{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,29]],"date-time":"2026-06-29T11:31:20Z","timestamp":1782732680441,"version":"3.54.5"},"reference-count":32,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2025,11,14]],"date-time":"2025-11-14T00:00:00Z","timestamp":1763078400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2025,11,14]],"date-time":"2025-11-14T00:00:00Z","timestamp":1763078400000},"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"],"published-print":{"date-parts":[[2026,1]]},"abstract":"Abstract<\/jats:title>\n \n Aims<\/jats:title>\n This study aimed to evaluate the efficacy and safety of triple therapy with lobeglitazone 0.5\u2009mg as an add\u2010on treatment compared with placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin and empagliflozin.<\/jats:p>\n <\/jats:sec>\n \n Materials and Methods<\/jats:title>\n \n In this Phase 3, multicentre, double\u2010blind, randomised trial, patients with\n T2DM<\/jats:styled-content>\n who had an insufficient response to metformin (\u22651000\u2009mg\/day) and empagliflozin 10\u2009mg\/day (Study 1) or 25\u2009mg\/day (Study 2) were randomised to receive either lobeglitazone 0.5\u2009mg\/day, or placebo once daily for 24\u2009weeks. Participants then entered an open\u2010label extension phase for an additional 28\u2009weeks, bringing the total treatment duration to 52\u2009weeks. The primary endpoint was the change from baseline in glycated haemoglobin (\n HbA1c<\/jats:styled-content>\n ) at 24\u2009weeks.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n At 24\u2009weeks, the mean change in\n HbA1c<\/jats:styled-content>\n was significantly greater with lobeglitazone than with placebo, regardless of the background empagliflozin dose (\u22120.71%; 95% confidence interval, \u22120.88 to \u22120.55;\n p<\/jats:italic>\n \u2009<\u20090.001 in Study 1 and \u22120.62%; \u22120.79 to \u22120.45;\n p<\/jats:italic>\n \u2009<\u20090.001 in Study 2). A higher proportion of patients achieved\n HbA1c<\/jats:styled-content>\n levels <7% with lobeglitazone compared to placebo (48.7% vs. 13.4% in Study 1, and 44.4% vs. 13.0% in Study 2;\n p<\/jats:italic>\n \u2009<\u20090.001). Although the incidence of adverse events was numerically different between groups, no statistically significant differences were observed, indicating a generally comparable profile for the triple combination therapy with metformin, empagliflozin, and lobeglitazone.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n Lobeglitazone as an add\u2010on to empagliflozin and metformin significantly improved glycaemic control in patients with T2DM inadequately controlled on metformin and empagliflozin dual therapy. The treatment was well tolerated, with a low incidence of adverse events.<\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/dom.70257","type":"journal-article","created":{"date-parts":[[2025,11,14]],"date-time":"2025-11-14T17:02:40Z","timestamp":1763139760000},"page":"728-740","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Lobeglitazone improves glycaemic control as add\u2010on therapy to empagliflozin plus metformin in patients with type 2 diabetes mellitus: A double\u2010blind, randomised, placebo\u2010controlled trial"],"prefix":"10.1111","volume":"28","author":[{"given":"Da Hea","family":"Seo","sequence":"first","affiliation":[{"name":"Division of Endocrinology and Metabolism, Department of Internal Medicine Inha University College of Medicine Incheon Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kyung Wan","family":"Min","sequence":"additional","affiliation":[{"name":"Division of Endocrinology and Metabolism, Department of Internal Medicine Eulji General Hospital, Eulji University School of Medicine Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ho Sang","family":"Sohn","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Daegu Catholic University School of Medicine Daegu Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sang Yong","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Endocrinology and Metabolism Chosun University Hospital, Chosun University School of Medicine Gwangju Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7857-546X","authenticated-orcid":false,"given":"In\u2010Kyung","family":"Jeong","sequence":"additional","affiliation":[{"name":"Division of Endocrinology and Metabolism, Department of Internal Medicine Kyung Hee University Hospital at Gangdong Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9415-9965","authenticated-orcid":false,"given":"Cheol\u2010Young","family":"Park","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9109-2208","authenticated-orcid":false,"given":"Kun\u2010Ho","family":"Yoon","sequence":"additional","affiliation":[{"name":"Division of Endocrinology and Metabolism, Department of Internal Medicine, College of Medicine, Seoul St Mary's Hospital The Catholic University of Korea Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2554-3664","authenticated-orcid":false,"given":"So Hun","family":"Kim","sequence":"additional","affiliation":[{"name":"Division of Endocrinology and Metabolism, Department of Internal Medicine Inha University College of Medicine Incheon Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0542-2854","authenticated-orcid":false,"given":"Bong\u2010Soo","family":"Cha","sequence":"additional","affiliation":[{"name":"Division of Endocrinology and Metabolism, Department of Internal Medicine, Endocrine Research Institute Yonsei University College of Medicine Seoul Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,11,14]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.4103\/2230-8210.183480"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc18-0588"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1515\/jom-2020-0153"},{"issue":"1","key":"e_1_2_9_5_1","first-page":"S158","article-title":"9. 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