{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T02:42:24Z","timestamp":1772160144269,"version":"3.50.1"},"reference-count":33,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2024,4,15]],"date-time":"2024-04-15T00:00:00Z","timestamp":1713139200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["dom-pubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2024,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>To explore the effect of renal function on the pharmacokinetic (PK) and pharmacodynamic (PD) profile and safety of enavogliflozin, a selective sodium\u2010glucose cotransporter 2 (SGLT2) inhibitor, in patients with type 2 diabetes mellitus (T2DM).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>An open\u2010label, two\u2010part clinical trial was conducted in T2DM patients, stratified by renal function: Group 1, normal renal function; Group 2, mild renal impairment (RI); Group 3, moderate RI; and Group 4, severe RI. In Part A, Groups 2 and 4 received enavogliflozin 0.5\u2009mg once. In Part B, Groups 1 and 3 received enavogliflozin 0.5\u2009mg once daily for 7\u2009days. Serial blood and timed urine samples were collected to analyse the PK and PD characteristics of enavogliflozin. Pearson's correlation coefficients were calculated to assess the correlations between PK or PD parameters and creatinine clearance (CrCL).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 21 patients completed the study as planned. The area under the curve (AUC) for enavogliflozin was not significantly correlated with CrCL, although the maximum concentration slightly decreased as renal function decreased. By contrast, daily urinary glucose excretion (UGE) was positively correlated with CrCL after both single\u2010 (\n                      <jats:italic>r<\/jats:italic>\n                      \u2009=\u20090.7866,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.0001) and multiple\u2010dose administration (\n                      <jats:italic>r<\/jats:italic>\n                      \u2009=\u20090.6606,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.0438).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>\n                      Systemic exposure to oral enavogliflozin 0.5\u2009mg was similar among the patients with T2DM regardless of their renal function levels. However, the glucosuric effect of enavogliflozin decreased with RI. Considering the UGE observed and approved therapeutic use of other SGLT2 inhibitors, the efficacy of enavogliflozin with regard to glycaemic control could be explored in patients with mild and moderate RI (estimated glomerular filtration rate \u226530 or\u2009\u226545\u2009mL\/min\/1.73 m\n                      <jats:sup>2<\/jats:sup>\n                      ) in a subsequent larger study.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.15573","type":"journal-article","created":{"date-parts":[[2024,4,15]],"date-time":"2024-04-15T06:00:20Z","timestamp":1713160820000},"page":"2588-2597","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["The effect of renal function on the pharmacokinetics and pharmacodynamics of enavogliflozin, a potent and selective\n                    <scp>sodium\u2010glucose cotransporter<\/scp>\n                    \u20102 inhibitor, in type 2 diabetes"],"prefix":"10.1111","volume":"26","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5299-4305","authenticated-orcid":false,"given":"Sae Im","family":"Jeong","sequence":"first","affiliation":[{"name":"Department of Clinical Pharmacology and Therapeutics Chungbuk National University College of Medicine and Hospital  Cheongju\u2010si Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7140-3032","authenticated-orcid":false,"given":"Mu Seong","family":"Ban","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology and Therapeutics Seoul National University College of Medicine and Bundang Hospital  Seongnam Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0965-0531","authenticated-orcid":false,"given":"Jun\u2010Gi","family":"Hwang","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology and Therapeutics Chungbuk National University College of Medicine and Hospital  Cheongju\u2010si Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9851-7555","authenticated-orcid":false,"given":"Min\u2010Kyu","family":"Park","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology and Therapeutics Chungbuk National University College of Medicine and Hospital  Cheongju\u2010si Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4137-1671","authenticated-orcid":false,"given":"Soo","family":"Lim","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Seoul National University College of Medicine and Seoul National University Bundang Hospital  Seongnam Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7238-9962","authenticated-orcid":false,"given":"Sejoong","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Seoul National University College of Medicine and Seoul National University Bundang Hospital  Seongnam Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9287-4490","authenticated-orcid":false,"given":"Soon Kil","family":"Kwon","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Chungbuk National University College of Medicine and Hospital  Cheongju\u2010si Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-2141-2407","authenticated-orcid":false,"given":"Yoonjin","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology and Therapeutics Seoul National University College of Medicine and Bundang Hospital  Seongnam Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-1357-8386","authenticated-orcid":false,"given":"Jae Min","family":"Cho","sequence":"additional","affiliation":[{"name":"Clinical Development Center Daewoong Pharmaceutical Co., Ltd.  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