{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,14]],"date-time":"2026-09-14T12:54:49Z","timestamp":1789390489174,"version":"build-2803163510"},"reference-count":36,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2018,6,1]],"date-time":"2018-06-01T00:00:00Z","timestamp":1527811200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100008349","name":"Boehringer Ingelheim","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008349","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004312","name":"Eli Lilly and Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004312","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["dom-pubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2018,9]]},"abstract":"<jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>\n                      This double\u2010blind, randomized, placebo\u2010controlled trial (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                      NCT02453555) evaluated the efficacy and safety of empagliflozin (Empa) 10 or 25 mg as add\u2010on to linagliptin (Lina) 5 mg (fixed\u2010dose combination, Empa\/Lina 10\/5 or 25\/5) in insufficiently controlled Japanese type 2 diabetes patients.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The trial (40 sites; May 2015\u2010March 2017) involved screening 433 adults (\u226520 years) who were treatment\u2010naive or were using one oral antidiabetic drug for \u226512 weeks, which was discontinued at enrolment. Patients with HbA1c 7.5%\u201010.0% after \u226516 weeks of using Lina (pre\u2010enrolment or during a 16\u2010week, open\u2010label period) and 2 weeks of using placebo (Plc) for Empa\/Lina 10\/5, plus Lina, were randomized (2:1) to once\u2010daily Empa\/Lina 10\/5 (n = 182) or Plc\/Lina 10\/5 (n = 93) for 24 weeks. Patients with HbA1c \u2265 7.0% at Week 24 received Empa\/Lina up\u2010titrated to 25\/5 (n = 126) or the corresponding placebo (n = 80), per randomization, from Week 28; 172 Empa\/Lina and 84 Plc\/Lina patients completed 52 weeks.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Change from baseline in HbA1c was greater (\n                      <jats:italic>P<\/jats:italic>\n                      &lt; .0001) with Empa\/Lina than with Plc\/Lina at Week 24 (primary outcome, \u22120.93% vs 0.21%; adjusted mean difference, \u22121.14%) and Week 52 (\u22121.16% vs 0.06%; adjusted mean difference, \u22121.22%). More patients with HbA1c &lt; 7.0% and greater decreases in fasting plasma glucose, body weight and systolic blood pressure were seen in the Empa\/Lina group than in the Plc\/Lina group. Empa\/Lina was well tolerated. The adverse events that were more frequent with Empa\/Lina were known empagliflozin\u2010associated events (eg, increased urination, increased blood ketones). There were no adjudication\u2010confirmed diabetic ketoacidosis events or lower limb amputations.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>These results support the notion that empagliflozin\u2010linagliptin in fixed\u2010dose combination is a therapeutic option for Japanese patients with type 2 diabetes.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.13352","type":"journal-article","created":{"date-parts":[[2018,5,15]],"date-time":"2018-05-15T22:41:47Z","timestamp":1526424107000},"page":"2200-2209","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":40,"title":["Empagliflozin as add\u2010on to linagliptin in a fixed\u2010dose combination in Japanese patients with type 2 diabetes: Glycaemic efficacy and safety profile in a 52\u2010week, randomized, placebo\u2010controlled trial"],"prefix":"10.1111","volume":"20","author":[{"given":"Ryuzo","family":"Kawamori","sequence":"first","affiliation":[{"name":"Sportology Center Juntendo University Graduate School of Medicine  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masakazu","family":"Haneda","sequence":"additional","affiliation":[{"name":"Division of Metabolism and Biosystemic Science, Department of Medicine Asahikawa Medical University  Asahikawa Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keiko","family":"Suzaki","sequence":"additional","affiliation":[{"name":"Nippon Boehringer Ingelheim Co. 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