Last updated: 11/16/2022 12:10:16

BRL49653C In Type 2 Diabetes -Comparison Study With Pioglitazone And Placebo By Monotherapy-

GSK study ID
AVD104742
See study documents
Clinicaltrials.gov ID
NCT00297063
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 Malate (BRL49653C) in Patients with Type 2 Diabetes Mellitus (Monotherapy) - Double-Blind Comparative Study of Rosiglitazone Maleate vs. Pioglitazone Hydrochloride and Placebo -
Trial description: This study is designed to compare the efficacy and safety of BRL49653C versus pioglitazone and placebo.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

HbA1c change from baseline at Week 28.

Timeframe: 28 Weeks

Secondary outcomes:

Efficacy variables (changes from baseline in FPG, fasting insulin, HOMA-IR and HOMA-beta) at stipulated date in each treatment group.

Timeframe: 28 Weeks

Interventions:
  • Drug: Rosiglitazone
    • Enrollment:
    350
    Primary completion date:
    2007-31-05
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Kikuchi M, Kaku K, Odawara M, Momomura S, Ishii R. Efficacy and tolerability of rosiglitazone and pioglitazone in drug-naïve Japanese patients with type 2 diabetes mellitus: a double-blind, 28 weeks treatment, comparative study. [Curr Med Res Opin]. 2012;28 (epub)(6):1007-16.
    MacDonald M, Petrie M, Home P, Komajda M, Jones N, Beck-Nielsen H, Gomis R, Hanefeld M, Pocock S, Curtis P, McMurray J. . Incidence and Prevalence of Unrecognized Myocardial Infarction in People With Diabetes Mellitus: A substudy of the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) study. . [Diabetes Care]. 2011;34:1394-1396.
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    rosiglitazone
    Collaborators
    Not applicable
    Study date(s)
    January 2006 to May 2007
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    20 - 75 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Type 2 diabetes mellitus.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Type 2 diabetes mellitus.
    • Managed by diet therapy.
    • Must have adequate blood, liver and kidney function. Exclusion criteria:
    • Serious cardiovascular disease or serious hepatic disease.

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Hokkaido, Japan, 051-0005
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ibaraki, Japan, 311-0113
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kanagawa, Japan, 224-0024
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tokyo, Japan, 125-0054
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tokyo, Japan, 130-0004
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Unknown, Japan
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 14 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
    2007-31-05
    Actual study completion date
    2007-31-05

    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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