medwireNews: Dasiglucagon, a next-generation glucagon analog in a ready-to-use formulation, rapidly restores plasma glucose (PG) levels after severe hypoglycemia in children and adolescents with type 1 diabetes. This shows the results of a phase 3 study.
Tadej Battelino (Ljubljana University Medical Center, Slovenia) and co-investigators state that glucagon prescriptions are recommended for anyone at risk of clinically significant hypoglycemia. However, emergency glucagon kits require “complex, time-consuming procedures for reconstitution,” which “a significant impediment to timely and accurate administration and has resulted in inadequate use of glucagon in the treatment of hypoglycemia. “
Therefore, “an aqueous, ready-to-use glucagon analog formulation can be a welcome addition to options for treating severe childhood hypoglycemia,” they add.
As reported in pediatric diabetes, the median time to PG recovery was 10 minutes for the 20 participants, ages 6-17 years old, who were randomly assigned a single subcutaneous injection of 0.6 mg dasiglucagon during insulin-induced hypoglycemia was a significant difference compared to 30 minutes for the 11 participants who received a placebo.
PG recovery was defined as the first increase of at least 20 mg / dL (1.1 mmol / L) after administration of treatment without intravenous glucose rescue, and this primary endpoint reflects “the critical importance of rapid reversal of hypoglycemia in one Emergency situation “against Battelino et al.
The median time to PG recovery was the same for those given dasiglucagon and the 10 participants given glucagon as a reference control after 10 minutes in both groups. However, the team points out that this does not include the time it takes to reconstitute the lyophilized glucagon.The reference product, and therefore the real reaction time for glucagon, would be longer. “
In addition, the researchers found that PG recovery rates within 15 minutes were significantly higher in dasiglucagon-treated subjects compared to placebo (95% versus 0%). All participants in the dasiglucagon arm had PG recovery within 20 minutes, while all participants who were administered glucagon experienced recovery within 15 minutes.
Battelino and his team say dasiglucagon was generally well tolerated with a safety profile “consistent with 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 results are consistent with those previously reported for adults and support “the use of a common [subcutaneous] Dose of dasiglucagon (0.6 mg) used to treat severe hypoglycaemia in children (6-17 years of age) and adults with diabetes, ”the researchers conclude.
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Pediatr Diabetes 2021; doi: 10.1111 / pedi.13220