Last updated: 11/04/2018 04:33:18

Study In Patients With Type 2 Diabetes Who Are Taking Metformin And Sulfonylurea, Metformin And Insulin, Or Insulin

GSK study ID
ADG104148
Clinicaltrials.gov ID
NCT00269061
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: An exploratory MRI study in Type 2 diabetic subjects: A randomized, double-blinded, placebo-controlled trial to evaluate the measurement of fluid volumes by MRI in the lower extremities of subjects receiving pioglitazone
Trial description: This study will use Magnetic Resonance Imaging (MRI) techniques to evaluate changes in fluid volume in the lower legs of diabetic patients who add either pioglitazone or placebo to their current diabetic regimen.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: pioglitazone
    • Enrollment:
    32
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Non-Insulin-Dependent Diabetes Mellitus
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    January 2006 to September 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 70 Years
    Accepts healthy volunteers
    no
    • Inclusion criteria:
    • Must have been diagnosed with Type 2 diabetes at least three months prior to screening.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Must have been diagnosed with Type 2 diabetes at least three months prior to screening.
    • Must be taking either metformin and a sulfonylurea, metformin and insulin, or insulin only, and doses of these medications must have been stable for at least three months.
    • Must have a Body Mass Index (BMI) of between 24 and 35.
    • If female, the subject must be post-menopausal.
    • HbA1c levels must be between 7% and 10%.
    • Subjects must be eligible for MRI scanning (ie, no metal implants, pacemaker, etc). Exclusion criteria:
    • Suffer from claustrophobia.
    • Use of tobacco, nicotine, or illegal drugs of abuse.
    • Use of caffeine within two days prior to each study visit.
    • HIV, hepatitis, edema, untreated blood pressure problems, heart, lung, nervous system or kidney disease, history of blood clots in the legs, diabetic neuropathy, or untreated thyroid disease.
    • Use of drugs or medications that affect the levels of fluid in the body, such as diuretics.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Belmont, Massachusetts, United States, 02478
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-07-09

    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

    Additional information
    Not applicable
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