FDA approval of Gvoke was based on the results of two unpublished, randomized, crossover trials in a total of 161 adults and one single-arm trial in 31 children ≥2 years old with type 1 diabetes (available as abstracts and summarized in the package insert). Patients were given a continuous insulin infusion to reduce their blood glucose to <50 mg/dL (adult studies) or <80 mg/dL (pediatric study) and then treated subcutaneously with glucagon from Gvoke HypoPen or Glucagon Emergency Kit (all pediatric patients received Gvoke). In the adult studies, treatment success, defined as an increase in blood glucose of ≥20 mg/dL or to >70 mg/dL at 30 minutes after administration, was achieved in 99% of patients with Gvoke and in 100% with Glucagon Emergency Kit; the mean time to relief of symptoms in the two groups was similar.2,3 In the pediatric study, 100% of patients had an increase in blood glucose of ≥25 mg/dL, the primary endpoint.4 As with other glucagon formulations, the most common adverse effects of Gvoke were nausea and vomiting.

In a crossover ease-of-use trial, 14 of 16 adults successfully used Gvoke PFS under simulated real-world conditions; 5 successfully used Glucagon Emergency Kit.5 In two validation studies, 148 of 150 adults and adolescents (99%) successfully used Gvoke HypoPen or Gvoke PFS. The mean time required for preparation and administration was 60-70 seconds shorter with Gvoke than with Glucagon Emergency Kit.5,6

Children <12 years old weighing <45 kg should be given a 0.5-mg dose of Gvoke; all other patients should receive 1 mg. The drug should be injected subcutaneously into the lower abdomen, outer thigh, or outer upper arm. Emergency medical services should be called immediately after a dose is given. If there is no response to the first dose, a second dose can be given 15 minutes later.