Last updated: 11/04/2018 03:15:02

AVANDIA With Glyburide In African American And Hispanic Patients With Type 2 Diabetes not Controlled by Glyburide Alone

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GSK study ID
49653/143
See study documents
Clinicaltrials.gov ID
NCT00333723
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 24-Week Randomized, Double-blind Study to Evaluate the Efficacy, Safety and Tolerability of AVANDIA (8mg once daily) in Combination with Glyburide in African American and Hispanic Patients with Type 2 Diabetes Mellitus who are Inadequately Controlled on Glyburide Monotherapy
Trial description: This study was designed to evaluate the safety and efficacy of AVANDIA (rosiglitazone) (8mg once daily) in African American and Hispanic patients with type 2 diabetes mellitus. As microvascular and macrovascular disease are significant contributors to diabetes morbidity and mortality and previous studies suggest that the thiazolidinedione compounds could have potentially beneficial vascular effects, the effects of rosiglitazone therapy on serum parameters associated with endothelial dysfunction, vascular inflammation and impaired fibrinolysis were examined in this study. Improvement in these parameters suggests that rosiglitazone may provide an additional beneficial vascular effect, apart from its ability to improve glycemic control.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Efficacy of rosiglitazone combined with glyburide to glyburide monotherapy in reducing glycosylated hemoglobin (HbA1c).

Timeframe: 24 Weeks

Secondary outcomes:

Efficacy of rosiglitazone combined with glyburide to glyburide monotherapy upon FPG, c-peptide, HOMA and responder rates.

Timeframe: 24 Weeks

Interventions:
  • Drug: Rosiglitazone
    • Enrollment:
    245
    Primary completion date:
    2003-06-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Abstract: Rosiglitazone Added to Sulfonylurea Improves Glycemic Control and Insulin Sensitivity in African American and Hispanic American Subjects with Type 2 Diabetes, CAMPBELL, JOHN C.; GOULD, ERROL M.; WATERHOUSE, BRIAN R.; COBITZ, ALEXANDER R. Orlando, FL; USA. 64th Annual Scientific Sessions of the American Diabetes Association. 6/4/2004
    Campbell JC, Gould EM, Waterhouse BR, Cobitz AR. Rosiglitazone added to sulfonylurea improves glycemic control and insulin sensitivity in African American and Hispanic American subjects with type 2 diabetes. Diabetes 2004;53(Suppl 2):A154. Poster 645 presented at ADA.
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    rosiglitazone
    Collaborators
    Not applicable
    Study date(s)
    July 2000 to January 2003
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    21+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • African American or Hispanic.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • African American or Hispanic.
    • Type 2 diabetes mellitus.
    • FPG>=140mg/dL plus HbA1c>=7.5% whilst receiving SU monotherapy. Exclusion criteria:
    • Patients who use insulin.
    • Clinically significant liver, kidney or heart disease, including high blood pressure.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    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
    2003-06-01
    Actual study completion date
    2003-06-01

    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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    AVANDIA With Glyburide In African American And Hispanic Patients With Type 2 Diabetes not Controlled by Glyburide Alone, Trial ID 49653%2F143 | GSK