Safety and Efficacy of Albiglutide in Type 2 Diabetes

November 18, 2016 updated by: GlaxoSmithKline

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide When Used in Combination With Pioglitazone With or Without Metformin in Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to determine the safety, tolerability and efficacy of albiglutide in the treatment of type 2 diabetes.

Study Overview

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

310

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

India
- - Aurangabad, India, 431001
    - GSK Investigational Site
  - Pune, India, 411011
    - GSK Investigational Site
Korea, Republic of
- - Seongnam-si, Korea, Republic of, 463712
    - GSK Investigational Site
  - Suwon, Kyonggi-do, Korea, Republic of, 443-721
    - GSK Investigational Site
Peru
- - Arequipa, Peru, 54
    - GSK Investigational Site
  - Lima, Peru, 17
    - GSK Investigational Site
  - Trujillo, Peru
    - GSK Investigational Site
- Lima
  - El Agustino, Lima, Peru, 10
    - GSK Investigational Site
  - Huacho, Lima, Peru
    - GSK Investigational Site
South Africa
- - Kempton Park, South Africa, 1619
    - GSK Investigational Site
  - Somerset West, South Africa, 07129
    - GSK Investigational Site
- Eastern Cape
  - Port Elizabeth, Eastern Cape, South Africa, 6014
    - GSK Investigational Site
- KwaZulu- Natal
  - Phoenix, KwaZulu- Natal, South Africa, 4068
    - GSK Investigational Site
United Kingdom
- - Glasgow, United Kingdom, G45 9AW
    - GSK Investigational Site
  - Liverpool, United Kingdom, L9 7AL
    - GSK Investigational Site
  - London, United Kingdom, SE1 9NH
    - GSK Investigational Site
- Kent
  - Canterbury, Kent, United Kingdom, CT1 3HX
    - 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
  - Birmingham, Alabama, United States, 35242
    - 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, 85028
    - GSK Investigational Site
  - Phoenix, Arizona, United States, 85023
    - GSK Investigational Site
  - Phoenix, Arizona, United States, 85032
    - GSK Investigational Site
  - Phoenix, Arizona, United States, 85051
    - 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
  - Carmichael, California, United States, 95608
    - GSK Investigational Site
  - Chula Vista, California, United States, 91910
    - 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
  - Indio, California, United States, 92201
    - GSK Investigational Site
  - Irvine, California, United States, 92618
    - GSK Investigational Site
  - La Jolla, California, United States, 92037
    - GSK Investigational Site
  - Lakewood, California, United States, 90712
    - 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
  - Palm Springs, California, United States, 92262
    - GSK Investigational Site
  - Pasadena, California, United States, 91105
    - GSK Investigational Site
  - Poway, California, United States, 92064
    - 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
  - Satna Monica, California, United States, 90404
    - GSK Investigational Site
  - Tarzana, California, United States, 91356
    - GSK Investigational Site
  - Torrance, California, United States, 90503
    - GSK Investigational Site
  - Tustin, California, United States, 92780
    - GSK Investigational Site
  - Victorville, California, United States, 92395
    - GSK Investigational Site
  - Walnut Creek, California, United States, 94598
    - GSK Investigational Site
  - West Hills, California, United States, 91307
    - GSK Investigational Site
- Colorado
  - Arvada, Colorado, United States, 80005
    - GSK Investigational Site
  - 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
  - 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, 33027
    - 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
  - Tampa, Florida, United States, 33603
    - 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
  - Tucker, Georgia, United States, 30084
    - 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
  - Chicago, Illinois, United States, 60607
    - GSK Investigational Site
  - Evergreen Park, Illinois, United States, 60805
    - 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
- Kentucky
  - Crescent Springs, Kentucky, United States, 41017
    - GSK Investigational Site
  - Lexington, Kentucky, United States, 40504
    - GSK Investigational Site
  - Louisville, Kentucky, United States, 40202
    - 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, 48708
    - GSK Investigational Site
  - Benzonia, Michigan, United States, 49616
    - GSK Investigational Site
  - Bloomfield Hills, Michigan, United States, 48302
    - 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
  - Minneapolis, 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, 63141
    - GSK Investigational Site
  - St. Louis, Missouri, United States, 63117
    - GSK Investigational Site
  - West Plains, Missouri, United States, 65775
    - GSK Investigational Site
- Montana
  - Billings, Montana, United States, 59102
    - GSK Investigational Site
  - Butte, Montana, United States, 59701
    - GSK Investigational Site
  - Great Falls, Montana, United States, 59404
    - 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
- 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
  - Stratford, New Jersey, United States, 08084
    - 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
- North Carolina
  - Asheboro, North Carolina, United States, 27203
    - GSK Investigational Site
  - 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
  - Chadbourn, North Carolina, United States, 28431
    - GSK Investigational Site
  - Durham, North Carolina, United States, 27710
    - 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
  - 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
  - Feasterville, Pennsylvania, United States, 19053
    - GSK Investigational Site
  - Harrisburg, Pennsylvania, United States, 17112
    - GSK Investigational Site
  - Landsdale, Pennsylvania, United States, 19446
    - GSK Investigational Site
  - Melrose Park, Pennsylvania, United States, 19027
    - GSK Investigational Site
  - Tipton, Pennsylvania, United States, 16684
    - GSK Investigational Site
  - Uniontown, Pennsylvania, United States, 15401
    - GSK Investigational Site
- Rhode Island
  - Cumberland, Rhode Island, United States, 02864
    - GSK Investigational Site
  - 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, 29605
    - GSK Investigational Site
  - Greenville, South Carolina, United States, 29601
    - GSK Investigational Site
  - Greer, South Carolina, United States, 29651
    - 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
- 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
  - Crossville, Tennessee, United States, 38555
    - GSK Investigational Site
  - Fayetteville, Tennessee, United States, 37334
    - GSK Investigational Site
  - Germantown, Tennessee, United States, 38138
    - GSK Investigational Site
  - Johnson City, Tennessee, United States, 37604
    - GSK Investigational Site
  - McKenzie, Tennessee, United States, 38201
    - GSK Investigational Site
  - Memphis, Tennessee, United States, 38125
    - 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
  - 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, 79707
    - 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, 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
  - Orem, Utah, United States, 84058
    - GSK Investigational Site
  - Salt Lake City, Utah, United States, 84107
    - 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
  - Norfolk, Virginia, United States, 23502
    - GSK Investigational Site
  - Richmond, Virginia, United States, 23294
    - GSK Investigational Site
  - Suffolk, Virginia, United States
    - GSK Investigational Site
  - Weber City, Virginia, United States, 24290
    - GSK Investigational Site
- Washington
  - Federal Way, Washington, United States, 98003
    - GSK Investigational Site
  - 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

Exclusion Criteria:

NYHA Class II to IV heart failure
females who are pregnant, lactating, or less than 6 weeks post-partum

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: DOUBLE

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: placebo + pioglitazone (with or without metformin) Placebo albiglutide weekly injection + pioglitazone (with or without metformin)	Drug: placebo placebo weekly subcutaneous injection
EXPERIMENTAL: albiglutide + pioglitazone (with or without metformin) albiglutide weekly injection + pioglitazone (with or without meformin)	Biological: albiglutide albiglutide weekly subcutaneous injection

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. The last observation carried forward (LOCF) method was used to impute missing post-BL 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. One Intent-to-Treat (ITT) participant (par.) had all post-BL HbA1c measurements occur after hyperglycemic rescue. This par. is included in the ITT Population counts but did not contribute to this analysis.	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 HbA1c at Weeks 104 and 156 Time Frame: Baseline and Weeks 104 and 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 Weeks 104 and 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 weight + 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 Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline FPG minus the Baseline FPG.	Baseline and Week 156
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 + prior myocardial infarction history + age category + region + current antidiabetic therapy.	Baseline and Week 52
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 52 Time Frame: Week 52	The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <6.5%, and <7.0% at Week 52) were assessed.	Week 52
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%, <6.5%, and <7.0% at Week 156) were assessed.	Week 156

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

Home PD, Ahren B, Reusch JEB, Rendell M, Weissman PN, Cirkel DT, Miller D, Ambery P, Carr MC, Nauck MA. Three-year data from 5 HARMONY phase 3 clinical trials of albiglutide in type 2 diabetes mellitus: Long-term efficacy with or without rescue therapy. Diabetes Res Clin Pract. 2017 Sep;131:49-60. doi: 10.1016/j.diabres.2017.06.013. Epub 2017 Jun 15.

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

January 1, 2009

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

February 19, 2009

First Submitted That Met QC Criteria

February 19, 2009

First Posted (ESTIMATE)

February 23, 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

112755

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: 112755

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol
Information identifier: 112755

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification
Information identifier: 112755

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report
Information identifier: 112755

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan
Information identifier: 112755

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form
Information identifier: 112755

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form
Information identifier: 112755

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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