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 |
| Secondary identifying numbers | n/a |
- 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
Not provided at time of registration
Contact information
Dr M.V. Huisman
Scientific
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 |
|---|---|
| m.v.huisman@lumc.nl |
Study information
| 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 |
| 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 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 |
| 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 Controls will get placebo In August 2001, when cerivastatin was withdrawn from the market, 0.4 mg cerivastatin was replaced by 20 mg simvastatin without deblinding the study.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 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 250 |
| Total final enrolment | 250 |
| 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 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Center
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Sponsor information
Leiden University Medical Centre (LUMC) (Netherlands)
University/education
University/education
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Website | http://www.lumc.nl/ |
|---|---|
"ROR" |
https://ror.org/027bh9e22 |
Funders
Funder type
Industry
Bayer B.V. (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | 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.
