Last updated: 11/04/2018 04:07:09

A Study To Evaluate The Safety And Efficacy Of An Investigational Diabetes Drug In Poorly Controlled Type II Diabetics

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GSK study ID
712753/004
See study documents
Clinicaltrials.gov ID
NCT00067951
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An open-label trial to evaluate the safety and efficacy of fixed dose rosiglitazone/metformin combination therapy in poorly-controlled subjects with type 2 diabetes mellitus
Trial description: The purpose of this research study is to determine if a new investigational diabetes drug is safe and effective in treating people who have Type II diabetes mellitus with very high HbA1c or FPG (fasting plasma glucose) levels. The HbA1c test, also called the hemoglobin A1c test or glycated hemoglobin test, is a measurement of the average amount of sugar in the blood over the last 2 to 3 months. FPG is a test that measures the amount of sugar in the blood after an 8 hour fast.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: rosiglitazone/metformin
    • Enrollment:
    190
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    metformin, rosiglitazone, rosiglitazone/metformin
    Collaborators
    Not applicable
    Study date(s)
    October 2003 to November 2004
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 70 years
    Accepts healthy volunteers
    No
    • Laboratory result for HbA1c >11% or FPG >270mg/dL
    • Clinical diagnosis of Type II diabetes
    • Women who are pregnant
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Laboratory result for HbA1c >11% or FPG >270mg/dL
    • Clinical diagnosis of Type II diabetes
    • Prior treatment with diet and/or exercise alone, or less than 15 days of prior treatment with an oral anti-diabetic medication or insulin.
    Exclusion criteria:
    • Women who are pregnant

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Las Vegas, Nevada, United States, 89103
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Moncton, New Brunswick, Canada, E1G 1A7
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Montreal, Québec, Canada, H1V 1X4
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Rotorua, New Zealand, 3201
    Status
    Study Complete
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    Location
    GSK Investigational Site
    North Bay, Ontario, Canada, P1B 2H3
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    New York, New York, United States, 10024
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Stoney Creek, Ontario, Canada, L8G 2V6
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Encinitas, California, United States, 92024
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Saint Insidore de Dorchester, Québec, Canada, G0S 2S0
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Caulfield, Victoria, Australia, 3162
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78237
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30308
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Regina, Saskatchewan, Canada, S4P 3X1
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Pusan, South Korea, 602-739
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75230
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Phoenix, Arizona, United States, 85050
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    West Chester, Pennsylvania, United States, 19382
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Camperdown, New South Wales, Australia, 2050
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    St. Louis, Missouri, United States, 63376
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Slidell, Louisiana, United States, 70461
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Montreal, Québec, Canada, H4N 2W2
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Anniston, Alabama, United States, 36207
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Los Banos, California, United States, 93635
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Laval, Québec, Canada, H7T 2P5
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Woolloongabba, Queensland, Australia, 4102
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Burlington, Ontario, Canada, L7M 4Y1
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sherbrooke, Québec, Canada, J1H 1Z1
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chesterfield, Missouri, United States, 63017
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kippa Ring, Queensland, Australia, 4021
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Beaumont, Texas, United States, 77701
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Saskatoon, Saskatchewan, Canada, S7K 0M5
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pointe-Claire, Québec, Canada, H9R 4S3
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Coquitlam, British Columbia, Canada, V3K 3V9
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Woodstock, Georgia, United States, 30189
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Orlando, Florida, United States, 32806
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kingston, New York, United States, 12401
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Plessisville, Québec, Canada, G6L 3J1
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Auckland, New Zealand, 1701
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Spokane, Washington, United States, 99207
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Miami, Florida, United States, 33156
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St. Cloud, Florida, United States, 34769
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Johnson City, Tennessee, United States, 37601
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78221
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Arlington, Texas, United States, 76017
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Fullerton, California, United States, 92835
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Perth, Western Australia, Australia, 6000
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Wollongong, New South Wales, Australia, 2500
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Wenatchee, Washington, United States, 98801
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chandler, Arizona, United States, 85224
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Phoenix, Arizona, United States, 85014
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fremantle, Western Australia, Australia, 6959
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Charlotte, North Carolina, United States, 28210
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Melbourne, Florida, United States, 32901
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Seoul, South Korea, 139-872
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Peterborough, Ontario, Canada, K9H 5G1
    Status
    Study Complete
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    Location
    GSK Investigational Site
    New York, New York, United States, 10029
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Kitchener, Ontario, Canada, N2C 2N9
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fayetteville, Georgia, United States, 30214
    Status
    Study Complete
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    Location
    GSK Investigational Site
    New York, New York, United States, 10032
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Uijeongbu,, South Korea, 480-821
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mission Viejo, California, United States, 92691
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Renfrew, Ontario, Canada, K7V 1P6
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Rochester, New York, United States, 14609
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tucson, Arizona, United States, 85745
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30342
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Chicago, Illinois, United States, 60607
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Warminster, Pennsylvania, United States, 18974
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kansas City, Missouri, United States, 64111
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Saint Marc Des Carrieres, Québec, Canada, G0A 4B0
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Jackson, Mississippi, United States, 39202
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Seattle, Washington, United States, 98108
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Peterborough, Ontario, Canada, K9J 7B3
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mogadore, Ohio, United States, 44260
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Evansville, Indiana, United States, 47713
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Christchurch, New Zealand, 8001
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Newburgh, Indiana, United States, 47630
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Brampton, Ontario, Canada, L6T 3T1
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Toronto, Ontario, Canada, M3J 1N2
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Langley, British Columbia, Canada, V3A 4H9
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Jacksonville, Florida, United States, 32204
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Calgary, Alberta, Canada, T3E 0C5
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Bryan, Texas, United States, 77802
    Status
    Study Complete
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    Location
    GSK Investigational Site
    North Adelaide, South Australia, Australia, 5006
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Midland, Texas, United States, 79705
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Halifax, Nova Scotia, Canada, B3K 5R3
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Downington, Pennsylvania, United States, 19335
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Corpus Christi, Texas, United States, 78411
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Sainte Jerome, Québec, Canada, J7Z 5T3
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Courtice, Ontario, Canada, L1E 3C3
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Oshawa, Ontario, Canada, L1H 1C2
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Montreal, Québec, Canada, H3S 2W1
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St Leonards, New South Wales, Australia, 2065
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Wellington, New Zealand, 6035
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2004-30-11

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

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