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

September 13, 2016 updated by: GlaxoSmithKline

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

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

Study Overview

Status

Completed

Conditions

Diabetes Mellitus

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

388

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Belgium
- - Brussel, Belgium, 1090
    - GSK Investigational Site
  - Sint Gillis-Waas, Belgium, 9170
    - GSK Investigational Site
Canada
- Manitoba
  - Winnipeg, Manitoba, Canada, R3E 3P4
    - GSK Investigational Site
Denmark
- - Aarhus, Denmark, DK-8000
    - GSK Investigational Site
  - Hellerup, Denmark, 2900
    - GSK Investigational Site
  - Hvidovre, Denmark, DK-2650
    - GSK Investigational Site
France
- - Dommartin-Les Toul, France, 54201
    - GSK Investigational Site
  - Paris Cedex 18, France, 75877
    - GSK Investigational Site
Germany
- Baden-Wuerttemberg
  - Heidelberg, Baden-Wuerttemberg, Germany, 69115
    - GSK Investigational Site
- Bayern
  - Muenchen, Bayern, Germany, 81241
    - GSK Investigational Site
  - Muenchen, Bayern, Germany, 80636
    - GSK Investigational Site
  - Muenchen, Bayern, Germany, 80805
    - GSK Investigational Site
- Nordrhein-Westfalen
  - Neuss, Nordrhein-Westfalen, Germany, 41460
    - GSK Investigational Site
- Rheinland-Pfalz
  - Mainz, Rheinland-Pfalz, Germany, 55116
    - GSK Investigational Site
- Saarland
  - Blieskastel, Saarland, Germany, 66440
    - GSK Investigational Site
- Sachsen
  - Dresden, Sachsen, Germany, 01307
    - GSK Investigational Site
Greece
- - Athens, Greece, 10676
    - GSK Investigational Site
  - N. Efkarpia, Thessaloniki, Greece, 564 29
    - GSK Investigational Site
  - Nikaia Piraeus, Greece, 184 54
    - GSK Investigational Site
Israel
- - Jerusalem, Israel
    - GSK Investigational Site
Italy
- Emilia-Romagna
  - Bologna, Emilia-Romagna, Italy, 40138
    - GSK Investigational Site
- Liguria
  - Genova, Liguria, Italy, 16132
    - GSK Investigational Site
- Lombardia
  - Milano, Lombardia, Italy, 21045
    - GSK Investigational Site
- Puglia
  - Acquavive delle Fonti (BA), Puglia, Italy, 70021
    - GSK Investigational Site
- Umbria
  - Perugia, Umbria, Italy, 06126
    - GSK Investigational Site
Netherlands
- - Utrecht, Netherlands, 3584 CJ
    - GSK Investigational Site
Norway
- - Oslo, Norway
    - GSK Investigational Site
  - Stavanger, Norway, N-4011
    - GSK Investigational Site
  - Tromsoe, Norway
    - GSK Investigational Site
Poland
- - Bialystok, Poland, 15-276
    - GSK Investigational Site
  - Krakow, Poland, 31-501
    - GSK Investigational Site
  - Lodz, Poland, 90-153
    - GSK Investigational Site
  - Olsztyn, Poland
    - GSK Investigational Site
  - Warszawa, Poland, 03-242
    - GSK Investigational Site
Slovakia
- - Bratislava, Slovakia, 813 69
    - GSK Investigational Site
  - Kosice, Slovakia, 041 90
    - GSK Investigational Site
  - Lubochna, Slovakia, 034 91
    - GSK Investigational Site
Spain
- - Alicante, Spain
    - GSK Investigational Site
  - Barcelona, Spain, 08022
    - GSK Investigational Site
  - Barcelona, Spain, 08097
    - GSK Investigational Site
  - Madrid, Spain, 28040
    - GSK Investigational Site
  - Madrid, Spain, 28035
    - GSK Investigational Site
  - Tarrasa, Barcelona, Spain, 08221
    - GSK Investigational Site
United Kingdom
- - London, United Kingdom
    - GSK Investigational Site
- Northumberland
  - Newcastle Upon Tyne, Northumberland, United Kingdom
    - GSK Investigational Site
- Warwickshire
  - Rugby, Warwickshire, United Kingdom, CV22 5PX
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Changes in Haematocrit following 7 days diuretic adminstration.

Secondary Outcome Measures

Outcome Measure
Total body fluid & extracellular fluid, body weight, haematocrit & haemoglobin.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Helpful Links

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Study Completion (ACTUAL)

January 1, 2004

Study Registration Dates

First Submitted

March 22, 2006

First Submitted That Met QC Criteria

March 22, 2006

First Posted (ESTIMATE)

March 24, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

September 15, 2016

Last Update Submitted That Met QC Criteria

September 13, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

49653/342

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

Informed Consent Form
Information identifier: 49653/342

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification
Information identifier: 49653/342

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan
Information identifier: 49653/342

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol
Information identifier: 49653/342

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form
Information identifier: 49653/342

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set
Information identifier: 49653/342

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report
Information identifier: 49653/342

Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.