No registrations found.
ID
Source
Brief title
Health condition
diabetes type II
Sponsors and support
GSK
BMS
Merck
Intervention
Outcome measures
Primary outcome
The total amount of targets reached with treatment with Rosiglitazone compared with treatment with no Rosiglitazone.
Secondary outcome
The outcome of glitazone to the recent discovered riskfactors of diabetic patients.
Background summary
N/A
Study objective
Targets of blood pressure, glucose and cholesterol are better feasable with rosiglitazone and structured treatment advice.
Intervention
Two 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.
Internal Medicine <br>
P.O. Box 1002
M.A. Ree, van de
Bosboomstraat 1
Utrecht 3582 KE
The Netherlands
+31 (0)30 2566566
MvdRee@diakonessenhuis.nl
Internal Medicine <br>
P.O. Box 1002
M.A. Ree, van de
Bosboomstraat 1
Utrecht 3582 KE
The Netherlands
+31 (0)30 2566566
MvdRee@diakonessenhuis.nl
Inclusion criteria
1. Patients with type 2 diabetes;
2. Signed informed consent.
Exclusion criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL352 |
| NTR-old | NTR391 |
| Other | : N/A |
| ISRCTN | ISRCTN18435077 |