{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T23:42:39Z","timestamp":1788910959742,"version":"build-2803163510"},"reference-count":27,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2021,8,18]],"date-time":"2021-08-18T00:00:00Z","timestamp":1629244800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["dom-pubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2021,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>To assess the safety and efficacy of oral insulin (ORMD\u20100801) in patients with type 2 diabetes (T2D).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>After a 2\u2010week washout of other medications, adult metformin\u2010treated patients with T2D were randomized to receive placebo or 16 or 24\u2009mg ORMD\u20100801, once daily, at bedtime, for 28\u2009days. The mean change from baseline weighted mean night\u2010time glucose levels was determined from 2 nights of continuous glucose monitoring (CGM) recordings during the placebo run\u2010in and last week of treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      In total, 188 patients (HbA1c: 7.82%\u2009\u00b1\u20090.88% [placebo] and 8.08%\u2009\u00b1\u20091.11% [pooled ORMD\u20100801 group]) were enrolled. In the placebo group, mean night\u2010time CGM increased from baseline by 13.7\u2009\u00b1\u200926.1\u00a0mg\/dL, whereas the increase was significantly smaller in the pooled ORMD\u20100801 group (1.7\u2009\u00b1\u200923.5\u00a0mg\/dL,\n                      <jats:italic>P<\/jats:italic>\n                      \u00a0=\u00a0.0120). Glycaemic control variables (24\u2010hour, fasting and daytime CGM glucose) also displayed smaller increases with ORMD\u20100801 versus placebo. Change from baseline HbA1c was \u22120.01% in the pooled ORMD\u20100801 group versus +0.20% in the placebo group (\n                      <jats:italic>P<\/jats:italic>\n                      \u00a0=\u00a0.0149). ORMD\u20100801 was well tolerated, with similar adverse event and hypoglycaemia rates as placebo.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In patients with T2D, bedtime ORMD\u20100801 curbed increases in night\u2010time glycaemia, 24\u2010hour glycaemia and HbA1c, without increasing the risk of hypoglycaemia or safety events compared with the control arm.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.14499","type":"journal-article","created":{"date-parts":[[2021,7,26]],"date-time":"2021-07-26T09:19:09Z","timestamp":1627291149000},"page":"2529-2538","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":35,"title":["Efficacy and safety of 28\u2010day treatment with oral insulin (\n                    <scp>ORMD<\/scp>\n                    \u20100801) in patients with type 2 diabetes: A randomized, placebo\u2010controlled trial"],"prefix":"10.1111","volume":"23","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1151-1370","authenticated-orcid":false,"given":"Roy","family":"Eldor","sequence":"first","affiliation":[{"name":"Diabetes Unit, Institute for Endocrinology, Metabolism and Hypertension Tel Aviv Sourasky Medical Center  Tel Aviv Israel"},{"name":"The Sackler Faculty of Medicine Tel\u2010Aviv University  Tel\u2010Aviv Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joel","family":"Neutel","sequence":"additional","affiliation":[{"name":"Orange County Research Center  Tustin California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3686-5199","authenticated-orcid":false,"given":"Kenneth","family":"Homer","sequence":"additional","affiliation":[{"name":"Integrium, LLC  Tustin California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7214-0999","authenticated-orcid":false,"given":"Miriam","family":"Kidron","sequence":"additional","affiliation":[{"name":"Oramed Pharmaceuticals  Jerusalem Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,8,18]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc14-2441"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1463-1326.2009.01153.x"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1177\/193229680900300322"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1177\/1932296817691303"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0059524"},{"issue":"1","key":"e_1_2_9_7_1","first-page":"S4","article-title":"Standards of Medical Care in Diabetes \u2010 2017: summary of 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