Last updated: 07/17/2024 17:47:27

A Study Of BRL49653C For The Treatment Of Type 2 Diabetes (Combination Therapy With Sulfonyl Urea) -With Placebo Study

GSK study ID
AVD105248
See study documents
Clinicaltrials.gov ID
NCT00432679
See results summary
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: Clinical Evaluation of Rosiglitazone Maleate (BRL49653C) in Patients with Type 2 Diabetes Mellitus (Combination Therapy with Sulfonyl Urea) - A Placebo-Controlled Double-Blind Study -
Trial description: This study was designed to compare the efficacy and safety of BRL49653C versus placebo with concomitant use of sulfonyl urea (SU).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Change from Baseline in glycosylated hemoglobin (HbA1c) after 16 weeks of treatment in rosiglitazone group and placebo group

Timeframe: Baseline (Day 0) and Week 16

Secondary outcomes:

Change from Baseline after 16 weeks of treatment in fasting plasma glucose (FPG)

Timeframe: Baseline (Day 0) and Week 16

Change from Baseline after 16 weeks of treatment in fasting insulin

Timeframe: Baseline (Day 0) and Week 16

Change from Baseline after 16 weeks of treatment in fasting proinsulin

Timeframe: Baseline (Day 0) and Week 16

Change from Baseline after 16 weeks of treatment in homeostasis model assessment of insulin resistance (HOMA-IR)

Timeframe: Baseline (Day 0) and Week 16

Change from Baseline after 16 weeks of treatment in homeostasis model assessment of beta-cell function (HOMA-beta)

Timeframe: Baseline (Day 0) and Week 16

Change from Baseline after 16 weeks of treatment in adiponectin

Timeframe: Baseline (Day 0) and Week 16

Change from Baseline after 16 weeks of treatment in leptin and high sensitivity C-reactive protein (hs-CRP)

Timeframe: Baseline (Day 0) and Week 16

Percentage of participants with changes in HbA1c and FPG meeting specified criteria after 16 weeks of treatment

Timeframe: Up to Week 16

Interventions:
  • Drug: Rosiglitazone (BRL49653C)
    • Enrollment:
    149
    Primary completion date:
    2007-28-03
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    This study has not been published in the scientific literature.
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    rosiglitazone
    Collaborators
    Not applicable
    Study date(s)
    May 2006 to March 2007
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    20+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Patients with type 2 diabetes mellitus managed by SU will be candidate for this study. These candidates will be checked up on their clinical laboratory data, and must have adequate blood, liver and kidney function.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Patients with type 2 diabetes mellitus managed by SU will be candidate for this study. These candidates will be checked up on their clinical laboratory data, and must have adequate blood, liver and kidney function. Exclusion criteria:
    • Patient with serious cardiovascular disease or serious hepatic disease will not be eligible.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Kumamoto, Japan, 862-0976
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Oita, Japan, 870-0039
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Unknown, Japan
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Kanagawa, Japan, 212-0024
    Status
    Study Complete
    Contact us

    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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2007-28-03
    Actual study completion date
    2007-28-03

    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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    Additional information
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