Biotechnology firm Zealand Pharma has completed the second phase 3 trial with dasiglucagon for the treatment of severe hypoglycemia in patients with type 1 diabetes.
Zealand Pharma invented and developed the dasiglucagon soluble glucagon analog, which has a unique stability profile in liquid formulation and is suitable for a ready-to-use rescue pen, the HypoPal for treating severe hypoglycemia.
The results of phase 2 clinical trials show that dasiglucagon can rapidly increase plasma glucose levels after insulin-induced hypoglycemia, with long lasting and more pronounced plasma glucose increase, compared to active comparator.
The aim of the second and pivotal phase 3 trial was 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, when compared to placebo.
The trial was conducted on 156 Type 1 Diabetes patients, who were administered with dasiglucagon, placebo or reconstituted glucagon in a parallel randomized double-blind design. Results from the trial are expected to be out in the third quarter of this year 2018.
The first Phase 3 trial with dasiglucagon for treating severe hypoglycemia was reported to have met its primary objective this March.
The primary aim of the trial was to evaluate the immunogenicity of repeated single doses of dasiglucagon (0.6 mg) followed by subcutaneous administration in 90 patients with type 1 diabetes. Results from that trial are expected in the second quarter of this year.
Zealand Pharma executive vice president, chief development and medical officer Adam Steensberg said: “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.”