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Realisation off established targets at patients with diabetes type 2 at primary care setting.


- candidate number1630
- NTR NumberNTR391
- ISRCTNISRCTN18435077
- Date ISRCTN created19-dec-2005
- date ISRCTN requested28-okt-2005
- Date Registered NTR13-sep-2005
- Secondary IDsN/A 
- Public TitleRealisation off established targets at patients with diabetes type 2 at primary care setting.
- Scientific TitleRealisation off established targets at patients with diabetes type 2 at primary care setting.
- ACRONYMFeistritz-trial
- hypothesisTargets of blood pressure, glucose and cholesterol are better feasable with rosiglitazone and structured treatment advice.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II)
- Inclusion criteria1. Patients with type 2 diabetes;
2. Signed informed consent.
- Exclusion criteria1. Age < 18 years;
2. QALY < 5 Years;
3. Use off insulin, fibrates or thiazolidines < 6 weeks before inclusion;
4. Heartfailure, NYHA class II or more;
5. MI, AP, TIA or CVA < 3 months before randomisation;
6. Surgery, severe trauma or infection < 3 months before randomisation;
7. Known liver disease or ALT, AST, gamma GT > 3 times upper limit;
8. Serum creatinine > 150 mmol/l;
9. Triglyceriden > 8 mmol/l.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-dec-2003
- planned closingdate1-jan-2010
- Target number of participants500
- InterventionsTwo treatmentarms:
Arm A:
Addition of Rosiglitazone 8 mg od or
Arm B: No addition of Rosiglitazone
For each patient a regiment of treatment will be arranged concerning the glucose, bloodpressure en cholesterol targets.
- Primary outcomeThe total amount of targets reached with treatment with Rosiglitazone compared with treatment with no Rosiglitazone.
- Secondary outcomeThe outcome of glitazone to the recent discovered riskfactors of diabetic patients.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. M.A. Ree, van de
- CONTACT for SCIENTIFIC QUERIESDr. M.A. Ree, van de
- Sponsor/Initiator Aventis, GlaxoSmithKline (GSK), Merck BV
- Funding
(Source(s) of Monetary or Material Support)
[default]
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD13-sep-2005 - 6-mrt-2006


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