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Completed

NCT Number: NCT00306696

Examining the Effect of Different Diuretics on Fluid Retention in Diabetics Treated With Rosiglitazone.

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

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Key information

Conditions

Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site, Brussels, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rosiglitazone

Drug

Spironolactone

Drug

Hydrochlorothiazide

Drug

frusemide

Drug

Other names: spironolactone, hydrochlorothiazide, Rosiglitazone

Primary outcomes

  1. Changes in Haematocrit following 7 days diuretic adminstration.

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2004
First posted
Mar 24, 2006
Registry last updated
Sep 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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