| - candidate number | 2439 |
| - NTR Number | NTR882 |
| - ISRCTN | ISRCTN wordt niet meer aangevraagd |
| - Date ISRCTN created | |
| - date ISRCTN requested | 7-feb-2007 |
| - Date Registered NTR | 29-jan-2007 |
| - Secondary IDs | NTR288, ISRCTN51822988 |
| - Public Title | A double blind placebo controlled study on the effect of cerivastatin on the process of atherosclerosis in non-insulin dependent diabetes mellitus (type 2). |
| - Scientific Title | A double blind placebo controlled study on the effect of cerivastatin on the process of atherosclerosis in non-insulin dependent diabetes mellitus (type 2). |
| - ACRONYM | N/A |
| - hypothesis | To assess the effect of statin therapy on the process of atherosclerosis in type 2 diabetes without manifest cardiovascular disease. |
| - Healt Condition(s) or Problem(s) studied | Diabetes Mellitus type 2 (DM type II) |
| - Inclusion criteria | 1. Patients with type 2 diabetes for at least 1 year; 2. Age 30-80 years; 3. Written informed consent; 4. With no prior cardiovascular disease; 5. Total cholesterol 4.0-6.9 mmol/l triglycerides < 6.0 mmol/l. |
| - Exclusion criteria | 1. Prior cardiovascular disease; 2. current/recent use of lipid lowering drugs; 3. Impaired renal function (<30 ml/min); 4. CK values > 3 ULN; 5. Uncontrolled thyroid disease; 6. Liver disease or ALAT > 2 ULN; 7. Inadequate contraception, pregnancy or lactation; 8. Life expectancy <2 years. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Placebo |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 25-aug-1999 |
| - planned closingdate | 31-mrt-2003 |
| - Target number of participants | 250 |
| - Interventions | Cerivastatin 0.4 mg (Bayer BV, Mijdrecht, the Netherlands) daily or placebo for 2 years. After the withdrawal of cerivastatin from the market, 0.4 mg cerivastatin was replaced by 20 mg simvastatin (Merck, Sharp and Dome, Haarlem, the Netherlands), without deblinding the study. |
| - Primary outcome | Change from baseline in mean intima-media thickness (IMT) of the common carotid artery. |
| - Secondary outcome | Changes in: 1. Mean IMT of the carotid bifurcation, internal carotid artery, common femoral artery and superficial femoral artery; 2. Distensibility of the common carotid artery; 3. Flow mediated vasodilation (FMD) of the brachial artery as a parameter for endothelial function; 4. 48 ambulatory ECG as a parameter for silent myocardial ischemia; 5. -hs-CRP and other blood parameters for vascular inflammation, hemostatis, fibrinolysis, platelet activation, endothelial function. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | stopped: trial finished |
| - CONTACT FOR PUBLIC QUERIES | E.D. Beishuizen |
| - CONTACT for SCIENTIFIC QUERIES | MD. PhD. M.V. Huisman |
| - Sponsor/Initiator | Leiden University Medical Center (LUMC), Department of Internal Medicine |
| - Funding (Source(s) of Monetary or Material Support) | Bayer, NL, Leiden University Medical Center (LUMC), Department of Internal Medicine, Merck, Sharp and Dome (Haarlem, the Netherlands) |
| - Publications | 1. Beishuizen et al:Two-year statin therapy does not alter the progression of Intima-media thickness in patients with type 2 diabetes without manifest cardiovascular disease.Diabetes Care 27:2887-2892, 2004; 2. Beishuizen et al: The effect of statin therapy on endothelial function in type 2 diabetes without manifest cardiovascular disease.Diabetes Care 28:1668-1674, 2005; 3. Beishuizen et al: No effect of statin therapy on silent myocardial ischemia in patients with type 2 diabetes without manifest cardiovascular disease. Diabetes Care 28: 1675-1679,2005; 4. Ray et al:Vascular phenotype and subclinical inflammation in diabetic Asian Indians without overt cardiovascular disease Diab.Res.Clin.Pract. (2006),doi:10.1016/j.diabres.2006.09.021. |
| - Brief summary | The goal of the trial was to study the effect of statin therapy on vascular parameters for atherosclerosis in type 2 diabetes without manifest cardiovascular disease. 250 patients received statin therapy (cerivastatin 0.4 mg, later simvastatin 20 mg) or placebo for 2 years in this double blind placebo controlled trial. Endpoints were IMT,FMD, distensibility, 48 hour AECG and laboratory parameters. |
| - Main changes (audit trail) | |
| - RECORD | 29-jan-2007 - 4-jun-2008 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl