Last updated: 11/04/2018 02:59:06

Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide

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GSK study ID
49653/048
See study documents
Clinicaltrials.gov ID
NCT00279045
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: A Randomized, Double-Blind Study to Compare the Durability of Glucose Lowering and Preservation of Pancreatic Beta-Cell Function of Rosiglitazone Monotherapy Compared to Metformin or Glyburide/Glibenclamide in Patients with Drug-Naive, Recently Diagnosed Type 2 Diabetes Mellitus
Trial description: The study will compare and evaluate the effects of long-term treatment of monotherapy with rosiglitazone, metformin and glyburide/glibenclamide on the improvement and maintenance of glycemic control in patients with recently diagnosed type 2 diabetes mellitus.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: Rosiglitazone
  • Drug: glyburide
  • Drug: metformin
    • Enrollment:
    4426
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    A Diabetes Outcome Progression Trial (ADOPT). Diabetes Care, Vol 25, No. 10, October, 2002.
    A Diabetes Outcome Progression Trial (ADOPT): baseline characteristics of Type 2 diabetic patients in North America and Europe. Diabetic Medicine, November, 2006.
    Glycemic Durability of Rosiglitazone, Metformin, or Glyburide Monotherapy. N Eng J Med: 355:2427-43, December, 2006.
    Obesity is a Major Determinant of the Association of C-Reactive Protein Levels and the Metabolic Syndrome in Type 2 Diabetes. Diabetes, August, 2006
    Phenotypic Characteristics of Glutamic Acid Decarboxylase Antibody Positive, Recently Diagnosed Subjects with Type 2 Diabetes in North America and Europe. Diabetes, December, 2004.
    Kahn S, Lachin J, Zinman B, Haffner S, Aftring R, Paul G, Kravitz B, Herman W, Viberti G, Holman R. Effects of rosiglitazone, glyburide and metformin on ß-cell function and insulin sensitivity in ADOPT. Diabetes. 2011;.(Mar 17)
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    rosiglitazone
    Collaborators
    Not applicable
    Study date(s)
    January 2000 to June 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    30 - 75 years
    Accepts healthy volunteers
    No
    • Newly diagnosed patients (< 3years) with type 2 diabetes.
    • Fasting plasma glucose (FPG) range of 126-240 mg/dL at Screening.
    • History of lactic acidosis.
    • Anemia (<11g for males, <10 g for females).
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Newly diagnosed patients (< 3years) with type 2 diabetes.
    • Fasting plasma glucose (FPG) range of 126-240 mg/dL at Screening.
    • No previous treatment with oral or parenteral glucose-lowering therapy.
    Exclusion criteria:
    • History of lactic acidosis.
    • Anemia (<11g for males, <10 g for females).
    • Unstable or severe NY Heart Association-class 3 or 4.
    • Any NY Heart Association congestive heart failure.
    • Patients with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Timmins, Ontario, Canada, P4N 8P2
    Status
    Study Complete
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    Location
    GSK Investigational Site
    GELEEN, Netherlands, 6166 GR
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Crawley, Sussex West, United Kingdom, RH10 1LL
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Austin, Texas, United States, 78745
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Francisco, California, United States, 94143
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mataro, Spain, 08034
    Status
    Terminated/Withdrawn
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    Showing 1 - 6 of 490 Results

    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
    2006-19-06

    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.

    Additional information about the trial

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