Realisation of established targets for patients with diabetes type 2 at primary care setting

ISRCTN	ISRCTN18435077
DOI	https://doi.org/10.1186/ISRCTN18435077
Secondary identifying numbers	NTR391

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr M.A. van de Ree
Scientific

Diakonessenhuis Utrecht/Zeist
P.O. Box 1002
Zeist
3700 BA
Netherlands

Phone	+31 (0)30 6989787
Email	mvdree@diakhuis.nl

Study design	Multicentre, randomised, placebo controlled, parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	Feistritz-trial
Study objectives	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(s)	Ethics approval received from the local medical ethics committee.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Rosiglitazone
Primary outcome measure	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 study start date	01/12/2003
Completion date	01/01/2010

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	500
Key inclusion criteria	1. Patients with type 2 diabetes 2. Signed informed consent
Key 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
Date of first enrolment	01/12/2003
Date of final enrolment	01/01/2010

Diakonessenhuis Utrecht/Zeist

Zeist
3700 BA
Netherlands

Aventis (The Netherlands)
Not defined

Postbus 2043
Gouda
2800 BD
Netherlands

Industry

Added on 03/07/2008:

No information available

Grants from:

No information available

GlaxoSmithKline (The Netherlands)
Government organisation / For-profit companies (industry)

Sanofi-Aventis (The Netherlands)

No information available

Merck Sharp and Dohme (The Netherlands)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan