A novel ready-to-use liquid stable glucagon rescue pen (GRP; Xeris Pharmaceuticals), was evaluated for preparation time and relief of symptoms during rescue treatment of severe hypoglycemia.
A Phase 3 non-inferiority, randomized, controlled, single-blind, crossover clinical trial enrolled 132 adults with T1D to compare subcutaneous 1 mg doses of GRP versus powdered glucagon (GHK; Novo Nordisk) to treat insulin-induced severe hypoglycemia. Drug preparation time by trained providers was recorded, and assessments of the overall sensation of hypoglycemia were performed at each treatment visit.
Criteria for non-inferiority were achieved, and all subjects achieved successful plasma glucose recovery. Mean drug preparation time for GRP was significantly faster than GHK (0.79±0.53 minutes, 1.76±0.68 minutes, p<0.001). Subjects administered GRP experienced comparable time to resolution of the overall feeling of hypoglycemia, compared to GHK (15.69±7.43 minutes, 15.32±8.48 minutes, p=0.91). The overall incidence of adverse events (AEs) was comparable in both groups; the most commonly reported AEs were mild to moderate nausea (GRP 42.5%, GHK 44.7%) and vomiting (GRP 12.6%, GHK 13.8%). No SAEs occurred related to GRP.
Prompt neurologic symptom relief is critical in the rescue from severe hypoglycemic emergencies. From decision to treat, GRP resulted in faster delivery of a full glucagon dose and achieved comparable relief from the sensation of hypoglycemia during insulin-induced severe hypoglycemia. GRP achieved successful plasma glucose recovery in a reliable manner, was safe and well tolerated, and had an incidence of nausea and vomiting comparable to GHK. GRP is a viable alternative to currently available GHK.