{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T04:32:19Z","timestamp":1789619539973,"version":"build-2803163510"},"reference-count":41,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2022,1,17]],"date-time":"2022-01-17T00:00:00Z","timestamp":1642377600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["dom-pubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2022,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>To investigate whether upper gastrointestinal (GI) disease has any effect on the exposure of oral semaglutide, an important consideration given that its absorption occurs primarily in the stomach.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>\n                      In an open\u2010label, parallel\u2010group trial (NCT02877355), subjects aged 18\u201080\u2009years with type 2 diabetes with mild\u2010to\u2010moderate upper GI disease (N\u00a0=\u00a036; chronic gastritis [n\u00a0=\u00a05], gastroesophageal reflux disease [n\u00a0=\u00a08], and both [n\u00a0=\u00a023]) or without upper GI disease (N\u00a0=\u00a019) received oral semaglutide 3 mg once daily for 5\u2009days, followed by 7\u00a0mg for 5\u2009days. The primary and key supportive endpoints were the area under the semaglutide plasma concentration\u2013time curve (AUC) from 0 to 24\u2009hours after last trial product administration on day 10 (AUC\n                      <jats:sub>0\u221224h,day10<\/jats:sub>\n                      ) and the maximum semaglutide plasma concentration (C\n                      <jats:sub>max,day10<\/jats:sub>\n                      ), respectively.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Semaglutide exposure was not statistically significantly different between subjects with and without upper GI disease. Estimated group ratios (subjects with\/without upper GI disease) were 1.18 (95% confidence interval [CI], 0.80, 1.75) for AUC\n                      <jats:sub>0\u221224h,day10<\/jats:sub>\n                      and 1.16 (95% CI, 0.77, 1.76) for C\n                      <jats:sub>max<\/jats:sub>\n                      . Time to C\n                      <jats:sub>max<\/jats:sub>\n                      and semaglutide half\u2010life were similar in subjects with and without upper GI disease. Oral semaglutide was well tolerated; all adverse events were mild\u2010to\u2010moderate, with no withdrawals because of adverse events.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>There was no significant difference in exposure to oral semaglutide in subjects with or without upper GI disease, hence no dose adjustment is required.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.14632","type":"journal-article","created":{"date-parts":[[2021,12,27]],"date-time":"2021-12-27T00:14:40Z","timestamp":1640564080000},"page":"684-692","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Effect of upper gastrointestinal disease on the pharmacokinetics of oral semaglutide in subjects with type 2 diabetes"],"prefix":"10.1111","volume":"24","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5835-8019","authenticated-orcid":false,"given":"Juris J.","family":"Meier","sequence":"first","affiliation":[{"name":"Diabetes Division, Department of Medicine I, St. Josef\u2010Hospital Ruhr\u2010University Bochum  Bochum Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charlotte","family":"Granhall","sequence":"additional","affiliation":[{"name":"Translational Medicine Novo Nordisk A\/S  S\u00f8borg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0940-8972","authenticated-orcid":false,"given":"Ulrike","family":"Hoevelmann","sequence":"additional","affiliation":[{"name":"Profil  Neuss Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Navarria","sequence":"additional","affiliation":[{"name":"Translational Medicine Novo Nordisk A\/S  S\u00f8borg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leona","family":"Plum\u2010Moerschel","sequence":"additional","affiliation":[{"name":"Profil  Mainz Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chethana","family":"Ramesh","sequence":"additional","affiliation":[{"name":"Novo Nordisk Service Centre India Private Ltd Novo Nordisk  Bangalore India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Tannapfel","sequence":"additional","affiliation":[{"name":"Diabetes Division, Department of Medicine I, St. Josef\u2010Hospital Ruhr\u2010University Bochum  Bochum Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9700-2373","authenticated-orcid":false,"given":"Christoph","family":"Kapitza","sequence":"additional","affiliation":[{"name":"Profil  Neuss Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,1,17]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrendo.2012.140"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12849"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1185\/03007990903421994"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00125-015-3608-6"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-020-01561-1"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2019.2942"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(19)31271-1"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc19-0749"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc19-0883"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2213-8587(19)30192-5"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2213-8587(19)30194-9"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc19-0898"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.14054"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1126\/scitranslmed.aar7047"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.3748\/wjg.v17.i25.3020"},{"key":"e_1_2_9_17_1","first-page":"643","article-title":"Prevalence of silent gastric ulcer, erosions or severe acute gastritis in patients with type 2 diabetes mellitus\u2010\u2010a cross\u2010sectional study","volume":"54","author":"Boehme MW","year":"2007","journal-title":"Hepatogastroenterology."},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.3748\/wjg.v16.i14.1782"},{"key":"e_1_2_9_19_1","unstructured":"ICH Harmonised Tripartite GuidelineGuideline for Good Clinical Practice E6(R1) current step 4 version including the post step 4 corrections; 10 Jun 1996."},{"key":"e_1_2_9_20_1","unstructured":"World Medical Association.Declaration of Helsinki \u2010 ethical principles for medical research involving human subjects 2013.https:\/\/www.wma.net\/policies-post\/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects\/. Accessed August 4 2021."},{"key":"e_1_2_9_21_1","unstructured":"Food and Drug AdministrationFDA Code of Federal Regulations 21 CFR 312.120. Foreign clinical studies not conducted under an IND 2014.https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?fr=312.120. Accessed August 4 2021."},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1097\/00000478-199610000-00001"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1136\/gut.45.2.172"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-018-0728-4"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2017.14752"},{"key":"e_1_2_9_26_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-018-0649-2"},{"key":"e_1_2_9_27_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2005.10.004"},{"key":"e_1_2_9_28_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc12-2480"},{"key":"e_1_2_9_29_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.xcrm.2021.100387"},{"key":"e_1_2_9_30_1","doi-asserted-by":"publisher","DOI":"10.1080\/17425255.2018.1488965"},{"key":"e_1_2_9_31_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1572-0241.1999.987_j.x"},{"key":"e_1_2_9_32_1","doi-asserted-by":"publisher","DOI":"10.4103\/2230-8210.139235"},{"key":"e_1_2_9_33_1","doi-asserted-by":"publisher","DOI":"10.1586\/17474124.2013.824707"},{"key":"e_1_2_9_34_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.diabres.2012.11.012"},{"key":"e_1_2_9_35_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.dsx.2020.05.009"},{"key":"e_1_2_9_36_1","doi-asserted-by":"publisher","DOI":"10.3748\/wjg.v21.i4.1305"},{"key":"e_1_2_9_37_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.14373"},{"key":"e_1_2_9_38_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00125-015-3538-3"},{"key":"e_1_2_9_39_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1464-5491.2002.00658.x"},{"key":"e_1_2_9_40_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-021-01025-x"},{"key":"e_1_2_9_41_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.1131"},{"key":"e_1_2_9_42_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12824"}],"container-title":["Diabetes, Obesity and Metabolism"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/dom.14632","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/dom.14632","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/dom-pubs.pericles-prod.literatumonline.com\/doi\/pdf\/10.1111\/dom.14632","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,30]],"date-time":"2025-10-30T22:18:44Z","timestamp":1761862724000},"score":1,"resource":{"primary":{"URL":"https:\/\/dom-pubs.pericles-prod.literatumonline.com\/doi\/10.1111\/dom.14632"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,1,17]]},"references-count":41,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2022,4]]}},"alternative-id":["10.1111\/dom.14632"],"URL":"https:\/\/doi.org\/10.1111\/dom.14632","archive":["Portico"],"relation":{"has-review":[{"id-type":"doi","id":"10.1111\/DOM.14632\/v2\/review2","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.14632\/v2\/response1","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.14632\/v2\/review1","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.14632\/v1\/decision1","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.14632\/v1\/review2","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.14632\/v1\/review1","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.14632\/v1\/review4","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.14632\/v2\/decision1","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.14632\/v1\/review3","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.14632\/v1\/review5","asserted-by":"object"}]},"ISSN":["1462-8902","1463-1326"],"issn-type":[{"value":"1462-8902","type":"print"},{"value":"1463-1326","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,1,17]]},"assertion":[{"value":"2021-09-09","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-12-22","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-01-17","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}