No registrations found.
ID
Source
Brief title
Health condition
Patients with type 2 diabetes without manifest cadiovascular disease.
Sponsors and support
The trial was supported by Bayer BV(Mijdrecht, the Netherlands). After the withdrawal of cerivastatin from the market, Merck, Sharp and Dome (Haarlem, the Netherlands) supplied the simvastatin/placebo tablets for the remaining study period.
Intervention
Outcome measures
Primary outcome
Change from baseline in mean intima-media thickness (IMT) of the common carotid artery.
Secondary outcome
Changes in:
1. Mean IMT of the carotid bifurcation, internal carotid artery, common femoral artery and superficial femoral artery;
2. Distensibility of the common carotid artery;
3. Flow mediated vasodilation (FMD) of the brachial artery as a parameter for endothelial function;
4. 48 ambulatory ECG as a parameter for silent myocardial ischemia;
5. -hs-CRP and other blood parameters for vascular inflammation, hemostatis, fibrinolysis, platelet activation, endothelial function.
Background summary
The goal of the trial was to study the effect of statin therapy on vascular parameters for atherosclerosis in type 2 diabetes without manifest cardiovascular disease.
250 patients received statin therapy (cerivastatin 0.4 mg, later simvastatin 20 mg) or placebo for 2 years in this double blind placebo controlled trial. Endpoints were IMT,FMD, distensibility, 48 hour AECG and laboratory parameters.
Study objective
To assess the effect of statin therapy on the process of atherosclerosis in type 2 diabetes without manifest cardiovascular disease.
Study design
N/A
Intervention
Cerivastatin 0.4 mg (Bayer BV, Mijdrecht, the Netherlands) daily or placebo for 2 years.
After the withdrawal of cerivastatin from the market, 0.4 mg cerivastatin was replaced by 20 mg simvastatin (Merck, Sharp and Dome, Haarlem, the Netherlands), without deblinding the study.
PO box 3015
E.D. Beishuizen
Zoetermeer 2700 KJ
The Netherlands
+ 31 79-3462626
beishue1@llz.nl
PO box 3015
E.D. Beishuizen
Zoetermeer 2700 KJ
The Netherlands
+ 31 79-3462626
beishue1@llz.nl
Inclusion criteria
1. Patients with type 2 diabetes for at least 1 year;
2. Age 30-80 years;
3. Written informed consent;
4. With no prior cardiovascular disease;
5. Total cholesterol 4.0-6.9 mmol/l
triglycerides < 6.0 mmol/l.
Exclusion criteria
1. Prior cardiovascular disease;
2. current/recent use of lipid lowering drugs;
3. Impaired renal function (<30 ml/min);
4. CK values > 3 ULN;
5. Uncontrolled thyroid disease;
6. Liver disease or ALAT > 2 ULN;
7. Inadequate contraception, pregnancy or lactation;
8. Life expectancy <2 years.
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 | NL868 |
| NTR-old | NTR882 |
| Other | : NTR288, ISRCTN51822988 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |
Summary results
2. Beishuizen et al: The effect of statin therapy on endothelial function in type 2 diabetes without manifest cardiovascular disease.Diabetes Care 28:1668-1674, 2005;<br>
3. Beishuizen et al: No effect of statin therapy on silent myocardial ischemia in patients with type 2 diabetes without manifest cardiovascular disease.
Diabetes Care 28: 1675-1679,2005;<br>
4. Ray et al:Vascular phenotype and subclinical inflammation in diabetic Asian Indians without overt cardiovascular disease
Diab.Res.Clin.Pract. (2006),doi:10.1016/j.diabres.2006.09.021.