Zealand Pharma achieves primary and all key secondary endpoints in pediatric Phase 3 trial with dasiglucagon for severe hypoglycemia

Zealand Pharma A/S announces positive results in the pediatric Phase 3 trial with dasiglucagon for severe hypoglycemia in diabetes. Dasiglucagon is a potential first-in-class soluble glucagon analog invented and developed by Zealand. It is being developed in the ready-to-use HypoPal rescue pen: an auto-injector for easy, fast and effective treatment of severe hypoglycemia in people with diabetes.

The trial compared the glycemic response observed after induction of hypoglycemia and administration of dasiglucagon (0.6 mg) with that of placebo and that of GlucaGen (1 mg), a currently marketed glucagon in powder form for reconstitution prior to injection. The primary endpoint was time to plasma glucose recovery, which was defined as first increase in plasma glucose of >/=20 mg/dL (1.1 mmol/L) from baseline without administration of rescue intravenous glucose. 42 pediatric subjects (divided into age groups of 6-11 and 12-17 years) were included in the trial: 21 in the dasiglucagon arm, 11 in the placebo arm, and 10 in the GlucaGen arm.

The primary result demonstrated that the median time to blood glucose recovery was 10 minutes for dasiglucagon, which was superior to placebo (median: 30 min; p<0.001). The median time to recovery for GlucaGen was 10 minutes.

Overall, no safety concerns were raised for dasiglucagon within the trial. Nausea and vomiting were reported with dasiglucagon in both age groups (6-11 years; nausea: 25% and vomiting: 25%; 12-17 years; nausea: 92% and vomiting: 67%). For GlucaGen (6-11 years; nausea: 50% and vomiting: 25%; 12-17 years; nausea: 17% and vomiting: 0%).