{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,31]],"date-time":"2025-10-31T03:28:26Z","timestamp":1761881306912,"version":"build-2065373602"},"reference-count":41,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2017,4,27]],"date-time":"2017-04-27T00:00:00Z","timestamp":1493251200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Sanofi K.K."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2017,9]]},"abstract":"<jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>\n                      To evaluate the pharmacodynamics of lixisenatide once daily vs sitagliptin once daily in\n                      <jats:styled-content style=\"fixed-case\">J<\/jats:styled-content>\n                      apanese patients with type 2 diabetes receiving insulin glargine\n                      <jats:styled-content style=\"fixed-case\">U100<\/jats:styled-content>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and methods<\/jats:title>\n                    <jats:p>\n                      This multicentre, open\u2010label, phase\n                      <jats:styled-content style=\"fixed-case\">IV<\/jats:styled-content>\n                      study (\n                      <jats:styled-content style=\"fixed-case\">NEXTAGE Study<\/jats:styled-content>\n                      ;\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/ClinicalTrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                      <jats:styled-content style=\"fixed-case\">number, NCT02200991<\/jats:styled-content>\n                      ) randomly assigned 136 patients to either lixisenatide once daily via subcutaneous injection (10\u2009\u00b5g initially increased weekly by 5 up to 20\u2009\u00b5g) or once\u2010daily oral sitagliptin 50\u2009mg. The primary endpoint was the change in postprandial glucose (\n                      <jats:styled-content style=\"fixed-case\">PPG<\/jats:styled-content>\n                      ) exposure 4\u2009hours after a standardized breakfast (\n                      <jats:styled-content style=\"fixed-case\">PPG<\/jats:styled-content>\n                      area under the plasma glucose concentration\u2013time curve [\n                      <jats:styled-content style=\"fixed-case\">\n                        AUC\n                        <jats:sub>0<\/jats:sub>\n                      <\/jats:styled-content>\n                      <jats:sub>:00\u20104:00h<\/jats:sub>\n                      ]) from baseline to day 29.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Lixisenatide reduced\n                      <jats:styled-content style=\"fixed-case\">PPG<\/jats:styled-content>\n                      exposure to a statistically significantly greater extent than sitagliptin: least squares (\n                      <jats:styled-content style=\"fixed-case\">LS<\/jats:styled-content>\n                      ) mean change from baseline in\n                      <jats:styled-content style=\"fixed-case\">\n                        PPG AUC\n                        <jats:sub>0<\/jats:sub>\n                      <\/jats:styled-content>\n                      <jats:sub>:00\u20104:00h<\/jats:sub>\n                      was \u2212347.3 h\u00b7mg\/dL (\u221219.3 h\u00b7mmol\/L) in the lixisenatide group and \u2212113.3 h\u00b7mg\/dL (\u22126.3 h\u00b7mmol\/L) in the sitagliptin group (\n                      <jats:styled-content style=\"fixed-case\">LS<\/jats:styled-content>\n                      mean between\u2010group difference \u2212234.0 h\u00b7mg\/dL [\u221213.0 h\u00b7mmol\/L], 95% confidence interval \u2212285.02 to \u2212183.00 h\u00b7mg\/dL [\u221215.8 to \u221210.2 h\u00b7mmol\/L];\n                      <jats:italic>\n                        <jats:styled-content style=\"fixed-case\">P<\/jats:styled-content>\n                      <\/jats:italic>\n                      \u2009&lt;\u2009.0001). Lixisenatide led to significantly greater\n                      <jats:styled-content style=\"fixed-case\">LS<\/jats:styled-content>\n                      mean reductions in maximum\n                      <jats:styled-content style=\"fixed-case\">PPG<\/jats:styled-content>\n                      excursion than sitagliptin (\u2212122.4 vs \u221246.6 mg\/dL [\u22126.8 vs \u22122.6 h\u00b7mmol\/L];\n                      <jats:italic>\n                        <jats:styled-content style=\"fixed-case\">P<\/jats:styled-content>\n                      <\/jats:italic>\n                      \u2009&lt;\u2009.0001). Change\u2010from\u2010baseline reductions in exposure to\n                      <jats:styled-content style=\"fixed-case\">C<\/jats:styled-content>\n                      \u2010peptide, fasting glycoalbumin levels, and the gastric emptying rate were greater in the lixisenatide than in the sitagliptin group. The incidence of treatment\u2010emergent adverse events was higher with lixisenatide (60.9%) than with sitagliptin (16.4%), with no serious events or severe hypoglycaemia reported.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>\n                      Lixisenatide reduced\n                      <jats:styled-content style=\"fixed-case\">PPG<\/jats:styled-content>\n                      significantly more than sitagliptin, when these agents were added to basal insulin glargine\n                      <jats:styled-content style=\"fixed-case\">U100<\/jats:styled-content>\n                      , and was well tolerated.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.12945","type":"journal-article","created":{"date-parts":[[2017,3,26]],"date-time":"2017-03-26T22:26:46Z","timestamp":1490567206000},"page":"1252-1259","source":"Crossref","is-referenced-by-count":4,"title":["Reduction of postprandial glucose by lixisenatide vs sitagliptin treatment in\n                    <scp>J<\/scp>\n                    apanese patients with type 2 diabetes on background insulin glargine:\n                    <scp>A<\/scp>\n                    randomized phase\n                    <scp>IV<\/scp>\n                    study (NEXTAGE Study)"],"prefix":"10.1111","volume":"19","author":[{"given":"Yuichiro","family":"Yamada","sequence":"first","affiliation":[{"name":"Department of Endocrinology, Diabetes and Geriatric Medicine Akita University Graduate School of Medicine and Faculty of Medicine  Akita Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masayuki","family":"Senda","sequence":"additional","affiliation":[{"name":"Medical Affairs Sanofi K.K.  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8033-6708","authenticated-orcid":false,"given":"Yusuke","family":"Naito","sequence":"additional","affiliation":[{"name":"Diabetes and Cardiovascular Medical Operations Sanofi K.K.  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masahiro","family":"Tamura","sequence":"additional","affiliation":[{"name":"Diabetes and Cardiovascular Medical Operations Sanofi K.K.  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daisuke","family":"Watanabe","sequence":"additional","affiliation":[{"name":"Biostatistics and Programming Sanofi K.K.  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yujin","family":"Shuto","sequence":"additional","affiliation":[{"name":"Diabetes and Cardiovascular Medical Operations Sanofi K.K.  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoshihisa","family":"Urita","sequence":"additional","affiliation":[{"name":"Department of General Medicine and Emergency Care Toho University School of Medicine, Omori Hospital  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,4,27]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1464-5491.2008.02565.x"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc06-1612"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.26.3.881"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1464-5491.2009.02809.x"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.diabres.2006.11.011"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.4158\/EP.13.S1.1"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc11-0174"},{"key":"e_1_2_6_9_1","unstructured":"LANTUS\u00ae (insulin glargine injection) solution for subcutaneous injection. 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