Examining the Effect of Different Diuretics on Fluid Retention in Diabetics Treated With Rosiglitazone.
Status and phase
Completed
Phase 4
Conditions
Diabetes Mellitus
Treatments
Drug: Rosiglitazone
Drug: spironolactone
Drug: frusemide
Drug: hydrochlorothiazide
Details and patient eligibility
About
Study examining the effect of different diuretics on fluid retention in diabetics treated with rosiglitazone.
Full description
A randomised, open-label, parallel group study to evaluate the management of rosiglitazone-related fluid retention by investigating the effect of diuretics on plasma volume in subjects with type 2 diabetes mellitus treated for twelve weeks with rosiglitazone 4mg bd in addition to background anti-diabetic agents.
Enrollment
388 patients
Sex
All
Ages
35 to 80 years old
Volunteers
No Healthy Volunteers
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 design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
Trial contacts and locations
46
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Data sourced from clinicaltrials.gov
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