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

Zealand Pharma (Nasdaq:ZEAL), a Copenhagen-based biotechnology company focused on the discovery and development of innovative peptide-based medicines, announces the successful results in the pivotal Phase 3 trial with dasiglucagon for severe hypoglycemia in diabetes.

As quoted in the press release:

Dasiglucagon is a potential first-in-class soluble glucagon analog invented and developed by Zealand. It is in development in the ready-to-use HypoPal^® rescue pen for easy, fast and effective treatment of severe hypoglycemia.

The pivotal Phase 3 trial demonstrates that a single dose of dasiglucagon rapidly increases blood glucose levels in patients with type 1 diabetes following insulin-induced hypoglycemia. The trial compares the glycemic response observed after administration of dasiglucagon with that of placebo and that of 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. 168 subjects were included in the trial: 82 to the dasiglucagon arm, 43 to the placebo arm, and 43 to the GlucaGen^® arm. Additional details about the trial are found at https://clinicaltrials.gov/ct2/show/NCT03378635.

Click here to read the full press release.