A double-blind placebo-controlled study on the effect of cerivastatin on the process of atherosclerosis in non-insulin-dependent diabetes mellitus

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 250

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change of IMT and distensibility after 24 months using B-mode ultrasound at the carotid artery level.

Secondary Outcome Measures

Name	Time	Method
<br> 1. The change in the prevalence of (silent) myocardial ischaemia after 24 months as monitored with 48 hour ambulatory ECG<br> 2. The change of endothelium function after 24 months using flow mediated vasodilatation assessed by ultrasound of the a. brachialis<br> 3. The change in blood levels of parameters for endothelial function, haemostasis, fibrinolysis, platelet activation, endothelial cell injury and vascular wall inflammation.<br> 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)<br> 5. Diabetic nephropathy: creatinine clearance and microalbuminuria<br> 6. Clinical endpoints of cardiovascular disease<br>

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Chief Scientist Office of the Scottish Executive Health Department (UK)

Updated 6/18/2018