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Clinical Trials/NCT00306696
NCT00306696CompletedPhase 4

A Randomised Study Examining the Effect of Different Diuretics on Fluid Balance in Diabetics Treated With Avandia

GlaxoSmithKline46 sites in 14 countries388 target enrollmentStarted: October 1, 2002Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
388
Locations
46
Primary Endpoint
Changes in Haematocrit following 7 days diuretic adminstration.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
35 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts 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.

Outcomes

Primary Outcomes

Changes in Haematocrit following 7 days diuretic adminstration.

Secondary Outcomes

  • Total body fluid & extracellular fluid, body weight, haematocrit & haemoglobin.

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (46)

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