{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,15]],"date-time":"2026-05-15T13:40:12Z","timestamp":1778852412968,"version":"3.51.4"},"reference-count":29,"publisher":"The Endocrine Society","issue":"9","license":[{"start":{"date-parts":[[2022,6,6]],"date-time":"2022-06-06T00:00:00Z","timestamp":1654473600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Diamyd Medical AB"},{"name":"Swedish Child Diabetes Foundation"},{"DOI":"10.13039\/501100008550","name":"Diabetesfonden","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100008550","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Swedish Diabetes Association"},{"name":"Contract Research Organizations","award":["NCT02352974"],"award-info":[{"award-number":["NCT02352974"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,8,18]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Aims<\/jats:title>\n                  <jats:p>Residual beta cell function in type 1 diabetes (T1D) is associated with lower risk of complications. Autoantigen therapy with GAD-alum (Diamyd) given in 3 intralymphatic injections with oral vitamin D has shown promising results in persons with T1D carrying the human leukocyte antigen (HLA) DR3-DQ2 haplotype in the phase 2b trial DIAGNODE-2. We aimed to explore the efficacy of intralymphatic GAD-alum on blood glucose recorded by continuous glucose monitoring (CGM).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>DIAGNODE-2 (NCT03345004) was a multicenter, randomized, placebo-controlled, double-blind trial of 109 recent-onset T1D patients aged 12 to 24 years with GAD65 antibodies and fasting C-peptide\u2005&amp;gt;\u20050.12 nmol\/L, which randomized patients to 3 intralymphatic injections of 4 \u03bcg GAD-alum and oral vitamin D, or placebo. We report results for exploratory endpoints assessed by 14-day CGM at months 0, 6, and 15. Treatment arms were compared by mixed-effects models for repeated measures adjusting for baseline values.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>We included 98 patients with CGM recordings of sufficient quality (DR3-DQ2-positive patients: 27 GAD-alum-treated and 15 placebo-treated). In DR3-DQ2-positive patients, percent of time in range (TIR, 3.9-10 mmol\/L) declined less between baseline and month 15 in GAD-alum-treated compared with placebo-treated patients (-5.1% and -16.7%, respectively; P\u2005=\u20050.0075), with reduced time\u2005&amp;gt;\u200513.9 mmol\/L (P\u2005=\u20050.0036), and significant benefits on the glucose management indicator (P\u2005=\u20050.0025). No differences were detected for hypoglycemia. GAD-alum compared to placebo lowered the increase in glycemic variability (standard deviation) observed in both groups (P\u2005=\u20050.0219). Change in C-peptide was correlated with the change in TIR.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Intralymphatic GAD-alum improves glycemic control in recently diagnosed T1D patients carrying HLA DR3-DQ2.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1210\/clinem\/dgac343","type":"journal-article","created":{"date-parts":[[2022,6,6]],"date-time":"2022-06-06T09:30:01Z","timestamp":1654507801000},"page":"2644-2651","source":"Crossref","is-referenced-by-count":32,"title":["Intralymphatic GAD-Alum (Diamyd\u00ae) Improves Glycemic Control in Type 1 Diabetes With HLA DR3-DQ2"],"prefix":"10.1210","volume":"107","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8435-3978","authenticated-orcid":false,"given":"Christoph","family":"Nowak","sequence":"first","affiliation":[{"name":"Department of Neurobiology, Care Sciences and Society, Karolinska Institutet , 14183 Huddinge , Sweden"},{"name":"Diamyd Medical AB , 11135 Stockholm , Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marcus","family":"Lind","sequence":"additional","affiliation":[{"name":"Department of Molecular and Clinical Medicine, University of Gothenburg, 41345 Gothenburg, Sweden, Sahlgrenska University Hospital, Gothenburg and NU-Hospital Group , S41553, Uddevalla , Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zdenek","family":"Sumnik","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital , 15000 Prague , Czech Republic"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Terezie","family":"Pelikanova","sequence":"additional","affiliation":[{"name":"Diabetes Centre of the Institute of Clinical and Experimental Medicine , 14000 Prague , Czech 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of Endocrinology and Nutrition, Virgen Macarena University Hospital , 41009 Sevilla , Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"MariSol","family":"Ruiz de Adana","sequence":"additional","affiliation":[{"name":"Diabetes Unit, Department of Endocrinology and Nutrition, Ibima, Ciberdem, General University Hospital , 29010 Malaga , Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9456-2044","authenticated-orcid":false,"given":"Jeanette","family":"Wahlberg","sequence":"additional","affiliation":[{"name":"Department of Endocrinology in Link\u00f6ping and Department of Health, Medicine and Caring Sciences, Link\u00f6ping University , 58183 Link\u00f6ping , Sweden"},{"name":"Department of Internal Medicine, School of Health and Medical Sciences, \u00d6rebro University , 70281 \u00d6rebro , Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ragnar","family":"Hanas","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, NU Hospital Group , 45153 Uddevalla , Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cristina","family":"Hernandez","sequence":"additional","affiliation":[{"name":"Department of Endocrinology and Nutrition, Vall d\u2019Hebron Hospital , 08035 Barcelona , Ciberdem , Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria","family":"Clemente-Le\u00f3n","sequence":"additional","affiliation":[{"name":"Department of Endocrinology, Pediatric Service, Vall d\u2019Hebron Hospital , 08035 Barcelona , Ciberer Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ana","family":"G\u00f3mez-Gila","sequence":"additional","affiliation":[{"name":"Pediatric Endocrinology Service, Virgen del Roc\u00edo University Hospital , 41013 Sevilla , Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marta","family":"Ferrer Lozano","sequence":"additional","affiliation":[{"name":"Department of Pediatric Endocrinology, Miguel Servet University Hospital , 50009 Zaragoza , Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Theo","family":"Sas","sequence":"additional","affiliation":[{"name":"Diabeter, National Treatment and Research Center for Children, Adolescents and Young Adults with type 1 diabetes, and Department of Pediatric Endocrinology, Erasmus University Medical Center , 3015 Rotterdam , The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stepanka","family":"Pruhova","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital , 15000 Prague , Czech 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