Last updated: 11/04/2018 03:26:28

Effect Of Rosiglitazone On Carotid Intima Media Thickness In Patients With Insulin Resistance Syndrome And/Or Type 2 Diabetes

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GSK study ID
49653/334
See study documents
Clinicaltrials.gov ID
NCT00306644
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: Effect of rosiglitazone and placebo on carotid intima media thickness in patients with insulin resistance syndrome and/or type 2 diabetes
Trial description: The study investigated the effect of rosiglitazone and placebo on carotid intima media thickness in patients with insulin resistance syndrome and/or type 2 diabetes.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Change from baseline of the composite intima-media thickness (IMT) in the carotid artery following 52 weeks of treatment.

Timeframe: 52 weeks

Secondary outcomes:

Plaque occurrence & stenosis within the right carotid artery.

Timeframe: 52 weeks

Interventions:
  • Drug: Rosiglitazone
    • Enrollment:
    556
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Hedblad B, Zambanini A, Nilsson P, Janzon L, Berglund G. Rosiglitazone and carotid IMT progression rate in a mixed cohort of patients with type 2 diabetes and the insulin resistance syndrome: main results from the Rosiglitazone Atherosclerosis Study. Journal Of Internal Medicine 2007; 261: 293-305.
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    rosiglitazone
    Collaborators
    Not applicable
    Study date(s)
    May 2002 to November 2004
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    35 - 80 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • insulin resistant syndrome or Type 2 Diabetes.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • insulin resistant syndrome or Type 2 Diabetes. Exclusion criteria:
    • Use of >= 2 concomitant oral antihyperglycaemic agents within 3 months of study start.
    • Initiation of anti-hypertensive or lipid lowering therapy <= 6 months prior to study start or who increased the dose 3 months prior to study start.
    • Unstable or severe angina or congestive heart failure NYHA class i-iv, history of acute myocardial infarction or stroke within last 6 months.
    • Any history of surgical intervention in the right carotid artery.
    • Clinically significant hepatic disease.
    • Creatinine clearance <40ml/min.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    MALMÖ, Sweden, SE-205 02
    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

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2004-04-11

    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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