Denmark-based biotechnology company Zealand Pharma has completed patient enrolment in a Phase lll clinical trial designed to validate the efficacy and safety of dasiglucagon for the rescue treatment of severe hypoglycemia in patients with type 1 diabetes.
The company has also completed dosing in the randomised, double-blind, parallel trial, which included 156 type 1 diabetes patients.
During the trial, patients were exposed to receive either dasiglucagon, placebo or reconstituted glucagon in a parallel randomised double-blind design.
The trial’s primary objective is to confirm a rapid increase in plasma glucose after a single dose administration of 0.6mg of dasiglucagon to type 1 diabetes mellitus patients with insulin-induced hypoglycemia, compared to placebo.
Findings from the trial are scheduled to be available by the third quarter of this year.
Zealand Pharma executive vice-president, chief development and medical officer Adam Steensberg said: “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.”
Zealand Pharma has previously completed a Phase lll trial of dasiglucagon for treatment of severe hypoglycemia and reported positive results from the trial in March this year.
The trial met its primary endpoint of analysing the immunogenicity of repeated single doses of 0.6mg of dasiglucagon following subcutaneous administration in 90 patients with type 1 diabetes.
Additional topline results from the trial are expected during the second quarter of this year.
Dasiglucagon is a soluble glucagon analog that has the potential to be used in a ready-to-use rescue pen, HypoPal, to treat severe hypoglycemia.