{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T16:58:15Z","timestamp":1782925095325,"version":"3.54.5"},"reference-count":26,"publisher":"The Endocrine Society","issue":"6","license":[{"start":{"date-parts":[[2020,3,27]],"date-time":"2020-03-27T00:00:00Z","timestamp":1585267200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"DOI":"10.13039\/100004330","name":"GlaxoSmithKline","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004330","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,6,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Context<\/jats:title>\n                  <jats:p>GLP-1 receptor agonists are an established therapy in patients with type 2 diabetes; however, their role in type 1 diabetes remains to be determined.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>Determine efficacy and safety of once-weekly albiglutide 30 mg (up-titration to 50 mg at week 6) versus placebo together with insulin in patients with new-onset type 1 diabetes and residual insulin production.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Design<\/jats:title>\n                  <jats:p>52-week, randomized, phase 2 study (NCT02284009).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>A prespecified Bayesian approach, incorporating placebo data from a prior study, allowed for 3:1 (albiglutide:placebo) randomization. The primary endpoint was 52-week change from baseline in mixed meal tolerance test (MMTT) stimulated 2-h plasma C-peptide area under the curve (AUC). Secondary endpoints included metabolic measures and pharmacokinetics of albiglutide.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>12\/17 (70.6%, placebo) and 40\/50 (80.0%, albiglutide) patients completed the study. Within our study, mean (standard deviation) change from baseline to week 52 in MMTT-stimulated 2-h plasma C-peptide AUC was \u22120.16 nmol\/L (0.366) with placebo and \u22120.13 nmol\/L (0.244) with albiglutide. For the primary Bayesian analysis (including prior study data) the posterior treatment difference (95% credible interval) was estimated at 0.12 nmol\/L (0\u20130.24); the probability of a difference \u22650.2 nmol\/L between treatments was low (0.097). A transient significant difference in maximum C-peptide was seen at week 28. Otherwise, no significant secondary endpoint differences were noted. On-therapy adverse events were reported in 82.0% (albiglutide) and 76.5% (placebo) of patients.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>In newly diagnosed patients with type 1 diabetes, albiglutide 30 to 50 mg weekly for 1 year had no appreciable effect on preserving residual \u03b2-cell function versus placebo.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1210\/clinem\/dgaa149","type":"journal-article","created":{"date-parts":[[2020,3,27]],"date-time":"2020-03-27T05:32:33Z","timestamp":1585287153000},"page":"e2192-e2206","source":"Crossref","is-referenced-by-count":41,"title":["Randomized 52-week Phase 2 Trial of Albiglutide Versus Placebo in Adult Patients With Newly Diagnosed Type 1 Diabetes"],"prefix":"10.1210","volume":"105","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5090-636X","authenticated-orcid":false,"given":"Paolo","family":"Pozzilli","sequence":"first","affiliation":[{"name":"University of Rome, Campus Bio-Medico, Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emanuele","family":"Bosi","sequence":"additional","affiliation":[{"name":"Diabetes Research Institute, IRCCS San Raffaele and San Raffaele Vita Salute University, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deborah","family":"Cirkel","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline, Stevenage, Hertfordshire, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia","family":"Harris","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline, Uxbridge, Middlesex, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicola","family":"Leech","sequence":"additional","affiliation":[{"name":"The Newcastle upon Tyne Hospitals Foundation Trust, Newcastle upon Tyne, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francisco J","family":"Tinahones","sequence":"additional","affiliation":[{"name":"Department of Endocrinology and Nutrition, Virgen de la Victoria Hospital (IBIMA), Malaga University. Centro de Investigaci\u00f3n Biom\u00e9dica en Red de la Fisiopatolog\u00eda de la Obesidad y Nutrici\u00f3n (CIBEROBN), Instituto de Salud Carlos III (ISCIII), M\u00e1laga, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie-Christine","family":"Vantyghem","sequence":"additional","affiliation":[{"name":"University of Lille, CHU Lille, Endocrinology, Diabetology and Metabolism Department, Inserm U1190\u2014European Genomic Institute for Diabetes, Lille, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Georgios","family":"Vlasakakis","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline, Uxbridge, Middlesex, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anette-Gabriele","family":"Ziegler","sequence":"additional","affiliation":[{"name":"Institute of Diabetes Research, Helmholtz Zentrum M\u00fcnchen, Germany, and Forschergruppe Diabetes, Technical University Munich, at Klinikum rechts der Isar, Munich, 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