Last updated: 11/04/2018 03:27:15

Examining the effect of different diuretics on fluid retention in diabetics treated with rosiglitazone.

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GSK study ID
49653/342
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Clinicaltrials.gov ID
NCT00306696
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 Randomised study Examining the Effect of Different Diuretics on Fluid Balance in Diabetics Treated with Avandia
Trial description: Study examining the effect of different diuretics on fluid retention in diabetics treated with rosiglitazone.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: Rosiglitazone
  • Drug: spironolactone
  • Drug: hydrochlorothiazide
  • Drug: frusemide
    • Enrollment:
    388
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Karalliedde J. Abstract (oral presentation). Management of Rosiglitazone Related Fluid Retention. Diabetes 2005; Vol 54, (suppl 1):Abstract number 81-OR
    Karalliedde J. Buckingham R. Starkie M. Lorand D. Stewart M. Viberti G. Effect of various diuretic treatments on rosiglitazone-induced fluid retention". Journal of the American Society of Nephrology 2006; 17(12):3482-3490."
    Medical condition
    Diabetes Mellitus
    Product
    rosiglitazone
    Collaborators
    Not applicable
    Study date(s)
    October 2002 to January 2004
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    35 - 80 years
    Accepts healthy volunteers
    No
    • Subjects with type 2 diabetes.
    • Stable FPG of >=7.0 and <=12.0mmol/L.
    • Subjects taking > 2 concomitant oral anti-diabetic agents.
    • Subjects with HbA1c >=10%.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects with type 2 diabetes.
    • Stable FPG of >=7.0 and <=12.0mmol/L.
    • Subjects had to have been established on SU treatment or SU+MET treatment for at least 2 months.
    • Serum creatinine level > 130 micromol/L.
    Exclusion criteria:
    • Subjects taking > 2 concomitant oral anti-diabetic agents.
    • Subjects with HbA1c >=10%.
    • Subjects already receiving diuretic medication.
    • Subjects unstable or severe angina.
    • CHF NYHA class i-iv.
    • Subjects with clinically significant hepatic disease.

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Mainz, Rheinland-Pfalz, Germany, 55116
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Winnipeg, Manitoba, Canada, R3E 3P4
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Acquavive delle Fonti (BA), Puglia, Italy, 70021
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Sint Gillis-Waas, Belgium, 9170
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Muenchen, Bayern, Germany, 80636
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Hvidovre, Denmark, DK-2650
    Status
    Terminated/Withdrawn
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    Showing 1 - 6 of 46 Results

    Study documents

    Clinical study report
    Available language(s): English
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    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
    2004-16-01

    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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