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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00306696
First received: March 22, 2006
Last updated: October 25, 2012
Last verified: March 2011
History of Changes
  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 4

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:

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:
    Drug: Rosiglitazone Drug: spironolactone Drug: hydrochlorothiazide Drug: frusemide
    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

  Hide Study Locations
Locations
Belgium
GSK Investigational Site
Brussel, Belgium, 1090
GSK Investigational Site
Sint Gillis-Waas, Belgium, 9170
Canada, Manitoba
GSK Investigational Site
Winnipeg, Manitoba, Canada, R3E 3P4
Denmark
GSK Investigational Site
Aarhus, Denmark, DK-8000
GSK Investigational Site
Hellerup, Denmark, 2900
France
GSK Investigational Site
Dommartin-Les Toul, France, 54201
GSK Investigational Site
Paris Cedex 18, France, 75877
Germany
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69115
GSK Investigational Site
Muenchen, Bayern, Germany, 80636
GSK Investigational Site
Muenchen, Bayern, Germany, 80805
GSK Investigational Site
Muenchen, Bayern, Germany, 81241
GSK Investigational Site
Neuss, Nordrhein-Westfalen, Germany, 41460
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55116
GSK Investigational Site
Blieskastel, Saarland, Germany, 66440
GSK Investigational Site
Dresden, Sachsen, Germany, 01307
Greece
GSK Investigational Site
Athens, Greece, 10676
GSK Investigational Site
N. Efkarpia, Thessaloniki, Greece, 564 29
GSK Investigational Site
Nikaia Piraeus, Greece, 184 54
Israel
GSK Investigational Site
Jerusalem, Israel
Italy
GSK Investigational Site
Bologna, Emilia-Romagna, Italy, 40138
GSK Investigational Site
Genova, Liguria, Italy, 16132
GSK Investigational Site
Milano, Lombardia, Italy, 21045
GSK Investigational Site
Acquavive delle Fonti (BA), Puglia, Italy, 70021
GSK Investigational Site
Perugia, Umbria, Italy, 06126
Netherlands
GSK Investigational Site
Utrecht, Netherlands, 3584 CJ
Norway
GSK Investigational Site
Oslo, Norway
GSK Investigational Site
Stavanger, Norway, N-4011
GSK Investigational Site
Tromsoe, Norway
Poland
GSK Investigational Site
Bialystok, Poland, 15-276
GSK Investigational Site
Krakow, Poland, 31-501
GSK Investigational Site
Olsztyn, Poland
GSK Investigational Site
Warszawa, Poland, 03-242
Slovakia
GSK Investigational Site
Bratislava, Slovakia, 813 69
GSK Investigational Site
Kosice, Slovakia, 041 90
GSK Investigational Site
Lubochna, Slovakia, 034 91
Spain
GSK Investigational Site
Alicante, Spain
GSK Investigational Site
Barcelona, Spain, 08097
GSK Investigational Site
Barcelona, Spain, 08022
GSK Investigational Site
Madrid, Spain, 28040
GSK Investigational Site
Madrid, Spain, 28035
GSK Investigational Site
Tarrasa, Barcelona, Spain, 08221
United Kingdom
GSK Investigational Site
Newcastle Upon Tyne, Northumberland, United Kingdom
GSK Investigational Site
Rugby, Warwickshire, United Kingdom, CV22 5PX
GSK Investigational Site
London, United Kingdom
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials 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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00306696     History of Changes
Other Study ID Numbers: 49653/342
Study First Received: March 22, 2006
Last Updated: October 25, 2012
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 May 19, 2013