Clinical trial NCT00306696: Examining the Effect of Different Diuretics on Fluid Retention in Diabetics Treated With Rosiglitazone.
Official title: A Randomised Study Examining the Effect of Different Diuretics on Fluid Balance in Diabetics Treated With Avandia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Keywords: rosiglitazone
fluid retention
Type 2 diabetes
diuretics
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-03-24
Enrollment: 388
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study examining the effect of different diuretics on fluid retention in diabetics treated with 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 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.

Primary outcomes:
measure: Changes in Haematocrit following 7 days diuretic adminstration.
Secondary outcomes:
measure: Total body fluid & extracellular fluid, body weight, haematocrit & haemoglobin.
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: GSK Investigational Site
city: Sint Gillis-Waas
country: Belgium
facility: GSK Investigational Site
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Aarhus
country: Denmark
facility: GSK Investigational Site
city: Hellerup
country: Denmark
facility: GSK Investigational Site
city: Hvidovre
country: Denmark
facility: GSK Investigational Site
city: Dommartin-Les Toul
country: France
facility: GSK Investigational Site
city: Paris Cedex 18
country: France
facility: GSK Investigational Site
city: Heidelberg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Neuss
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Blieskastel
country: Germany
facility: GSK Investigational Site
state: Saarland
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Athens
country: Greece
facility: GSK Investigational Site
city: N. Efkarpia, Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Nikaia Piraeus
country: Greece
facility: GSK Investigational Site
city: Jerusalem
country: Israel
facility: GSK Investigational Site
city: Bologna
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Genova
country: Italy
facility: GSK Investigational Site
state: Liguria
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Acquavive delle Fonti (BA)
country: Italy
facility: GSK Investigational Site
state: Puglia
city: Perugia
country: Italy
facility: GSK Investigational Site
state: Umbria
city: Utrecht
country: Netherlands
facility: GSK Investigational Site
city: Oslo
country: Norway
facility: GSK Investigational Site
city: Stavanger
country: Norway
facility: GSK Investigational Site
city: Tromsoe
country: Norway
facility: GSK Investigational Site
city: Bialystok
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Olsztyn
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Bratislava
country: Slovakia
facility: GSK Investigational Site
city: Kosice
country: Slovakia
facility: GSK Investigational Site
city: Lubochna
country: Slovakia
facility: GSK Investigational Site
city: Alicante
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Tarrasa, Barcelona
country: Spain
facility: GSK Investigational Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: GSK Investigational Site
state: Northumberland
city: Rugby
country: United Kingdom
facility: GSK Investigational Site
state: Warwickshire
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Karalliedde J. Abstract (oral presentation). Management of Rosiglitazone Related Fluid Retention. Diabetes 2005; Vol 54, (suppl 1):Abstract number 81-OR
citation: 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.