{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,9]],"date-time":"2026-11-09T22:56:37Z","timestamp":1794264997894,"version":"4.9.0"},"reference-count":13,"publisher":"American Diabetes Association","issue":"6","license":[{"start":{"date-parts":[[2020,4,21]],"date-time":"2020-04-21T00:00:00Z","timestamp":1587427200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.diabetesjournals.org\/content\/license"}],"content-domain":{"domain":["diabetesjournals.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2021,6,1]]},"abstract":"<jats:sec>\n                  <jats:title>OBJECTIVE<\/jats:title>\n                  <jats:p>To evaluate the efficacy and safety of dasiglucagon, a ready-to-use, next-generation glucagon analog in aqueous formulation for subcutaneous dosing, for treatment of severe hypoglycemia in adults with type 1 diabetes.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>RESEARCH DESIGN AND METHODS<\/jats:title>\n                  <jats:p>This randomized, double-blind trial included 170 adult participants with type 1 diabetes, each randomly assigned to receive a single subcutaneous dose of 0.6 mg dasiglucagon, placebo, or 1 mg reconstituted glucagon (2:1:1 randomization) during controlled insulin-induced hypoglycemia. The primary end point was time to plasma glucose recovery, defined as an increase of \u226520 mg\/dL from baseline without rescue intravenous glucose. The primary comparison was dasiglucagon versus placebo; reconstituted lyophilized glucagon was included as reference.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>RESULTS<\/jats:title>\n                  <jats:p>Median (95% CI) time to recovery was 10 (10, 10) minutes for dasiglucagon compared with 40 (30, 40) minutes for placebo (P &amp;lt; 0.001); the corresponding result for reconstituted glucagon was 12 (10, 12) minutes. In the dasiglucagon group, plasma glucose recovery was achieved within 15 min in all but one participant (99%), superior to placebo (2%; P &amp;lt; 0.001) and similar to glucagon (95%). Similar outcomes were observed for the other investigated time points at 10, 20, and 30 min after dosing. The most frequent adverse effects were nausea and vomiting, as expected with glucagon treatment.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>CONCLUSIONS<\/jats:title>\n                  <jats:p>Dasiglucagon provided rapid and effective reversal of hypoglycemia in adults with type 1 diabetes, with safety and tolerability similar to those reported for reconstituted glucagon injection. The ready-to-use, aqueous formulation of dasiglucagon offers the potential to provide rapid and reliable treatment of severe hypoglycemia.<\/jats:p>\n               <\/jats:sec>","DOI":"10.2337\/dc20-2995","type":"journal-article","created":{"date-parts":[[2021,4,21]],"date-time":"2021-04-21T21:55:27Z","timestamp":1619042127000},"page":"1361-1367","update-policy":"https:\/\/doi.org\/10.2337\/ada-journal-policies","source":"Crossref","is-referenced-by-count":48,"title":["Dasiglucagon\u2014A Next-Generation Glucagon Analog for Rapid and Effective Treatment of Severe Hypoglycemia: Results of Phase 3 Randomized Double-Blind Clinical Trial"],"prefix":"10.2337","volume":"44","clinical-trial-number":[{"clinical-trial-number":"nct03378635","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3554-0405","authenticated-orcid":false,"given":"Thomas R.","family":"Pieber","sequence":"first","affiliation":[{"name":"Medical University of Graz, Graz, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8976-2321","authenticated-orcid":false,"given":"Ronnie","family":"Aronson","sequence":"additional","affiliation":[{"name":"LMC Diabetes and Endocrinology, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0940-8972","authenticated-orcid":false,"given":"Ulrike","family":"H\u00f6velmann","sequence":"additional","affiliation":[{"name":"Profil, Neuss, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie","family":"Willard","sequence":"additional","affiliation":[{"name":"ProSciento, San Diego, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leona","family":"Plum-M\u00f6rschel","sequence":"additional","affiliation":[{"name":"Profil, Mainz, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kim M.","family":"Knudsen","sequence":"additional","affiliation":[{"name":"Zealand Pharma, S\u00f8borg, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benedikte","family":"Bandak","sequence":"additional","affiliation":[{"name":"Zealand Pharma, S\u00f8borg, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramin","family":"Tehranchi","sequence":"additional","affiliation":[{"name":"Zealand Pharma, S\u00f8borg, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1167","published-online":{"date-parts":[[2021,4,21]]},"reference":[{"key":"2022050922325151200_B1","doi-asserted-by":"crossref","first-page":"10","DOI":"10.2337\/cd20-as01","article-title":"Standards of Medical Care in Diabetes-2020 abridged for primary care providers","volume":"38","author":"American Diabetes Association","year":"2020","journal-title":"Clin Diabetes"},{"key":"2022050922325151200_B2","doi-asserted-by":"crossref","first-page":"123","DOI":"10.4158\/EP15831.OR","article-title":"Glucagon prescription patterns in patients with either type 1 or 2 diabetes with newly prescribed insulin","volume":"22","author":"Mitchell","year":"2016","journal-title":"Endocr Pract"},{"key":"2022050922325151200_B3","doi-asserted-by":"crossref","first-page":"22","DOI":"10.1002\/pdi.138","article-title":"Glucagon administration \u2013 underevaluated and undertaught","volume":"18","author":"Harris","year":"2001","journal-title":"Pract Diabetes Int"},{"key":"2022050922325151200_B4","doi-asserted-by":"crossref","first-page":"337","DOI":"10.2147\/DMSO.S20633","article-title":"Treatment of severe diabetic hypoglycemia with glucagon: an underutilized therapeutic approach","volume":"4","author":"Kedia","year":"2011","journal-title":"Diabetes Metab Syndr Obes"},{"key":"2022050922325151200_B5","doi-asserted-by":"crossref","first-page":"522","DOI":"10.1089\/dia.2019.0148","article-title":"Human factors usability and validation studies of a glucagon autoinjector in a simulated severe hypoglycemia rescue situation","volume":"21","author":"Valentine","year":"2019","journal-title":"Diabetes Technol Ther"},{"key":"2022050922325151200_B6","doi-asserted-by":"crossref","first-page":"407","DOI":"10.4158\/EP-2019-0502","article-title":"Nasal glucagon delivery is more successful than injectable delivery: a simulated severe hypoglycemia rescue","volume":"26","author":"Settles","year":"2020","journal-title":"Endocr Pract"},{"key":"2022050922325151200_B7","unstructured":"U.S. Food and Drug Administration\n          . 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