spain, 28050
    - GSK Investigational Site
  - Malaga, Spain, 29010
    - GSK Investigational Site
  - Málaga, Spain, 29010
    - GSK Investigational Site
  - Palma de Mallorca, Spain, 07010
    - GSK Investigational Site
  - Palma de Mallorca, Spain, 07198
    - GSK Investigational Site
  - Pontevedra, Spain, 36071
    - GSK Investigational Site
  - Pozuelo De Alarcón/Madrid, Spain, 28223
    - GSK Investigational Site
  - Sagunto/Valencia, Spain, 46520
    - GSK Investigational Site
  - San Juan (Alicante), Spain, 03550
    - GSK Investigational Site
  - Sanlucar De Barrameda - Cádiz, Spain, 11540
    - GSK Investigational Site
  - Santa Coloma De Gramanet (Barcelona), Spain, 08923
    - GSK Investigational Site
  - Santiago De Compostela, Spain, 15706
    - GSK Investigational Site
  - Sevilla, Spain, 41014
    - GSK Investigational Site
  - Tarrasa, Barcelona, Spain, 08221
    - GSK Investigational Site
  - Valencia, Spain, 46017
    - GSK Investigational Site
  - Valencia, Spain, 46026
    - GSK Investigational Site
  - Valencia, Spain, 46010
    - GSK Investigational Site
  - Vigo-Pontevedra, Spain, 36312
    - GSK Investigational Site
Sweden
- - Borås, Sweden, SE-506
    - GSK Investigational Site
  - Eksjö, Sweden, SE-575 35
    - GSK Investigational Site
  - Göteborg, Sweden, SE-413 45
    - GSK Investigational Site
  - Helsingborg, Sweden, SE-252
    - GSK Investigational Site
  - Härnösand, Sweden, SE-871
    - GSK Investigational Site
  - Karlskrona, Sweden, SE-371 41
    - GSK Investigational Site
  - Kristianstad, Sweden, SE-291 85
    - GSK Investigational Site
  - Linköping, Sweden, SE-587 58
    - GSK Investigational Site
  - Ljungby, Sweden, SE-341
    - GSK Investigational Site
  - Malmö, Sweden, SE-205 02
    - GSK Investigational Site
  - Rättvik, Sweden, SE-795 30
    - GSK Investigational Site
  - Stockholm, Sweden, SE-182 88
    - GSK Investigational Site
  - Stockholm, Sweden, SE-113 61
    - GSK Investigational Site
  - Stockholm, Sweden, SE-111
    - GSK Investigational Site
  - Umeå, Sweden, SE-901 85
    - GSK Investigational Site
  - Uppsala, Sweden, SE-752
    - GSK Investigational Site
  - Örebro, Sweden, SE-703 62
    - GSK Investigational Site
Taiwan
- - Changhua, Taiwan, 500
    - GSK Investigational Site
  - Hualien, Taiwan, 970
    - GSK Investigational Site
  - Kaohsiung, Taiwan, 833
    - GSK Investigational Site
  - Taichung, Taiwan, 433
    - GSK Investigational Site
  - Tainan, Taiwan, 71004
    - GSK Investigational Site
  - Taipei, Taiwan, 112
    - GSK Investigational Site
  - Taipei, Taiwan, 10002
    - GSK Investigational Site
Thailand
- - Bangkok, Thailand, 10400
    - GSK Investigational Site
  - Bangkok, Thailand, 10330
    - GSK Investigational Site
  - Chiangmai, Thailand, 50200
    - GSK Investigational Site
  - Pathumthani, Thailand, 12120
    - GSK Investigational Site
  - Songkla, Thailand, 90110
    - GSK Investigational Site
Ukraine
- - Chernivtsi, Ukraine, 58022
    - GSK Investigational Site
  - Dnipropetrovsk, Ukraine, 49038
    - GSK Investigational Site
  - Kharkiv, Ukraine, 61070
    - GSK Investigational Site
  - Kharkiv, Ukraine, 61058
    - GSK Investigational Site
  - Kherson, Ukraine, 73000
    - GSK Investigational Site
  - Kyiv, Ukraine, 02091
    - GSK Investigational Site
  - Kyiv, Ukraine, 03049
    - GSK Investigational Site
  - Kyiv, Ukraine, 04050
    - GSK Investigational Site
  - Kyiv, Ukraine, 01021
    - GSK Investigational Site
  - Kyiv, Ukraine, 04114
    - GSK Investigational Site
  - Kyiv, Ukraine, 01004
    - GSK Investigational Site
  - Mykolaiv, Ukraine, 54003
    - GSK Investigational Site
  - Odesa, Ukraine, 65025
    - GSK Investigational Site
  - Poltava, Ukraine, 36011
    - GSK Investigational Site
  - Uzhgorod, Ukraine, 88000
    - GSK Investigational Site
  - Vinnytsia, Ukraine, 21010
    - GSK Investigational Site
  - Zaporizhzhya, Ukraine, 69001
    - GSK Investigational Site
United Kingdom
- - Aberdeen, United Kingdom, AB25 2
    - GSK Investigational Site
  - Axbridge, Somerset, United Kingdom, BS26 2
    - GSK Investigational Site
  - Ayr, United Kingdom, KA6 6D
    - GSK Investigational Site
  - Blackpool, United Kingdom, FY3 8NR
    - GSK Investigational Site
  - Bristol, United Kingdom, BS10 5
    - GSK Investigational Site
  - Dumfries, United Kingdom, DG1 4AP
    - GSK Investigational Site
  - Dundee, United Kingdom, DD1 9S
    - GSK Investigational Site
  - Dundee, United Kingdom, DD4 6Q
    - GSK Investigational Site
  - Dundee, United Kingdom, DD5 4LX
    - GSK Investigational Site
  - Fife, United Kingdom, KY14 7AW
    - GSK Investigational Site
  - Fife, United Kingdom, KY2 5A
    - GSK Investigational Site
  - Gloucester, United Kingdom, GL1 3N
    - GSK Investigational Site
  - Lancaster, United Kingdom, LA1 4R
    - GSK Investigational Site
  - Manchester, United Kingdom, M23 9LT
    - GSK Investigational Site
  - Newport, United Kingdom, PO30 5
    - GSK Investigational Site
  - Oxford, United Kingdom, OX3 7L
    - GSK Investigational Site
  - Rotherham, United Kingdom, S60 2UD
    - GSK Investigational Site
  - Sidcup, Kent, United Kingdom, DA14 6
    - GSK Investigational Site
  - Trowbridge, United Kingdom, BA14 9
    - GSK Investigational Site
  - Wigan, United Kingdom, WN1 2NN
    - GSK Investigational Site
- Cambridgeshire
  - Soham, Cambridgeshire, United Kingdom, CB7 5J
    - GSK Investigational Site
- Derbyshire
  - Chesterfield, Derbyshire, United Kingdom, S40 4AAA
    - GSK Investigational Site
- Essex
  - Romford, Essex, United Kingdom, RM1 3P
    - GSK Investigational Site
- Middlesex
  - Northwood, Middlesex, United Kingdom, HA6 2R
    - GSK Investigational Site
- Midlothian
  - Edinburgh, Midlothian, United Kingdom, EH4 2XU
    - GSK Investigational Site
- Wiltshire
  - Trowbridge, Wiltshire, United Kingdom, BA14 8
    - GSK Investigational Site
United States
- Alabama
  - Birmingham, Alabama, United States, 35235
    - GSK Investigational Site
  - Birmingham, Alabama, United States, 35211
    - GSK Investigational Site
  - Mobile, Alabama, United States, 36608
    - GSK Investigational Site
- Arizona
  - Chandler, Arizona, United States, 85284
    - GSK Investigational Site
  - Glendale, Arizona, United States, 85308
    - GSK Investigational Site
  - Goodyear, Arizona, United States, 85395
    - GSK Investigational Site
  - Tempe, Arizona, United States, 85283
    - GSK Investigational Site
  - Tucson, Arizona, United States, 85745
    - GSK Investigational Site
  - Tucson, Arizona, United States, 85741
    - GSK Investigational Site
- Arkansas
  - Little Rock, Arkansas, United States, 72209
    - GSK Investigational Site
  - Searcy, Arkansas, United States, 72143
    - GSK Investigational Site
- California
  - Chula Vista, California, United States, 91910
    - GSK Investigational Site
  - Lancaster, California, United States, 93534
    - GSK Investigational Site
  - Lomita, California, United States, 90717
    - GSK Investigational Site
  - Long Beach, California, United States, 90807
    - GSK Investigational Site
  - Long Beach, California, United States, 90822
    - GSK Investigational Site
  - Los Angeles, California, United States, 90073
    - GSK Investigational Site
  - Los Angeles, California, United States, 90017
    - GSK Investigational Site
  - Moreno Valley, California, United States, 92555
    - GSK Investigational Site
  - Northridge, California, United States, 91325
    - GSK Investigational Site
  - Oakland, California, United States, 94607
    - GSK Investigational Site
  - San Diego, California, United States, 92103
    - GSK Investigational Site
  - San Diego, California, United States, 92117
    - GSK Investigational Site
  - San Marino, California, United States, 91108
    - GSK Investigational Site
  - San Ramon, California, United States, 94583
    - GSK Investigational Site
  - Simi Valley, California, United States, 93065
    - GSK Investigational Site
  - Stanford, California, United States, 94305
    - GSK Investigational Site
  - Torrance, California, United States, 90502
    - GSK Investigational Site
- Colorado
  - Denver, Colorado, United States, 80220
    - GSK Investigational Site
  - Littleton, Colorado, United States, 80120
    - GSK Investigational Site
  - Littleton, Colorado, United States, 80127
    - GSK Investigational Site
- Connecticut
  - New Haven, Connecticut, United States, 06511
    - GSK Investigational Site
- Florida
  - Belle Glade, Florida, United States, 33430
    - GSK Investigational Site
  - Bradenton, Florida, United States, 34201
    - GSK Investigational Site
  - Bradenton, Florida, United States, 34209
    - GSK Investigational Site
  - Coral Gables, Florida, United States, 33134
    - GSK Investigational Site
  - Coral Springs, Florida, United States, 33065
    - GSK Investigational Site
  - Fleming Island, Florida, United States, 32003
    - GSK Investigational Site
  - Inverness, Florida, United States, 34452
    - GSK Investigational Site
  - Jacksonville, Florida, United States, 32216
    - GSK Investigational Site
  - Lake Worth, Florida, United States, 33467
    - GSK Investigational Site
  - Lakeland, Florida, United States, 33805
    - GSK Investigational Site
  - Miami, Florida, United States, 33174
    - GSK Investigational Site
  - Ocala, Florida, United States, 34471
    - GSK Investigational Site
  - Ponte Vedra, Florida, United States, 32081
    - GSK Investigational Site
  - Port Charlotte, Florida, United States, 33952
    - GSK Investigational Site
  - Port Orange, Florida, United States, 32127
    - GSK Investigational Site
  - Saint Petersburg, Florida, United States, 33713
    - GSK Investigational Site
  - Vero Beach, Florida, United States, 32960
    - GSK Investigational Site
  - Wellington, Florida, United States, 33449
    - GSK Investigational Site
- Georgia
  - Atlanta, Georgia, United States, 30342
    - GSK Investigational Site
  - Atlanta, Georgia, United States, 30318
    - GSK Investigational Site
  - Conyers, Georgia, United States, 30094
    - GSK Investigational Site
  - Cumming, Georgia, United States, 30041
    - GSK Investigational Site
  - Decatur, Georgia, United States, 30033
    - GSK Investigational Site
  - Dunwoody, Georgia, United States, 30338
    - GSK Investigational Site
  - Snellville, Georgia, United States, 30078
    - GSK Investigational Site
  - Tucker, Georgia, United States, 30084
    - GSK Investigational Site
- Illinois
  - Aurora, Illinois, United States, 60504
    - GSK Investigational Site
  - Champaign, Illinois, United States, 61820
    - GSK Investigational Site
  - Gurnee, Illinois, United States, 60031
    - GSK Investigational Site
  - Moline, Illinois, United States, 61265
    - GSK Investigational Site
- Indiana
  - Avon, Indiana, United States, 46123
    - GSK Investigational Site
  - Franklin, Indiana, United States, 46131
    - GSK Investigational Site
  - Greenfield, Indiana, United States, 46140
    - GSK Investigational Site
  - Muncie, Indiana, United States, 47304-
    - GSK Investigational Site
  - Munster, Indiana, United States, 46321
    - GSK Investigational Site
- Iowa
  - West Des Moines, Iowa, United States, 50265
    - GSK Investigational Site
- Kansas
  - Topeka, Kansas, United States, 66606
    - GSK Investigational Site
- Kentucky
  - Lexington, Kentucky, United States, 40503
    - GSK Investigational Site
  - Louisville, Kentucky, United States, 40213
    - GSK Investigational Site
- Louisiana
  - New Orleans, Louisiana, United States, 70115
    - GSK Investigational Site
- Maine
  - Lewiston, Maine, United States, 04240
    - GSK Investigational Site
- Maryland
  - Annapolis, Maryland, United States, 21401
    - GSK Investigational Site
- Minnesota
  - Saint Cloud, Minnesota, United States, 56303
    - GSK Investigational Site
  - Saint Paul, Minnesota, United States, 55102
    - GSK Investigational Site
- Missouri
  - Saint Louis, Missouri, United States, 63136
    - GSK Investigational Site
- Nebraska
  - Omaha, Nebraska, United States, 68124
    - GSK Investigational Site
- Nevada
  - Las Vegas, Nevada, United States, 89086
    - GSK Investigational Site
- New Jersey
  - Camden, New Jersey, United States, 08103
    - GSK Investigational Site
  - Haddon Heights, New Jersey, United States, 08035
    - GSK Investigational Site
- New Mexico
  - Albuquerque, New Mexico, United States, 87102
    - GSK Investigational Site
- New York
  - Brooklyn, New York, United States, 11215
    - GSK Investigational Site
  - North Massapequa, New York, United States, 11758
    - GSK Investigational Site
- North Carolina
  - Charlotte, North Carolina, United States, 28207
    - GSK Investigational Site
  - Charlotte, North Carolina, United States, 28209
    - GSK Investigational Site
  - Charlotte, North Carolina, United States, 28277
    - GSK Investigational Site
  - Hickory, North Carolina, United States, 28601
    - GSK Investigational Site
  - Rocky Mount, North Carolina, United States, 27804
    - GSK Investigational Site
  - Salisbury, North Carolina, United States, 28144
    - GSK Investigational Site
  - Statesville, North Carolina, United States, 28625
    - GSK Investigational Site
  - Wilmington, North Carolina, United States, 28401
    - GSK Investigational Site
  - Winston-Salem, North Carolina, United States, 27157
    - GSK Investigational Site
- North Dakota
  - Fargo, North Dakota, United States, 58103
    - GSK Investigational Site
- Ohio
  - Cleveland, Ohio, United States, 44122
    - GSK Investigational Site
  - Columbus, Ohio, United States, 43210
    - GSK Investigational Site
  - Sandusky, Ohio, United States, 44870
    - GSK Investigational Site
  - Springfield, Ohio, United States, 45504
    - GSK Investigational Site
  - Toledo, Ohio, United States, 43614
    - GSK Investigational Site
- Pennsylvania
  - Camp Hill, Pennsylvania, United States, 17011
    - GSK Investigational Site
  - Feasterville, Pennsylvania, United States, 19053
    - GSK Investigational Site
  - Harleysville, Pennsylvania, United States, 19438
    - GSK Investigational Site
  - Jersey Shore, Pennsylvania, United States, 17740
    - GSK Investigational Site
  - Lansdale, Pennsylvania, United States, 19446
    - GSK Investigational Site
  - Newport, Pennsylvania, United States, 17074
    - GSK Investigational Site
  - Penndel, Pennsylvania, United States, 19047
    - GSK Investigational Site
  - Pittsburgh, Pennsylvania, United States, 15212
    - GSK Investigational Site
  - Pittsburgh, Pennsylvania, United States, 15240
    - GSK Investigational Site
  - Sellersville, Pennsylvania, United States, 18960
    - GSK Investigational Site
- Rhode Island
  - Pawtucket, Rhode Island, United States, 02860
    - GSK Investigational Site
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - GSK Investigational Site
  - Columbia, South Carolina, United States, 29223
    - GSK Investigational Site
  - Myrtle Beach, South Carolina, United States, 29572
    - GSK Investigational Site
- South Dakota
  - Rapid City, South Dakota, United States, 57701
    - GSK Investigational Site
  - Rapid City, South Dakota, United States, 57702
    - GSK Investigational Site
- Tennessee
  - Bristol, Tennessee, United States, 37620
    - GSK Investigational Site
  - Kingsport, Tennessee, United States, 37660
    - GSK Investigational Site
  - Memphis, Tennessee, United States, 38119
    - GSK Investigational Site
  - Memphis, Tennessee, United States, 38104
    - GSK Investigational Site
  - Nashville, Tennessee, United States, 37212
    - GSK Investigational Site
  - Nashville, Tennessee, United States, 37203
    - GSK Investigational Site
- Texas
  - Arlington, Texas, United States, 76014
    - GSK Investigational Site
  - Austin, Texas, United States, 78731
    - GSK Investigational Site
  - Bellaire, Texas, United States, 77401
    - GSK Investigational Site
  - Dallas, Texas, United States, 75231
    - GSK Investigational Site
  - Dallas, Texas, United States, 75216
    - GSK Investigational Site
  - Dallas, Texas, United States, 75234
    - GSK Investigational Site
  - Dallas, Texas, United States
    - GSK Investigational Site
  - El Paso, Texas, United States, 79925
    - GSK Investigational Site
  - Georgetown, Texas, United States, 78626
    - GSK Investigational Site
  - Houston, Texas, United States, 77070
    - GSK Investigational Site
  - Huntsville, Texas, United States, 77340
    - GSK Investigational Site
  - Kingwood, Texas, United States, 77339
    - GSK Investigational Site
  - Plano, Texas, United States, 75093
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78229
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78258
    - GSK Investigational Site
  - Schertz, Texas, United States, 78154
    - GSK Investigational Site
  - Suite 101, Texas, United States, 76132
    - GSK Investigational Site
  - Tyler, Texas, United States, 75708
    - GSK Investigational Site
- Utah
  - Layton, Utah, United States, 84401
    - GSK Investigational Site
- Virginia
  - Manassas, Virginia, United States, 20109
    - GSK Investigational Site
- Washington
  - Federal Way, Washington, United States, 98003
    - GSK Investigational Site
  - Spokane, Washington, United States, 99208
    - GSK Investigational Site
  - Tacoma, Washington, United States, 98405
    - GSK Investigational Site
  - Wenatchee, Washington, United States, 98801
    - GSK Investigational Site
- Wisconsin
  - Madison, Wisconsin, United States, 53713
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Men or women at least 40 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy.
Diagnosis of type 2 diabetes.
Established cardiovascular disease with at least one of the following: coronary artery disease, cerebrovascular disease, or peripheral arterial disease.
HbA1c >7.0% (53 mmol/mol) (based on the most recent documented laboratory measurement within 6 months).
Able and willing to provide informed consent.

Exclusion Criteria:

Severely reduced kidney function: eGFR <30 ml/min/1.73 m^2 (based on the last measured and documented laboratory measurement within 6 months) or renal replacement therapy.
Use of a GLP-1 receptor agonist at Screening.
Severe gastroparesis
History of pancreatitis or considered clinically at significant risk of developing pancreatitis during the course of the study.
Personal or family history of medullary carcinoma of the thyroid or subject with multiple endocrine neoplasia type 2 (MEN-2). Personal history of pancreatic neuroendocrine tumours.
Medical history which might limit the subject's ability to take trial treatments for the duration of the study or to otherwise complete the study.
Breastfeeding, pregnancy, or planning a pregnancy during the course of the study. Note: a pregnancy test will be performed on all women of child bearing potential prior to study entry.
Known allergy to any GLP-1 receptor agonist or excipients of albiglutide.
Use of another investigational product within 30 days or according to local regulations, or currently enrolled in a study of an investigational device.
Any other reason the investigator deems the subject to be unsuitable for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Biological: Albiglutide 30 mg Once weekly subcutaneous injection. Starting dose 30 mg may be increased to 50 mg if needed. Biological: Albiglutide 50 mg Once weekly subcutaneous injection. Starting dose 30 mg may be increased to 50 mg if needed.
Placebo Comparator: Placebo Placebo once weekly by subcutaneous injection. Placebo will be administered in addition to standard therapy for diabetes and cardiovascular health.	Biological: Albiglutide matching placebo Once weekly subcutaneous injection. Matched to 30 mg and 50 mg albiglutide.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Median of 1.65 person years for CV follow-up time period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Occurrence of MACE or Urgent Revascularization for Unstable Angina Time Frame: Median of 1.65 person years for CV follow-up time period	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.	Median of 1.65 person years for CV follow-up time period
Time to Adjudicated CV Death Time Frame: Median of 1.65 person years for the CV follow-up time period	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.	Median of 1.65 person years for the CV follow-up time period
Time to First Occurrence of Adjudicated MI Time Frame: Median of 1.65 person years for CV follow-up time period	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.	Median of 1.65 person years for CV follow-up time period
Time to First Occurrence of Adjudicated Stroke Time Frame: Median of 1.65 person years for CV follow-up time period	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.	Median of 1.65 person years for CV follow-up time period
Time to First Occurrence of Adjudicated CV Death or Hospitalization for Heart Failure (HF) Time Frame: Median of 1.65 person years for CV follow-up time period	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.	Median of 1.65 person years for CV follow-up time period
Time to Initiation of Insulin of More Than 3 Months Duration for Those Participants Not Treated With Insulin at Study Start Time Frame: Up to 2.7 years	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.	Up to 2.7 years
Time to Initiation of Prandial Insulin in Those Participants on Basal Insulin at Study Start Time Frame: Up to 2.7 years	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).	Up to 2.7 years
Percentage of Participants Achieving Composite Metabolic Endpoint Time Frame: Months 8, 16, 24 and final assessment (up to 2.7 years)	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.	Months 8, 16, 24 and final assessment (up to 2.7 years)
Time to First Occurrence of a Clinically Important Microvascular Event Time Frame: Up to 2.7 years	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.	Up to 2.7 years
Change From Baseline in HbA1c Time Frame: Baseline and Months 8 and 16	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.	Baseline and Months 8 and 16
Change From Baseline in Body Weight Time Frame: Baseline and Months 8 and 16	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.	Baseline and Months 8 and 16
Change From Baseline in Treatment Related Impact Measures-Diabetes (TRIM-D) Total Score Time Frame: Baseline and Months 8 and 16	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.	Baseline and Months 8 and 16
Change From Baseline in EuroQol- 5 Dimension (EQ-5D) Visual Analogue Scale (VAS) Score Time Frame: Baseline and Months 8 and 16	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.	Baseline and Months 8 and 16
Time to Death Time Frame: Median of 1.73 years for the Vital Status follow-up time period	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.	Median of 1.73 years for the Vital Status follow-up time period
Number of Participants With Non-fatal Serious Adverse Events (SAEs) Time Frame: Up to 2.7 years	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.	Up to 2.7 years
Number of Participants With Adverse Events (AEs) Leading to Discontinuation of Investigational Product (AELD) Time Frame: Up to 2.7 years	The number of participants with on-therapy AEs leading to discontinuation of investigational product is reported.	Up to 2.7 years
Number of Participants With AEs of Special Interest Time Frame: Up to 2.7 years	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.	Up to 2.7 years
Change in Estimated Glomerular Filtration Rate (eGFR) Calculated Using Modification of Diet in Renal Disease (MDRD) Formula Time Frame: Baseline and Months 8 and 16	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.	Baseline and Months 8 and 16
Change From Baseline in Blood Pressure Time Frame: Baseline and Months 8,16,24 and end of study (up to 2.7 years)	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.	Baseline and Months 8,16,24 and end of study (up to 2.7 years)
Change From Baseline in Heart Rate Time Frame: Baseline and Months 8, 16, 24 and end of study (up to 2.7 years)	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.	Baseline and Months 8, 16, 24 and end of study (up to 2.7 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Collaborators

Duke Clinical Research Institute

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

February 20, 2018

Study Completion (Actual)

March 14, 2018

Study Registration Dates

First Submitted

June 4, 2015

First Submitted That Met QC Criteria

June 4, 2015

First Posted (Estimate)

June 8, 2015

Study Record Updates

Last Update Posted (Actual)

March 6, 2019

Last Update Submitted That Met QC Criteria

February 11, 2019

Last Verified

February 1, 2019

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Other Study ID Numbers

116174
2014-001824-32 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Clinical Trials on Diabetes Mellitus

Clinical Trials on Albiglutide 30 mg

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