Last updated: 11/04/2018 06:10:55

Study to Determine the Utility of Novel Technologies and Biomarkers to Measure Human Response to Rosiglitazone Maleate

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GSK study ID
DIX110434
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Clinicaltrials.gov ID
NCT00551564
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 Single-Center, Non-Randomized, Open-Label, Comparative Study to Assess the Utility of Novel Technologies and Biomarkers as Methods for Measuring Human Pharmacodynamic Response to 8 Weeks of Administration of Rosiglitazone Maleate 4mg BID in Healthy Normal or Overweight Controls, Healthy Obese Subjects and Subjects with Type 2 Diabetes Mellitus (T2DM)
Trial description: Insulin resistance (IR) is common in many metabolic disorders and predisposes an individual to Type 2 Diabetes Mellitus (T2DM), the Metabolic Syndrome and coronary atherosclerosis. Non-diabetics with IR are at risk, but can be difficult to diagnose.
A major problem with the use of IR as a predictor or marker of disease is the lack of a simple, robust test that can be used to quantify this parameter in a wide variety of clinical situations. The current ‘gold standard’ methods for measuring insulin sensitivity, such as the hyperinsulinemic-euglycemic (H-E) clamp, are complex, time consuming and costly. Alternative, simpler methods, such as the Homeostasis Model Assessment (HOMA-IR) score, may be less accurate and are not widely accepted.
Primary purpose:
Diagnostic
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Insulin resistance

Timeframe: baseline and after 8 weeks of Rosiglitazone treatment

Secondary outcomes:

Insulin resistance

Timeframe: baseline, after 2 weeks treatment, 2 weeks after discontinuation treatment

hepatic glucose output: baseline, after 8 weeks treatment Insulin secretion from oral glucose tolerance

Timeframe: baseline, after 8 weeks treatment

Body composition

Timeframe: baseline & after 8 weeks treatment

Interventions:
  • Drug: rosiglitazone maleate
    • Enrollment:
    36
    Primary completion date:
    Not applicable
    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)
    July 2007 to September 2008
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    Yes
    • Male and/or females aged 18-65 years
    • Females must either be of non-childbearing potential or childbearing potential (but not pregnant) and using appropriate methods of contraception.
    • Clinically significant past or current medical conditions
    • Clinically significant abnormalities in vital signs or routine laboratory parameters
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Male and/or females aged 18-65 years
    • Females must either be of non-childbearing potential or childbearing potential (but not pregnant) and using appropriate methods of contraception.
    • Healthy normal or overweight control subjects or healthy obese subjects or subjects with T2DM.
    Exclusion criteria:
    • Clinically significant past or current medical conditions
    • Clinically significant abnormalities in vital signs or routine laboratory parameters

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Chula Vista, California, United States, 91911
    Status
    Will Be Recruiting
    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

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2008-08-09

    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
    Results for study DIX110434 can be found on the GSK Clinical Study Register.
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