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

Sponsors

Lead Sponsor: GlaxoSmithKline

Source GlaxoSmithKline
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.

Overall Status Completed
Start Date October 2002
Completion Date January 2004
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Changes in Haematocrit following 7 days diuretic adminstration.
Secondary Outcome
Measure Time Frame
Total body fluid & extracellular fluid, body weight, haematocrit & haemoglobin.
Enrollment 388
Condition
Intervention

Intervention Type: Drug

Intervention Name: Rosiglitazone

Intervention Type: Drug

Intervention Name: spironolactone

Intervention Type: Drug

Intervention Name: hydrochlorothiazide

Intervention Type: Drug

Intervention Name: frusemide

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.

Gender: All

Minimum Age: 35 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
GSK Clinical Trials Study Director GlaxoSmithKline
Location
Facility:
GSK Investigational Site | Brussel, 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-Les Toul, 54201, France
GSK Investigational Site | Paris Cedex 18, 75877, France
GSK Investigational Site | Heidelberg, Baden-Wuerttemberg, 69115, Germany
GSK Investigational Site | Muenchen, Bayern, 80636, Germany
GSK Investigational Site | Muenchen, Bayern, 80805, Germany
GSK Investigational Site | Muenchen, Bayern, 81241, Germany
GSK Investigational Site | Neuss, Nordrhein-Westfalen, 41460, Germany
GSK Investigational Site | Mainz, Rheinland-Pfalz, 55116, Germany
GSK Investigational Site | Blieskastel, Saarland, 66440, Germany
GSK Investigational Site | Dresden, Sachsen, 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 | Bologna, Emilia-Romagna, 40138, Italy
GSK Investigational Site | Genova, Liguria, 16132, Italy
GSK Investigational Site | Milano, Lombardia, 21045, Italy
GSK Investigational Site | Acquavive delle Fonti (BA), Puglia, 70021, 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 | Tromsoe, 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 | Warszawa, 03-242, Poland
GSK Investigational Site | Bratislava, 813 69, Slovakia
GSK Investigational Site | Kosice, 041 90, Slovakia
GSK Investigational Site | Lubochna, 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
Location Countries

Belgium

Canada

Denmark

France

Germany

Greece

Israel

Italy

Netherlands

Norway

Poland

Slovakia

Spain

United Kingdom

Verification Date

September 2016

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov