Examining the Effect of Different Diuretics on Fluid Retention in Diabetics Treated With Rosiglitazone.
A Randomised Study Examining the Effect of Different Diuretics on Fluid Balance in Diabetics Treated With Avandia
1 other identifier
interventional
388
14 countries
46
Brief Summary
Study examining the effect of different diuretics on fluid retention in diabetics treated with rosiglitazone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 diabetes-mellitus
Started Oct 2002
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 22, 2006
CompletedFirst Posted
Study publicly available on registry
March 24, 2006
CompletedSeptember 15, 2016
September 1, 2016
March 22, 2006
September 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in Haematocrit following 7 days diuretic adminstration.
Secondary Outcomes (1)
Total body fluid & extracellular fluid, body weight, haematocrit & haemoglobin.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (46)
GSK Investigational Site
Brussels, 1090, Belgium
GSK Investigational Site
Sint-Gillis-Waas, 9170, Belgium
GSK Investigational Site
Winnipeg, Manitoba, R3E 3P4, Canada
GSK Investigational Site
Aarhus, DK-8000, Denmark
GSK Investigational Site
Hellerup, 2900, Denmark
GSK Investigational Site
Hvidovre, DK-2650, Denmark
GSK Investigational Site
Dommartin-lès-Toul, 54201, France
GSK Investigational Site
Paris, 75877, France
GSK Investigational Site
Heidelberg, Baden-Wurttemberg, 69115, Germany
GSK Investigational Site
Munich, Bavaria, 80636, Germany
GSK Investigational Site
Munich, Bavaria, 80805, Germany
GSK Investigational Site
Munich, Bavaria, 81241, Germany
GSK Investigational Site
Neuss, North Rhine-Westphalia, 41460, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55116, Germany
GSK Investigational Site
Blieskastel, Saarland, 66440, Germany
GSK Investigational Site
Dresden, Saxony, 01307, Germany
GSK Investigational Site
Athens, 10676, Greece
GSK Investigational Site
N. Efkarpia, Thessaloniki, 564 29, Greece
GSK Investigational Site
Nikaia Piraeus, 184 54, Greece
GSK Investigational Site
Jerusalem, Israel
GSK Investigational Site
Acquavive Delle Fonti (BA), Apulia, 70021, Italy
GSK Investigational Site
Bologna, Emilia-Romagna, 40138, Italy
GSK Investigational Site
Genoa, Liguria, 16132, Italy
GSK Investigational Site
Milan, Lombardy, 21045, Italy
GSK Investigational Site
Perugia, Umbria, 06126, Italy
GSK Investigational Site
Utrecht, 3584 CJ, Netherlands
GSK Investigational Site
Oslo, Norway
GSK Investigational Site
Stavanger, N-4011, Norway
GSK Investigational Site
Tromsø, Norway
GSK Investigational Site
Bialystok, 15-276, Poland
GSK Investigational Site
Krakow, 31-501, Poland
GSK Investigational Site
Lodz, 90-153, Poland
GSK Investigational Site
Olsztyn, Poland
GSK Investigational Site
Warsaw, 03-242, Poland
GSK Investigational Site
Bratislava, 813 69, Slovakia
GSK Investigational Site
Košice, 041 90, Slovakia
GSK Investigational Site
Ľubochňa, 034 91, Slovakia
GSK Investigational Site
Alicante, Spain
GSK Investigational Site
Barcelona, 08022, Spain
GSK Investigational Site
Barcelona, 08097, Spain
GSK Investigational Site
Madrid, 28035, Spain
GSK Investigational Site
Madrid, 28040, Spain
GSK Investigational Site
Tarrasa, Barcelona, 08221, Spain
GSK Investigational Site
Newcastle upon Tyne, Northumberland, United Kingdom
GSK Investigational Site
Rugby, Warwickshire, CV22 5PX, United Kingdom
GSK Investigational Site
London, United Kingdom
Related Publications (2)
Karalliedde J. Abstract (oral presentation). Management of Rosiglitazone Related Fluid Retention. Diabetes 2005; Vol 54, (suppl 1):Abstract number 81-OR
RESULTKaralliedde 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.
PMID: 17093067RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2006
First Posted
March 24, 2006
Study Start
October 1, 2002
Study Completion
January 1, 2004
Last Updated
September 15, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.