Achieving tight glycaemic control without severe hypoglycaemia still shows a tangled task 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.

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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.

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Key findings of the study were:

• 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:

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The study findings were published in the journal Diabetes Care on April 21, 2021.

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