Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/12/2005
Date assigned
19/12/2005
Last edited
03/07/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M.A. van de Ree

ORCID ID

Contact details

Diakonessenhuis Utrecht/Zeist
P.O. Box 1002
Zeist
3700 BA
Netherlands
+31 (0)30 6989787
mvdree@diakhuis.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR391

Study information

Scientific title

Acronym

Feistritz-trial

Study hypothesis

Targets of blood pressure, glucose and cholesterol are more feasible with rosiglitazone and structured treatment advice.

Please note that as of 03/07/2008 more details on the sources of funding have been added to this record. This can be seen below in the sources of funding section.

Ethics approval

Ethics approval received from the local medical ethics committee.

Study design

Multicentre, randomised, placebo controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Diabetes mellitus type II (DM type II)

Intervention

Two treatment arms:
Arm A: Addition of rosiglitazone 8 mg once daily (od) or
Arm B: No addition of rosiglitazone

For each patient a regimen of treatment will be arranged concerning the glucose, blood pressure and cholesterol targets.

Intervention type

Drug

Phase

Not Specified

Drug names

Rosiglitazone

Primary outcome measures

The total amount of targets reached with treatment with rosiglitazone compared with treatment with no rosiglitazone.

Secondary outcome measures

The outcome of glitazone on the recently discovered risk factors of diabetic patients.

Overall trial start date

01/12/2003

Overall trial end date

01/01/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with type 2 diabetes
2. Signed informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

Participant exclusion criteria

1. Aged less than 18 years
2. Quality-adjusted life years (QALY) less than 5 years
3. Use of insulin, fibrates or thiazolidines less than 6 weeks before inclusion
4. Heart failure, New York Heart Association (NYHA) class II or more
5. Myocardial infarction (MI), angina pectoris (AP), transient ischaemic attack (TIA) or cerebrovascular attack (CVA) less than 3 months before randomisation
6. Surgery, severe trauma or infection less than 3 months before randomisation
7. Known liver disease or alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyltransferase (GT) greater than three times upper limit
8. Serum creatinine greater than 150 mmol/l
9. Triglycerides greater than 8 mmol/l

Recruitment start date

01/12/2003

Recruitment end date

01/01/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

Diakonessenhuis Utrecht/Zeist
Zeist
3700 BA
Netherlands

Sponsor information

Organisation

Aventis (The Netherlands)

Sponsor details

Postbus 2043
Gouda
2800 BD
Netherlands
+31 (0)182 557696
info.nl@aventis.com

Sponsor type

Not defined

Website

Funders

Funder type

Industry

Funder name

Added on 03/07/2008:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Grants from:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

GlaxoSmithKline (The Netherlands)

Alternative name(s)

GlaxoSmithKline Plc., GSK

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

Funder name

Sanofi-Aventis (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Merck Sharp and Dohme (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes