Effect of Ezetimibe or Simvastatin or Both on Low Densitiy Lipoprotein -Subfractions in Patients With Type 2 Diabetes
NCT ID: NCT01384058
Last Updated: 2012-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
41 participants
INTERVENTIONAL
2007-11-30
2010-06-30
Brief Summary
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Detailed Description
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The primary objective of this study will be whether there is a change of the concentrations of Apolipoprotein B (ApoB) in dLDL from baseline in each of the 3 treatment groups. The comparison between treatment groups is exploratory due to insufficient power to detect any change between treatments.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ezetimibe 10mg/d
intake of ezetimibe 10mg per day for six weeks after wash-out
ezetimibe
ezetimibe 10 mg per day for six weeks
Simvastatin 20 mg per day
intake of simvastatin 20 mg per day for six weeks after wash-out
simvastatin
Simvastatin 20 mg per day for six weeks
Ezetimibe 10 mg/d and Simvastatin 20mg/d
intake of ezetimibe 10 mg and simvastatin 20 mg per day for six weeks after wash-out
Ezetimibe 10/Simvastatin 20
Ezetimibe 10mg/Simvastatin 20mg per day for six weeks
Interventions
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ezetimibe
ezetimibe 10 mg per day for six weeks
simvastatin
Simvastatin 20 mg per day for six weeks
Ezetimibe 10/Simvastatin 20
Ezetimibe 10mg/Simvastatin 20mg per day for six weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* post-menopausal women ≤ 75 years (follicle stimulating hormone (FSH) \>30 mIU/ml, women \> 60 years FSH \> 20 mIU/ml )
* well controlled diabetes mellitus type II (glycohaemoglobin ≤ 8,0 %)
* LDL-cholesterol ≤ 160 mg/dl
* LDL-subfractions: concentration of apoB-100 in dLDL (LDL-5 und LDL-6) \> 25 mg/dl
* written informed consent
Exclusion Criteria
* patient is unable to give written informed consent
* Body mass index \<15 kg/m² and \> 35 kg/m²
* clinical atherosclerotic disease (coronary heart disease, peripheral artery disease, carotid artery disease)
* malignoma
* uncontrolled arterial hypertension (\>160/\>100 mmHg)
* clinically relevant disease of liver and/or kidneys
* clinically relevant endocrinally or hematologic problems
* allergy to study medication (Ezetimibe and/or Simvastatin)
* alcohol- or drug abuse
* laboratory: alanine aminotransferase, aspartate aminotransferase, total bilirubin \> 3 x ULN, creatine kinase \> 5 x ULN
* Concurrent treatment with potent CYP3A4-inhibitors (e.g. itraconazole, ketoconazole, HIV-protease-inhibitors, erythromycin, clarithromycin, telithromycin und nefazodone)
* other relevant diseases
18 Years
75 Years
ALL
No
Sponsors
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Essex Pharma GmbH
INDUSTRY
University Hospital Freiburg
OTHER
Responsible Party
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Karl Winkler
MD, Prof. Dr. med., Kommissarischer Ärztlicher Direktor
Principal Investigators
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Karl Winkler, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Freiburg
Locations
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Institut für Stoffwechselforschung
Frankfurt, Germany, Germany
Stephan Jacob, MD
Villingen-Schwenningen, Germany, Germany
Countries
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References
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Haffner SM, Lehto S, Ronnemaa T, Pyorala K, Laakso M. Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction. N Engl J Med. 1998 Jul 23;339(4):229-34. doi: 10.1056/NEJM199807233390404.
Reaven GM, Chen YD, Jeppesen J, Maheux P, Krauss RM. Insulin resistance and hyperinsulinemia in individuals with small, dense low density lipoprotein particles. J Clin Invest. 1993 Jul;92(1):141-6. doi: 10.1172/JCI116541.
Austin MA, Edwards KL. Small, dense low density lipoproteins, the insulin resistance syndrome and noninsulin-dependent diabetes. Curr Opin Lipidol. 1996 Jun;7(3):167-71. doi: 10.1097/00041433-199606000-00010.
Winkler K, Abletshauser C, Hoffmann MM, Friedrich I, Baumstark MW, Wieland H, Marz W. Effect of fluvastatin slow-release on low density lipoprotein (LDL) subfractions in patients with type 2 diabetes mellitus: baseline LDL profile determines specific mode of action. J Clin Endocrinol Metab. 2002 Dec;87(12):5485-90. doi: 10.1210/jc.2002-020370.
Austin MA, King MC, Vranizan KM, Krauss RM. Atherogenic lipoprotein phenotype. A proposed genetic marker for coronary heart disease risk. Circulation. 1990 Aug;82(2):495-506. doi: 10.1161/01.cir.82.2.495.
Nigon F, Lesnik P, Rouis M, Chapman MJ. Discrete subspecies of human low density lipoproteins are heterogeneous in their interaction with the cellular LDL receptor. J Lipid Res. 1991 Nov;32(11):1741-53.
Dejager S, Bruckert E, Chapman MJ. Dense low density lipoprotein subspecies with diminished oxidative resistance predominate in combined hyperlipidemia. J Lipid Res. 1993 Feb;34(2):295-308.
Anber V, Griffin BA, McConnell M, Packard CJ, Shepherd J. Influence of plasma lipid and LDL-subfraction profile on the interaction between low density lipoprotein with human arterial wall proteoglycans. Atherosclerosis. 1996 Aug 2;124(2):261-71. doi: 10.1016/0021-9150(96)05842-x.
Nordestgaard BG, Nielsen LB. Atherosclerosis and arterial influx of lipoproteins. Curr Opin Lipidol. 1994 Aug;5(4):252-7. doi: 10.1097/00041433-199408000-00002.
Griffin BA, Freeman DJ, Tait GW, Thomson J, Caslake MJ, Packard CJ, Shepherd J. Role of plasma triglyceride in the regulation of plasma low density lipoprotein (LDL) subfractions: relative contribution of small, dense LDL to coronary heart disease risk. Atherosclerosis. 1994 Apr;106(2):241-53. doi: 10.1016/0021-9150(94)90129-5.
Gardner CD, Fortmann SP, Krauss RM. Association of small low-density lipoprotein particles with the incidence of coronary artery disease in men and women. JAMA. 1996 Sep 18;276(11):875-81.
Stampfer MJ, Krauss RM, Ma J, Blanche PJ, Holl LG, Sacks FM, Hennekens CH. A prospective study of triglyceride level, low-density lipoprotein particle diameter, and risk of myocardial infarction. JAMA. 1996 Sep 18;276(11):882-8.
Lamarche B, Tchernof A, Moorjani S, Cantin B, Dagenais GR, Lupien PJ, Despres JP. Small, dense low-density lipoprotein particles as a predictor of the risk of ischemic heart disease in men. Prospective results from the Quebec Cardiovascular Study. Circulation. 1997 Jan 7;95(1):69-75. doi: 10.1161/01.cir.95.1.69.
Berneis KK, Krauss RM. Metabolic origins and clinical significance of LDL heterogeneity. J Lipid Res. 2002 Sep;43(9):1363-79. doi: 10.1194/jlr.r200004-jlr200.
Blake GJ, Otvos JD, Rifai N, Ridker PM. Low-density lipoprotein particle concentration and size as determined by nuclear magnetic resonance spectroscopy as predictors of cardiovascular disease in women. Circulation. 2002 Oct 8;106(15):1930-7. doi: 10.1161/01.cir.0000033222.75187.b9.
ALTSCHUL R, HOFFER A, STEPHEN JD. Influence of nicotinic acid on serum cholesterol in man. Arch Biochem Biophys. 1955 Feb;54(2):558-9. doi: 10.1016/0003-9861(55)90070-9. No abstract available.
Charman RC, Matthews LB, Braeuler C. Nicotinic acid in the treatment of hypercholesterolemia. A long term study. Angiology. 1972 Jan;23(1):29-35. doi: 10.1177/000331977202300105. No abstract available.
DiPalma JR, Thayer WS. Use of niacin as a drug. Annu Rev Nutr. 1991;11:169-87. doi: 10.1146/annurev.nu.11.070191.001125. No abstract available.
Winkler K, Weltzien P, Friedrich I, Schmitz H, Nickell HH, Hauck P, Hoffmann MM, Baumstark MW, Wieland H, Marz W. Qualitative effect of fenofibrate and quantitative effect of atorvastatin on LDL profile in combined hyperlipidemia with dense LDL. Exp Clin Endocrinol Diabetes. 2004 May;112(5):241-7. doi: 10.1055/s-2004-817970.
Winkler K, Friedrich I, Baumstark MW, Wieland H, März W 2002 Pioglitazone reduces atherogenic dense low density lipoprotein (LDL) particles in patients with type 2 diabetes mellitus. Br J Diabetes Vasc Dis 2:143-148
Winkler K, Konrad T, Fullert S, Friedrich I, Destani R, Baumstark MW, Krebs K, Wieland H, Marz W. Pioglitazone reduces atherogenic dense LDL particles in nondiabetic patients with arterial hypertension: a double-blind, placebo-controlled study. Diabetes Care. 2003 Sep;26(9):2588-94. doi: 10.2337/diacare.26.9.2588.
Winkler K, Jacob S, Muller-Schewe T, Hoffmann MM, Konrad T. Ezetimibe alone and in combination lowers the concentration of small, dense low-density lipoproteins in type 2 diabetes mellitus. Atherosclerosis. 2012 Jan;220(1):189-93. doi: 10.1016/j.atherosclerosis.2011.10.043. Epub 2011 Nov 9.
Other Identifiers
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2006-005906-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
442006
Identifier Type: -
Identifier Source: org_study_id
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