Realisation of established targets for patients with diabetes type 2 at primary care setting
| ISRCTN | ISRCTN18435077 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18435077 |
| Protocol serial number | NTR391 |
| Sponsor | Aventis (The Netherlands) |
| Funders | Added on 03/07/2008:, Grants from:, GlaxoSmithKline (The Netherlands), Sanofi-Aventis (The Netherlands), Merck Sharp and Dohme (The Netherlands) |
- Submission date
- 19/12/2005
- Registration date
- 19/12/2005
- Last edited
- 03/07/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
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
Contact information
Dr M.A. van de Ree
Scientific
Scientific
Diakonessenhuis Utrecht/Zeist
P.O. Box 1002
Zeist
3700 BA
Netherlands
| Phone | +31 (0)30 6989787 |
|---|---|
| mvdree@diakhuis.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, randomised, placebo controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Rosiglitazone |
| Primary outcome measure(s) |
The total amount of targets reached with treatment with rosiglitazone compared with treatment with no rosiglitazone. |
| Key secondary outcome measure(s) |
The outcome of glitazone on the recently discovered risk factors of diabetic patients. |
| Completion date | 01/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Diakonessenhuis Utrecht/Zeist
Zeist
3700 BA
Netherlands
3700 BA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
