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

Tracking Information

First Received Date ^ICMJE

March 22, 2006

Last Updated Date

May 15, 2009

Start Date ^ICMJE

October 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Changes in Haematocrit following 7 days diuretic adminstration.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00306696 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

See Detailed Description

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Non-Insulin-Dependent Diabetes Mellitus

Intervention ^ICMJE

Drug: Rosiglitazone
Drug: spironolactone
Drug: hydrochlorothiazide
Drug: frusemide

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

388

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

35 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

Administrative Information

NCT ID ^ICMJE

NCT00306696

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

49653/342

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, DM, FRCP

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP