Phase 3 Trial Results Show Promise for Drug to Treat Severe Hypoglycemia

Earlier this week Diabetes Care published results from a Phase 3 trial evaluating dasiglucagon for the treatment of severe hypoglycemia in adults with diabetes. Zealand Pharma is marketing the drug as Zegalogue.

The study found that dasiglucagon administration resulted in a reversal of hypoglycemia (with a median recovery time of 10 minutes) with 99% of trial participants reaching 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,” says Thomas Pieber, professor of Medicine, head of the Division of Endocrinology and Metabolism and Chairman of the Department of Internal Medicine at Medical University of Graz, Austria. “This study provides convincing evidence of the potential of dasiglucagon as a treatment that can help patients and their caregivers to address severe hypoglycemia.”

The randomized, double-blind, placebo-controlled multicenter Phase 3 study enrolled 170 adults with type 1 diabetes, each randomized to receive a single subcutaneous dose of dasiglucagon 0.6 mg, placebo, or reconstituted glucagon 1 mg during controlled insulin-induced hypoglycemia. The primary efficacy endpoint was time to plasma glucose recovery, defined as an increase of more than 20 mg/dL from baseline without the need for rescue with intravenous glucose, in adult patients treated with dasiglucagon versus placebo, with reconstituted glucagon included as a reference.

In this study, the median time to recovery was 10 minutes for dasiglucagon, compared to 40 minutes for placebo (P < 0.001); and 12 minutes for reconstituted glucagon. In the dasiglucagon group, plasma glucose recovery was achieved within 15 minutes in all but one participant (99%), superior to placebo (2%; P < 0.001) and similar to glucagon (95%). All patients achieved recovery within the study period after receiving one dose. The most common adverse events reported (≥2%) were nausea, vomiting, headache, diarrhea, and injection site pain in adults.