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

Sponsor:	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 Diabetes Mellitus	Drug: Rosiglitazone Drug: spironolactone Drug: hydrochlorothiazide Drug: frusemide	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	See Detailed Description

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

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

Intervention Details:

Other Names:

spironolactone
hydrochlorothiazide
Rosiglitazone
frusemide

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

Publications:

Karalliedde J. Abstract (oral presentation). Management of Rosiglitazone Related Fluid Retention. Diabetes 2005; Vol 54, (suppl 1):Abstract number 81-OR

Karalliedde J, Buckingham R, Starkie M, Lorand D, Stewart M, Viberti G; Rosiglitazone Fluid Retention Study Group. Effect of various diuretic treatments on rosiglitazone-induced fluid retention. J Am Soc Nephrol. 2006 Dec;17(12):3482-90. Epub 2006 Nov 8.

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00306696 History of Changes
Other Study ID Numbers:	49653/342
Study First Received:	March 22, 2006
Last Updated:	March 17, 2011
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:

rosiglitazone
fluid retention
Type 2 diabetes
diuretics

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Diuretics
Furosemide
Hydrochlorothiazide
Spironolactone
Rosiglitazone
Natriuretic Agents
Physiological Effects of Drugs

Pharmacologic Actions
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses
Sodium Chloride Symporter Inhibitors
Antihypertensive Agents
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents

ClinicalTrials.gov processed this record on February 09, 2012