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A double blind placebo controlled study on the effect of cerivastatin on the process of atherosclerosis in non-insulin dependent diabetes mellitus (type 2).


- candidate number2439
- NTR NumberNTR882
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested7-feb-2007
- Date Registered NTR29-jan-2007
- Secondary IDsNTR288, ISRCTN51822988 
- Public TitleA double blind placebo controlled study on the effect of cerivastatin on the process of atherosclerosis in non-insulin dependent diabetes mellitus (type 2).
- Scientific TitleA double blind placebo controlled study on the effect of cerivastatin on the process of atherosclerosis in non-insulin dependent diabetes mellitus (type 2).
- ACRONYMN/A
- hypothesisTo 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) studiedDiabetes Mellitus Type 2 (DM type II)
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 25-aug-1999
- planned closingdate31-mrt-2003
- Target number of participants250
- InterventionsCerivastatin 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 outcomeChange from baseline in mean intima-media thickness (IMT) of the common carotid artery.
- Secondary outcomeChanges 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.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES E.D. Beishuizen
- CONTACT for SCIENTIFIC QUERIESMD. 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)
- Publications1. 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 summaryThe 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)
- RECORD29-jan-2007 - 4-jun-2008


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