Elizabeth Seaquist, Marga Giménez, Yu Yan, Munehide Matsuhisa, Christi Yuting Kao, R Paul Wadwa, Yukiko Nagai, Kamlesh Khunti
{"title":"鼻用胰高血糖素可逆转胰岛素诱发的低血糖症，且反弹高血糖症较少：临床试验汇总分析。","authors":"Elizabeth Seaquist, Marga Giménez, Yu Yan, Munehide Matsuhisa, Christi Yuting Kao, R Paul Wadwa, Yukiko Nagai, Kamlesh Khunti","doi":"10.1210/jendso/bvae034","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Rebound hyperglycemia may occur following glucagon treatment for severe hypoglycemia. We assessed rebound hyperglycemia occurrence after nasal glucagon (NG) or injectable glucagon (IG) administration in patients with type 1 diabetes (T1D) and type 2 diabetes (T2D).</p><p><strong>Methods: </strong>This was a pooled analysis of 3 multicenter, randomized, open-label studies (NCT03339453, NCT03421379, NCT01994746) in patients ≥18 years with T1D or T2D with induced hypoglycemia. Proportions of patients achieving treatment success [blood glucose (BG) increase to ≥70 mg/dL or increase of ≥20 mg/dL from nadir within 15 and 30 minutes]; BG ≥70 mg/dL within 15 minutes; in-range BG (70-180 mg/dL) 1 to 2 and 1 to 4 hours postdose; and BG >180 mg/dL 1 to 2 and 1 to 4 hours postdose were compared. Incremental area under curve (iAUC) of BG >180 mg/dL and area under curve (AUC) of observed BG values postdose were analyzed. Safety was assessed in all studies.</p><p><strong>Results: </strong>Higher proportions of patients had in-range BG with NG vs IG (1-2 hours: <i>P</i> = .0047; 1-4 hours: <i>P</i> = .0034). Lower proportions of patients had at least 1 BG value >180 mg/dL with NG vs IG (1-2 hours: <i>P</i> = .0034; 1-4 hours: <i>P</i> = .0068). iAUC and AUC were lower with NG vs IG (<i>P</i> = .025 and <i>P</i> < .0001). As expected, similar proportions of patients receiving NG or IG achieved treatment success at 15 and 30 minutes (97-100%). Most patients had BG ≥70 mg/dL within 15 minutes (93-96%). The safety profile was consistent with previous studies.</p><p><strong>Conclusion: </strong>This study demonstrated lower rebound hyperglycemia risk after NG treatment compared with IG.</p><p><strong>Clinical trial registration: </strong>NCT03421379, NCT03339453, NCT01994746.</p>","PeriodicalId":17334,"journal":{"name":"Journal of the Endocrine Society","volume":"8 4","pages":"bvae034"},"PeriodicalIF":3.0000,"publicationDate":"2024-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10913376/pdf/","citationCount":"0","resultStr":"{\"title\":\"Nasal Glucagon Reverses Insulin-induced Hypoglycemia With Less Rebound Hyperglycemia: Pooled Analysis of Clinical Trials.\",\"authors\":\"Elizabeth Seaquist, Marga Giménez, Yu Yan, Munehide Matsuhisa, Christi Yuting Kao, R Paul Wadwa, Yukiko Nagai, Kamlesh Khunti\",\"doi\":\"10.1210/jendso/bvae034\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Rebound hyperglycemia may occur following glucagon treatment for severe hypoglycemia. We assessed rebound hyperglycemia occurrence after nasal glucagon (NG) or injectable glucagon (IG) administration in patients with type 1 diabetes (T1D) and type 2 diabetes (T2D).</p><p><strong>Methods: </strong>This was a pooled analysis of 3 multicenter, randomized, open-label studies (NCT03339453, NCT03421379, NCT01994746) in patients ≥18 years with T1D or T2D with induced hypoglycemia. Proportions of patients achieving treatment success [blood glucose (BG) increase to ≥70 mg/dL or increase of ≥20 mg/dL from nadir within 15 and 30 minutes]; BG ≥70 mg/dL within 15 minutes; in-range BG (70-180 mg/dL) 1 to 2 and 1 to 4 hours postdose; and BG >180 mg/dL 1 to 2 and 1 to 4 hours postdose were compared. Incremental area under curve (iAUC) of BG >180 mg/dL and area under curve (AUC) of observed BG values postdose were analyzed. Safety was assessed in all studies.</p><p><strong>Results: </strong>Higher proportions of patients had in-range BG with NG vs IG (1-2 hours: <i>P</i> = .0047; 1-4 hours: <i>P</i> = .0034). Lower proportions of patients had at least 1 BG value >180 mg/dL with NG vs IG (1-2 hours: <i>P</i> = .0034; 1-4 hours: <i>P</i> = .0068). iAUC and AUC were lower with NG vs IG (<i>P</i> = .025 and <i>P</i> < .0001). As expected, similar proportions of patients receiving NG or IG achieved treatment success at 15 and 30 minutes (97-100%). Most patients had BG ≥70 mg/dL within 15 minutes (93-96%). The safety profile was consistent with previous studies.</p><p><strong>Conclusion: </strong>This study demonstrated lower rebound hyperglycemia risk after NG treatment compared with IG.</p><p><strong>Clinical trial registration: </strong>NCT03421379, NCT03339453, NCT01994746.</p>\",\"PeriodicalId\":17334,\"journal\":{\"name\":\"Journal of the Endocrine Society\",\"volume\":\"8 4\",\"pages\":\"bvae034\"},\"PeriodicalIF\":3.0000,\"publicationDate\":\"2024-02-26\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10913376/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of the Endocrine Society\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1210/jendso/bvae034\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/2/19 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"ENDOCRINOLOGY & METABOLISM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of the Endocrine Society","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1210/jendso/bvae034","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/2/19 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}
Nasal Glucagon Reverses Insulin-induced Hypoglycemia With Less Rebound Hyperglycemia: Pooled Analysis of Clinical Trials.
Background: Rebound hyperglycemia may occur following glucagon treatment for severe hypoglycemia. We assessed rebound hyperglycemia occurrence after nasal glucagon (NG) or injectable glucagon (IG) administration in patients with type 1 diabetes (T1D) and type 2 diabetes (T2D).
Methods: This was a pooled analysis of 3 multicenter, randomized, open-label studies (NCT03339453, NCT03421379, NCT01994746) in patients ≥18 years with T1D or T2D with induced hypoglycemia. Proportions of patients achieving treatment success [blood glucose (BG) increase to ≥70 mg/dL or increase of ≥20 mg/dL from nadir within 15 and 30 minutes]; BG ≥70 mg/dL within 15 minutes; in-range BG (70-180 mg/dL) 1 to 2 and 1 to 4 hours postdose; and BG >180 mg/dL 1 to 2 and 1 to 4 hours postdose were compared. Incremental area under curve (iAUC) of BG >180 mg/dL and area under curve (AUC) of observed BG values postdose were analyzed. Safety was assessed in all studies.
Results: Higher proportions of patients had in-range BG with NG vs IG (1-2 hours: P = .0047; 1-4 hours: P = .0034). Lower proportions of patients had at least 1 BG value >180 mg/dL with NG vs IG (1-2 hours: P = .0034; 1-4 hours: P = .0068). iAUC and AUC were lower with NG vs IG (P = .025 and P < .0001). As expected, similar proportions of patients receiving NG or IG achieved treatment success at 15 and 30 minutes (97-100%). Most patients had BG ≥70 mg/dL within 15 minutes (93-96%). The safety profile was consistent with previous studies.
Conclusion: This study demonstrated lower rebound hyperglycemia risk after NG treatment compared with IG.
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