Examining the Effect of Different Diuretics on Fluid Retention in Diabetics Treated With Rosiglitazone.
NCT ID: NCT00306696
Last Updated: 2016-09-15
Study Results
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Basic Information
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COMPLETED
PHASE4
388 participants
INTERVENTIONAL
2002-10-31
2004-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Rosiglitazone
spironolactone
hydrochlorothiazide
frusemide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 with HbA1c \>=10%.
* Subjects already receiving diuretic medication.
* Subjects unstable or severe angina.
* CHF NYHA class i-iv.
* Subjects with clinically significant hepatic disease.
35 Years
80 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Brussels, , Belgium
GSK Investigational Site
Sint-Gillis-Waas, , Belgium
GSK Investigational Site
Winnipeg, Manitoba, Canada
GSK Investigational Site
Aarhus, , Denmark
GSK Investigational Site
Hellerup, , Denmark
GSK Investigational Site
Hvidovre, , Denmark
GSK Investigational Site
Dommartin-lès-Toul, , France
GSK Investigational Site
Paris, , France
GSK Investigational Site
Heidelberg, Baden-Wurttemberg, Germany
GSK Investigational Site
Munich, Bavaria, Germany
GSK Investigational Site
Munich, Bavaria, Germany
GSK Investigational Site
Munich, Bavaria, Germany
GSK Investigational Site
Neuss, North Rhine-Westphalia, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, Germany
GSK Investigational Site
Blieskastel, Saarland, Germany
GSK Investigational Site
Dresden, Saxony, Germany
GSK Investigational Site
Athens, , Greece
GSK Investigational Site
N. Efkarpia, Thessaloniki, , Greece
GSK Investigational Site
Nikaia Piraeus, , Greece
GSK Investigational Site
Jerusalem, , Israel
GSK Investigational Site
Acquavive Delle Fonti (BA), Apulia, Italy
GSK Investigational Site
Bologna, Emilia-Romagna, Italy
GSK Investigational Site
Genoa, Liguria, Italy
GSK Investigational Site
Milan, Lombardy, Italy
GSK Investigational Site
Perugia, Umbria, Italy
GSK Investigational Site
Utrecht, , Netherlands
GSK Investigational Site
Oslo, , Norway
GSK Investigational Site
Stavanger, , Norway
GSK Investigational Site
Tromsø, , Norway
GSK Investigational Site
Bialystok, , Poland
GSK Investigational Site
Krakow, , Poland
GSK Investigational Site
Lodz, , Poland
GSK Investigational Site
Olsztyn, , Poland
GSK Investigational Site
Warsaw, , Poland
GSK Investigational Site
Bratislava, , Slovakia
GSK Investigational Site
Košice, , Slovakia
GSK Investigational Site
Ľubochňa, , Slovakia
GSK Investigational Site
Alicante, , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Tarrasa, Barcelona, , Spain
GSK Investigational Site
Newcastle upon Tyne, Northumberland, United Kingdom
GSK Investigational Site
Rugby, Warwickshire, United Kingdom
GSK Investigational Site
London, , United Kingdom
Countries
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References
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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. doi: 10.1681/ASN.2006060606. Epub 2006 Nov 8.
Study Documents
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Document Type: Informed Consent Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Statistical Analysis Plan
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Study Protocol
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Annotated Case Report Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Clinical Study Report
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentRelated Links
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Other Identifiers
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49653/342
Identifier Type: -
Identifier Source: org_study_id
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