Last updated: 11/04/2018 03:27:15
Examining the effect of different diuretics on fluid retention in diabetics treated with rosiglitazone.
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55116
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Winnipeg, Manitoba, Canada, R3E 3P4
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Acquavive delle Fonti (BA), Puglia, Italy, 70021
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Muenchen, Bayern, Germany, 80636
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rugby, Warwickshire, United Kingdom, CV22 5PX
Status
Study Complete
Location
GSK Investigational Site
Dresden, Sachsen, Germany, 01307
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Muenchen, Bayern, Germany, 81241
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Muenchen, Bayern, Germany, 80805
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Newcastle Upon Tyne, Northumberland, United Kingdom
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bologna, Emilia-Romagna, Italy, 40138
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69115
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Neuss, Nordrhein-Westfalen, Germany, 41460
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Tarrasa, Barcelona, Spain, 08221
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Blieskastel, Saarland, Germany, 66440
Status
Terminated/Withdrawn
Location
GSK Investigational Site
N. Efkarpia, Thessaloniki, Greece, 564 29
Status
Terminated/Withdrawn
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
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.
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