Diabetes Mellitus
Conditions
Keywords
rosiglitazone, fluid retention, Type 2 diabetes, diuretics
Brief summary
Study examining the effect of different diuretics on fluid retention in diabetics treated with rosiglitazone.
Detailed 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.
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Haematocrit following 7 days diuretic adminstration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Total body fluid & extracellular fluid, body weight, haematocrit & haemoglobin. | — |
Countries
Belgium, Canada, Denmark, France, Germany, Greece, Israel, Italy, Netherlands, Norway, Poland, Slovakia, Spain, United Kingdom
Outcome results
None listed