All subjects have been enrolled and dosed in the second and pivotal Phase 3 trial to confirm the clinical efficacy and safety of dasiglucagon for the rescue treatment of severe hypoglycemia in patients with type 1 diabetes.
Dasiglucagon is a soluble glucagon analog invented and developed by Zealand Pharma. The primary aim of this second and pivotal Phase 3 trial is to confirm a rapid increase in plasma glucose after single dose administration of dasiglucagon (0.6mg) to type 1 diabetes mellitus subjects with insulin-induced hypoglycemia, as compared to placebo. The trial was conducted in 156 Type 1 Diabetes patients, exposed to either dasiglucagon, placebo or reconstituted glucagon in a parallel randomized double-blind design (ClinicalTrials.gov identifier: NCT03378635). Results from the trial are now expected already in Q3 2018.
The first Phase 3 trial with dasiglucagon for treatment of severe hypoglycemia was reported to have successfully met its primary objective in March 2018. The primary aim of that trial was to evaluate the immunogenicity of repeated single doses of dasiglucagon (0.6 mg) following subcutaneous administration in 90 patients with type 1 diabetes. Further topline results from that trial are expected during Q2 2018.
“We are excited to be ahead of schedule in completing this pivotal Phase 3 trial and we look forward to the results in Q3, bringing us one step closer to making our HypoPal rescue pen available to patients. Most insulin-dependent people with diabetes and their relatives live in constant fear of experiencing too low blood sugar. A user-friendly solution to address severe hypoglycemia holds great potential to significantly reduce this fear and to ensure better patient care,” said Adam Steensberg, Executive Vice President, Chief Development and Medical Officer of Zealand.