In March, the FDA approved dasiglucagon (Zegalogue) for the treatment of severe hypoglycemia in people with diabetes aged 6 years or older.
Dasiglucagon (Zegalogue) is an analog of human glucagon for the treatment of type 1 diabetes in a dual-hormone artificial pancreas pump containing both insulin and glucagon. In March, the FDA approved dasiglucagon for the treatment of severe hypoglycemia in people with diabetes aged 6 years or older.
The approval was based on positive results from 3 phase 3 studies, all of which were double-blind, placebo-controlled, multicenter trials. All participants were children 6 to 17 years of age with type 1 diabetes.
The primary endpoint for the studies was time to plasma glucose success—which was defined as an increase in blood glucose of ≥20 mg/dL from time of injection —and without additional intervention within 45 minutes. This goal was achieved across the pediatric population as well as within the adult population in the corresponding phase 3 adult trial.
Patients who received dasiglucagon achieved a significantly faster median time to blood glucose recovery of only 10 minutes following administration—compared with 30-45 minutes with placebo. Further, 99% of adults treated with dasiglucagon recovered within 15 minutes.
The most common adverse events reported in adults were nausea, vomiting, headache, diarrhea, and injection site pain. In children, adverse events were nausea, vomiting, headache, and injection site pain.