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NCT00306696 Clinical Trial

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

Diabetes Mellitus Clinical Trial

Official title:
A Randomised Study Examining the Effect of Different Diuretics on Fluid Balance in Diabetics Treated With Avandia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00306696
Other study ID # 49653/342
Secondary ID
Status Completed
Phase Phase 4
First received March 22, 2006
Last updated September 13, 2016
Start date October 2002
Est. completion date January 2004

Study information
Verified date September 2016
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

Study examining the effect of different diuretics on fluid retention in diabetics treated with rosiglitazone.

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.

Recruitment information / eligibility
Status Completed
Enrollment 388
Est. completion date January 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 35 Years to 80 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Rosiglitazone

• spironolactone

• hydrochlorothiazide

• frusemide

Locations
Country Name City State
Belgium GSK Investigational Site Brussel
Belgium GSK Investigational Site Sint Gillis-Waas
Canada GSK Investigational Site Winnipeg Manitoba
Denmark GSK Investigational Site Aarhus
Denmark GSK Investigational Site Hellerup
Denmark GSK Investigational Site Hvidovre
France GSK Investigational Site Dommartin-Les Toul
France GSK Investigational Site Paris Cedex 18
Germany GSK Investigational Site Blieskastel Saarland
Germany GSK Investigational Site Dresden Sachsen
Germany GSK Investigational Site Heidelberg Baden-Wuerttemberg
Germany GSK Investigational Site Mainz Rheinland-Pfalz
Germany GSK Investigational Site Muenchen Bayern
Germany GSK Investigational Site Muenchen Bayern
Germany GSK Investigational Site Muenchen Bayern
Germany GSK Investigational Site Neuss Nordrhein-Westfalen
Greece GSK Investigational Site Athens
Greece GSK Investigational Site N. Efkarpia, Thessaloniki
Greece GSK Investigational Site Nikaia Piraeus
Israel GSK Investigational Site Jerusalem
Italy GSK Investigational Site Acquavive delle Fonti (BA) Puglia
Italy GSK Investigational Site Bologna Emilia-Romagna
Italy GSK Investigational Site Genova Liguria
Italy GSK Investigational Site Milano Lombardia
Italy GSK Investigational Site Perugia Umbria
Netherlands GSK Investigational Site Utrecht
Norway GSK Investigational Site Oslo
Norway GSK Investigational Site Stavanger
Norway GSK Investigational Site Tromsoe
Poland GSK Investigational Site Bialystok
Poland GSK Investigational Site Krakow
Poland GSK Investigational Site Lodz
Poland GSK Investigational Site Olsztyn
Poland GSK Investigational Site Warszawa
Slovakia GSK Investigational Site Bratislava
Slovakia GSK Investigational Site Kosice
Slovakia GSK Investigational Site Lubochna
Spain 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
United Kingdom GSK Investigational Site London
United Kingdom GSK Investigational Site Newcastle Upon Tyne Northumberland
United Kingdom GSK Investigational Site Rugby Warwickshire

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Belgium,  Canada,  Denmark,  France,  Germany,  Greece,  Israel,  Italy,  Netherlands,  Norway,  Poland,  Slovakia,  Spain,  United Kingdom, 

References & Publications (2)

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. Epub 2006 Nov 8. — View Citation

Karalliedde J. Abstract (oral presentation). Management of Rosiglitazone Related Fluid Retention. Diabetes 2005; Vol 54, (suppl 1):Abstract number 81-OR

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in Haematocrit following 7 days diuretic adminstration.
Secondary Total body fluid & extracellular fluid, body weight, haematocrit & haemoglobin.
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