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

Plain English Summary

Not provided at time of registration

Study website

Type

Scientific

Contact name

Dr M.V. Huisman

ORCID ID

Contact details

Leiden University Medical Center
Department of General Internal Medicine
Albinusdreef 2
C2-R
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 625 9111
m.v.huisman@lumc.nl

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

n/a

Scientific title

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

Acronym

CERDIA

Study hypothesis

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

Study design

Randomized placebo-controlled double-blind clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Hospital

Study type

Treatment

Patient information sheet

Condition

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In August 2001, when cerivastatin was withdrawn from the market, 0.4 mg cerivastatin was replaced by 20 mg simvastatin without deblinding the study.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

Pharmaceutical study type(s)

Phase

Not Applicable

Drug/device/biological/vaccine name(s)

Cerivastatin

Primary outcome measure

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

Secondary outcome measures

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

Overall study start date

01/08/1999

Overall study end date

31/03/2003

Reason abandoned (if study stopped)

Participant 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

Participant type(s)

Patient

Age group

Adult

Sex

Both

Target number of participants

250

Total final enrolment

250

Participant 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

Recruitment start date

01/08/1999

Recruitment end date

31/03/2003

Countries of recruitment

Netherlands

Study participating centre

Leiden University Medical Center
Leiden
2300 RC
Netherlands

Organisation

Leiden University Medical Centre (LUMC) (Netherlands)

Sponsor details

Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands

Sponsor type

University/education

Website

http://www.lumc.nl/

ROR

https://ror.org/027bh9e22

Funder type

Industry

Funder name

Bayer B.V. (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Individual participant data (IPD) sharing plan

Not provided at time of registration

IPD sharing plan summary

Not provided at time of registration

Study outputs