{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,2]],"date-time":"2026-09-02T02:21:06Z","timestamp":1788315666039,"version":"build-2803163510"},"reference-count":11,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2023,1,31]],"date-time":"2023-01-31T00:00:00Z","timestamp":1675123200000},"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":[[2023,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>Pramlintide improves postprandial glucose but requires additional injections. We investigated the pharmacokinetics\/pharmacodynamics, efficacy and safety of ADO09, pramlintide\/insulin A21G co\u2010formulation, in type 1 diabetes (T1D).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>This double\u2010blinded, randomized, two\u2010period cross\u2010over study compared prandial administration of ADO09 or insulin aspart over 24\u2009days in T1D using either \u226440\u2009U bolus insulin per day [low\u2010dose group (LD), n\u00a0=\u00a028] or 40\u201075\u2009U [high\u2010dose group (HD), n\u00a0=\u00a016]. Glycaemic responses through continuous glucose monitoring, and pharmacokinetics\/pharmacodynamics profiles following mixed\u2010meal\u2010tolerance tests were evaluated at baseline and at the end of treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Glucose increments from 0 to 4\u00a0h after mixed\u2010meal\u2010tolerance test (primary endpoint) were 39% (not statistically significantly) lower with ADO09 in the low\u2010dose group and 69% lower in the high\u2010dose group. Mean continuous glucose monitoring glucose during ambulatory treatment was lower with ADO09 than with aspart (LD: \u20138.2\u2009\u00b1\u20097.9\u00a0mg\/dl,\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0=\u00a0.0001; HD: \u20137.0\u2009\u00b1\u200910\u00a0mg\/ml,\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0=\u00a0.0127), and time\u2010in\u2010range (70\u2013180\u2009mg\/dl) improved (LD: +4%,\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0=\u00a0.0134; HD: +4%,\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0=\u00a0.0432). Body weight declined significantly with ADO09 (LD: \u20130.8\u00a0kg; HD: \u20131.6\u00a0kg). Hypoglycaemic events were slightly more frequent with ADO09 versus aspart (LD: 142 vs. 115; HD: 96 vs. 79). Gastrointestinal events occurred more frequently with ADO09 but were generally transient, and no other safety signals were identified.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In comparison with aspart, ADO09 was well tolerated and effective in T1D across a wide range of dosage, significantly improving the average blood glucose level and body weight during 24\u2009days of ambulatory treatment. Meal test profiles confirmed improvement of glycaemic patterns and other responses with ADO09.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.14972","type":"journal-article","created":{"date-parts":[[2023,1,12]],"date-time":"2023-01-12T09:44:16Z","timestamp":1673516656000},"page":"1241-1248","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["A co\u2010formulation of pramlintide and insulin\n                    <scp>A21G<\/scp>\n                    (\n                    <scp>ADO09<\/scp>\n                    ) improves postprandial glucose and short\u2010term control of mean glucose, time in range, and body weight versus insulin aspart in adults with type 1 diabetes"],"prefix":"10.1111","volume":"25","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9260-7165","authenticated-orcid":false,"given":"Grit","family":"Andersen","sequence":"first","affiliation":[{"name":"Profil  Neuss Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rosy","family":"Eloy","sequence":"additional","affiliation":[{"name":"Adocia  Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susanne","family":"Famulla","sequence":"additional","affiliation":[{"name":"Profil  Neuss Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8346-2037","authenticated-orcid":false,"given":"Tim","family":"Heise","sequence":"additional","affiliation":[{"name":"Profil  Neuss Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gr\u00e9gory","family":"Meiffren","sequence":"additional","affiliation":[{"name":"Adocia  Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cyril","family":"Seroussi","sequence":"additional","affiliation":[{"name":"Adocia  Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Gaudier","sequence":"additional","affiliation":[{"name":"Adocia  Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claire","family":"M\u00e9gret","sequence":"additional","affiliation":[{"name":"Adocia  Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"You\u2010Ping","family":"Chan","sequence":"additional","affiliation":[{"name":"Adocia  Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olivier","family":"Soula","sequence":"additional","affiliation":[{"name":"Adocia  Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1169-3036","authenticated-orcid":false,"given":"Matthew","family":"Riddle","sequence":"additional","affiliation":[{"name":"Division of Endocrinology, Diabetes, &amp; Clinical Nutrition Oregon Health &amp; Science University  Portland Oregon USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,1,31]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc18-1091"},{"key":"e_1_2_7_3_1","unstructured":"Astra Zeneca Pharmaceuticals L.Symlin\u00ae full prescribing information.2016."},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.18632\/oncotarget.16008"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12504"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0009540"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.14302"},{"key":"e_1_2_7_8_1","volume-title":"ICH Topic E6 (R2) Guideline for Good Clinical Practice","author":"ICH Harmonised Tripartite Guideline","year":"2017"},{"key":"e_1_2_7_9_1","volume-title":"Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects \u2010 Last Amended by the 64th WMA General Assembly","author":"Word Medical Association","year":"2013"},{"issue":"1","key":"e_1_2_7_10_1","article-title":"In an open\u2010label clinical study pramlintide lowered A1c, body weight, and insulin use in patients with type 1 diabetes failing to achieve glycemic targets with insulin therapy","volume":"54","author":"Guthrie R","year":"2005","journal-title":"Diabetes"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc06-1026"},{"key":"e_1_2_7_12_1","volume-title":"Gebrauchsanweisung Super GL compact","author":"Dr. M\u00fcller Ger\u00e4tebau GmbH","year":"2011"}],"container-title":["Diabetes, Obesity and Metabolism"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/dom.14972","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/dom.14972","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/dom-pubs.pericles-prod.literatumonline.com\/doi\/pdf\/10.1111\/dom.14972","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,31]],"date-time":"2025-10-31T06:54:02Z","timestamp":1761893642000},"score":1,"resource":{"primary":{"URL":"https:\/\/dom-pubs.pericles-prod.literatumonline.com\/doi\/10.1111\/dom.14972"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,1,31]]},"references-count":11,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2023,5]]}},"alternative-id":["10.1111\/dom.14972"],"URL":"https:\/\/doi.org\/10.1111\/dom.14972","archive":["Portico"],"relation":{"has-review":[{"id-type":"doi","id":"10.1111\/DOM.14972\/v2\/response1","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.14972\/v2\/decision1","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.14972\/v1\/review2","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.14972\/v1\/decision1","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.14972\/v1\/review1","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.14972\/v2\/review1","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.14972\/v1\/review5","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.14972\/v1\/review4","asserted-by":"object"},{"id-type":"doi","id":"10.1111\/DOM.14972\/v1\/review3","asserted-by":"object"}]},"ISSN":["1462-8902","1463-1326"],"issn-type":[{"value":"1462-8902","type":"print"},{"value":"1463-1326","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,1,31]]},"assertion":[{"value":"2022-10-27","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-01-08","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-01-31","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}