{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,13]],"date-time":"2026-01-13T22:30:39Z","timestamp":1768343439704,"version":"3.49.0"},"reference-count":17,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2015,9,14]],"date-time":"2015-09-14T00:00:00Z","timestamp":1442188800000},"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":"publisher","id":[{"id":"10.13039\/100004339","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2015,12]]},"abstract":"\n Aims<\/jats:title>\n \n To compare the efficacy and safety of new insulin glargine 300 U\/ml (\n Gla<\/jats:styled-content>\n \u2010300) with insulin glargine 100 U\/ml (\n Gla<\/jats:styled-content>\n \u2010100) over 12 months of treatment in people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs (\n OADs<\/jats:styled-content>\n ).\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n EDITION<\/jats:styled-content>\n 2 (\n NCT01499095<\/jats:styled-content>\n ) was a randomized, 6\u2010month, multicentre, open\u2010label, two\u2010arm, phase\n IIIa<\/jats:styled-content>\n study investigating once\u2010daily\n Gla<\/jats:styled-content>\n \u2010300 versus\n Gla<\/jats:styled-content>\n \u2010100, plus\n OADs<\/jats:styled-content>\n (excluding sulphonylureas), with a 6\u2010month safety extension.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Similar numbers of participants in each group completed 12 months of treatment [\n Gla<\/jats:styled-content>\n \u2010300, 315 participants (78%);\n Gla<\/jats:styled-content>\n \u2010100, 314 participants (77%)]. The reduction in glycated haemoglobin was maintained for 12 months with both treatments: least squares (\n LS<\/jats:styled-content>\n ) mean (standard error) change from baseline \u22120.55 (0.06)% for\n G<\/jats:styled-content>\n la\u2010300 and \u22120.50 (0.06)% for\n Gla<\/jats:styled-content>\n \u2010100;\n LS<\/jats:styled-content>\n mean difference \u22120.06 [95% confidence interval (\n CI<\/jats:styled-content>\n ) \u22120.22 to 0.10)%]. A significant relative reduction of 37% in the annualized rate of nocturnal confirmed [\u22643.9 mmol\/l (\u226470 mg\/dl)] or severe hypoglycaemia was observed with\n Gla<\/jats:styled-content>\n \u2010300 compared with\n Gla<\/jats:styled-content>\n \u2010100: rate ratio 0.63 [(95%\n CI<\/jats:styled-content>\n 0.42\u20130.96); p = 0.031], and fewer participants experienced \u22651 event [relative risk 0.84 (95%\n CI<\/jats:styled-content>\n 0.71\u20130.99)]. Severe hypoglycaemia was infrequent. Weight gain was significantly lower with\n Gla<\/jats:styled-content>\n \u2010300 than\n Gla<\/jats:styled-content>\n \u2010100 [\n LS<\/jats:styled-content>\n mean difference \u22120.7 (95%\n CI<\/jats:styled-content>\n \u22121.3 to \u22120.2) kg; p = 0.009]. Both treatments were well tolerated with a similar pattern of adverse events (incidence of 69 and 60% in the\n Gla<\/jats:styled-content>\n \u2010300 and\n Gla<\/jats:styled-content>\n \u2010100 groups).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n \n In people with type 2 diabetes treated with\n Gla<\/jats:styled-content>\n \u2010300 or\n Gla<\/jats:styled-content>\n \u2010100, and non\u2010sulphonylurea\n OADs<\/jats:styled-content>\n , glycaemic control was sustained over 12 months, with less nocturnal hypoglycaemia in the\n Gla<\/jats:styled-content>\n \u2010300 group.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/dom.12532","type":"journal-article","created":{"date-parts":[[2015,7,14]],"date-time":"2015-07-14T10:57:27Z","timestamp":1436871447000},"page":"1142-1149","source":"Crossref","is-referenced-by-count":105,"title":["Glycaemic control and hypoglycaemia with new insulin glargine 300 U\/ml versus insulin glargine 100 U\/ml in people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs: the EDITION 2 randomized 12\u2010month trial including 6\u2010month extension"],"prefix":"10.1111","volume":"17","author":[{"given":"H.","family":"Yki\u2010J\u00e4rvinen","sequence":"first","affiliation":[{"name":"Division of Diabetes, Faculty of Medicine University of Helsinki, Helsinki University Central Hospital Helsinki Finland"},{"name":"Minerva Foundation Institute for Medical Research Helsinki Finland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"R. M.","family":"Bergenstal","sequence":"additional","affiliation":[{"name":"International Diabetes Center at Park Nicollet Minneapolis MN USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"G. B.","family":"Bolli","sequence":"additional","affiliation":[{"name":"Department of Medicine University of Perugia Perugia Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.","family":"Ziemen","sequence":"additional","affiliation":[{"name":"Sanofi\u2010Aventis Deutschland GmbH Frankfurt am Main Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.","family":"Wardecki","sequence":"additional","affiliation":[{"name":"Sanofi Warsaw Poland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"I.","family":"Muehlen\u2010Bartmer","sequence":"additional","affiliation":[{"name":"Sanofi\u2010Aventis Deutschland GmbH Frankfurt am Main Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.","family":"Maroccia","sequence":"additional","affiliation":[{"name":"Umanis Levallois\u2010Perret France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M. C.","family":"Riddle","sequence":"additional","affiliation":[{"name":"Division of Endocrinology, Diabetes & Clinical Nutrition Oregon Health & Science University Portland OR USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2015,9,14]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"crossref","first-page":"637","DOI":"10.2337\/dc14-0006","article-title":"New insulin glargine 300 units.mL\u20101 provides a more even activity profile and prolonged glycemic control at steady state compared with insulin glargine 100 units.mL\u20101","volume":"38","author":"Becker RH","year":"2015","journal-title":"Diabetes Care"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1742-1241.2009.02176.x"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc14-0990"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12438"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc14-0991"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-139-2-200307150-00013"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.28.5.1245"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1464-5491.1990.tb01421.x"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1464-5491.1988.tb00976.x"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(12)60205-0"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc12-1205"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc12-2329"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12472"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12485"},{"key":"e_1_2_7_16_1","first-page":"LB22","article-title":"New insulin glargine 300 U\/mL: glycemic control and hypoglycemia in Japanese people with T1DM (EDITION JP 1)","volume":"63","author":"Matsuhisa M","year":"2014","journal-title":"Diabetes"},{"key":"e_1_2_7_17_1","first-page":"LB19","article-title":"Glycemic control and hypoglycemia with new insulin glargine 300 U\/mL in people with T1DM (EDITION 4)","volume":"63","author":"Home P","year":"2014","journal-title":"Diabetes"},{"key":"e_1_2_7_18_1","first-page":"LB24","article-title":"Glycemic control and hypoglycemia in Japanese people with T2DM receiving new insulin glargin 300 U\/mL in combination with OADs (EDITION JP 2)","volume":"63","author":"Terauchi Y","year":"2014","journal-title":"Diabetes"}],"container-title":["Diabetes, Obesity and Metabolism"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fdom.12532","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/dom.12532","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/dom.12532","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/dom-pubs.pericles-prod.literatumonline.com\/doi\/pdf\/10.1111\/dom.12532","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,30]],"date-time":"2025-10-30T22:07:32Z","timestamp":1761862052000},"score":1,"resource":{"primary":{"URL":"https:\/\/dom-pubs.pericles-prod.literatumonline.com\/doi\/10.1111\/dom.12532"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,9,14]]},"references-count":17,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2015,12]]}},"alternative-id":["10.1111\/dom.12532"],"URL":"https:\/\/doi.org\/10.1111\/dom.12532","archive":["Portico"],"relation":{},"ISSN":["1462-8902","1463-1326"],"issn-type":[{"value":"1462-8902","type":"print"},{"value":"1463-1326","type":"electronic"}],"subject":[],"published":{"date-parts":[[2015,9,14]]}}}