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

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

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
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.

Ages Eligible for Study:   35 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

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

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:
fluid retention
Type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Diuretics, Potassium Sparing
Hypoglycemic Agents
Sodium Potassium Chloride Symporter Inhibitors

ClinicalTrials.gov processed this record on July 28, 2016