Examining the Effect of Different Diuretics on Fluid Retention in Diabetics Treated With Rosiglitazone. - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00306696

Purpose

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

Condition	Intervention	Phase
Non-Insulin-Dependent Diabetes Mellitus	Drug: Rosiglitazone Drug: spironolactone Drug: hydrochlorothiazide Drug: frusemide	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	See Detailed Description

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Spironolactone Furosemide Hydrochlorothiazide Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Changes in Haematocrit following 7 days diuretic adminstration.

Secondary Outcome Measures:

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

Estimated Enrollment:	388
Study Start Date:	October 2002

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.

Eligibility

Ages Eligible for Study:	35 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306696

Show 44 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, DM, FRCP

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	49653/342
Study First Received:	March 22, 2006
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00306696 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:

Type 2 diabetes
rosiglitazone
diuretics
fluid retention

Study placed in the following topic categories:

Metabolic Diseases
Hormone Antagonists
Sodium Chloride Symporter Inhibitors
Diuretics
Hormones, Hormone Substitutes, and Hormone Antagonists
Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents
Antihypertensive Agents
Urinary Retention
Hormones

Hydrochlorothiazide
Furosemide
Spironolactone
Hypoglycemic Agents
Aldosterone Antagonists
Diabetes Mellitus, Type 2
Endocrinopathy
Sodium Potassium Chloride Symporter Inhibitors
Glucose Metabolism Disorders
Metabolic Disorder
Rosiglitazone

Additional relevant MeSH terms:

Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Sodium Chloride Symporter Inhibitors
Physiological Effects of Drugs
Diuretics
Hormones, Hormone Substitutes, and Hormone Antagonists
Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents
Antihypertensive Agents
Furosemide

Hydrochlorothiazide
Pharmacologic Actions
Spironolactone
Membrane Transport Modulators
Hypoglycemic Agents
Aldosterone Antagonists
Natriuretic Agents
Therapeutic Uses
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Sodium Potassium Chloride Symporter Inhibitors
Rosiglitazone

ClinicalTrials.gov processed this record on September 11, 2009