{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,31]],"date-time":"2025-10-31T21:40:46Z","timestamp":1761946846800,"version":"build-2065373602"},"reference-count":23,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2021,2,17]],"date-time":"2021-02-17T00:00:00Z","timestamp":1613520000000},"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":[[2021,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>To evaluate the efficacy and safety of adding the once\u2010weekly oral dipeptidyl peptidase\u20104 inhibitor omarigliptin to treatment of Japanese patients with type 2 diabetes and inadequate glycaemic control on insulin monotherapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>\n                      In a 52\u2010week clinical trial, Japanese patients on insulin monotherapy were randomized to once\u2010weekly omarigliptin 25\u2009mg (\n                      <jats:italic>N<\/jats:italic>\n                      = 123) or placebo (\n                      <jats:italic>N<\/jats:italic>\n                      = 61) for a 16\u2010week, double\u2010blind, placebo\u2010controlled period. After Week 16, patients continued or switched to omarigliptin for a 36\u2010week open\u2010label period.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      From a mean baseline of approximately 8.8%, the Week 16 least squares mean changes in HbA1c were \u22120.61% (omarigliptin) and 0.29% (placebo); the between\u2010group difference was \u22120.90% (\n                      <jats:italic>p<\/jats:italic>\n                      &lt;\u2009.001). At Week 52, the mean change from baseline in HbA1c was \u22120.57% in both the group on omarigliptin for 52\u2009weeks and the group on omarigliptin for 36\u2009weeks (switched from placebo at Week 16). During the first 16\u2009weeks of treatment, the incidences of adverse events (AEs), serious AEs, drug\u2010related AEs and discontinuation from trial medication because of an AE were similar in both groups. A slight increase in incidence of symptomatic hypoglycaemia was observed in the omarigliptin group (\n                      <jats:italic>n<\/jats:italic>\n                      =\u200913 [10.6%]) compared with placebo (\n                      <jats:italic>n<\/jats:italic>\n                      =\u20094 [6.6%]). No severe hypoglycaemia was reported during the study. No new safety signals emerged with treatment beyond Week 16 through Week 52.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The addition of once\u2010weekly omarigliptin to insulin therapy for up to 52\u2009weeks was generally well tolerated and provided clinically meaningful improvement in glycaemic control throughout the trial period. ClinicalTrials.gov: NCT02906709<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.14331","type":"journal-article","created":{"date-parts":[[2021,1,29]],"date-time":"2021-01-29T11:09:37Z","timestamp":1611918577000},"page":"1242-1251","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["A randomized, placebo\u2010controlled study to evaluate the efficacy and safety of adding omarigliptin to insulin therapy in\n                    <scp>Japanese<\/scp>\n                    patients with type 2 diabetes and inadequate glycaemic control"],"prefix":"10.1111","volume":"23","author":[{"given":"Takashi","family":"Kadowaki","sequence":"first","affiliation":[{"name":"Department of Prevention of Diabetes and Lifestyle\u2010Related Diseases, Graduate School of Medicine The University of Tokyo  Tokyo Japan"},{"name":"Toranomon Hospital  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yutaka","family":"Seino","sequence":"additional","affiliation":[{"name":"Kansai Electric Power Hospital  Osaka Japan"},{"name":"Kansai Electric Power Medical Research Institute  Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1574-0565","authenticated-orcid":false,"given":"Kohei","family":"Kaku","sequence":"additional","affiliation":[{"name":"Kawasaki Medical School  Okayama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5494-462X","authenticated-orcid":false,"given":"Taro","family":"Okamoto","sequence":"additional","affiliation":[{"name":"Japan Development MSD K.K.  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