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New information from a phase 3 trial used as part of the FDA approval is providing insight into the safety and efficacy of dasiglucagon for treatment of severe hypoglycemia in adult patients with type 1 diabetes.
Data from a phase 3 trial used as part of the agent's approval is providing clinicians with insight into the use of dasiglucagon (Zegalogue) in patients with type 1 diabetes and severe hypoglycemia.
The trial, which randomized 170 adult patients and compared dasiglucagon against placebo and reconstituted glucagon, found the ready-to-use, next-generation glucagon analog from Zealand Pharma helped 99% of patients achieve plasma glucose recovery within 15 minutes.
"The results of this trial add significantly to the clinical evidence supporting the use of dasiglucagon for the treatment of severe hypoglycemia, and these data build upon the strong clinical data reported throughout dasiglucagon’s clinical trial program in this indication," said Thomas Pieber, MD, Head of the Division of Endocrinology and Metabolism and Chairman of the Department of Internal Medicine at Medical University of Graz, Austria, in a statement. "This study provides convincing evidence of the potential of dasiglucagon as a treatment that can help patients and their caregivers to address severe hypoglycemia.”
With the US Food and Drug Administration awarding approval to dasiglucagon for treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and older, this most recent article, which was published in Diabetes Care, offer clinicians some of the best insight yet into use of the injectable. Of note, this phase 3 trial was used as part of the approval of dasiglucagon.
A randomized, double-blind trial, the study enrolled 170 patients with type 1 diabetes and randomized them in 2:1:1 ratio to 0.6 mg dasiglucagon, placebo, or 1 mg reconstituted glucagon during controlled insulin-induced hypoglycemia. In total, 84 patients were randomized to dasiglucagon and 43 were randomized to both placebo and reconstituted glucagon.
The trial’s primary end point was time to plasma glucose recovery, which was defined as an increase of 20 mg/dL or more from baseline without rescue intravenous glucose. Investigators noted the primary comparison of interest was dasiglucagon against placebo and reconstituted lyophilized glucagon was included as a reference.
At the end of the trial, the median time to recovery was 10 (95% CI, 10-10) minutes among patients receiving dasiglucagon compared to 40 (95% CI, 30-40) minutes among patients receiving placebo (P <.001). Investigators noted the corresponding result for patients receiving reconstituted glucagon was 12 (95% CI, 10-12) minutes.
Overall, plasma glucose recovery was achieved within 15 in all but one patient, which investigators noted was superior to placebo (2%; P <.001) and similar to glucagon (95%). Additionally, similar outcomes were noted when assessing time to plasma glucose recovery at 10, 20, and 30 minutes after dosing. Investigators also pointed out all patients in the study achieved recovery with a single dose.
In safety analyses, the most frequent adverse effects, defined as occurring in 2% of patients or more, were nausea and vomiting. Of note, both of these are listed as potential adverse reactions within the prescribing information for dasiglucagon.
“The outcomes from this study are clinically meaningful and offer patients impacted by severe hypoglycemia an additional treatment option,” said Frank Sanders, President of Zealand Pharma US, in the aforementioned statement. “As minutes matter in severe hypoglycemia, this is an incredibly promising and exciting moment for both patients and Zealand.”
This study, “Dasiglucagon: A Next-Generation Glucagon Analog for Rapid and Effective Treatment of Severe Hypoglycemia Results of Phase 3 Randomized Double-Blind Clinical Trial,” was published in Diabetes Care.