{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T21:52:58Z","timestamp":1791237178848,"version":"4.1.0"},"reference-count":25,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T00:00:00Z","timestamp":1791158400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T00:00:00Z","timestamp":1791158400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["dom-pubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Obesity Metabolism"],"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>To evaluate the long\u2010term efficacy and safety of teneligliptin add\u2010on in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin and empagliflozin.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>\n                      In this randomised, double\u2010blind, phase 3 trial, 214 patients received teneligliptin 20\u2009mg (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009107) or placebo (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009107) once daily for 24\u2009weeks, in addition to metformin (\u2265\u20091000\u2009mg\/day) and empagliflozin (25\u2009mg\/day). In a subsequent 28\u2010week open\u2010label extension, all patients received teneligliptin 20\u2009mg\/day. The primary endpoint was HbA1c change from baseline to week 24.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      At week 24, the least squares mean (LSM) change in HbA1c from baseline was \u22120.70%\u2009\u00b1\u20090.06% in the teneligliptin group and \u22120.03%\u2009\u00b1\u20090.06% in the placebo group, with a placebo\u2010adjusted LSM change of \u22120.67% (95% CI, \u22120.84 to \u22120.49;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.0001), demonstrating the superiority of teneligliptin. A significant between\u2010group difference was already evident at week 4 (placebo\u2010adjusted LSM change, \u22120.36%;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.0001). Significant reductions in fasting plasma glucose and glycated albumin and improvement in pancreatic\n                      <jats:italic>\u03b2<\/jats:italic>\n                      \u2010cell function were observed at week 24. During the open\u2010label extension, glycaemic improvements were maintained through week 52, although no concurrent randomised control was available beyond week 24. Placebo\u2010group patients achieved a similar benefit after switching to teneligliptin. Safety outcomes did not differ between groups.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>\n                      Adding teneligliptin to metformin and empagliflozin in patients with inadequately controlled T2DM significantly improved glycaemic control and\n                      <jats:italic>\u03b2<\/jats:italic>\n                      \u2010cell function over 24\u2009weeks and was well tolerated through 52\u2009weeks.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trail Registration<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                      Identifier: NCT05504226.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.71315","type":"journal-article","created":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T21:01:06Z","timestamp":1791234066000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A 52\u2010Week Efficacy and Safety Study of Teneligliptin, as an Add\u2010On to Empagliflozin and Metformin in Patients With Type 2 Diabetes Mellitus: A Randomised, Double\u2010Blind, Placebo\u2010Controlled Phase 3 Trial (\n                    <scp>TERA305<\/scp>\n                    Study)"],"prefix":"10.1111","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1569-3068","authenticated-orcid":false,"given":"Jun Sung","family":"Moon","sequence":"first","affiliation":[{"name":"Division of Endocrinology and Metabolism, Department of Internal Medicine Yeungnam University College of Medicine  Daegu Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6436-1938","authenticated-orcid":false,"given":"Kyung Ah","family":"Han","sequence":"additional","affiliation":[{"name":"Division of Endocrinology and Metabolism, Department of Internal Medicine Nowon Eulji Medical Center, Eulji University School of Medicine  Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dong\u2010Lim","family":"Kim","sequence":"additional","affiliation":[{"name":"Division of Endocrinology and Metabolism, Department of Internal Medicine Konkuk University School of Medicine  Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sang Yong","family":"Kim","sequence":"additional","affiliation":[{"name":"Division of Endocrinology and Metabolism, Department of Internal Medicine Chosun University School of Medicine  Gwangju Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Soo\u2010Kyung","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine CHA Bundang Medical Center, CHA University School of Medicine  Seongnam Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bon Jeong","family":"Ku","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Chungnam National University School of Medicine  Daejeon Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Woo Je","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Asan Medical Center, University of Ulsan College of Medicine  Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2998-9671","authenticated-orcid":false,"given":"Tae Keun","family":"Oh","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Chungbuk National University Hospital  Cheongju Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ji A","family":"Seo","sequence":"additional","affiliation":[{"name":"Division of Endocrinology and Metabolism, Department of Internal Medicine Korea University Ansan Hospital, Korea University College of Medicine  Ansan Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sang\u2010Ah","family":"Chang","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine The Catholic University of Korea  Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Moon\u2010Kyu","family":"Lee","sequence":"additional","affiliation":[{"name":"Division of Endocrinology and Metabolism, Department of Internal Medicine Uijeongbu Eulji Medical Center, Eulji University  Uijeongbu Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kyu Jeung","family":"Ahn","sequence":"additional","affiliation":[{"name":"Division of Endocrinology and Metabolism, Department of Internal Medicine Kyung Hee University Hospital at Gangdong, and Kyung Hee University School of Medicine  Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0855-6348","authenticated-orcid":false,"given":"Chul Sik","family":"Kim","sequence":"additional","affiliation":[{"name":"Division of Endocrinology, Department of Internal Medicine Yongin Severance Hospital, Yonsei University College of Medicine  Yongin South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tae Nyun","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Cardiovascular and Metabolic Disease Center, College of Medicine Inje University  Busan 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