{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T19:34:50Z","timestamp":1777577690409,"version":"3.51.4"},"reference-count":19,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2013,4,5]],"date-time":"2013-04-05T00:00:00Z","timestamp":1365120000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2013,9]]},"abstract":"<jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>This phase 3, 26\u2010week, open\u2010label, treat\u2010to\u2010target trial investigated the efficacy and safety of insulin degludec\/insulin aspart (IDegAsp) in insulin\u2010na\u00efve Japanese adults with type 2 diabetes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Subjects were randomized to once\u2010daily injections of IDegAsp (n\u2009=\u2009147) or insulin glargine (IGlar) (n\u2009=\u2009149), both \u00b1\u22642 oral antidiabetic treatments. IDegAsp was given before the largest meal at the discretion of each subject (and maintained throughout the trial); IGlar was dosed according to label. Both insulins were titrated to a target prebreakfast self\u2010measured plasma glucose of 3.9 to &lt;5.0\u2009mmol\/l.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      After 26\u2009weeks, mean HbA1c was 7% with IDegAsp and 7.3% with IGlar; superiority of IDegAsp to IGlar was shown (estimated treatment difference, ETD; IDegAsp\u2013IGlar: \u20130.28% points [\u22120.46; \u20130.10]\n                      <jats:sub>95% CI<\/jats:sub>\n                      , p\u2009&lt;\u20090.01). At end\u2010of\u2010trial, mean fasting plasma glucose (\n                      <jats:styled-content style=\"fixed-case\">FPG<\/jats:styled-content>\n                      ) was similar for IDegAsp and IGlar (5.7 vs. 5.6\u2009mmol\/l; ETD IDegAsp\u2013IGlar: 0.15\u2009mmol\/l [\u22120.29; 0.60]\n                      <jats:sub>95% CI<\/jats:sub>\n                      , p\u2009=\u2009NS). IDegAsp was associated with numerically lower rates of overall confirmed (27%) and nocturnal confirmed hypoglycaemia (25%) versus IGlar (estimated rate ratio IDegAsp\/IGlar: 0.73 [0.50; 1.08]\n                      <jats:sub>95% CI<\/jats:sub>\n                      , p\u2009=\u2009NS, and 0.75 [0.34; 1.64]\n                      <jats:sub>95% CI<\/jats:sub>\n                      , p\u2009=\u2009NS, respectively). Mean daily insulin doses were similar between groups at end\u2010of\u2010trial (both: 0.41\u2009U\/kg) as were the increases in body weight from baseline (both: 0.7\u2009kg). Adverse event profiles were similar between groups.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>IDegAsp provided superior long\u2010term glycaemic control compared to IGlar, with similar FPG and doses and numerically lower rates of overall and nocturnal hypoglycaemia (p\u2009=\u2009NS).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.12097","type":"journal-article","created":{"date-parts":[[2013,3,14]],"date-time":"2013-03-14T06:54:57Z","timestamp":1363244097000},"page":"826-832","source":"Crossref","is-referenced-by-count":84,"title":["Superior glycaemic control with once\u2010daily insulin degludec\/insulin aspart versus insulin glargine in Japanese adults with type 2 diabetes inadequately controlled with oral drugs: a randomized, controlled phase 3 trial"],"prefix":"10.1111","volume":"15","author":[{"given":"Y.","family":"Onishi","sequence":"first","affiliation":[{"name":"The Institute for Adult Diseases Asahi Life Foundation  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Y.","family":"Ono","sequence":"additional","affiliation":[{"name":"Internal Medicine Takagi Hospital  Fukuoka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"R.","family":"Rab\u00f8l","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S  S\u00f8borg Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"L.","family":"Endahl","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S  S\u00f8borg Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S.","family":"Nakamura","sequence":"additional","affiliation":[{"name":"Internal Medicine Heiwadai Hospital  Miyazaki Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2013,4,5]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2009.726"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/dmrr.296"},{"key":"e_1_2_7_4_1","volume-title":"IDF Diabetes Atlas","author":"International Diabetes Federation","year":"2011"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1463-1326.2011.01395.x"},{"issue":"2","key":"e_1_2_7_6_1","first-page":"32","article-title":"Ultra\u2010long acting insulin degludec can be combined with rapid\u2010acting insulin aspart in a soluble co\u2010formulation","volume":"16","author":"Jonassen I","year":"2010","journal-title":"J Pept Sci"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1463-1326.2012.01638.x"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11095-012-0739-z"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1463-1326.2012.01627.x"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc10-1925"},{"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":"10.1016\/S0140-6736(12)60204-9"},{"key":"e_1_2_7_13_1","unstructured":"World Medical Association. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects \u2010 Last amended by the 59th WMA General Assembly Seoul 2008."},{"key":"e_1_2_7_14_1","unstructured":"International Conference on Harmonisation. ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice E6 (R1) Step 4 1996."},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.28.5.1245"},{"key":"e_1_2_7_16_1","unstructured":"Food and Drug Administration. Food and Drug Administration Code of Federal Regulations Guidance for Industry Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention. 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