Status:
COMPLETED
Examining the Effect of Different Diuretics on Fluid Retention in Diabetics Treated With Rosiglitazone.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
35-80 years
Phase:
PHASE4
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 dia...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2004
Estimated Enrollment :
388 Patients enrolled
Trial Details
Trial ID
NCT00306696
Start Date
October 1 2002
End Date
January 1 2004
Last Update
September 15 2016
Active Locations (46)
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1
GSK Investigational Site
Brussels, Belgium, 1090
2
GSK Investigational Site
Sint-Gillis-Waas, Belgium, 9170
3
GSK Investigational Site
Winnipeg, Manitoba, Canada, R3E 3P4
4
GSK Investigational Site
Aarhus, Denmark, DK-8000