{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,11]],"date-time":"2026-04-11T12:12:57Z","timestamp":1775909577516,"version":"3.50.1"},"reference-count":43,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2023,6,1]],"date-time":"2023-06-01T00:00:00Z","timestamp":1685577600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J of Diabetes Invest"],"published-print":{"date-parts":[[2023,9]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Aims\/Introduction<\/jats:title><jats:p>Substantial variability in demographic and clinical characteristics exists among patients with type 2 diabetes mellitus, which may impact treatment. This <jats:italic>post\u2010hoc<\/jats:italic> analysis evaluated the efficacy and safety of imeglimin 1,000\u2009mg twice daily (BID) monotherapy in type 2 diabetes mellitus patients according to demographic and clinical characteristics.<\/jats:p><\/jats:sec><jats:sec><jats:title>Materials and Methods<\/jats:title><jats:p>Data were pooled from two placebo\u2010controlled, 24 week, randomized, double\u2010blind studies in adults with type 2 diabetes mellitus. Outcomes (least squares mean [LSM] change in HbA1c from baseline to week 24, and safety) were analyzed according to subgroups based on demographics, clinical characteristics, and comorbidities.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The difference in LSM change in HbA1c from baseline to week 24 was statistically significant for imeglimin vs placebo in all patient subgroups analyzed (<jats:italic>P<\/jats:italic>\u2009&lt;\u20090.05 each), including demographics (age, body mass index), clinical characteristics (duration of type 2 diabetes mellitus, chronic kidney disease [CKD] stage, and prior medication use) and comorbidities (hypertension, dyslipidemia, risk of hepatic fibrosis and liver function parameter status). A statistically significant separation from placebo in HbA1c was observed at week 4 and maintained through week 24. No new safety concerns were identified with imeglimin in any patient subpopulations.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The efficacy and safety of imeglimin was demonstrated across patient subgroups, irrespective of baseline demographic and clinical characteristics. Our findings confirm the efficacy and safety of imeglimin across a broad spectrum of patients with type 2 diabetes mellitus.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jdi.14035","type":"journal-article","created":{"date-parts":[[2023,6,2]],"date-time":"2023-06-02T11:49:44Z","timestamp":1685706584000},"page":"1101-1109","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Effect of patient characteristics on the efficacy and safety of imeglimin monotherapy in Japanese patients with type 2 diabetes mellitus: A <scp>post\u2010hoc<\/scp> analysis of two randomized, <scp>placebo\u2010controlled<\/scp> trials"],"prefix":"10.1111","volume":"14","author":[{"given":"Katsuhiko","family":"Hagi","sequence":"first","affiliation":[{"name":"Sumitomo Pharma Co., Ltd  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kenji","family":"Kochi","sequence":"additional","affiliation":[{"name":"Sumitomo Pharma Co., Ltd  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