{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,27]],"date-time":"2026-06-27T03:11:07Z","timestamp":1782529867868,"version":"3.54.5"},"reference-count":53,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2017,1,30]],"date-time":"2017-01-30T00:00:00Z","timestamp":1485734400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Novartis Pharma AG, Basel, Switzerland"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2017,3]]},"abstract":"<jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>To determine the impact of race and ethnicity on the efficacy, body weight and hypoglycaemia incidence with vildagliptin treatment in patients with type 2 diabetes mellitus using patient\u2010level data from the vildagliptin clinical trial programme.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Data from 22 randomized, placebo\u2010controlled global and local (Japan, China) registration studies of vildagliptin (50 mg once\u2010daily or twice\u2010daily) of \u226512\u2010week duration were analysed by race (Caucasian [n = 2764] and Asian [n = 2232]) and by ethnicity (Japanese, Chinese,\n                      <jats:styled-content style=\"fixed-case\">and I<\/jats:styled-content>\n                      ndian). The placebo\u2010subtracted differences in the change in glycated haemoglobin (\n                      <jats:styled-content style=\"fixed-case\">HbA1c<\/jats:styled-content>\n                      ) and body weight from baseline to week 12 or week 24 were evaluated by race or ethnicity using repeated measure analysis of unstructured covariance. Hypoglycaemia incidences were summarized using descriptive statistics.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The\n                      <jats:styled-content style=\"fixed-case\">HbA1c<\/jats:styled-content>\n                      reduction from baseline with vildagliptin was similar across the racial\/ethnic subgroups (\u22120.83% \u00b1 0.02% to \u22121.01% \u00b1 0.05%). Placebo\u2010corrected\n                      <jats:styled-content style=\"fixed-case\">HbA1c<\/jats:styled-content>\n                      reduction was similar between Caucasian (\u22120.68% \u00b1 0.03%) and Asian (\u22120.80% \u00b1 0.03%) patients (\n                      <jats:italic>P<\/jats:italic>\n                      value for interaction = .56); analysis by race and ethnicity showed better efficacy (\n                      <jats:italic>P<\/jats:italic>\n                      &lt; .02) in Japanese patients. Japanese patients were drug\u2010na\u00efve and treated with a single oral anti\u2010diabetes drug only; they showed no response to placebo. Weight neutrality of vildagliptin was demonstrated in all groups (0.47 \u00b1 0.11 kg to \u22120.29 \u00b1 0.08 kg). Hypoglycaemic events (\u22651) were infrequent in all ethnic subgroups.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The glycaemic efficacy of vildagliptin was similar in Caucasian and Asian patients. The slightly better efficacy observed in Japanese patients was driven by the absence of placebo effect and might be explained by their earlier stage of diabetes compared to other subgroups.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.12844","type":"journal-article","created":{"date-parts":[[2016,12,10]],"date-time":"2016-12-10T06:27:06Z","timestamp":1481351226000},"page":"429-435","source":"Crossref","is-referenced-by-count":10,"title":["Effect of race and ethnicity on vildagliptin efficacy: A pooled analysis of phase\n                    <scp>II<\/scp>\n                    and\n                    <scp>III<\/scp>\n                    studies"],"prefix":"10.1111","volume":"19","author":[{"given":"Plamen","family":"Kozlovski","sequence":"first","affiliation":[{"name":"Novartis Pharma AG  Basel Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marilia","family":"Fonseca","sequence":"additional","affiliation":[{"name":"School of Public Health 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