{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T06:14:47Z","timestamp":1791440087088,"version":"4.3.3"},"reference-count":33,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2025,3,21]],"date-time":"2025-03-21T00:00:00Z","timestamp":1742515200000},"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":[[2025,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>The ongoing FAMILIAR trial aims to provide evidence for clinical decision\u2010making and offer a novel treatment paradigm in type 2 diabetes mellitus (T2DM) management. The interim findings of FAMILIAR through Week 24 are reported.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>FAMILIAR is a multicentre, randomised, double\u2010blind study comparing the efficacy and safety of imeglimin versus placebo in adult Japanese patients with T2DM and inadequate glycaemic control despite dipeptidyl peptidase\u20104 (DPP\u20104) inhibitor monotherapy, plus diet\/exercise modifications. Patients entered a 24\u2010week double\u2010blind treatment phase (oral imeglimin 1000\u2009mg or placebo twice daily) followed by an 80\u2010week open\u2010label phase (oral imeglimin 1000\u2009mg twice daily). The primary end\u2010point was change in glycated haemoglobin (HbA1c) level from baseline at Week 24. Safety was also monitored.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Overall, 117 patients were randomised (imeglimin,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200958; placebo,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200954; excluded,\n                      <jats:italic>n<\/jats:italic>\n                      = 5). The least squares mean (standard error) changes in HbA1c level (baseline to Week 24) for the imeglimin and placebo groups, respectively, were \u22120.65% (0.11%) and 0.38% (0.11%) in the overall population (group\u2010difference \u22121.02% [95% confidence interval \u22121.33%, \u22120.72%];\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.001); \u22120.47% (0.17%) and 0.32% (0.18%) in patients aged &lt;65\u2009years (\u22120.79% [\u22121.29%, \u22120.29%];\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.003); and \u22120.80% (0.14%) and 0.42% (0.14%) in patients aged \u226565\u2009years (\u22121.22% [\u22121.61%, \u22120.82%];\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.001). One patient in the imeglimin group had mild hypoglycaemia; the safety profile was favourable.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Imeglimin represents a potential new treatment option for patients with T2DM and inadequate glycaemic control with DPP\u20104 inhibitors, including those aged \u226565\u2009years.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trial Registration<\/jats:title>\n                    <jats:p>jRCTs061210082.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.16336","type":"journal-article","created":{"date-parts":[[2025,3,23]],"date-time":"2025-03-23T07:03:30Z","timestamp":1742713410000},"page":"3212-3222","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Efficacy and safety of imeglimin add\u2010on to\n                    <scp>DPP<\/scp>\n                    \u20104 inhibitor therapy in Japanese patients with type 2 diabetes mellitus: An interim analysis of the randomised, double\u2010blind\n                    <scp>FAMILIAR<\/scp>\n                    trial"],"prefix":"10.1111","volume":"27","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1574-0565","authenticated-orcid":false,"given":"Kohei","family":"Kaku","sequence":"first","affiliation":[{"name":"Department of Diabetes, Endocrinology and Metabolism Kawasaki Medical School  Okayama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4223-9613","authenticated-orcid":false,"given":"Masashi","family":"Shimoda","sequence":"additional","affiliation":[{"name":"Department of Diabetes, Endocrinology and Metabolism Kawasaki Medical School  Okayama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takeshi","family":"Osonoi","sequence":"additional","affiliation":[{"name":"Nakakinen Clinic  Ibaraki Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masahiro","family":"Iwamoto","sequence":"additional","affiliation":[{"name":"Iwamoto Naika Iin  Kagawa Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hideaki","family":"Kaneto","sequence":"additional","affiliation":[{"name":"Department of Diabetes, Endocrinology and Metabolism Kawasaki Medical School  Okayama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,3,21]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc23-S002"},{"key":"e_1_2_11_3_1","unstructured":"Ministry of Health Labour and Welfare.Results of the National Health and Nutrition Survey 2016. 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