Safety and Efficacy Study of Albiglutide in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00849017
First received: February 19, 2009
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to determine whether albiglutide is effective in the treament of patients with type 2 diabetes.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Biological: albiglutide
Biological: albiglutide uptitration
Biological: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Determine the Efficacy and Safety of Two Dose Levels of Albiglutide Compared With Placebo in Subjects With Type 2 Diabetes.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • HbA1c change from baseline [ Time Frame: one year ] [ Designated as safety issue: No ]
    change from baseline


Secondary Outcome Measures:
  • FPG change from baseline [ Time Frame: one year ] [ Designated as safety issue: No ]
    change from baseline

  • body weight change from baseline [ Time Frame: one year ] [ Designated as safety issue: No ]
    change from baseline


Enrollment: 309
Study Start Date: January 2009
Study Completion Date: January 2013
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: albiglutide
albiglutide weekly injection
Biological: albiglutide
albiglutide weekly injection
Placebo Comparator: placebo
albiglutide matching placebo
Biological: placebo
matching albiglutide placebo weekly injection
Experimental: albiglutide up-titration
albiglutide weekly injection uptitration at week 12
Biological: albiglutide uptitration
albiglutide uptitration at week 12

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • type 2 diabetes
  • BMI 20-45kg/m2 inclusive

Exclusion Criteria:

  • females who are pregnant, lactating, or <6 weeks post-partum
  • CHF NYHA class III-IV
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00849017

  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site
Alabaster, Alabama, United States, 35007
GSK Investigational Site
Birmingham, Alabama, United States, 35235
GSK Investigational Site
Birmingham, Alabama, United States, 35242
GSK Investigational Site
Dothan, Alabama, United States, 36301
United States, Arizona
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Chandler, Arizona, United States, 85225
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Gilbert, Arizona, United States, 85295
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Green Valley, Arizona, United States, 85614
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Phoenix, Arizona, United States, 85051
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Tucson, Arizona, United States, 85745
United States, Arkansas
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Bull Shoals, Arkansas, United States, 72619
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Hot Springs, Arkansas, United States, 71913
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Jonesboro, Arkansas, United States, 72401
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Little Rock, Arkansas, United States, 72205
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Searcy, Arkansas, United States, 72143
United States, California
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Carmichael, California, United States, 95608
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Chula Vista, California, United States, 91910
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Foothill Ranch, California, United States, 92610
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Fresno, California, United States, 93720
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Huntington Beach, California, United States, 92646
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Huntington Beach, California, United States, 92648
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Indio, California, United States, 92201
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Irvine, California, United States, 92618
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Lakewood, California, United States, 90712
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Long Beach, California, United States, 90806
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Los Alamitos, California, United States, 90720
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Los Angeles, California, United States, 90022
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Los Angeles, California, United States, 90017
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Los Angeles, California, United States, 90025
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Mission Viejo, California, United States, 92691
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Northridge, California, United States, 91325
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Palm Desert, California, United States, 92260
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Pasadena, California, United States, 91105
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Riverside, California, United States, 92506
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Sacramento, California, United States, 95825
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San Diego, California, United States, 92120
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San Diego, California, United States, 92128
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San Diego, California, United States, 92117
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San Diego, California, United States, 92177
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Santa Ana, California, United States, 92701
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Satna Monica, California, United States, 90404
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Spring Valley, California, United States, 91978
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Tarzana, California, United States, 91356
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Torrance, California, United States, 90503
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Victorville, California, United States, 92395
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Vista, California, United States, 92083
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Walnut Creek, California, United States, 94598
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West Hills, California, United States, 91307
United States, Colorado
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Arvada, Colorado, United States, 80005
United States, Connecticut
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New Britain, Connecticut, United States, 06050
United States, Delaware
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Middletown, Delaware, United States, 19709
United States, Florida
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Clearwater, Florida, United States, 33756
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Cocoa, Florida, United States, 32927
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Cutler Bay, Florida, United States, 33189
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Deerfield Beach, Florida, United States, 33442
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Delray Beach, Florida, United States, 33445
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Fort Lauderdale, Florida, United States, 33316
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Hallandale Beach, Florida, United States, 33009
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Hialeah, Florida, United States, 33012
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Hollywood, Florida, United States, 33023
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Lauderdale Lakes, Florida, United States, 33319
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Marianna, Florida, United States, 32446
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Miami, Florida, United States, 33156
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Ocala, Florida, United States, 34471
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Orlando, Florida, United States, 32822
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Ormond Beach, Florida, United States, 32174
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Oviedo, Florida, United States, 32765
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Panama City, Florida, United States, 32401
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Pembroke Pines, Florida, United States, 33027
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Pembroke Pines, Florida, United States, 33026
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Plantation, Florida, United States, 33317
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St. Cloud, Florida, United States, 34769
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West Palm Beach, Florida, United States, 33401
United States, Georgia
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Atlanta, Georgia, United States, 30308
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Atlanta, Georgia, United States, 30312
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Atlanta, Georgia, United States, 30342
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Atlanta, Georgia, United States, 30338
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Blue Ridge, Georgia, United States, 30513
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Columbus, Georgia, United States, 31904
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Decatur, Georgia, United States, 30032
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Savannah, Georgia, United States, 31419
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Savannah, Georgia, United States, 31406
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Snellville, Georgia, United States, 30078
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Tucker, Georgia, United States, 30084
United States, Hawaii
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Honolulu, Hawaii, United States, 96814
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Honolulu, Hawaii, United States, 96813
United States, Idaho
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Idaho Falls, Idaho, United States, 83404
United States, Illinois
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Chicago, Illinois, United States, 60607
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Evergreen Park, Illinois, United States, 60805
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La Grange, Illinois, United States, 60525
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Naperville, Illinois, United States, 60564
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Peoria, Illinois, United States, 61602
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Avon, Indiana, United States, 46123
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Evansville, Indiana, United States, 47714
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Fishers, Indiana, United States, 46037
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Indianapolis, Indiana, United States, 46254
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La Porte, Indiana, United States, 46350
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South Bend, Indiana, United States, 46614
United States, Iowa
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Council Bluffs, Iowa, United States, 51501
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Dubuque, Iowa, United States, 52001
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Iowa City, Iowa, United States, 52243
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Waterloo, Iowa, United States, 50701
United States, Kansas
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Arkansas City, Kansas, United States, 67005
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Mission, Kansas, United States, 66202
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Newton, Kansas, United States, 67114
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Overland Park, Kansas, United States, 66211
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Topeka, Kansas, United States, 66606
United States, Kentucky
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Crescent Springs, Kentucky, United States, 41017
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Lexington, Kentucky, United States, 40504
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Louisville, Kentucky, United States, 40202
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Madisonville, Kentucky, United States, 42431
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Paducah, Kentucky, United States, 42003
United States, Louisiana
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Covington, Louisiana, United States, 70433
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Lake Charles, Louisiana, United States, 70601
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Shreveport, Louisiana, United States, 71101
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Shreveport, Louisiana, United States, 71115
United States, Maryland
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Baltimore, Maryland, United States, 21237-3998
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Oxon Hill, Maryland, United States, 20745
United States, Massachusetts
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Haverhill, Massachusetts, United States, 01830
United States, Michigan
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Bay City, Michigan, United States, 48708
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Benzonia, Michigan, United States, 49616
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Dearborn, Michigan, United States, 48124
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Interlochen, Michigan, United States, 49643
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Kalamazoo, Michigan, United States, 49048
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Kalamazoo, Michigan, United States, 49009
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St Clair Shores, Michigan, United States, 48081
United States, Mississippi
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Picayune, Mississippi, United States, 39466
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Rolling Fork, Mississippi, United States, 39159
United States, Missouri
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Chesterfield, Missouri, United States, 63017
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Jefferson City, Missouri, United States, 65109
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Kansas City, Missouri, United States, 64111
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Springfield, Missouri, United States, 65807
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St. Louis, Missouri, United States, 63141
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West Plains, Missouri, United States, 65775
United States, Montana
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Great Falls, Montana, United States, 59405
United States, Nebraska
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Broken Bow, Nebraska, United States, 68822
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Lincoln, Nebraska, United States, 68516
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Omaha, Nebraska, United States, 68134
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Omaha, Nebraska, United States, 68124
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Omaha, Nebraska, United States, 68131
United States, Nevada
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Las Vegas, Nevada, United States, 89103
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Las Vegas, Nevada, United States, 89128
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Las Vegas, Nevada, United States, 89106
United States, New Jersey
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Berlin, New Jersey, United States, 08009
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Elizabeth, New Jersey, United States, 07202
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Haddon Heights, New Jersey, United States, 08035
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Hainesport, New Jersey, United States, 08036
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Stratford, New Jersey, United States, 08084
United States, New York
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North Massapequa, New York, United States, 11758
United States, North Carolina
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Asheboro, North Carolina, United States, 27203
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Asheville, North Carolina, United States, 28803
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Burlington, North Carolina, United States, 27215
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Calabash, North Carolina, United States, 28467
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Chadbourn, North Carolina, United States, 28431
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Fayetteville, North Carolina, United States, 28304
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Greensboro, North Carolina, United States, 27455
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Hickory, North Carolina, United States, 28601
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Lenoir, North Carolina, United States, 28645
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Mint Hill, North Carolina, United States, 28227
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Morehead City, North Carolina, United States, 28557
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Shelby, North Carolina, United States, 28150
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Tabor City, North Carolina, United States, 28463
United States, Ohio
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Akron, Ohio, United States, 44320
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Canal Fulton, Ohio, United States, 44614
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Cleveland, Ohio, United States, 44122
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Columbus, Ohio, United States, 43213
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Dayton, Ohio, United States, 45439
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Dayton, Ohio, United States, 45432
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Kettering, Ohio, United States, 45429
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Mason, Ohio, United States, 45040
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Maumee, Ohio, United States, 43537-9402
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Thornville, Ohio, United States, 43076
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Zanesville, Ohio, United States, 43701
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
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Tulsa, Oklahoma, United States, 74136
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Tulsa, Oklahoma, United States, 74104
United States, Oregon
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Ashland, Oregon, United States, 97520
United States, Pennsylvania
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Bensalem, Pennsylvania, United States, 19020
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Downington, Pennsylvania, United States, 19335
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Harrisburg, Pennsylvania, United States, 17112
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Lansdale, Pennsylvania, United States, 19446
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Melrose Park, Pennsylvania, United States, 19027
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Pittsburgh, Pennsylvania, United States, 15243
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Tipton, Pennsylvania, United States, 16684
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Uniontown, Pennsylvania, United States, 15401
United States, Rhode Island
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East Providence, Rhode Island, United States, 02914
United States, South Carolina
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Columbia, South Carolina, United States, 29201
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Greenville, South Carolina, United States, 29601
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Greenville, South Carolina, United States, 29615
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Greer, South Carolina, United States, 29651
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Murrells Inlet, South Carolina, United States, 29576
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North Myrtle Beach, South Carolina, United States, 29582
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Orangeburg, South Carolina, United States, 29115
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Simpsonville, South Carolina, United States, 29681
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Taylors, South Carolina, United States, 29687
United States, Tennessee
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Bristol, Tennessee, United States, 37620
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Clarksville, Tennessee, United States, 37043
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Columbia, Tennessee, United States, 38401
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Crossville, Tennessee, United States, 38555
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Johnson City, Tennessee, United States, 37604
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McKenzie, Tennessee, United States, 38201
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Nashville, Tennessee, United States, 37203
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Tullahoma, Tennessee, United States, 37388
United States, Texas
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Arlington, Texas, United States, 76012
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Cleburne, Texas, United States, 76033
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Corpus Christi, Texas, United States, 78414
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Dallas, Texas, United States, 75251
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Dallas, Texas, United States, 75224
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Dallas, Texas, United States, 75235
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Dallas, Texas, United States, 75230
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Deer Park, Texas, United States, 77536
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El Paso, Texas, United States, 79925
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Fort Worth, Texas, United States, 76104
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Houston, Texas, United States, 77030
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Houston, Texas, United States, 77024
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Houston, Texas, United States, 77070
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Houston, Texas, United States, 77074
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Houston, Texas, United States, 77058
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Houston, Texas, United States, 77034
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Houston, Texas, United States, 77036
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Houston, Texas, United States, 77055
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Hurst, Texas, United States, 76054
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Katy, Texas, United States, 77450
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Lewisville, Texas, United States, 75067
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Midland, Texas, United States, 79705
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Odessa, Texas, United States, 79761
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San Antonio, Texas, United States, 78224
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San Antonio, Texas, United States, 78218
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San Antonio, Texas, United States, 78229
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San Antonio, Texas, United States, 78215
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San Antonio, Texas, United States, 78258
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San Antonio, Texas, United States, 78229-4801
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Schertz, Texas, United States, 78154
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Sugar Land, Texas, United States, 77479
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Sugarland, Texas, United States, 77479
United States, Utah
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Salt Lake City, Utah, United States, 84120
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Salt Lake City, Utah, United States, 84107
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Salt Lake City, Utah, United States, 84102
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West Jordan, Utah, United States, 84088
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West Valley City, Utah, United States, 84120
United States, Vermont
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South Burlington, Vermont, United States, 05403
United States, Virginia
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Burke, Virginia, United States, 22015
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Manassas, Virginia, United States, 20110
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Norfolk, Virginia, United States, 23502
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Suffolk, Virginia, United States, 23434
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Virgina Beach, Virginia, United States, 23455
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Weber City, Virginia, United States, 24290
United States, Washington
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Richland, Washington, United States, 99352
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Selah, Washington, United States, 98942
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Spokane, Washington, United States, 99216
United States, West Virginia
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Lewisburg, West Virginia, United States, 24901
United States, Wisconsin
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Milwaukee, Wisconsin, United States, 53226
Mexico
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Tijuana, Baja California Norte, Mexico, 22010
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Pachuca, Hidalgo, Mexico, 42086
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Guadalajara, Jalisco, Mexico, 44690
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Zapopan, Jalisco, Mexico, 45200
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Morelia, Michoacán, Mexico, C.P. 58249
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Hermosillo, Sonora, Mexico, 83000
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Merida, Yucatán, Mexico, 97000
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Cuernavaca, Mexico, 62250
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Distrito Federal, Mexico, 06700
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Durango, Mexico, 34080
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Guadalajara, Mexico, 44680
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Guadalajara, Mexico, 44600
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Mexico City, Mexico, 11570
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Mexico City, Mexico, 03300
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Nezahualcoyotl, Mexico, 57170
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Puebla, Mexico, 72190
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Torreón, Mexico, 27000
South Africa
GSK Investigational Site
Parow, South Africa, 7505
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00849017     History of Changes
Other Study ID Numbers: 112756
Study First Received: February 19, 2009
Last Updated: January 31, 2013
Health Authority: South Africa: Medicines Control Council
Mexico: Ministry of Health
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
placebo
albiglutide
monotherapy
diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014