{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,1]],"date-time":"2026-11-01T02:15:16Z","timestamp":1793499316525,"version":"4.5.0"},"reference-count":22,"publisher":"Wiley","issue":"S4","license":[{"start":{"date-parts":[[2020,9,16]],"date-time":"2020-09-16T00:00:00Z","timestamp":1600214400000},"content-version":"vor","delay-in-days":15,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100004339","name":"Sanofi","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004339","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["dom-pubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2020,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>To assess efficacy and safety of 26\u2010week treatment with insulin glargine\/lixisenatide fixed\u2010ratio combination (iGlarLixi) compared with insulin glargine U100 (iGlar) in Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on oral antidiabetic drugs (OADs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>This phase 3, multicentre, open\u2010label, 1:1 randomized, parallel\u2010group study compared efficacy of iGlarLixi and iGlar in patients with T2DM, HbA1c of \u22657.5% to \u22649.5% and fasting plasma glucose \u226410.0\u2009mmol\/L (180\u2009mg\/dL). The primary endpoint was change in HbA1c from baseline to week 26.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Patients were randomized to iGlarLixi (n = 260) or iGlar (n = 261) (mean age 59.7\u2009years, baseline BMI 26.04\u2009kg\/m\n                      <jats:sup>2<\/jats:sup>\n                      , and HbA1c 8.04% [64.4\u2009mmol\/mol]). HbA1c reduction was significantly greater with iGlarLixi (\u22121.40% [\u221215.3\u2009mmol\/mol]) than with iGlar (\u22120.76% [\u22128.3\u2009mmol\/mol]). Significantly more iGlarLixi patients reached HbA1c &lt;7% at week 26 (71.5% vs 38.5%,\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u2009.0001), with significantly lower weight gain (LS mean difference\u2009\u22121.06\u2009kg,\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u2009.0001). Documented symptomatic hypoglycemia (plasma glucose \u22643.9\u2009mmol\/L [70\u2009mg\/dL]) was recorded in 14.2% of patients with iGlarLixi and 12.3% with iGlar. No severe hypoglycemia was reported in either group. Other than the expected gastrointestinal issues associated with glucagon\u2010like peptide 1 receptor agonists, we found no major difference in the incidence of TEAEs.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>HbA1c reduction was significantly greater with iGlarLixi than with iGlar; significantly more patients achieved HbA1c &lt;7%, with no additional risk of hypoglycemia and without weight gain. iGlarLixi (1:1) provided an effective treatment option for Japanese patients with T2DM inadequately controlled on OADs.<\/jats:p>\n                    <jats:p>Clinical Trial Number: NCT02752828<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.14036","type":"journal-article","created":{"date-parts":[[2020,4,15]],"date-time":"2020-04-15T02:49:52Z","timestamp":1586918992000},"page":"14-23","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":39,"title":["Efficacy and safety of insulin glargine\/lixisenatide fixed\u2010ratio combination (\n                    <scp>iGlarLixi<\/scp>\n                    1:1) in Japanese patients with type 2 diabetes mellitus inadequately controlled on oral antidiabetic drugs: A randomized, 26\u2010week, open\u2010label, multicentre study: The\n                    <scp>LixiLan JP\u2010O2<\/scp>\n                    randomized clinical trial"],"prefix":"10.1111","volume":"22","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8872-3697","authenticated-orcid":false,"given":"Yasuo","family":"Terauchi","sequence":"first","affiliation":[{"name":"Department of Endocrinology and Metabolism, Graduate School of Medicine Yokohama City University  Yokohama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takahiro","family":"Nakama","sequence":"additional","affiliation":[{"name":"Research &amp; Development, Sanofi K.K.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Spranger","sequence":"additional","affiliation":[{"name":"Diabetes, Cardiovascular and Metabolics Development, Sanofi\u2010Aventis Deutschland GmbH  Frankfurt Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3698-6871","authenticated-orcid":false,"given":"Atsushi","family":"Amano","sequence":"additional","affiliation":[{"name":"Research &amp; Development, Sanofi K.K.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takahiro","family":"Inoue","sequence":"additional","affiliation":[{"name":"Research &amp; Development, Sanofi K.K.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisabeth","family":"Niemoeller","sequence":"additional","affiliation":[{"name":"Diabetes, Cardiovascular and Metabolics Development, Sanofi\u2010Aventis Deutschland GmbH  Frankfurt Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,9,16]]},"reference":[{"key":"e_1_2_9_2_1","unstructured":"Ministry of Health Labour and Welfare. Summary results of national health and nutrition survey 2016.https:\/\/www.mhlw.go.jp\/file\/04\u2010Houdouhappyou\u201010904750\u2010Kenkoukyoku\u2010Gantaisakukenkouzoushinka\/kekkagaiyou_7.pdf. Accessed September 10 2019."},{"key":"e_1_2_9_3_1","unstructured":"Japan Diabetes Clinical Data Management Study Group. Fundamental Statistics on Diabetes in Japan 2017.http:\/\/jddm.jp\/data\/index-2017.html. 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