{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T05:54:20Z","timestamp":1790402060129,"version":"4.1.0"},"reference-count":32,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2015,5,31]],"date-time":"2015-05-31T00:00:00Z","timestamp":1433030400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2015,8]]},"abstract":"\n Aims<\/jats:title>\n \n To compare the efficacy and safety of\n LY2963016<\/jats:styled-content>\n insulin glargine (\n LY IGlar<\/jats:styled-content>\n ) and the reference product (\n L<\/jats:styled-content>\n antus\u00ae) insulin glargine (\n IGlar<\/jats:styled-content>\n ) in combination with oral antihyperglycaemic medications in patients with type 2 diabetes (\n T2D<\/jats:styled-content>\n ).\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n This phase\n III<\/jats:styled-content>\n , randomized, double\u2010blind, 24\u2010week study enrolled patients with\n T2D<\/jats:styled-content>\n who were insulin\u2010na\u00efve [glycated haemoglobin (\n HbA1c<\/jats:styled-content>\n ) \u22657 and \u226411.0%] or previously on\n IGlar<\/jats:styled-content>\n (\n HbA1c<\/jats:styled-content>\n \u226411%) and treated with \u22652 oral antihyperglycaemic medications. Patients were randomized to receive once\u2010daily\n LY IGlar<\/jats:styled-content>\n (n\u2009=\u2009376) or\n IGlar<\/jats:styled-content>\n (n\u2009=\u2009380) for 24\u2009weeks. The primary efficacy outcome was to test the non\u2010inferiority (0.4% and then 0.3% margin) of\n LY IGlar<\/jats:styled-content>\n to\n IGlar<\/jats:styled-content>\n , as measured by change in\n HbA1c<\/jats:styled-content>\n from baseline to 24\u2009weeks.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Both treatment groups had similar and significant (p\u2009<\u20090.001) within\u2010group decreases in mean\n HbA1c<\/jats:styled-content>\n values from baseline.\n LY IGlar<\/jats:styled-content>\n met non\u2010inferiority criteria compared with\n IGlar<\/jats:styled-content>\n for change in\n HbA1c<\/jats:styled-content>\n from baseline [\u22121.29 vs \u22121.34%; respectively, least\u2010squares mean difference 0.052% (95% confidence interval \u22120.070 to 0.175); p\u2009>\u20090.05]. There were no treatment differences (p\u2009>\u20090.05) in fasting plasma glucose, proportion of patients reaching\n HbA1c<\/jats:styled-content>\n <7% or insulin dose at 24\u2009weeks. Adverse events, allergic reactions, weight change, hypoglycaemia and insulin antibodies were similar between treatment groups. Similar findings were observed in patients who were insulin\u2010na\u00efve or previously treated with\n IGlar<\/jats:styled-content>\n at baseline.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n \n Both\n LY IGlar<\/jats:styled-content>\n and\n IGlar<\/jats:styled-content>\n , when used in combination with oral antihyperglycaemic medications, provided effective and similar glucose control with similar safety profiles in patients with\n T2D<\/jats:styled-content>\n .\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/dom.12482","type":"journal-article","created":{"date-parts":[[2015,4,30]],"date-time":"2015-04-30T04:54:17Z","timestamp":1430369657000},"page":"734-741","source":"Crossref","is-referenced-by-count":100,"title":["Similar efficacy and safety of\n LY2963016<\/scp>\n insulin glargine and insulin glargine (\n L<\/scp>\n antus\u00ae) in patients with type 2 diabetes who were insulin\u2010na\u00efve or previously treated with insulin glargine: a randomized, double\u2010blind controlled trial (the\n ELEMENT<\/scp>\n 2 study)"],"prefix":"10.1111","volume":"17","author":[{"given":"J.","family":"Rosenstock","sequence":"first","affiliation":[{"name":"Dallas Diabetes and Endocrine Center at Medical City Dallas TX USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P.","family":"Hollander","sequence":"additional","affiliation":[{"name":"Baylor Endocrine Center Dallas TX USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Bhargava","sequence":"additional","affiliation":[{"name":"Iowa Diabetes and Endocrinology Research Center Des Moines IA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L. L.","family":"Ilag","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company Indianapolis IN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R. K.","family":"Pollom","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company Indianapolis IN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J. S.","family":"Zielonka","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company Indianapolis IN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"W. J.","family":"Huster","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company Indianapolis IN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M. J.","family":"Prince","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company Indianapolis IN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2015,5,31]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.2337\/diaclin.27.2.60"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00125-012-2534-0"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.26.11.3080"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.28.4.950"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jdiacomp.2014.04.003"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.23.8.1130"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00125-005-0132-0"},{"key":"e_1_2_7_9_1","unstructured":"European Medicines Agency.Abasaglar (previously Abasria).2014. 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