Safety and Efficacy of Albiglutide in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00849056
First received: February 19, 2009
Last updated: February 7, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Type 2
Biological: albiglutide + pioglitazone with or without metfomin
Biological: placebo + pioglitazone with or without metformin
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 Albiglutide When Used in Combination With Pioglitazone With or Without Metformin 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: 310
Study Start Date: January 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo + pioglitazone (with or without metformin)
Placebo albiglutide weekly injection + pioglitazone (with or without metformin)
Biological: placebo + pioglitazone with or without metformin
placebo albiglutide weekly injection + pioglitazone (with or without metformin)
Experimental: albiglutide + pioglitazone (with or without metformin)
albiglutide weekly injection + pioglitazone (+/- meformin)
Biological: albiglutide + pioglitazone with or without metfomin
albiglutide weekly injection + pioglitazone (with or without metformin)

  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

Exclusion Criteria:

  • NYHA Class II to IV heart failure
  • females who are pregnant, lactating, or less than 6 weeks post-partum
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00849056

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Locations
United States, Alabama
GSK Investigational Site
Alabaster, Alabama, United States, 35007
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Birmingham, Alabama, United States, 35235
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Birmingham, Alabama, United States, 35242
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Birmingham, Alabama, United States, 35205
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Dothan, Alabama, United States, 36301
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Hueytown, Alabama, United States, 35023
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Mobile, Alabama, United States, 36617
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Tuscaloosa, Alabama, United States, 35406
United States, Arizona
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Chandler, Arizona, United States, 85224
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Gilbert, Arizona, United States, 85295
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Green Valley, Arizona, United States, 85614
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Peoria, Arizona, United States, 85381 - 4828
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Phoenix, Arizona, United States, 85028
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Little Rock, Arkansas, United States, 72205
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Searcy, Arkansas, United States, 72143
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Buena Park, California, United States, 90620
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Carmichael, California, United States, 95608
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Foothill Ranch, California, United States, 92610
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Fresno, California, United States, 93720
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Fullerton, California, United States, 92835
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Huntington Beach, California, United States, 92646
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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, 49009
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Kalamazoo, Michigan, United States, 49048
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St Clair Shores, Michigan, United States, 48081
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Minneapolis, Minnesota, United States, 55430
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Gulfport, Mississippi, United States, 39501
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Picayune, Mississippi, United States, 39466
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Rolling Fork, Mississippi, United States, 39159
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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, 64106
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Kansas City, Missouri, United States
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St. Louis, Missouri, United States, 63141
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St. Louis, Missouri, United States, 63117
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West Plains, Missouri, United States, 65775
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Billings, Montana, United States, 59102
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Butte, Montana, United States, 59701
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Great Falls, Montana, United States, 59405
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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, 68131
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Omaha, Nebraska, United States, 68134
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Omaha, Nebraska, United States, 68124
United States, Nevada
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Las Vegas, Nevada, United States, 89102
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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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New York, New York, United States, 10022
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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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Durham, North Carolina, United States, 27710
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Fayetteville, North Carolina, United States, 28304
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Greensboro, North Carolina, United States, 27405
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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
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Akron, Ohio, United States, 44320
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Canal Fulton, Ohio, United States, 44614
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Cincinnati, Ohio, United States, 45227
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Cincinnati, Ohio, United States, 45245
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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
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Oklahoma City, Oklahoma, United States, 73103
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Oklahoma City, Oklahoma, United States, 73116
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Tulsa, Oklahoma, United States, 74104
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Tulsa, Oklahoma, United States, 74136
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Ashland, Oregon, United States, 97520
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Bensalem, Pennsylvania, United States, 19020
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Carlisle, Pennsylvania, United States, 17013
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Downington, Pennsylvania, United States, 19335
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Feasterville, Pennsylvania, United States, 19053
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Harrisburg, Pennsylvania, United States, 17112
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Landsdale, Pennsylvania, United States, 19446
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Melrose Park, Pennsylvania, United States, 19027
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Tipton, Pennsylvania, United States, 16684
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Uniontown, Pennsylvania, United States, 15401
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Cumberland, Rhode Island, United States, 02864
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East Providence, Rhode Island, United States, 02914
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Columbia, South Carolina, United States, 29201
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Greenville, South Carolina, United States, 29605
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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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Bristol, Tennessee, United States, 37620
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Chattanooga, Tennessee, United States, 37421
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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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Fayetteville, Tennessee, United States, 37334
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Germantown, Tennessee, United States, 38138
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Johnson City, Tennessee, United States, 37604
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McKenzie, Tennessee, United States, 38201
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Memphis, Tennessee, United States, 38125
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Nashville, Tennessee, United States, 37203
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Tullahoma, Tennessee, United States, 37398
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Arlington, Texas, United States, 76012
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Bedford, Texas, United States, 76201
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Cleburne, Texas, United States, 76033
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Corpus Christi, Texas, United States, 78414
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Corpus Christi, Texas, United States, 78404
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Dallas, Texas, United States, 75235
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Dallas, Texas, United States, 75230
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Dallas, Texas, United States, 75224
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Dallas, Texas, United States, 75246
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Dallas, Texas, United States, 75251
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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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Fort Worth, Texas, United States, 76135
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Houston, Texas, United States, 77055
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Houston, Texas, United States, 77034
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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, 77024
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Houston, Texas, United States, 77030
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Houston, Texas, United States, 77070
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Houston, Texas, United States, 77027
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Houston, Texas, United States, 77036
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Hurst, Texas, United States, 76054
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Katy, Texas, United States, 77450
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Lake Jackson, Texas, United States, 77566
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Lewisville, Texas, United States, 75067
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Midland, Texas, United States, 79707
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North Richland Hills, Texas, United States, 76180
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Odessa, Texas, United States, 79761
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San Antonio, Texas, United States, 78215
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San Antonio, Texas, United States, 78205
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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, 78258
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San Antonio, Texas, United States, 78224
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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
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Bountiful, Utah, United States, 84010
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Orem, Utah, United States, 84058
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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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West Jordan, Utah, United States, 84088
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West Valley City, Utah, United States, 84120
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South Burlington, Vermont, United States, 05403
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Burke, Virginia, United States, 22015
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Hampton, Virginia, United States, 23666
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Manassas, Virginia, United States, 20110
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Norfolk, Virginia, United States, 23502
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Richmond, Virginia, United States, 23294
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Suffolk, Virginia, United States
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Weber City, Virginia, United States, 24290
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Federal Way, Washington, United States, 98003
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Renton, Washington, United States, 98057
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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
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Spokane, Washington, United States, 99208
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Tacoma, Washington, United States, 98405
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Lewisburg, West Virginia, United States, 24901
United States, Wisconsin
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Milwaukee, Wisconsin, United States, 53226
India
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Aurangabad, India, 431001
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Pune, India, 411011
Korea, Republic of
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Seongnam-si, Korea, Republic of, 463712
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Suwon, Kyonggi-do, Korea, Republic of, 443-721
Peru
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El Agustino, Lima, Peru, 10
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Huacho, Lima, Peru
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Arequipa, Peru, 54
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Lima, Peru, 17
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Trujillo, Peru
South Africa
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Port Elizabeth, Eastern Cape, South Africa, 6014
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Phoenix, KwaZulu- Natal, South Africa, 4068
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Kempton Park, South Africa, 1619
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Somerset West, South Africa, 07129
United Kingdom
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Blackpool, Lancashire, United Kingdom, FY4 3AD
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Sunbury-on-Thames, Middlesex, United Kingdom, TW16 6RH
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Port Glasgow, Renfrewshire, United Kingdom, PA14 6HW
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Coventry, West Midlands, United Kingdom, CV2 2DX
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Glasgow, United Kingdom, G45 9AW
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Liverpool, United Kingdom, L9 7AL
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London, United Kingdom, SE1 9NH
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00849056     History of Changes
Other Study ID Numbers: 112755
Study First Received: February 19, 2009
Last Updated: February 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014