Aims: Severe hypoglycaemia (SH) remains common in type 1 diabetes (T1D). SH can be treated with glucagon, but its cost, short shelf life and difficulty of preparation and administration make glucagon underused. Dasiglucagon is a glucagon analogue available in a ready-to-use aqueous formulation. This is an integrated analysis of the safety and efficacy of dasiglucagon to treat SH in T1D.

Materials and methods: An integrated analysis of dasiglucagon safety was conducted on data from two placebo-controlled trials (placebo-controlled pool) and two placebo-controlled and four non-placebo-controlled trials (broad pool) in adults with T1D. An integrated analysis of dasiglucagon efficacy was conducted on pooled data and within demographic subgroups from the two placebo-controlled and two non-placebo-controlled trials in adults with T1D.

Results: Dasiglucagon had a similar safety and tolerability profile to reconstituted glucagon. In the placebo-controlled data sets, no serious adverse events (AEs), AEs leading to withdrawal from the trial or deaths were reported. The most common causally related AEs were nausea (56.5%) and vomiting (24.6%). The broad pool safety analysis showed similar results. Dasiglucagon efficacy in time to plasma glucose recovery from insulin-induced SH was similar to reconstituted glucagon (median 10.0 and 12.0 minutes, respectively) and superior to placebo (median 40.0 minutes, P < .0001). Median recovery time was consistent across all placebo-controlled trial subgroups.

Conclusions: Dasiglucagon was well tolerated and effective as a rapid rescue agent for insulin-induced SH in people with T1D.

Gov identifiers: NCT03378635, NCT03688711, NCT02660008, NCT03895697, NCT03216226, NCT02367053 This article is protected by copyright. All rights reserved.