A Phase 3 Comparison of a Novel Liquid Glucagon Autoinjector to Glucagon Emergency Kit for the Treatment of Severe Hypoglycemia

Abstract

Objective: To prevent medical complications and serious sequalae of severe hypoglycemic emergencies, prompt and reliable rescue intervention is critically important. A novel ready-to-use stable liquid glucagon autoinjector (GAI; Xeris Pharmaceuticals) was evaluated for the rescue treatment of severe hypoglycemia. Research Design and Methods: A randomized, controlled, double-blind, crossover clinical trial was conducted in 80 adults with T1D (mean age 43.6 years) to compare subcutaneous 1 mg doses of GAI vs. Glucagon Emergency Kit (GEK; Eli Lilly) for the treatment of insulin-induced severe hypoglycemia. Efficacy was evaluated as either an increase in plasma glucose to ≥70 mg/dL or an increase in plasma glucose ≥20 mg/dL from a baseline glucose <50 mg/dL, within 30 min of dosing. Results: On an intent-to-treat basis, efficacy was comparable between the groups (97.4% GAI, 100% GEK, p=NS), and all subjects were rescued from severe hypoglycemia without additional measures. GAI was similar to GEK in terms of glucose Cmax, Tmax, and AUC (0-90 min). The incidence of AEs was low in both groups; the most commonly reported AE was nausea [GAI (20.5%), GEK (12.7%); p=NS], followed by vomiting and headache. Conclusions: These results demonstrate that GAI is an effective, safe, and well tolerated rescue treatment for severe hypoglycemia and is a viable alternative to GEK. Disclosure M.P. Christiansen: Research Support; Self; Dexcom, Inc., Insulet Corporation, Medtronic MiniMed, Inc., Abbott, Novo Nordisk Inc., Senseonics, REMD Biotherapeutics, Xeris Pharmaceuticals, Inc. M.J. Cummins: Employee; Self; Xeris Pharmaceuticals, Inc. S.J. Prestrelski: Employee; Self; Xeris Pharmaceuticals, Inc. P. Strange: Other Relationship; Self; AstraZeneca. Consultant; Self; Valeritas, Inc.. Stock/Shareholder; Self; Valeritas, Inc..