Severe hypoglycemia is a feared complication of insulin therapy and requires urgent assistance. Dasiglucagon is a peptide analog of human glucagon, stable in aqueous solution, in development for treatment of severe hypoglycemia via a ready-to-use auto-injector.
In this pivotal Phase 3 trial, the clinical efficacy and safety of 0.6 mg dasiglucagon were compared to placebo and with reference to GlucaGen®. In total, 168 patients with T1D were randomized (2:1:1) and dosed following induced hypoglycemia. The primary endpoint was time to plasma glucose (PG) recovery, defined as first PG increase ≥20 mg/dL after treatment initiation.
Data showed dasiglucagon 0.6mg rapidly increased PG. The median time to recovery was 10 min for dasiglucagon and 12 and 40 min for GlucaGen® and placebo, respectively. In the dasiglucagon arm, 65% of patients had recovered within 10 min vs 49% of patients receiving GlucaGen®. Similarly after 15 min, 99% of patients treated with dasiglucagon had recovered vs 95% of patients treated with GlucaGen®. Nausea and vomiting were reported with similar frequencies for dasiglucagon and GlucaGen® (nausea: 55% and 53%, vomiting: 23% and 19%, respectively). Injection site reactions 30 minutes post dose were reported in 2%, 7% and 5% of patients in the dasiglucagon, GlucaGen® and placebo groups, respectively.
In conclusion, dasiglucagon 0.6mg was demonstrated to be a fast and effective treatment for severe hypoglycemia. The stability of dasiglucagon in aqueous formulation enables further development of dasiglucagon as a treatment option in the entire spectrum of mild, moderate and severe hypoglycemia.