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

ISRCTN	ISRCTN51822988
DOI	https://doi.org/10.1186/ISRCTN51822988
Protocol serial number	n/a
Sponsor	Leiden University Medical Centre (LUMC) (Netherlands)
Funder	Bayer B.V. (The Netherlands)

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 09/11/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr M.V. Huisman
Scientific

Leiden University Medical Center
Department of General Internal Medicine
Albinusdreef 2, C2-R
P.O. Box 9600
Leiden
2300 RC
Netherlands

Phone	+31 (0)71 625 9111
Email	m.v.huisman@lumc.nl

Study information

Primary study design	Interventional
Study design	Randomized placebo-controlled double-blind clinical trial
Secondary study design	Randomised controlled trial
Scientific title	A double-blind placebo-controlled study on the effect of cerivastatin on the process of atherosclerosis in non-insulin-dependent diabetes mellitus
Study acronym	CERDIA
Study objectives	Cardiovascular disease (CVD) is the most important cause of mortality in patients with type 2 diabetes. We aimed to determine the effect of statin therapy versus placebo on the progression of carotid Intima-Media Thickness (IMT) in type 2 diabetic patients without manifest CVD.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Diabetes mellitus type II (DM type II)
Intervention	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 Controls will get placebo In August 2001, when cerivastatin was withdrawn from the market, 0.4 mg cerivastatin was replaced by 20 mg simvastatin without deblinding the study.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Cerivastatin
Primary outcome measure(s)	The change of IMT and distensibility after 24 months using B-mode ultrasound at the carotid artery level.
Key secondary outcome measure(s)	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
Completion date	31/03/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	250
Total final enrolment	250
Key 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
Key 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
Date of first enrolment	01/08/1999
Date of final enrolment	31/03/2003

Locations

Countries of recruitment

Netherlands

Study participating centre

Leiden University Medical Center

Leiden
2300 RC
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Date created	Peer reviewed?	Patient-facing?
Results article	01/12/2004	Yes	No
Results article	01/07/2005	Yes	No
Results article	01/07/2005	Yes	No

Editorial Notes

09/11/2022: Total final enrolment added.