A Study to Determine the Safety and Efficacy of Albiglutide in Patients With Type 2 Diabetes

November 18, 2016 updated by: GlaxoSmithKline

A Randomized, Open-label, Parallel-group, Multicenter Study to Determine the Efficacy and Long-term Safety of Albiglutide Compared With Insulin in Subjects With Type 2 Diabetes Mellitus.

A study to determine the safety and efficacy of albiglutide in subjects with type 2 diabetes.

Study Overview

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

779

Phase

Phase 3

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

Russian Federation
- - Arkhangelsk, Russian Federation, 163045
    - GSK Investigational Site
  - Irkutsk, Russian Federation, 664003
    - GSK Investigational Site
  - Nizhniy Novgorod, Russian Federation, 603126
    - GSK Investigational Site
  - Saratov, Russian Federation, 410030
    - GSK Investigational Site
  - Smolensk, Russian Federation, 214019
    - GSK Investigational Site
  - Yaroslavl, Russian Federation, 150062
    - GSK Investigational Site
South Africa
- - Cape Town, South Africa, 7530
    - GSK Investigational Site
  - Kempton Park, South Africa, 1619
    - GSK Investigational Site
  - Parow, South Africa, 7505
    - GSK Investigational Site
- Eastern Cape
  - Port Elizabeth, Eastern Cape, South Africa, 6014
    - GSK Investigational Site
- Gauteng
  - Johannesburg, Gauteng, South Africa, 2013
    - GSK Investigational Site
  - Johannesburg, Gauteng, South Africa, 01820
    - GSK Investigational Site
  - Lenasia, Gauteng, South Africa, 1827
    - GSK Investigational Site
  - Parktown, Gauteng, South Africa, 2193
    - GSK Investigational Site
  - Pretoria, Gauteng, South Africa, 00083
    - GSK Investigational Site
- KwaZulu- Natal
  - Phoenix, KwaZulu- Natal, South Africa, 4068
    - GSK Investigational Site
- Western Province
  - Somerset West, Western Province, South Africa, 7129
    - GSK Investigational Site
United Kingdom
- - Liverpool, United Kingdom, L9 7AL
    - GSK Investigational Site
  - London, United Kingdom, SE1 9NH
    - GSK Investigational Site
- Lancashire
  - Blackpool, Lancashire, United Kingdom, FY4 3AD
    - GSK Investigational Site
- Middlesex
  - Sunbury-on-Thames, Middlesex, United Kingdom, TW16 6RH
    - GSK Investigational Site
- Renfrewshire
  - Port Glasgow, Renfrewshire, United Kingdom, PA14 6HW
    - GSK Investigational Site
- West Midlands
  - Coventry, West Midlands, United Kingdom, CV2 2DX
    - GSK Investigational Site
United States
- Alabama
  - Alabaster, Alabama, United States, 35007
    - GSK Investigational Site
  - Birmingham, Alabama, United States, 35235
    - GSK Investigational Site
  - Birmingham, Alabama, United States, 35205
    - GSK Investigational Site
  - Dothan, Alabama, United States, 36301
    - GSK Investigational Site
  - Hueytown, Alabama, United States, 35023
    - GSK Investigational Site
  - Mobile, Alabama, United States, 36617
    - GSK Investigational Site
  - Tuscaloosa, Alabama, United States, 35406
    - GSK Investigational Site
- Arizona
  - Chandler, Arizona, United States, 85224
    - GSK Investigational Site
  - Gilbert, Arizona, United States, 85295
    - GSK Investigational Site
  - Green Valley, Arizona, United States, 85614
    - GSK Investigational Site
  - Phoenix, Arizona, United States, 85032
    - GSK Investigational Site
  - Phoenix, Arizona, United States, 85051
    - GSK Investigational Site
  - Tucson, Arizona, United States, 85712
    - GSK Investigational Site
  - Tucson, Arizona, United States, 85745
    - GSK Investigational Site
- Arkansas
  - Bull Shoals, Arkansas, United States, 72619
    - GSK Investigational Site
  - Harrisburg, Arkansas, United States, 72432
    - GSK Investigational Site
  - Hot Springs, Arkansas, United States, 71913
    - GSK Investigational Site
  - Jonesboro, Arkansas, United States, 72401
    - GSK Investigational Site
  - Little Rock, Arkansas, United States, 72205
    - GSK Investigational Site
  - Searcy, Arkansas, United States, 72143
    - GSK Investigational Site
- California
  - Buena Park, California, United States, 90620
    - GSK Investigational Site
  - Cathedral City, California, United States, 92234
    - GSK Investigational Site
  - Chino, California, United States, 91710
    - GSK Investigational Site
  - Chula Vista, California, United States, 91911
    - GSK Investigational Site
  - Commerce, California, United States, 90040
    - GSK Investigational Site
  - Escondido, California, United States, 92026
    - GSK Investigational Site
  - Foothill Ranch, California, United States, 92610
    - GSK Investigational Site
  - Fountain Valley, California, United States, 92708
    - GSK Investigational Site
  - Fresno, California, United States, 93720
    - GSK Investigational Site
  - Fullerton, California, United States, 92835
    - GSK Investigational Site
  - Huntington Beach, California, United States, 92648
    - GSK Investigational Site
  - Huntington Beach, California, United States, 92646
    - GSK Investigational Site
  - Irvine, California, United States, 92618
    - GSK Investigational Site
  - La Jolla, California, United States, 92037
    - GSK Investigational Site
  - LaJolla, California, United States, 92037
    - GSK Investigational Site
  - Lakewood, California, United States, 90712
    - GSK Investigational Site
  - Loma Linda, California, United States, 92354
    - GSK Investigational Site
  - Long Beach, California, United States, 90806
    - GSK Investigational Site
  - Los Alamitos, California, United States, 90720
    - GSK Investigational Site
  - Los Angeles, California, United States, 90025
    - GSK Investigational Site
  - Los Angeles, California, United States, 90017
    - GSK Investigational Site
  - Los Angeles, California, United States, 90022
    - GSK Investigational Site
  - Mission Viejo, California, United States, 92691
    - GSK Investigational Site
  - Northridge, California, United States, 91325
    - GSK Investigational Site
  - Palm Desert, California, United States, 92260
    - GSK Investigational Site
  - Pasadena, California, United States, 91105
    - GSK Investigational Site
  - Riverside, California, United States, 92506
    - GSK Investigational Site
  - Sacramento, California, United States, 95821
    - GSK Investigational Site
  - Sacramento, California, United States, 95825
    - GSK Investigational Site
  - San Diego, California, United States, 92120
    - GSK Investigational Site
  - San Diego, California, United States, 92117
    - GSK Investigational Site
  - San Diego, California, United States, 92128
    - GSK Investigational Site
  - Satna Monica, California, United States, 90404
    - GSK Investigational Site
  - Spring Valley, California, United States, 91978
    - GSK Investigational Site
  - Tarzana, California, United States, 91356
    - GSK Investigational Site
  - Tustin, California, United States, 92780
    - GSK Investigational Site
  - Victorville, California, United States, 92395
    - GSK Investigational Site
  - Vista, California, United States, 92083
    - GSK Investigational Site
  - West Hills, California, United States, 91307
    - GSK Investigational Site
- Colorado
  - Denver, Colorado, United States, 80209
    - GSK Investigational Site
- Connecticut
  - New Britain, Connecticut, United States, 06050
    - GSK Investigational Site
  - Trumbull, Connecticut, United States, 06611
    - GSK Investigational Site
  - Waterbury, Connecticut, United States, 06708
    - GSK Investigational Site
- Delaware
  - Middletown, Delaware, United States, 19709
    - GSK Investigational Site
- Florida
  - Boynton Beach, Florida, United States, 33437
    - GSK Investigational Site
  - Boynton Beach, Florida, United States, 33426
    - GSK Investigational Site
  - Clearwater, Florida, United States, 33756
    - GSK Investigational Site
  - Clearwater, Florida, United States, 33765
    - GSK Investigational Site
  - Cocoa, Florida, United States, 32927
    - GSK Investigational Site
  - Cutler Bay, Florida, United States, 33189
    - GSK Investigational Site
  - Deerfield Beach, Florida, United States, 33442
    - GSK Investigational Site
  - Delray Beach, Florida, United States, 33445
    - GSK Investigational Site
  - Edgewater, Florida, United States, 32132
    - GSK Investigational Site
  - Fort Lauderdale, Florida, United States, 33316
    - GSK Investigational Site
  - Gainesville, Florida, United States, 32605
    - GSK Investigational Site
  - Hallandale Beach, Florida, United States, 33009
    - GSK Investigational Site
  - Hialeah, Florida, United States, 33012
    - GSK Investigational Site
  - Hialeah, Florida, United States, 33013
    - GSK Investigational Site
  - Hollywood, Florida, United States, 33023
    - GSK Investigational Site
  - Jacksonville, Florida, United States, 32205
    - GSK Investigational Site
  - Lauderdale Lakes, Florida, United States, 33319
    - GSK Investigational Site
  - Marianna, Florida, United States, 32446
    - GSK Investigational Site
  - Miami, Florida, United States, 33156
    - GSK Investigational Site
  - Miami, Florida, United States, 33135
    - GSK Investigational Site
  - North Miami, Florida, United States, 33161
    - GSK Investigational Site
  - Ocala, Florida, United States, 34471
    - GSK Investigational Site
  - Orlando, Florida, United States, 32822
    - GSK Investigational Site
  - Ormond Beach, Florida, United States, 32174
    - GSK Investigational Site
  - Oviedo, Florida, United States, 32765
    - GSK Investigational Site
  - Panama City, Florida, United States, 32401
    - GSK Investigational Site
  - Pembroke Pines, Florida, United States, 33026
    - GSK Investigational Site
  - Plantation, Florida, United States, 33317
    - GSK Investigational Site
  - Ponte Verda, Florida, United States, 32081
    - GSK Investigational Site
  - St. Cloud, Florida, United States, 34769
    - GSK Investigational Site
  - St. Petersburg, Florida, United States, 33709
    - GSK Investigational Site
  - Tampa, Florida, United States, 33603
    - GSK Investigational Site
  - West Palm Beach, Florida, United States, 33401
    - GSK Investigational Site
- Georgia
  - Atlanta, Georgia, United States, 30342
    - GSK Investigational Site
  - Atlanta, Georgia, United States, 30309
    - GSK Investigational Site
  - Atlanta, Georgia, United States, 30312
    - GSK Investigational Site
  - Atlanta, Georgia, United States, 30308
    - GSK Investigational Site
  - Atlanta, Georgia, United States, 30338
    - GSK Investigational Site
  - Atlanta, Georgia, United States, 30328
    - GSK Investigational Site
  - Blue Ridge, Georgia, United States, 30513
    - GSK Investigational Site
  - Columbus, Georgia, United States, 31904
    - GSK Investigational Site
  - Decatur, Georgia, United States, 30032
    - GSK Investigational Site
  - Savannah, Georgia, United States, 31419
    - GSK Investigational Site
  - Savannah, Georgia, United States, 31406
    - GSK Investigational Site
  - Snellville, Georgia, United States, 30078
    - GSK Investigational Site
  - Stone Mountain, Georgia, United States, 30088
    - GSK Investigational Site
- Hawaii
  - Honolulu, Hawaii, United States, 96813
    - GSK Investigational Site
  - Honolulu, Hawaii, United States, 96814
    - GSK Investigational Site
- Idaho
  - Boise, Idaho, United States, 83702
    - GSK Investigational Site
  - Idaho Falls, Idaho, United States, 83404
    - GSK Investigational Site
- Illinois
  - Aurora, Illinois, United States, 60504
    - GSK Investigational Site
  - Chicago, Illinois, United States, 60607
    - GSK Investigational Site
  - Evergreen Park, Illinois, United States, 60805
    - GSK Investigational Site
  - Gurnee, Illinois, United States, 60031
    - GSK Investigational Site
  - La Grange, Illinois, United States, 60525
    - GSK Investigational Site
  - Naperville, Illinois, United States, 60564
    - GSK Investigational Site
  - Peoria, Illinois, United States, 61602
    - GSK Investigational Site
- Indiana
  - Avon, Indiana, United States, 46123
    - GSK Investigational Site
  - Evansville, Indiana, United States, 47714
    - GSK Investigational Site
  - Fishers, Indiana, United States, 46037
    - GSK Investigational Site
  - Indianapolis, Indiana, United States, 46254
    - GSK Investigational Site
  - La Porte, Indiana, United States, 46350
    - GSK Investigational Site
  - Lafayette, Indiana, United States, 47904
    - GSK Investigational Site
  - South Bend, Indiana, United States, 46614
    - GSK Investigational Site
- Iowa
  - Council Bluffs, Iowa, United States, 51501
    - GSK Investigational Site
  - Des Moines, Iowa, United States, 50314
    - GSK Investigational Site
  - Dubuque, Iowa, United States, 52001
    - GSK Investigational Site
  - Iowa City, Iowa, United States, 52243
    - GSK Investigational Site
  - Waterloo, Iowa, United States, 50701
    - GSK Investigational Site
- Kansas
  - Arkansas City, Kansas, United States, 67005
    - GSK Investigational Site
  - Mission, Kansas, United States, 66202
    - GSK Investigational Site
  - Newton, Kansas, United States, 67114
    - GSK Investigational Site
  - Overland Park, Kansas, United States, 66211
    - GSK Investigational Site
  - Topeka, Kansas, United States, 66606
    - GSK Investigational Site
  - Wichita, Kansas, United States, 67211
    - GSK Investigational Site
- Kentucky
  - Fort Mitchell, Kentucky, United States, 41017
    - GSK Investigational Site
  - Lexington, Kentucky, United States, 40504
    - GSK Investigational Site
  - Lexington, Kentucky, United States, 40503
    - GSK Investigational Site
  - Louisville, Kentucky, United States, 40202
    - GSK Investigational Site
  - Madisonville, Kentucky, United States, 42431
    - GSK Investigational Site
  - Paducah, Kentucky, United States, 42003
    - GSK Investigational Site
- Louisiana
  - Covington, Louisiana, United States, 70433
    - GSK Investigational Site
  - Lake Charles, Louisiana, United States, 70601
    - GSK Investigational Site
  - Shreveport, Louisiana, United States, 71101
    - GSK Investigational Site
  - Shreveport, Louisiana, United States, 71115
    - GSK Investigational Site
- Maryland
  - Baltimore, Maryland, United States, 21237
    - GSK Investigational Site
  - Hyattsville, Maryland, United States, 20782
    - GSK Investigational Site
  - Oxon Hill, Maryland, United States, 20745
    - GSK Investigational Site
- Massachusetts
  - Haverhill, Massachusetts, United States, 01830
    - GSK Investigational Site
- Michigan
  - Bay City, Michigan, United States, 48706
    - GSK Investigational Site
  - Benzonia, Michigan, United States, 49616
    - GSK Investigational Site
  - Bloomfield Hills, Michigan, United States, 48302
    - GSK Investigational Site
  - Cadillac, Michigan, United States, 49601
    - GSK Investigational Site
  - Dearborn, Michigan, United States, 48124
    - GSK Investigational Site
  - Interlochen, Michigan, United States, 49643
    - GSK Investigational Site
  - Kalamazoo, Michigan, United States, 49009
    - GSK Investigational Site
  - Kalamazoo, Michigan, United States, 49048
    - GSK Investigational Site
  - St Clair Shores, Michigan, United States, 48081
    - GSK Investigational Site
- Minnesota
  - Brooklyn Center, Minnesota, United States, 55430
    - GSK Investigational Site
- Mississippi
  - Gulfport, Mississippi, United States, 39501
    - GSK Investigational Site
  - Picayune, Mississippi, United States, 39466
    - GSK Investigational Site
  - Rolling Fork, Mississippi, United States, 39159
    - GSK Investigational Site
- Missouri
  - Chesterfield, Missouri, United States, 63017
    - GSK Investigational Site
  - Jefferson City, Missouri, United States, 65109
    - GSK Investigational Site
  - Kansas City, Missouri, United States
    - GSK Investigational Site
  - Kansas City, Missouri, United States, 64106
    - GSK Investigational Site
  - St. Louis, Missouri, United States, 63117
    - GSK Investigational Site
  - St. Louis, Missouri, United States, 63108
    - GSK Investigational Site
  - West Plains, Missouri, United States, 65775
    - GSK Investigational Site
- Montana
  - Butte, Montana, United States, 59701
    - GSK Investigational Site
  - Great Falls, Montana, United States, 59405
    - GSK Investigational Site
- Nebraska
  - Broken Bow, Nebraska, United States, 68822
    - GSK Investigational Site
  - Lincoln, Nebraska, United States, 68516
    - GSK Investigational Site
  - Omaha, Nebraska, United States, 68131
    - GSK Investigational Site
  - Omaha, Nebraska, United States, 68124
    - GSK Investigational Site
  - Omaha, Nebraska, United States, 68134
    - GSK Investigational Site
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - GSK Investigational Site
  - Las Vegas, Nevada, United States, 89102
    - GSK Investigational Site
  - Las Vegas, Nevada, United States, 89103
    - GSK Investigational Site
  - Las Vegas, Nevada, United States, 89128
    - GSK Investigational Site
  - Las Vegas, Nevada, United States, 89130
    - GSK Investigational Site
- New Jersey
  - Berlin, New Jersey, United States, 08009
    - GSK Investigational Site
  - Elizabeth, New Jersey, United States, 07202
    - GSK Investigational Site
  - Haddon Heights, New Jersey, United States, 08035
    - GSK Investigational Site
  - Hainesport, New Jersey, United States, 08036
    - GSK Investigational Site
  - New Brunswick, New Jersey, United States, 08903
    - GSK Investigational Site
  - Stratford, New Jersey, United States, 08084
    - GSK Investigational Site
- New Mexico
  - Albuquerque, New Mexico, United States, 87106
    - GSK Investigational Site
- New York
  - New York, New York, United States, 10022
    - GSK Investigational Site
  - North Massapequa, New York, United States, 11758
    - GSK Investigational Site
  - Syracuse, New York, United States, 13210
    - GSK Investigational Site
- North Carolina
  - Asheville, North Carolina, United States, 28803
    - GSK Investigational Site
  - Burlington, North Carolina, United States, 27215
    - GSK Investigational Site
  - Calabash, North Carolina, United States, 28467
    - GSK Investigational Site
  - Fayetteville, North Carolina, United States, 28304
    - GSK Investigational Site
  - Greensboro, North Carolina, United States, 27405
    - GSK Investigational Site
  - Hickory, North Carolina, United States, 28601
    - GSK Investigational Site
  - Lenoir, North Carolina, United States, 28645
    - GSK Investigational Site
  - Mint HIll, North Carolina, United States, 28227
    - GSK Investigational Site
  - Morehead City, North Carolina, United States, 28557
    - GSK Investigational Site
  - Shelby, North Carolina, United States, 28150
    - GSK Investigational Site
  - Tabor City, North Carolina, United States, 28463
    - GSK Investigational Site
- Ohio
  - Akron, Ohio, United States, 44320
    - GSK Investigational Site
  - Canal Fulton, Ohio, United States, 44614
    - GSK Investigational Site
  - Cincinnati, Ohio, United States, 45245
    - GSK Investigational Site
  - Cincinnati, Ohio, United States, 45227
    - GSK Investigational Site
  - Cleveland, Ohio, United States, 44122
    - GSK Investigational Site
  - Columbus, Ohio, United States, 43213
    - GSK Investigational Site
  - Columbus, Ohio, United States, 43212
    - GSK Investigational Site
  - Dayton, Ohio, United States, 45439
    - GSK Investigational Site
  - Dayton, Ohio, United States, 45432
    - GSK Investigational Site
  - Kettering, Ohio, United States, 45429
    - GSK Investigational Site
  - Mason, Ohio, United States, 45040
    - GSK Investigational Site
  - Maumee, Ohio, United States, 43537-9402
    - GSK Investigational Site
  - Thornville, Ohio, United States, 43076
    - GSK Investigational Site
  - Zanesville, Ohio, United States, 43701
    - GSK Investigational Site
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73103
    - GSK Investigational Site
  - Oklahoma City, Oklahoma, United States, 73116
    - GSK Investigational Site
  - Tulsa, Oklahoma, United States, 74104
    - GSK Investigational Site
  - Tulsa, Oklahoma, United States, 74136
    - GSK Investigational Site
- Oregon
  - Ashland, Oregon, United States, 97520
    - GSK Investigational Site
- Pennsylvania
  - Bensalem, Pennsylvania, United States, 19020
    - GSK Investigational Site
  - Carlisle, Pennsylvania, United States, 17013
    - GSK Investigational Site
  - Downington, Pennsylvania, United States, 19335
    - GSK Investigational Site
  - Harrisburg, Pennsylvania, United States, 17112
    - GSK Investigational Site
  - Landsdale, Pennsylvania, United States, 19446
    - GSK Investigational Site
  - Pittsburgh, Pennsylvania, United States, 15243
    - GSK Investigational Site
  - Tipton, Pennsylvania, United States, 16684
    - GSK Investigational Site
  - Uniontown, Pennsylvania, United States, 15401
    - GSK Investigational Site
- Rhode Island
  - East Providence, Rhode Island, United States, 02914
    - GSK Investigational Site
- South Carolina
  - Columbia, South Carolina, United States, 29201
    - GSK Investigational Site
  - Greenville, South Carolina, United States, 29615
    - GSK Investigational Site
  - Greenville, South Carolina, United States, 29601
    - GSK Investigational Site
  - Greer, South Carolina, United States, 29651
    - GSK Investigational Site
  - Manning, South Carolina, United States, 29102
    - GSK Investigational Site
  - Murrells Inlet, South Carolina, United States, 29576
    - GSK Investigational Site
  - North Myrtle Beach, South Carolina, United States, 29582
    - GSK Investigational Site
  - Orangeburg, South Carolina, United States, 29115
    - GSK Investigational Site
  - Simpsonville, South Carolina, United States, 29681
    - GSK Investigational Site
  - Taylors, South Carolina, United States, 29687
    - GSK Investigational Site
- Tennessee
  - Bristol, Tennessee, United States, 37620
    - GSK Investigational Site
  - Chattanooga, Tennessee, United States, 37421
    - GSK Investigational Site
  - Clarksville, Tennessee, United States, 37043
    - GSK Investigational Site
  - Columbia, Tennessee, United States, 38401
    - GSK Investigational Site
  - Fayetteville, Tennessee, United States, 37334
    - GSK Investigational Site
  - Johnson City, Tennessee, United States, 37604
    - GSK Investigational Site
  - McKenzie, Tennessee, United States, 38201
    - GSK Investigational Site
  - Nashville, Tennessee, United States, 37203
    - GSK Investigational Site
  - Tullahoma, Tennessee, United States, 37398
    - GSK Investigational Site
- Texas
  - Arlington, Texas, United States, 76012
    - GSK Investigational Site
  - Bedford, Texas, United States, 76201
    - GSK Investigational Site
  - Cleburne, Texas, United States, 76033
    - GSK Investigational Site
  - Corpus Christi, Texas, United States, 78404
    - GSK Investigational Site
  - Corpus Christi, Texas, United States, 78414
    - GSK Investigational Site
  - Dallas, Texas, United States, 75246
    - GSK Investigational Site
  - Dallas, Texas, United States, 75230
    - GSK Investigational Site
  - Dallas, Texas, United States, 75224
    - GSK Investigational Site
  - Dallas, Texas, United States, 75251
    - GSK Investigational Site
  - Dallas, Texas, United States, 75235
    - GSK Investigational Site
  - Deer Park, Texas, United States, 77536
    - GSK Investigational Site
  - El Paso, Texas, United States, 79925
    - GSK Investigational Site
  - Fort Worth, Texas, United States, 76104
    - GSK Investigational Site
  - Fort Worth, Texas, United States, 76135
    - GSK Investigational Site
  - Houston, Texas, United States, 77030
    - GSK Investigational Site
  - Houston, Texas, United States, 77027
    - GSK Investigational Site
  - Houston, Texas, United States, 77036
    - GSK Investigational Site
  - Houston, Texas, United States, 77070
    - GSK Investigational Site
  - Houston, Texas, United States, 77074
    - GSK Investigational Site
  - Houston, Texas, United States, 77024
    - GSK Investigational Site
  - Houston, Texas, United States, 77058
    - GSK Investigational Site
  - Houston, Texas, United States, 77055
    - GSK Investigational Site
  - Houston, Texas, United States, 77034
    - GSK Investigational Site
  - Houston, Texas, United States, 77094
    - GSK Investigational Site
  - Hurst, Texas, United States, 76054
    - GSK Investigational Site
  - Katy, Texas, United States, 77450
    - GSK Investigational Site
  - Lake Jackson, Texas, United States, 77566
    - GSK Investigational Site
  - Lewisville, Texas, United States, 75067
    - GSK Investigational Site
  - Midland, Texas, United States, 79705
    - GSK Investigational Site
  - North Richland Hills, Texas, United States, 76180
    - GSK Investigational Site
  - Odessa, Texas, United States, 79761
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78229
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78215
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78217
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78258
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78218
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78205
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78224
    - GSK Investigational Site
  - Schertz, Texas, United States, 78154
    - GSK Investigational Site
  - Sugar Land, Texas, United States, 77479
    - GSK Investigational Site
  - Sugarland, Texas, United States, 77479
    - GSK Investigational Site
- Utah
  - Bountiful, Utah, United States, 84010
    - GSK Investigational Site
  - Murray, Utah, United States, 84123
    - GSK Investigational Site
  - Orem, Utah, United States, 84058
    - GSK Investigational Site
  - Salt Lake City, Utah, United States, 84120
    - GSK Investigational Site
  - West Jordan, Utah, United States, 84088
    - GSK Investigational Site
  - West Valley City, Utah, United States, 84120
    - GSK Investigational Site
- Vermont
  - South Burlington, Vermont, United States, 05403
    - GSK Investigational Site
- Virginia
  - Burke, Virginia, United States, 22015
    - GSK Investigational Site
  - Hampton, Virginia, United States, 23666
    - GSK Investigational Site
  - Manassas, Virginia, United States, 20110
    - GSK Investigational Site
  - Richmond, Virginia, United States, 23294
    - GSK Investigational Site
  - Suffolk, Virginia, United States, 23434
    - GSK Investigational Site
  - Weber City, Virginia, United States, 24290
    - GSK Investigational Site
- Washington
  - Renton, Washington, United States, 98057
    - GSK Investigational Site
  - Richland, Washington, United States, 99352
    - GSK Investigational Site
  - Selah, Washington, United States, 98942
    - GSK Investigational Site
  - Spokane, Washington, United States, 99216
    - GSK Investigational Site
  - Spokane, Washington, United States, 99208
    - GSK Investigational Site
  - Tacoma, Washington, United States, 98405
    - GSK Investigational Site
- West Virginia
  - Lewisburg, West Virginia, United States, 24901
    - GSK Investigational Site
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53226
    - 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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

type 2 diabetes
BMI 20-45kg/m2 inclusive

Exclusion Criteria:

females who are pregnant, lactating or within <6 weeks post-partum
current symptomatic heart failure (NYHA Class III-IV)

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: NONE

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: albiglutide weekly injection albiglutide weekly subcutaneous injection	Biological: albiglutide albiglutide weekly injection
ACTIVE_COMPARATOR: insulin glargine insulin glargine daily injection	Drug: insulin glargine insulin glargine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 Time Frame: Baseline and Week 52	HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region + current antidiabetic therapy. Difference of least squares means (albiglutide - insulin glargine) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.	Baseline and Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Hyperglycemia Rescue Time Frame: From the start of study medication until the end of the treatment (up to Week 156)	Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and <Week 4; FPG >=250 mg/dL between >=Week 4 and <Week 12; HbA1c >=8.5% and a <=0.5% reduction from Baseline between >=Week 12 and <Week 24; HbA1c >=8.5% between >=Week 24 and <Week 48; HbA1c >=8.0% between >= Week 48 and <Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in weeks.	From the start of study medication until the end of the treatment (up to Week 156)
Change From Baseline in Body Weight at Week 156 Time Frame: Baseline and Week 156	The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight.	Baseline and Week 156
Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156 Time Frame: Week 156	The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 156) were assessed.	Week 156
Change From Baseline in HbA1c at Week 156 Time Frame: Baseline and Week 156	HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.	Baseline and Week 156
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 Time Frame: Baseline and Week 52	The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region + current antidiabetic therapy.	Baseline and Week 52
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156 Time Frame: Baseline and Week 156	The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.	Baseline and Week 156
Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52 Time Frame: Week 52	The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) were assessed.	Week 52
Change From Baseline in Body Weight at Week 52 Time Frame: Baseline and Week 52	The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region + current antidiabetic therapy.	Baseline and Week 52
Change From Baseline in Glucose Profile Measured by 24-hour Area Under Curve (AUC) at Week 52 Time Frame: Baseline and Week 52	A 24-hour glucose profile was collected at Baseline and Week 52 at a subset of sites in a subset of participants per treatment group using the continuous glucose monitoring device. Glucose measurements were obtained at 5 minute increments in the 24-hour period. The area under the curve (AUC) was determined using the trapezoidal method on the measurements obtained during the first 24 hours of continuous monitoring. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. The Baseline value is the last non-missing value before the start of treatment.	Baseline and Week 52
Albiglutide Plasma Concentrations at Week 8 and Week 24 Time Frame: Weeks 8 and 24	Albiglutide plasma concentration data was analyzed at Week 8 pre-dose, Week 8 post-dose, Week 24 pre-dose and Week 24 post-dose. All participants receiving albiglutide were initiated on a 30 mg weekly dosing regimen; however, beginning at Week 4, uptitration of albiglutide was allowed based on glycemic response. As such, albiglutide plasma concentrations achieved at each sampling time represent a mixed population of participants receiving either 30 mg or 50 mg weekly for various durations.	Weeks 8 and 24

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

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

February 1, 2009

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

February 5, 2009

First Submitted That Met QC Criteria

February 5, 2009

First Posted (ESTIMATE)

February 9, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 9, 2017

Last Update Submitted That Met QC Criteria

November 18, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

diabetes

Additional Relevant MeSH Terms

Other Study ID Numbers

112754

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

Individual Participant Data Set
Information identifier: 112754

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol
Information identifier: 112754

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification
Information identifier: 112754

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form
Information identifier: 112754

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form
Information identifier: 112754

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report
Information identifier: 112754

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan
Information identifier: 112754

Information comments: For additional information about this study please refer to the GSK Clinical Study Register

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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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start

Primary Completion (ACTUAL)

Study Completion (ACTUAL)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (ESTIMATE)

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Study Data/Documents

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on albiglutide

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