{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T12:51:40Z","timestamp":1788871900632,"version":"build-2803163510"},"reference-count":25,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2015,2,12]],"date-time":"2015-02-12T00:00:00Z","timestamp":1423699200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004339","name":"Sanofi","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100004339","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2015,4]]},"abstract":"\n Aims<\/jats:title>\n \n To compare the efficacy and safety of new insulin glargine 300\u2009U\/ml (\n Gla\u2010300<\/jats:styled-content>\n ) with that of glargine 100\u2009U\/ml (\n Gla\u2010100<\/jats:styled-content>\n ) in insulin\u2010na\u00efve people with type 2 diabetes using oral glucose\u2010lowering drugs.\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n The\n EDITION<\/jats:styled-content>\n 3 study was a multicentre, open\u2010label, parallel\u2010group study. Participants were randomized to\n Gla\u2010300<\/jats:styled-content>\n or\n Gla\u2010100<\/jats:styled-content>\n once daily for 6\u2009months, discontinuing sulphonylureas and glinides, with a dose titration aimed at achieving pre\u2010breakfast plasma glucose concentrations of 4.4\u20135.6\u2009mmol\/l (80\u2013100\u2009mg\/dl). The primary endpoint was change in glycated haemoglobin (\n HbA1c<\/jats:styled-content>\n ) from baseline to month\u20096. The main secondary endpoint was percentage of participants with \u22651 nocturnal confirmed [\u22643.9\u2009mmol\/l (\u226470\u2009mg\/dl)] or severe hypoglycaemia from week\u20099 to month\u20096. Other measures of glycaemia and hypoglycaemia, weight change and insulin dose were assessed.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Randomized participants (n\u2009=\u2009878) had a mean (standard deviation) age of 57.7 (10.1)\u2009years, diabetes duration 9.8 (6.4)\u2009years, body mass index 33.0 (6.7)\u2009kg\/m\n 2<\/jats:sup>\n and\n HbA1c<\/jats:styled-content>\n 8.54 (1.06)\u2009% [69.8 (11.6)\u2009mmol\/mol].\n HbA1c<\/jats:styled-content>\n levels decreased by equivalent amounts with the two treatments; the least squares mean difference in change from baseline was 0.04 [95% confidence interval (\n CI<\/jats:styled-content>\n ) \u22120.09 to 0.17]\u2009% or 0.4 (\u22121.0 to 1.9)\u2009mmol\/mol. Numerically fewer participants reported \u22651 nocturnal confirmed (\u22643.9\u2009mmol\/l) or severe hypoglycaemia from week\u20099 to month\u20096 [relative risk (\n RR<\/jats:styled-content>\n ) 0.89 (95%\n CI<\/jats:styled-content>\n 0.66 to 1.20)] with\n Gla\u2010300<\/jats:styled-content>\n versus\n Gla\u2010100<\/jats:styled-content>\n ; a significantly lower risk of hypoglycaemia with this definition was found over the 6\u2010month treatment period [\n RR<\/jats:styled-content>\n 0.76 (95%\n CI<\/jats:styled-content>\n 0.59 to 0.99)]. No between\u2010treatment differences in adverse events were identified.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n \n Gla\u2010300 is as effective as\n Gla\u2010100<\/jats:styled-content>\n in reducing\n HbA1c<\/jats:styled-content>\n in insulin\u2010na\u00efve people with type 2 diabetes, with lower hypoglycaemia risk.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/dom.12438","type":"journal-article","created":{"date-parts":[[2015,1,14]],"date-time":"2015-01-14T15:40:13Z","timestamp":1421250013000},"page":"386-394","source":"Crossref","is-referenced-by-count":267,"title":["New insulin glargine 300 U\/ml compared with glargine 100 U\/ml in insulin\u2010na\u00efve people with type 2 diabetes on oral glucose\u2010lowering drugs: a randomized controlled trial (EDITION 3)"],"prefix":"10.1111","volume":"17","author":[{"given":"G. B.","family":"Bolli","sequence":"first","affiliation":[{"name":"Department of Medicine Perugia University Medical School, Hospital Santa Maria della Misericordia Perugia Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M. C.","family":"Riddle","sequence":"additional","affiliation":[{"name":"Department of Medicine Oregon Health & Science University Portland OR USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R. M.","family":"Bergenstal","sequence":"additional","affiliation":[{"name":"International Diabetes Center at Park Nicollet Minneapolis MN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Ziemen","sequence":"additional","affiliation":[{"name":"Sanofi\u2010Aventis Deutschland GmbH Frankfurt am Main Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K.","family":"Sestakauskas","sequence":"additional","affiliation":[{"name":"Sanofi Chilly Mazarin France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H.","family":"Goyeau","sequence":"additional","affiliation":[{"name":"EXPERIS IT Nanterre France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P. D.","family":"Home","sequence":"additional","affiliation":[{"name":"Institute of Cellular Medicine Newcastle University Newcastle upon Tyne UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"on\u00a0behalf of the EDITION 3 study investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2015,2,12]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc12-0413"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.28.10.2543"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc10-0099"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1464-5491.2012.03605.x"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1742-1241.2009.02176.x"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12061"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1203858"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.26.11.3080"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(08)60485-7"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1463-1326.2008.00873.x"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(12)60439-5"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc14-0006"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc14-0991"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc14-0990"},{"key":"e_1_2_7_16_1","volume-title":"Definition, Diagnosis and Classification of Diabetes Mellitus and its Complications: Report of a WHO Consultation. 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