Diabetes mellitus type II (DM type II) Nutritional, Metabolic, Endocrine Diabetes
Conditions
Interventions
1. Patients of the intervention group will be treated with cerivastatin 0.4 mg/day for two years
2. Controls will get placebo
In August 2001, when cerivastatin was wit
Sponsors
Leiden University Medical Centre (LUMC) (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient with Non-Insulin Dependent Diabetes Mellitus. The diagnosis is based upon: 1.1. The age of onset 1.2. The presence of obesity 1.3. The absence of ketoacidosis at the time of diagnosis 1.4. 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, Percutaneous Transluminal Coronary Angioplasty (PTCA) or Coronary Artery Bypass Graft (CABG) 3. Positive Electrocardiogram (ECG) criteria for a myocardial infarction in the past 4. History of ischemic Cerebrovascular Accident (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 less than 30 ml/min 10. Baseline Creatine Kinase (CK) values more than 3 x ULN 11. Fasting total cholesterol above 69 mmol/l despite diet or below 40 mmol/l or triglycerides above 60 mmol/l 12. Any hereditary dyslipidemia 13. Known allergy to 3-Hydroxy-3-Methyl-Glutaryl (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 ischaemia after 24 months as monitored with 48 hour ambulatory ECG 2. The change of endothelium function after 24 months using flow mediated vasodilatation 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, High Density Lipoprotein (HDL)-cholesterol, (calculated) Low Density Lipoprotein (LDL)-cholesterol, triglycerides, LDL/ApoB100 ratio, Lipoprotein A-I (LpA-I), Lp(a) 5. Diabetic nephropathy: creatinine clearance and microalbuminuria 6. Clinical endpoints of cardiovascular disease | — |
Countries
Netherlands
Outcome results
None listed