Glucagon nasal powder viable option for hypoglycemia in children with diabetes

Children with type 1 diabetes who experienced insulin-induced hypoglycemia showed a 25 mg/dL rise in plasma glucose within 20 minutes of receiving intranasal glucagon powder therapy, according to study findings presented at the 51st European Association for the Study of Diabetes Annual Meeting.

“Current treatment of severe hypoglycemia consists of an injected kit that requires multiple steps,” Jennifer Sherr, MD, PhD, assistant professor of pediatrics at the Yale School of Medicine, said during a presentation. “With the complexity of administering the kit, there are errors in delivering the glucagon therapy. This issue is further compounded in our youth, who spend nearly one-third of their day outside of the care of their parents.”

Jennifer Sherr

Sherr and colleagues analyzed data from 45 children aged 4 to 16 years with type 1 diabetes participating in the Type 1 Diabetes Exchange. Researchers randomly assigned the two youngest cohorts, children aged 4 to 7 years (mean age, 6.5 years; 17% girls; 100% white; mean HbA1c, 8.1%) and children aged 8 to 11 years (mean age, 11.1 years; 44% girls; 89% white; mean HbA1c, 7.9%), to 2 mg and 3 mg of intranasal glucagon on two separate days in a double blind, random order, or to a single, weight-based dose of intramuscular glucagon administered during a single session.

Researchers randomly assigned children in the cohort aged 12 to 16 years (mean age, 14.6 years; 42% girls; 83% white; mean HbA1c, 8.2%) 1 mg intranasal glucagon during one session and 3 mg intranasal glucagon during a separate session. Glucagon was administered after blood glucose was lowered to less than 80 mg/dL; the primary outcome was a 25 mg/dL or greater rise in plasma glucose.

Researchers found that all but one child who received either intramuscular glucagon or intranasal glucagon achieved a 25 mg/dL or greater rise in plasma glucose within 10 to 20 minutes of administration. Both the time to peak and peak glucagon levels were similar across groups.

One child, aged 6 years, who did not achieve a rise in plasma glucose, blew his nose immediately after administration of the intranasal therapy and was not included in the efficacy analysis, Sherr said.

Transient nausea with or without vomiting occurred in 67% of children assigned intramuscular glucagon vs. 43% of children assigned 3 mg intranasal glucagon and 39% of children assigned 2 mg intranasal glucagon (P = .06).

“Intranasal glucagon was well tolerated with transient adverse effects, and given the similar efficacy and safety of the intranasal doses, for simplicity, a single dose of 3 mg of intranasal glucagon can be used across the pediatric population,” Sherr said. “These data support the efficacy and safety of a novel glucagon in powder delivery device for treatment of severe hypoglycemia in youth with type 1 diabetes.”

Sherr noted that intranasal glucagon can be stored at room temperature and is believed to have a shelf life of about 2 years. The medication is absorbed passively, so an unconscious patient experiencing hypoglycemia would not need to inhale the intranasal medication, Sherr said. – by Regina Schaffer

Reference:

Sherr J, et al. Abstract #42. Presented at: 51st EASD Annual Meeting; Sept. 14-18, 2015; Stockholm.

Disclosure: Sherr reports receiving product support from Medtronic Diabetes for investigator-initiated studies.