A double blind placebo controlled study on the effect of cerivastatin on the process of atherosclerosis in non-insulin dependent diabetes mellitus (type 2).
- Conditions
- Patients with type 2 diabetes without manifest cadiovascular disease.
- Registration Number
- NL-OMON21494
- Lead Sponsor
- The trial was ïnvestigator driven (see scientific contact). 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.
- Brief Summary
1. Beishuizen et al:Two-year statin therapy does not alter the progression of Intima-media thickness in patients with type 2 diabetes without manifest cardiovascular disease.Diabetes Care 27:2887-2892, 2004;<br> 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 250
1. Patients with type 2 diabetes for at least 1 year;
2. Age 30-80 years;
1. Prior cardiovascular disease;
2. current/recent use of lipid lowering drugs;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in mean intima-media thickness (IMT) of the common carotid artery.
- Secondary Outcome Measures
Name Time Method Changes in:<br /><br>1. Mean IMT of the carotid bifurcation, internal carotid artery, common femoral artery and superficial femoral artery;<br /><br>2. Distensibility of the common carotid artery;<br /><br>3. Flow mediated vasodilation (FMD) of the brachial artery as a parameter for endothelial function;<br /><br>4. 48 ambulatory ECG as a parameter for silent myocardial ischemia;<br /><br>5. -hs-CRP and other blood parameters for vascular inflammation, hemostatis, fibrinolysis, platelet activation, endothelial function.