Abstract

Aims

To perform an integrated analysis of the safety and efficacy of dasiglucagon, a glucagon analogue available in a ready‐to‐use aqueous formulation, to treat severe hypoglycaemia (SH) in type 1 diabetes (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 of 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 that of reconstituted glucagon. In the placebo‐controlled datasets, 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 that of reconstituted glucagon (median 10.0 and 12.0 minutes, respectively) and superior to placebo (median 40.0 minutes; P < 0.0001). The 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.