{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,14]],"date-time":"2026-01-14T00:58:11Z","timestamp":1768352291074,"version":"3.49.0"},"reference-count":24,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2016,1,21]],"date-time":"2016-01-21T00:00:00Z","timestamp":1453334400000},"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":[[2016,4]]},"abstract":"\n Aims<\/jats:title>\n \n To compare the efficacy and safety of insulin glargine 300 U\/ml (Gla\u2010300) with glargine 100 U\/ml (Gla\u2010100) in Japanese people with type 2 diabetes using basal insulin plus oral antihyperglycaemic drug(s) [\n OAD<\/jats:styled-content>\n (s)].\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n The\n EDITION JP<\/jats:styled-content>\n 2 study (\n NCT01689142<\/jats:styled-content>\n ) was a 6\u2010month, multicentre, open\u2010label, phase\n III<\/jats:styled-content>\n study. Participants (n = 241, male 61%, mean diabetes duration 14 years, mean weight 67 kg, mean body mass index 25 kg\/m\n 2<\/jats:sup>\n , mean glycated haemoglobin (\n HbA1c<\/jats:styled-content>\n ) 8.02 %, mean basal insulin dose 0.24 U\/kg\/day) were randomized to Gla\u2010300 or Gla\u2010100, while continuing\n OAD<\/jats:styled-content>\n (s). Basal insulin was titrated to target fasting self\u2010monitored plasma glucose 4.4\u22125.6 mmol\/l. The primary efficacy endpoint was\n HbA1c<\/jats:styled-content>\n change over 6 months. Safety endpoints included hypoglycaemia and weight change.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Gla\u2010300 was non\u2010inferior to Gla\u2010100 for\n HbA1c<\/jats:styled-content>\n reduction [least squares (LS) mean difference 0.10 (95% confidence interval [\n CI<\/jats:styled-content>\n ] \u22120.08, 0.27) %]. The mean\n HbA1c<\/jats:styled-content>\n at month 6 was 7.56 and 7.52 % with Gla\u2010300 and Gla\u2010100, respectively. Nocturnal confirmed (\u22643.9 mmol\/l) or severe hypoglycaemia risk was 38% lower with Gla\u2010300 versus Gla\u2010100 [relative risk 0.62 (95%\n CI<\/jats:styled-content>\n 0.44, 0.88)]; annualized rates were 55% lower at night [rate ratio 0.45 (95%\n CI<\/jats:styled-content>\n 0.21, 0.96)] and 36% lower at any time [24 h; rate ratio 0.64 (95%\n CI<\/jats:styled-content>\n 0.43, 0.96)]. Severe hypoglycaemia was infrequent. A significant between\u2010treatment difference in weight change favoured Gla\u2010300 [LS mean difference \u22121.0 (95%\n CI<\/jats:styled-content>\n \u22121.5, \u22120.5) kg; p = 0.0003]. Adverse event rates were comparable between groups.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n \n Japanese people with type 2 diabetes using basal insulin plus\n OAD<\/jats:styled-content>\n (s) experienced less hypoglycaemia with Gla\u2010300 than with Gla\u2010100, while glycaemic control did not differ.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/dom.12618","type":"journal-article","created":{"date-parts":[[2015,12,11]],"date-time":"2015-12-11T02:44:46Z","timestamp":1449801886000},"page":"366-374","source":"Crossref","is-referenced-by-count":98,"title":["New insulin glargine 300 U\/ml versus glargine 100 U\/ml in Japanese people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs: glucose control and hypoglycaemia in a randomized controlled trial (\n EDITION JP<\/scp>\n 2)"],"prefix":"10.1111","volume":"18","author":[{"given":"Y.","family":"Terauchi","sequence":"first","affiliation":[{"name":"Graduate School of Medicine Yokohama City University Yokohama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.","family":"Koyama","sequence":"additional","affiliation":[{"name":"Sanofi Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"X.","family":"Cheng","sequence":"additional","affiliation":[{"name":"Sanofi Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Y.","family":"Takahashi","sequence":"additional","affiliation":[{"name":"Sanofi Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M. C.","family":"Riddle","sequence":"additional","affiliation":[{"name":"Oregon Health & Science University Portland OR USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"G. B.","family":"Bolli","sequence":"additional","affiliation":[{"name":"Perugia University Medical School Perugia Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"T.","family":"Hirose","sequence":"additional","affiliation":[{"name":"Toho University School of Medicine Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2016,1,21]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc15-S010"},{"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":"10.1111\/j.1464-5491.2012.03605.x"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdi.12136"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/dmrr.1012"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.2174\/157339912799424546"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2011.0068"},{"key":"e_1_2_7_9_1","doi-asserted-by":"crossref","first-page":"637","DOI":"10.2337\/dc14-0006","article-title":"New insulin glargine 300 U.ml\u22121 provides a more even activity profile and prolonged glycemic control at steady state compared with insulin glargine 100 U.mL\u22121","volume":"38","author":"Becker RH","year":"2015","journal-title":"Diabetes Care"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12415"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc14-0991"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc14-0990"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12438"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc15-0249"},{"key":"e_1_2_7_15_1","first-page":"S400","article-title":"New insulin glargine 300 U\/mL: glycemic control and hypoglycaemia in Japanese people with type 1 diabetes mellitus (EDITION JP 1)","volume":"57","author":"Matsuhisa M","year":"2014","journal-title":"Diabetologia"},{"key":"e_1_2_7_16_1","unstructured":"ICH.ICH harmonized tripartite guideline: Guideline for Good Clinical Practice E6 (R1) 1996."},{"key":"e_1_2_7_17_1","unstructured":"World Medical Association.Declaration of Helsinki. 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