Dasiglucagon Study Findings

Achieving tight glycaemic control without severe hypoglycaemia still presents a complex challenge in insulin-treated diabetes. Closed-loop artificial pancreas systems hold promise for reducing the burden of diabetes self-management, but there is still potential for improvement with regard to avoidance of both hypoglycaemia and hyperglycaemia.

In a recent study, researchers have found that dasiglucagon offers the potential to provide rapid and reliable treatment of severe hypoglycemia. The study findings were published in the journal Diabetes Care on April 21, 2021.

Recently, Dasiglucagon was approved by the US Food and Drug Administration for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and older based on the findings of this phase 3 trial. Dasiglucagon is a potential first-in-class soluble glucagon analog invented and developed by Zealand Pharma. Dr. Thomas R. Piebe and his team conducted a phase 3 trial to evaluate the efficacy and safety of dasiglucagon, a ready-to-use, next-generation glucagon analog in aqueous formulation for subcutaneous dosing, for treatment of severe hypoglycemia in adults with type 1 diabetes.

It was a randomized, double-blind trial of 170 adult participants with type 1 diabetes. The researchers randomly assigned the patients to receive a single subcutaneous dose of 0.6 mg dasiglucagon, placebo, or 1 mg reconstituted glucagon during controlled insulin-induced hypoglycemia. The major outcome assessed was time to plasma glucose recovery, defined as an increase of ≥20 mg/dL from baseline without rescue intravenous glucose. The researchers compared dasiglucagon versus placebo; reconstituted lyophilized glucagon was included as a reference.

Key Findings of the Study

• Upon evaluation, the researchers found that the time to recovery was 10 minutes for dasiglucagon compared with 40 minutes for placebo; the corresponding result for reconstituted glucagon was 12 minutes.
• They noted that the participants in the dasiglucagon group achieved plasma glucose recovery within 15 min in all but one participant (99%), superior to placebo (2%) and similar to glucagon (95%).
• They observed similar outcomes for the other investigated time points at 10, 20, and 30 min after dosing.
• The most frequent adverse effects reported were nausea and vomiting, as expected with glucagon treatment.

The authors concluded, "Dasiglucagon provided rapid and effective reversal of hypoglycemia in adults with type 1 diabetes, with safety and tolerability similar to those reported for reconstituted glucagon injection. The ready-to-use, aqueous formulation of dasiglucagon offers the potential to provide rapid and reliable treatment of severe hypoglycemia."

For Further Information

DOI: https://doi.org/10.2337/DC20-2995