medwireNews: Dasiglucagon, a next-generation glucagon analog in a ready-to-use formulation, rapidly restores plasma glucose (PG) levels following severe hypoglycemia in children and adolescents with type 1 diabetes, show findings from a phase 3 trial.
Tadej Battelino (University Medical Centre Ljubljana, Slovenia) and co-investigators explain that glucagon prescriptions are recommended for all people at risk for clinically significant hypoglycemia, but glucagon emergency kits require “complex, time-consuming procedures for reconstitution,” which “represents a significant barrier to timely and accurate administration and has led to underutilization of glucagon for the treatment of hypoglycemia.”
Therefore, “an aqueous, ready-to-use glucagon analog formulation may be a welcome addition to the options for the treatment of severe hypoglycemia in childhood,” they add.
As reported in Pediatric Diabetes, the median time to PG recovery was 10 minutes for the 20 participants aged 6–17 years who were randomly assigned to receive a single subcutaneous injection of dasiglucagon 0.6 mg during insulin-induced hypoglycemia, compared with 30 minutes for the 11 participants given placebo, a significant difference.
PG recovery was defined as the first increase of at least 20 mg/dL (1.1 mmol/L) after treatment administration without rescue intravenous glucose, and this primary endpoint reflects “the critical importance of fast reversal of hypoglycemia in an emergency situation,” note Battelino et al.
The median time to PG recovery was the same among individuals given dasiglucagon and the 10 participants given glucagon as a reference control, at 10 minutes in both groups, but the team points out “that this does not include the time taken to reconstitute the lyophilized glucagon reference product and, hence, the real-life time to response for glucagon would be longer.”
In addition, the researchers found that rates of PG recovery within 15 minutes were significantly higher among individuals treated with dasiglucagon versus placebo (95 vs 0%). All participants in the dasiglucagon arm had PG recovery within 20 minutes, while all participants given glucagon experienced recovery within 15 minutes.
Battelino and team say that dasiglucagon was well-tolerated overall, with a safety profile “consistent with the known side effects of glucagon treatment.” The most commonly reported adverse events in the dasiglucagon arm were nausea (65 vs 0 and 30% in the placebo and glucagon arms, respectively) and vomiting (50 vs 0 vs 10%).
Taken together, these findings are in accordance with previously reported results for adults, and support “the use of a common [subcutaneous] dose of dasiglucagon (0.6 mg) to treat severe hypoglycemia in pediatric (6-17 years) and adult individuals with diabetes,” conclude the investigators.
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