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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: September 13, 2016
Last verified: September 2016
  Purpose
Study examining the effect of different diuretics on fluid retention in diabetics treated with rosiglitazone.

Condition Intervention Phase
Diabetes Mellitus Drug: Rosiglitazone Drug: spironolactone Drug: hydrochlorothiazide Drug: frusemide Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Study Examining the Effect of Different Diuretics on Fluid Balance in Diabetics Treated With Avandia

Resource links provided by NLM:


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.

Enrollment: 388
Study Start Date: October 2002
Study Completion Date: January 2004
Intervention Details:
    Drug: Rosiglitazone Drug: spironolactone Drug: hydrochlorothiazide Drug: frusemide
    Other Names:
    • spironolactone
    • hydrochlorothiazide
    • 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.
  Eligibility

Ages Eligible for Study:   35 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
GSK Investigational Site
Hvidovre, Denmark, DK-2650
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
Lodz, Poland, 90-153
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, 08022
GSK Investigational Site
Barcelona, Spain, 08097
GSK Investigational Site
Madrid, Spain, 28035
GSK Investigational Site
Madrid, Spain, 28040
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

Additional Information:
Publications:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 49653/342
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 49653/342
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 49653/342
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 49653/342
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 49653/342
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 49653/342
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 49653/342
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00306696     History of Changes
Other Study ID Numbers: 49653/342
Study First Received: March 22, 2006
Last Updated: September 13, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
rosiglitazone
fluid retention
Type 2 diabetes
diuretics

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hydrochlorothiazide
Diuretics
Spironolactone
Rosiglitazone
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Diuretics, Potassium Sparing

ClinicalTrials.gov processed this record on July 25, 2017