Intranasal glucagon is emerging as a promising alternative to intramuscular glucagon as a rescue treatment for hypoglycemia in young people with type 1 diabetes, researchers report. For patients with type 1 diabetes and their families, fear of hypoglycemia may lead to less than optimal metabolic control, especially in young children, the researchers noted in a paper online in Diabetes Care.
“While severe hypoglycemic events are alarming in and of themselves, fear of hypoglycemia may be increased by the daunting task of treating such events with currently available glucagon emergency kits,” they write. Such kits require the user to reconstitute the powder in a diluent immediately before delivering an intramuscular injection.
To assess the safety and appropriate dosing of intranasal glucagon, the multicenter T1D Exchange Intranasal Glucagon Investigators recruited 48 youngsters with type 1 diabetes and divided them into three age cohorts: 4 to <8, 8 to <12, and 12 to <17. Participants in the two youngest cohorts were randomly assigned to receive either 2 or 3 mg intranasal glucagon in two separate sessions or a single weight-based dose of IM glucagon. Older children were randomly assigned to receive a 1 mg dose of IM glucagon in one session and a 3 mg dose of intranasal glucagon in the other session.
Before each session, participants received insulin to lower their blood glucose levels to less than 80 mg/dL. Five minutes after stopping the insulin, they were given either intranasal or IM glucagon.
The primary outcome of at least a 25 mg/dL rise in plasma glucose within 20 minutes was achieved in all 24 IM dosing sessions and in 58 of the 59 intranasal dosing sessions (a six-year-old blew his nose immediately after administration of the 2-mg intranasal dose, which resulted in a peak glucagon level 10-fold less than the mean detected in the other participants in his session).
Plasma glucagon levels increased rapidly within five minutes of both intranasal and IM treatments. Transient nausea occurred in 67 percent of the IM sessions versus 42 percent of the intranasal sessions, and both efficacy and safety of the 2-mg and 3-mg intranasal doses were similar in the youngest participants. The authors concluded that “a single 3-mg intranasal dose appears to be appropriate for use across the entire 4 to <17 year range.”
The intranasal system is currently in Phase III trials, according to Deirdre Ibsen, senior director of product development for Lilly, which acquired worldwide rights to the system from Locemia Solutions in October 2015.