{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,28]],"date-time":"2026-03-28T21:10:04Z","timestamp":1774732204058,"version":"3.50.1"},"reference-count":8,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2013,9,30]],"date-time":"2013-09-30T00:00:00Z","timestamp":1380499200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/3.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabet. Med."],"published-print":{"date-parts":[[2013,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aims<\/jats:title><jats:p>The aim of this study was to compare long\u2010term safety and efficacy of the basal insulin analogue degludec with glargine in insulin\u2010naive subjects with Type\u00a02 diabetes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This open\u2010label trial included a 52\u2010week core period followed by a 52\u2010week extension. Participants were randomized 3:1 to once\u2010daily degludec or glargine, administered with metformin\u00a0\u00b1\u00a0dipeptidyl peptidase\u20104 inhibitors. Basal insulin was titrated to target pre\u2010breakfast plasma glucose 3.9\u20134.9\u00a0mmol\/l.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>At end of treatment (104\u00a0weeks), mean HbA<jats:sub>1c<\/jats:sub> reductions were similar for degludec and glargine; estimated treatment difference between degludec and glargine was 1\u00a0mmol\/mol (95%\u00a0<jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content> \u22121 to 3) [0.07% (95%\u00a0<jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content> \u22120.07 to 0.22)], <jats:italic>P\u00a0<\/jats:italic>=\u00a00.339 in the extension trial set (degludec 551, glargine 174), comprising subjects who completed core trial and continued into the extension trial. Overall confirmed hypoglycaemia rates (1.72 vs. 2.05\u00a0episodes\/patient\u2010year), rates of adverse events possibly or probably related to trial product (0.19\u00a0events\/patient\u2010year), weight gain (2.7 vs. 2.4\u00a0kg) and mean daily insulin doses (0.63\u00a0U\/kg) were similar between treatments in the safety analysis set (degludec 766, glargine 257) comprising all treated subjects. Rates of nocturnal confirmed hypoglycaemia (0.27 vs. 0.46 episodes\/patient\u2010year; <jats:italic>P\u00a0<\/jats:italic>=\u00a00.002) and severe hypoglycaemia (0.006 vs. 0.021 episodes\/patient\u2010year, <jats:italic>P\u00a0<\/jats:italic>=\u00a00.023) were significantly lower with degludec for the safety analysis set (analysis based on intention\u2010to\u2010treat full analysis set comprising all randomized subjects).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>In Type\u00a02 diabetes, insulin degludec in combination with oral anti\u2010diabetic drugs, safely and effectively improves long\u2010term glycaemic control, with a significantly lower risk of nocturnal hypoglycaemia as compared with glargine.<\/jats:p><\/jats:sec>","DOI":"10.1111\/dme.12303","type":"journal-article","created":{"date-parts":[[2013,8,19]],"date-time":"2013-08-19T01:11:39Z","timestamp":1376874699000},"page":"1298-1304","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":80,"title":["Comparison of insulin degludec with insulin glargine in insulin\u2010naive subjects with Type\u00a02 diabetes: a 2\u2010year randomized, treat\u2010to\u2010target trial"],"prefix":"10.1111","volume":"30","author":[{"given":"H. W.","family":"Rodbard","sequence":"first","affiliation":[{"name":"Endocrine and Metabolic Consultants Rockville MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"B.","family":"Cariou","sequence":"additional","affiliation":[{"name":"Clinique d'Endocrinologie l'Institut du Thorax CHU Nantes Nantes France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"B.","family":"Zinman","sequence":"additional","affiliation":[{"name":"Samuel Lunenfeld Research Institute Mount Sinai Hospital University of Toronto Toronto ON Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Y.","family":"Handelsman","sequence":"additional","affiliation":[{"name":"Metabolic Institute of America Tarzana CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A.","family":"Philis\u2010Tsimikas","sequence":"additional","affiliation":[{"name":"Scripps Whittier Diabetes Institute La Jolla CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"T. V.","family":"Skj\u00f8th","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S S\u00f8borg Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A.","family":"Rana","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S S\u00f8borg Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C.","family":"Mathieu","sequence":"additional","affiliation":[{"name":"UZ Leuven University of Leuven Leuven Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"The BEGIN Once Long Trial Investigators","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2013,9,30]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11095-012-0739-z"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc12-1205"},{"key":"e_1_2_7_4_1","first-page":"403","article-title":"Ethical principles for medical research involving human subjects","volume":"107","author":"Declaration of Helsinki","year":"2009","journal-title":"J Indian Med Assoc"},{"key":"e_1_2_7_5_1","first-page":"199","article-title":"Guideline for good clinical practice","volume":"47","author":"ICH Harmonised Tripartite Guideline","year":"2001","journal-title":"J Postgrad Med"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1463-1326.2012.01638.x"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1463-1326.2012.01627.x"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00125-002-0822-9"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1742-1241.2008.01757.x"}],"container-title":["Diabetic Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fdme.12303","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/dme.12303","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/dme.12303","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/dme.12303","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,3]],"date-time":"2023-10-03T01:10:07Z","timestamp":1696295407000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/dme.12303"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2013,9,30]]},"references-count":8,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2013,11]]}},"alternative-id":["10.1111\/dme.12303"],"URL":"https:\/\/doi.org\/10.1111\/dme.12303","archive":["Portico"],"relation":{},"ISSN":["0742-3071","1464-5491"],"issn-type":[{"value":"0742-3071","type":"print"},{"value":"1464-5491","type":"electronic"}],"subject":[],"published":{"date-parts":[[2013,9,30]]},"assertion":[{"value":"2013-08-12","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2013-09-30","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}