Dasiglucagon in a ready-to-use rescue pen
Dasiglucagon is being developed to offer a stable ready-to-use rescue treatment for severe hypoglycemia.
All type 1 diabetes patients and the most severely affected type 2 patients depend on insulin injections to maintain blood glucose. Consequently, patients must monitor and adjust their blood glucose levels to remain in proper glycemic control, as both high and low blood glucose may affect their health, both in the short and long term.
Severe hypoglycemia is an acute, life-threatening condition resulting from a critical drop in blood glucose levels associated primarily with insulin therapy and is one of the most feared complications of diabetes treatment. The condition of severe hypoglycemia is most frequently seen in people who inject insulin multiple times per day.
Pivotal Phase 3 results
The pivotal Phase 3 trial demonstrates that a single dose of dasiglucagon rapidly increases blood glucose levels in patients with type 1 diabetes following insulin-induced hypoglycemia. The trial compares the glycemic response observed after administration of dasiglucagon with that of placebo and with reference to currently marketed glucagon (GlucaGen®), in powder form for reconstitution prior to injection.
The primary endpoint was time to plasma glucose recovery, which was defined as first increase in plasma glucose of ≥20 mg/dL (1.1 mmol/L) from baseline without administration of rescue intravenous glucose. 168 subjects were included in the trial: 82 in the dasiglucagon arm, 43 in the placebo arm, and 43 in the GlucaGen® arm. Additional details about the trial are found at https://clinicaltrials.gov/ct2/show/NCT03378635.
The primary result demonstrates that the median time to blood glucose recovery was 10 min for dasiglucagon, which was superior to placebo (median: 40 min; p<0.001). The median time to recovery for GlucaGen® was 12 min.
99% of subjects were recovered from the insulin-induced hypoglycemia within 15 min following dosing with dasiglucagon, versus 2% with placebo and 95% with GlucaGen®.
Overall, no safety concerns were raised for dasiglucagon within the trial. Nausea and vomiting were reported with similar numbers for dasiglucagon and GlucaGen® (nausea: 55% and 53%, vomiting: 23% and 19%, respectively). A pediatric trial initiated in September 2018 with readout in Q3 2019. The New Drug Application (NDA) filing with the FDA is planned for the end of 2019.