{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,31]],"date-time":"2025-10-31T07:34:44Z","timestamp":1761896084040},"reference-count":13,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2015,6,29]],"date-time":"2015-06-29T00:00:00Z","timestamp":1435536000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Sanofi Korea Ltd"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Diabetes"],"published-print":{"date-parts":[[2016,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The aim of the present 24\u2010week multicentre randomized non\u2010inferiority trial was to compare the efficacy and safety of two insulin intensification strategies in uncontrolled type 2 diabetes despite optimized basal insulin therapy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients with fasting plasma glucose (<jats:styled-content style=\"fixed-case\">FPG<\/jats:styled-content>) &lt;130\u2009mg\/dL and <jats:styled-content style=\"fixed-case\">HbA1c<\/jats:styled-content> 7.0%\u201310.0% while on insulin glargine were randomized to a basal\u2010prandial group (stepwise addition of insulin glulisine) or a premixed insulin group (insulin aspart\/insulin aspart protamine 30\/70 starting with 6\u2009<jats:styled-content style=\"fixed-case\">IU<\/jats:styled-content> twice daily). The primary endpoint was the change in <jats:styled-content style=\"fixed-case\">HbA1c<\/jats:styled-content> after 24 weeks (non\u2010inferiority margin 0.4%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>At Week 24, the adjusted mean change from baseline <jats:styled-content style=\"fixed-case\">HbA1c<\/jats:styled-content> was \u20130.94\u2009\u00b1\u20090.09% and \u20131.04\u2009\u00b1\u20090.09% in basal\u2010prandial and premixed insulin groups, respectively, with a mean difference of \u20130.09% (95% confidence interval [<jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>] \u20130.35, 0.16). A lower rate of hypoglycemia with a similar reduction in <jats:styled-content style=\"fixed-case\">HbA1c<\/jats:styled-content> was observed during stabilization of the total daily insulin dose in the premixed insulin group (Weeks 0\u201312). After stabilization of the total daily insulin dose, the rate of hypoglycemia and the total daily insulin dose were similar in the two groups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The efficacy and safety of the two intensifying regimens were similar after stabilization of the total daily insulin dose when oral agents were maintained. Starting with a lower total daily insulin dose with a gradual change in the treatment regimen was helpful in reducing the rate of hypoglycemia during initial stabilization of the total daily insulin dose.<\/jats:p><\/jats:sec>","DOI":"10.1111\/1753-0407.12312","type":"journal-article","created":{"date-parts":[[2015,5,8]],"date-time":"2015-05-08T05:03:26Z","timestamp":1431061406000},"page":"405-413","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":21,"title":["Basal\u2010prandial versus premixed insulin in patients with type 2 diabetes requiring insulin intensification after basal insulin optimization: A 24\u2010week randomized non\u2010inferiority trial"],"prefix":"10.1111","volume":"8","author":[{"given":"Sang\u2010Man","family":"Jin","sequence":"first","affiliation":[{"name":"Department of Medicine Samsung Medical Center Sungkyunkwan University School of Medicine  Seoul South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jae Hyeon","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Medicine Samsung Medical Center Sungkyunkwan University School of Medicine  Seoul South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kyung Wan","family":"Min","sequence":"additional","affiliation":[{"name":"Diabetes Center Eulji General Hospital Eulji University School of Medicine  Seoul South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ji Hyun","family":"Lee","sequence":"additional","affiliation":[{"name":"Catholic University of Daegu"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kue Jeong","family":"Ahn","sequence":"additional","affiliation":[{"name":"Kyung Hee University School of Medicine  Seoul South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeong Hyun","family":"Park","sequence":"additional","affiliation":[{"name":"College of Medicine Paik Institute for Clinical Research Inje University  Busan South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hak Chul","family":"Jang","sequence":"additional","affiliation":[{"name":"Seoul National University Bundang Hospital Seoul National University College of Medicine  Seongnam South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Seok Won","family":"Park","sequence":"additional","affiliation":[{"name":"CHA Bundang Medical Center CHA University School of Medicine  Seongnam South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kwan Woo","family":"Lee","sequence":"additional","affiliation":[{"name":"Ajou University School of Medicine  Suwon South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kyu Chang","family":"Won","sequence":"additional","affiliation":[{"name":"Yeungnam University College of Medicine  Daegu South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Young\u2010Il","family":"Kim","sequence":"additional","affiliation":[{"name":"Ulsan University Hospital University of Ulsan College of Medicine  Ulsan South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Choon Hee","family":"Chung","sequence":"additional","affiliation":[{"name":"Wonju College of Medicine Yonsei University  Wonju South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tae Sun","family":"Park","sequence":"additional","affiliation":[{"name":"Chonbuk National University Medical School  Jeonju South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jee\u2010Hyun","family":"Lee","sequence":"additional","affiliation":[{"name":"Departments of Internal Medicine Sanofi\u2010Aventis Korea Co. 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