Last updated: 11/04/2018 03:25:21

Efficacy and Safety In Poorly Controlled Type 2 Diabetics

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GSK study ID
49653/326
See study documents
Clinicaltrials.gov ID
NCT00044460
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, Parallel-Group, Multicenter Study to Demonstrate the Efficacy and Safety of Two Different Rosiglitazone Dosing Regimens, 4mg OD and 8mg OD, in Poorly-Controlled Drug Naive Patients with Type 2 Diabetes Mellitus
Trial description: The purpose of this study is to gain safety and efficacy information in patients with type 2 diabetes, who have not previously taken any oral antidiabetic medications, and who have an HbA1c value of greater than or equal to 10%, despite diet and exercise.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: rosiglitazone
    • Enrollment:
    142
    Primary completion date:
    2003-10-04
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Abstract: The Effects of Rosiglitazone in Poorly-Controlled, Drug-Naive Patients with Type 2 Diabetes Mellitus, KATHLEEN L. WYNE, ALEXANDER R. COBITZ, BRIAN R. WATERHOUSE, LEANNE J. STROW. Dallas, TX; King of Prussia, PA; Orlando, FL; USA. 64th Annual Scientific Sessions of the American Diabetes Association. 6/4/2004
    Wyne KL, Cobitz AR, Waterhouse BR, Strow LJ. The effects of rosiglitazone in poorly-controlled drug-naive patients with type 2 diabetes mellitus. Diabetes 2004;53(Suppl 2):A152. Poster 639 presented at ADA
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    rosiglitazone
    Collaborators
    Not applicable
    Study date(s)
    May 2002 to April 2003
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 70 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Type 2 diabetes
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Type 2 diabetes
    • Drug-naive.
    • Laboratory test result for HbA1c of greater than or equal to 10%.
    • Written informed consent. Exclusion criteria:
    • Prior use of antidiabetic medications within 3 months of screening.
    • Fluid retention (edema).
    • Significant liver disease.
    • Low red blood cells (anemia).
    • Severe or unstable angina (chest pain).
    • Congestive heart failure.
    • Severe high blood pressure.
    • Alcohol or drug abuse.
    • Other inclusion or exclusion criteria to be determined by the physician and study sponsor.

    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
    2003-10-04
    Actual study completion date
    2003-10-04

    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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