Pharmacodynamics, pharmacokinetics, safety, and tolerability of a ready‐to‐use, room temperature, liquid stable glucagon administered via an autoinjector pen to youth with type 1 diabetes. Issue 6 (24th May 2022)

• Record Type: Journal Article
• Authors: Buckingham, Bruce; Sherr, Jennifer; Prestrelski, Steven J.; Conoscenti, Valentina
• Is Part Of: Pediatric diabetes. Volume 23:Issue 6(2022)
• Page Start: 754
• Page End: 762
• Publication Date: 2022-05-24
• Subjects: diabetes -- glucagon -- hypoglycemia -- pediatric; Diabetes in children -- Periodicals; 616.462
• DOI: 10.1111/pedi.13360
• Languages: English
• ISSNs: 1399-543X

Abstract

Abstract: Background: Prompt and reliable management of hypoglycemia in youth with diabetes is important to prevent serious medical complications. Objectives: To determine efficacy, pharmacodynamics (PD), pharmacokinetics (PK), safety, and tolerability of a ready‐to‐use, liquid stable glucagon formulation administered subcutaneously via an autoinjector pen to youth with type 1 diabetes (T1D). Methods: After plasma glucose concentration was < 80 mg/dL (< 4.4 mmol/L) after insulin, participants aged 2 to < 12 years with T1D were administered 0.5 mg of glucagon; participants aged 12 to < 18 years instead received 1 mg of glucagon. Then, adolescents were challenged with 0.5 mg after a 7‐ to 28‐day washout period. Primary endpoint was mean plasma glucose concentration at 30 min after glucagon. Results: Plasma glucose concentrations significantly ( p < 0.001) increased from baseline to 30 min after glucagon, with mean change in plasma glucose concentration between baseline and 30 min for each age cohort as follows: 2 to < 6 years ( n = 7; 81.4 mg/dL [4.5 mmol/L]); 6 to < 12 years (13; 84.2 mg/dL [4.7 mmol/L]); 12 to < 18 years (11; dose, 1 mg; 54.0 mg/dL [3.0 mmol/L]); and 12 to < 18 years (11; 0.5 mg; 52.4 mg/dL [2.9 mmol/L]). Among age cohorts, no clinically relevant differences were observed for PD and PK parameters. Common adverse events were nausea, vomiting, and hypoglycemia. Conclusion: Age‐appropriate dosing of this glucagon formulation was effective at 30 min in reversing plasma glucose concentrations from < 80 mg/dL in youth with T1D.