{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,23]],"date-time":"2026-04-23T08:51:48Z","timestamp":1776934308553,"version":"3.51.2"},"reference-count":40,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2017,10,10]],"date-time":"2017-10-10T00:00:00Z","timestamp":1507593600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004339","name":"Sanofi","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004339","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009857","name":"Regeneron Pharmaceuticals","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009857","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2017,12]]},"abstract":"\n \n \n Video abstract:<\/jats:bold>\n View a\n video\u00a0abstract<\/jats:ext-link>\n for this article.\n <\/jats:p>\n <\/jats:sec>\n \n Aims<\/jats:title>\n To investigate the efficacy and safety of alirocumab in participants with type 2 (T2D) or type 1 diabetes (T1D) treated with insulin who have elevated LDL cholesterol levels despite maximally tolerated statin therapy.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n Participants at high cardiovascular risk with T2D (n = 441) or T1D (n = 76) and LDL cholesterol levels \u22651.8 mmol\/L (\u226570 mg\/dL) were randomized 2:1 to alirocumab:placebo administered subcutaneously every 2 weeks, for 24 weeks' double\u2010blind treatment. Alirocumab\u2010treated participants received 75 mg every 2 weeks, with blinded dose increase to 150 mg every 2 weeks at week 12 if week 8 LDL cholesterol levels were \u22651.8 mmol\/L. Primary endpoints were percentage change in calculated LDL cholesterol from baseline to week 24, and safety assessments.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Alirocumab reduced LDL cholesterol from baseline to week 24 by a mean \u00b1 standard error of 49.0% \u00b1 2.7% and 47.8% \u00b1 6.5% vs placebo (both\n P<\/jats:italic>\n < .0001) in participants with T2D and T1D, respectively. Significant reductions were observed in non\u2010HDL cholesterol (\n P<\/jats:italic>\n < .0001), apolipoprotein B (\n P<\/jats:italic>\n < .0001) and lipoprotein (a) (\n P<\/jats:italic>\n \u2264 .0039). At week 24, 76.4% and 70.2% of the alirocumab group achieved LDL cholesterol <1.8 mmol\/L in the T2D and T1D populations (\n P<\/jats:italic>\n < .0001), respectively. Glycated haemoglobin and fasting plasma glucose levels remained stable for the study duration. Treatment\u2010emergent adverse events were observed in 64.5% of alirocumab\u2010 vs 64.1% of placebo\u2010treated individuals (overall population).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n Alirocumab produced significant LDL cholesterol reductions in participants with insulin\u2010treated diabetes regardless of diabetes type, and was generally well tolerated. Concomitant administration of alirocumab and insulin did not raise any safety concerns (NCT02585778).<\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/dom.13114","type":"journal-article","created":{"date-parts":[[2017,9,14]],"date-time":"2017-09-14T03:29:40Z","timestamp":1505359780000},"page":"1781-1792","source":"Crossref","is-referenced-by-count":123,"title":["Efficacy and safety of alirocumab in insulin\u2010treated individuals with type 1 or type 2 diabetes and high cardiovascular risk: The\n ODYSSEY DM\u2010INSULIN<\/scp>\n randomized trial"],"prefix":"10.1111","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1040-6229","authenticated-orcid":false,"given":"Lawrence A.","family":"Leiter","sequence":"first","affiliation":[{"name":"Li Ka Shing Knowledge Institute, St. Michael's Hospital University of Toronto Toronto Ontario Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bertrand","family":"Cariou","sequence":"additional","affiliation":[{"name":"Department of Endocrinology, l'institut du thorax CHU Nantes, INSERM, CNRS, UNIV Nantes Nantes France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dirk","family":"M\u00fcller\u2010Wieland","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine I University Hospital RWTH Aachen Aachen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Helen M.","family":"Colhoun","sequence":"additional","affiliation":[{"name":"University of Edinburgh Edinburgh UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5388-0270","authenticated-orcid":false,"given":"Stefano","family":"Del Prato","sequence":"additional","affiliation":[{"name":"Department of Clinical and Experimental Medicine University of Pisa Pisa Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francisco J.","family":"Tinahones","sequence":"additional","affiliation":[{"name":"Hospital Virgen de la Victoria, CIBERobn M\u00e1laga University M\u00e1laga Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kausik K.","family":"Ray","sequence":"additional","affiliation":[{"name":"Department of Primary Care and Public Health School of Public Health, Imperial College London London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maja","family":"Bujas\u2010Bobanovic","sequence":"additional","affiliation":[{"name":"Sanofi Paris France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Catherine","family":"Domenger","sequence":"additional","affiliation":[{"name":"Sanofi Gentilly France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jonas","family":"Mandel","sequence":"additional","affiliation":[{"name":"Sanofi Chilly\u2010Mazarin France"},{"name":"IviData Stats Levallois\u2010Perret Paris France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rita","family":"Samuel","sequence":"additional","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc. 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