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

• Published in: Diabetes (New York, N.Y.) Vol. 67; no. Supplement_1
• Main Authors: CHRISTIANSEN, MARK P., CUMMINS, MARTIN J., STEVEN J., PRESTRELSKI, STRANGE, POUL
• Format: Journal Article
• Language: English
• Published: 01.07.2018
• ISSN: 0012-1797; 1939-327X
• DOI: 10.2337/db18-304-OR

Objective: A novel ready-to-use stable liquid glucagon autoinjector (GAI; Xeris Pharmaceuticals), was evaluated for relief of symptoms during 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. Serial assessments of 4 autonomic and 4 neuroglycopenic symptoms and sensation of hypoglycemia were performed at each treatment visit. Results: The mean time to symptom relief was comparable between GAI and GEK for both autonomic symptoms (15.4±12.1 min and 14.2±9.7 min, p=NS), and neuroglycopenic symptoms (16.3±10.9 min and 13.9±9.4 min, p=NS). Mean time to resolution of the global feeling of hypoglycemia was also similar between groups. The incidence of all AEs was low in both groups; the most commonly reported AE was nausea (GAI 20.5%, GEK 12.7%, p=NS). Conclusions: The prompt relief of neurologic symptoms is critical in the rescue of severe hypoglycemic emergencies. GAI achieved both autonomic and neuroglycopenic symptom relief during induced severe hypoglycemia, and was safe and well tolerated. These results demonstrate that ready-to-use GAI 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..