{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,26]],"date-time":"2026-10-26T18:54:56Z","timestamp":1793040896643,"version":"4.5.0"},"reference-count":17,"publisher":"The Endocrine Society","issue":"8","license":[{"start":{"date-parts":[[2024,11,25]],"date-time":"2024-11-25T00:00:00Z","timestamp":1732492800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Zealand Pharma A\/S"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,7,15]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Context<\/jats:title>\n                  <jats:p>Congenital hyperinsulinism (CHI) is a cause of persistent hypoglycemia in childhood with a considerable risk of lifelong neurological sequelae. Available pharmacological therapies are limited. Dasiglucagon is a glucagon analog for the treatment of hypoglycemia.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>To assess the efficacy and safety of dasiglucagon in children with CHI up to 1 year of age.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>This study included a randomized, crossover, double-blind, placebo-controlled part 1 and an open-label, single-arm part 2 at 4 centers in Germany, the United Kingdom, and the United States. Participants comprised children with CHI aged 7 days to 12 months who were dependent on IV glucose. In part 1, participants were randomized to dasiglucagon or placebo for 48\u2005hours, then crossed over to the other treatment for 48\u2005hours. In part 2, all participants received dasiglucagon for 21 days. The primary outcome was mean IV glucose infusion rate (GIR) in the last 12\u2005hours of part 1.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Between June 19, 2020, and February 9, 2022, 12 eligible participants were randomized to dasiglucagon\u2013placebo (n = 7) or placebo\u2013dasiglucagon (n = 5). The IV GIR was significantly reduced with dasiglucagon compared with placebo (least-squares mean 4.3\u2005mg\/kg\/min [95% confidence interval [CI], 1.04 to 7.60\u2005mg\/kg\/min] and 9.5\u2005mg\/kg\/min [95% CI, 6.24 to 12.81\u2005mg\/kg\/min], respectively; P = .004). The most frequent adverse events in both treatment groups were gastrointestinal, dermatological, and metabolism and nutritional disorders.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>In infants with CHI, dasiglucagon significantly reduced the amount of IV glucose needed to maintain euglycemia compared with placebo. Dasiglucagon represents a promising treatment for the management of CHI.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1210\/clinem\/dgae818","type":"journal-article","created":{"date-parts":[[2024,11,25]],"date-time":"2024-11-25T06:34:54Z","timestamp":1732516494000},"page":"e2674-e2681","source":"Crossref","is-referenced-by-count":4,"title":["Dasiglucagon in Children With Congenital Hyperinsulinism Up to 1 Year of Age: Results From a Randomized Clinical Trial"],"prefix":"10.1210","volume":"110","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1225-8087","authenticated-orcid":false,"given":"Diva D","family":"De Leon","sequence":"first","affiliation":[{"name":"Congenital Hyperinsulinism Center, Division of Endocrinology and Diabetes, The Children's Hospital of Philadelphia , Philadelphia, PA 19104 ,","place":["USA"]},{"name":"Department of Pediatrics, Perelman School of Medicine at the University of Pennsylvania , Philadelphia, PA 19104 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