{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T20:23:40Z","timestamp":1792787020669,"version":"4.5.0"},"reference-count":30,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2015,6,23]],"date-time":"2015-06-23T00:00:00Z","timestamp":1435017600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004312","name":"Eli Lilly and Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004312","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Boehringer Ingelheim"}],"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 (Lantus\u00ae) insulin glargine (\n IGlar<\/jats:styled-content>\n ) in patients with type 1 diabetes (\n T1D<\/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, open\u2010label, 52\u2010week study enrolled patients with\n T1D<\/jats:styled-content>\n [glycated haemoglobin (\n HbA1c<\/jats:styled-content>\n ) \u226411%] being treated with basal (once\u2010daily) and bolus insulin. Patients were randomized to receive once\u2010daily\n LY IGlar<\/jats:styled-content>\n (n\u2009=\u2009268) or\n IGlar<\/jats:styled-content>\n (n\u2009=\u2009267) in combination with mealtime insulin lispro for 52\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 the non\u2010inferiority criteria compared with\n IGlar<\/jats:styled-content>\n for change in\n HbA1c<\/jats:styled-content>\n from baseline to 24\u2009weeks [\u22120.35 vs \u22120.46%, least\u2010squares mean difference 0.108% (95% confidence interval \u22120.002 to 0.219), p\u2009>\u20090.05]. There were no significant (p\u2009>\u20090.05) treatment differences in other efficacy measures, including proportion of patients reaching\n HbA1c<\/jats:styled-content>\n <7%, daily mean blood glucose, and insulin dose at 24 and 52\u2009weeks. At 52\u2009weeks, similar findings were observed between\n LY IGlar<\/jats:styled-content>\n and\n IGlar<\/jats:styled-content>\n for safety outcomes, including adverse events, allergic reactions, hypoglycaemia, weight change and insulin antibodies.\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 mealtime insulin lispro, provided effective and similar glucose control and similar safety profiles.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/dom.12496","type":"journal-article","created":{"date-parts":[[2015,5,14]],"date-time":"2015-05-14T03:47:20Z","timestamp":1431575240000},"page":"726-733","source":"Crossref","is-referenced-by-count":72,"title":["Efficacy and safety of\n LY2963016<\/scp>\n insulin glargine compared with insulin glargine (\n L<\/scp>\n antus\u00ae) in patients with type 1 diabetes in a randomized controlled trial: the\n ELEMENT<\/scp>\n 1 study"],"prefix":"10.1111","volume":"17","author":[{"given":"T. C.","family":"Blevins","sequence":"first","affiliation":[{"name":"Texas Diabetes & Endocrinology Austin TX USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D.","family":"Dahl","sequence":"additional","affiliation":[{"name":"Gemeinschaftspraxis f\u00fcr Innere Medizin und Diabetologie Hamburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.","family":"Rosenstock","sequence":"additional","affiliation":[{"name":"Dallas Diabetes and Endocrine Center at Medical City Dallas TX 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":"W. J.","family":"Huster","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":"R. K.","family":"Pollom","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":[[2015,6,23]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1126\/science.6337396"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1177\/1474651410369234"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrd4210"},{"key":"e_1_2_7_5_1","unstructured":"European Medicines Agency.Marvel Life\u2010Sciences Ltd withdraws its marketing authorisation applications for Insulin Human Rapid Marvel Insulin Human Long Marvel and Insulin Human 30\/70 Mix Marvel. EMEA\/2435\/2008. Press Release.2008. Available from URL:www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2009\/11\/WC500015335.pdf. Accessed 15 October 2014."},{"key":"e_1_2_7_6_1","unstructured":"European Medicines Agency.Marvel Life Sciences Ltd withdraws its marketing authorisation applications for Solumarv Isomarv medium and Combimarv (human insulin). Press Release.2012. Available from URL:http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Press_release\/2012\/11\/WC500135156.pdf. Accessed 15 October 2014."},{"key":"e_1_2_7_7_1","unstructured":"European Medicines Agency.Abasaglar (previously Abasria).2014. Available from URL:http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=\/pages\/medicines\/human\/medicines\/002835\/human_med_001790.jsp&mid=WC0b01ac058001d124. Accessed 31 March 2015."},{"key":"e_1_2_7_8_1","unstructured":"Food and Drug Administration.Drug Approval Package: Lantus (Insulin Glargine [rDNA Origin]). NDA #21\u20100812000. Available from URL:http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2000\/21081_Lantus.cfm. Accessed 31 March 2015."},{"key":"e_1_2_7_9_1","unstructured":"Eli Lilly and Company.FDA grants tentative approval for Lilly and Boehringer Ingelheim's Basaglar\u2122 (insulin glargine injection).2014. Available from URL:https:\/\/investor.lilly.com\/releasedetail.cfm?ReleaseID=866751. Accessed 31 March 2015."},{"key":"e_1_2_7_10_1","unstructured":"Food and Drug Administration.Biologics Price Competition and Innovation Act.2009. Available from URL:http:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/UCM216146.pdf. Accessed 31 March 2015."},{"key":"e_1_2_7_11_1","unstructured":"European Medicines Agency.European public assessment report: Abasria.2014. Available from URL:http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/EPAR_\u2010_Public_assessment_report\/human\/002835\/WC500175383.pdf. Accessed 31 March 2015."},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-014-0226-4"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.23.11.1666"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.23.5.639"},{"key":"e_1_2_7_15_1","unstructured":"European Medicines Agency.Committee for Medicinal Products for Human Use. Guideline on similar biological medicinal products.2005. Available from URL:http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2009\/09\/WC500003517.pdf. Accessed 31 March 2015."},{"key":"e_1_2_7_16_1","unstructured":"World Health Organization.Expert Committee on biological standardization. Guidelines on evaluation of Similar Biotherapeutic Products (SBPs).2009. Available from URL:http:\/\/www.who.int\/biologicals\/areas\/biological_therapeutics\/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf. Accessed 31 March 2015."},{"key":"e_1_2_7_17_1","unstructured":"Food and Drug Administration.Guidance for industry: clinical pharmacology data to support a demonstration of biosimilarity to a reference product.2014. Available from URL:http:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM397017.pdf. Accessed 31 March 2015."},{"key":"e_1_2_7_18_1","unstructured":"European Medicines Agency.Guideline on non\u2010clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues.2014. Available from URL:http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2014\/04\/WC500165988.pdf. Accessed 31 March 2015."},{"key":"e_1_2_7_19_1","first-page":"1650","article-title":"Comparative subchronic toxicity studies in rats of LY2963016 (LY), an insulin glargine product, with USA sourced Lantus\u00ae (US\u2010L) and EU\u2010sourced Lantus\u00ae (EU\u2010L)","volume":"138","author":"Byrd RA","year":"2014","journal-title":"Toxicologist"},{"key":"e_1_2_7_20_1","first-page":"889\u2010P","article-title":"Comparative pharmacokinetics (PK) and pharmacodynamics (PD) of LY2963016 insulin glargine and EU\u2010 and U.S.\u2010approved versions of Lantus\u00ae insulin glargine in healthy subjects","volume":"63","author":"Linnebjerg H","year":"2014","journal-title":"Diabetes"},{"key":"e_1_2_7_21_1","first-page":"890\u2010P","article-title":"Comparative pharmacokinetics and pharmacodynamics of two insulin glargine products, LY2963016 and Lantus\u00ae, in healthy subjects at two dose levels","volume":"63","author":"Zhang X","year":"2014","journal-title":"Diabetes"},{"key":"e_1_2_7_22_1","first-page":"891\u2010P","article-title":"Duration of action of 2 insulin glargine products, LY2963016 and Lantus\u00ae, in subjects with type I diabetes mellitus (T1DM)","volume":"63","author":"Heise T","year":"2014","journal-title":"Diabetes"},{"key":"e_1_2_7_23_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12482"},{"key":"e_1_2_7_24_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.1997.03540350075038"},{"key":"e_1_2_7_25_1","unstructured":"Food and Drug Administration.Guidance for industry: diabetes mellitus: developing drugs and therapeutic biologics for treatment and prevention. Draft guidance February 2008.2008. Available from URL:http:\/\/www.fda.gov\/downloads\/Drugs\/Guidances\/ucm071624.pdf. Accessed 1 April 2015."},{"key":"e_1_2_7_26_1","unstructured":"Food and Drug Administration.Guidance for industry: non\u2010inferiority clinical trials. Draft guidance March 2010.2010. Available from URL:http:\/\/www.fda.gov\/downloads\/Drugs\/&\/Guidances\/UCM202140.pdf. Accessed 1 April 2015."},{"key":"e_1_2_7_27_1","unstructured":"European Medicines Agency.Guideline on the choice of the non\u2010inferiority margin.2005. Available from URL:http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Scientific_guideline\/2009\/09\/WC500003636.pdf. Accessed 15 October 2014."},{"key":"e_1_2_7_28_1","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2012.0105"},{"key":"e_1_2_7_29_1","unstructured":"European Medicines Agency.LANTUS: EPAR\u00a0\u2013\u00a0Product information.2015. Available from URL:http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/EPAR_\u2010_Product_Information\/human\/000284\/WC500036082.pdf. Accessed 1 April 2015."},{"key":"e_1_2_7_30_1","unstructured":"U.S. National Library of Medicine. LANTUS\u2010 insulin glargine injection solution.Drug label information.2015. Available from URL:http:\/\/dailymed.nlm.nih.gov\/dailymed\/lookup.cfm?setid=d5e07a0c\u20107e14\u20104756\u20109152\u20109fea485d654a. Accessed 1 April 2015."},{"key":"e_1_2_7_31_1","doi-asserted-by":"crossref","unstructured":"LinnebjergH LamECQ SegerMEet\u2009al.Comparison of the pharmacokinetics and pharmacodynamics of LY2963016 insulin glargine and EU\u2010 and US\u2010approved versions of Lantus\u00ae insulin glargine in healthy subjects: 3 randomized euglycemic clamp studies (under review).2015.","DOI":"10.2337\/dc14-2623"}],"container-title":["Diabetes, Obesity and Metabolism"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fdom.12496","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/dom.12496","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/dom.12496","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/dom-pubs.pericles-prod.literatumonline.com\/doi\/pdf\/10.1111\/dom.12496","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,31]],"date-time":"2025-10-31T05:16:40Z","timestamp":1761887800000},"score":1,"resource":{"primary":{"URL":"https:\/\/dom-pubs.pericles-prod.literatumonline.com\/doi\/10.1111\/dom.12496"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,6,23]]},"references-count":30,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2015,8]]}},"alternative-id":["10.1111\/dom.12496"],"URL":"https:\/\/doi.org\/10.1111\/dom.12496","archive":["Portico"],"relation":{},"ISSN":["1462-8902","1463-1326"],"issn-type":[{"value":"1462-8902","type":"print"},{"value":"1463-1326","type":"electronic"}],"subject":[],"published":{"date-parts":[[2015,6,23]]}}}