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

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.

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.

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.