Non-insulin dependent diabetes mellitus (NIDDM)
Conditions
Interventions
1. Patients of the intervention group will be treated with cerivastatin 0.4mg/day for two years
2. Controls will get placebo. In August 2001, when cerivastatin was withdrawn from the market, 0.4 mg cerivastatin was replaced by 20 mg simvastatin without deblinding the study.
Sponsors
Leiden University Medical Center, Dept. of General Internal Medicine and dept. of Cardiology.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient with Non-Insulin Dependent Diabetes Mellitus. The diagnosis based upon the age of onset, the presence of obesity and the absence of ketoacidosis at the time of diagnosis and the use of diet or oral anti-diabetic drugs for more than one year from diagnosis; 2. Males and females; 3. Age range: 30 - 80 years; 4. Given written informed consent.
Exclusion criteria
Exclusion criteria: 1. Angina pectoris; 2. History of myocardial infarction, PTCA or CABG; 3. Positive ECG criteria for a myocardial infarction in the past; 4. History of ischemic CVA; 5. Peripheral artery by-pass surgery or amputation because of atherosclerotic disease or claudication; 6. Secondary diabetes (steroid induced, Cushing, haemochromatosis, alcohol abuse, pancreatitis); 7. Untreated or uncontrolled hyperthyroidism or hypothyroidism; 8. Active liver disease (hepatitis, cirrhosis or biliary obstruction) or hepatic dysfunction (repeated aminotransferase-values more than 150% of the upper limit of normal (ULN); 9. Impaired renal function with creatinine clearance < 30 ml/min; 10. Baseline CK values $ 3 x ULN; 11. Fasting total cholesterol above 6.9 mmol/l despite diet or below 4.0 mmol/l or triglycerides above 6.0 mmol/l; 12. Any hereditary dyslipidemia; 13. Known allergy to HMG-coA-reductase inhibitors; 14. Pregnancy or lactation; 15. Women of childbearing potential, not using adequate contraceptives; 16. Use of lipid lowering medication, within eight weeks before the start of the study; 17. Life expectancy of less than two years; 18. Any other condition that in the opinion of the investigator could lead to inappropriate absorption, metabolism or elimination of the medication or compromise the patients= safety, or lead to insufficient compliance with the study drug regimen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of IMT and distensibility after 24 months using B-mode ultrasound at the carotid artery level. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The change in the prevalence of (silent) myocardial ischemia after 24 months as monitored with 48h-ambulatory ECG; 2. The change of endothelium function after 24 months using flow mediated vasodilation assessed by ultrasound of the a. brachialis; 3. The change in blood levels of parameters for endothelial function, haemostasis, fibrinolysis, platelet activation, endothelial cell injury and vascular wall inflammation; 4. Biochemical endpoints: total cholesterol, HDL-cholesterol, (calculated) LDL-cholesterol, triglycerides, LDL/ApoB100 ratio, LpA-I, Lp(a); 5. Diabetic nephropathy: Creatinine clearance and microalbuminuria; 6. Clinical endpoints of cardiovascular disease. | — |
Contacts
Public ContactM.V. Huisman
Leiden University Medical Center (LUMC) Department of Thrombosis and Haemostasis Room C4-68 P.O Box 9600
Outcome results
None listed