SAN FRANCISCO — Dasiglucagon, a stable peptide analog of human glucagon, is a fast and effective treatment option for severe hypoglycemia. The study results, presented at the American Diabetes Association’s 79th Scientific Sessions, held June 7 to 11, 2019, in San Francisco, California, also supported the safety profile of the medication.
As glucagon products are not stable in solution, complex reconstitution steps are required before injection for treatment of severe hypoglycemia. Dasiglucagon is administered with a ready-to-use auto-injector for treatment of severe hypoglycemia.
The goal of this phase 3 trial was to assess the efficacy and safety of dasiglucagon compared with placebo and GlucaGen® in patients with type 1 diabetes.
The study enrolled 168 patients with type 1 diabetes who were randomly assigned (2:1:1) to 1 of the 3 study groups following induced hypoglycemia to a glucose target of 55 mg/dL. Time to plasma glucose recovery, defined as a ≥20 mg/dL increase following treatment without rescue glucose, was the primary study outcome.
In patients treated with dasiglucagon, the time to plasma glucose recovery was faster compared with placebo (10 minutes for dasiglucagon vs 12 and 40 minutes for GlucaGen and placebo, respectively; P <.001 for comparison of dasiglucagon with placebo).
Almost two-thirds of the patients treated with dasiglucagon (65%) recovered within 10 minutes compared with half of the patients treated with GlucaGen (49%). In a similar fashion, after 15 minutes, almost all of the patients treated with dasiglucagon (99%) had recovered compared with 95% of the patients treated with GlucaGen.
Incidence of nausea and vomiting was similar with dasiglucagon and GlucaGen (55% vs 53%; 23% vs 19%, respectively) and there were no serious adverse events in any group.
“Dasiglucagon 0.6mg was demonstrated to be a safe, fast and effective treatment option for severe hypoglycemia,” concluded the investigators.
Disclosures: Multiple authors disclosed associations with the pharmaceutical industry. Please see the original abstract for a full list of authors’ disclosures.
Pieber TR, Hoevelmann U, Willard J, et al. Phase 3 results for dasiglucagon as a fast and effective treatment for severe hypoglycemia. Presented at: American Diabetes Association 79th Scientific Sessions; June 7-11, 2019; San Francisco, CA. Oral Presentation 286-OR.