Type 1 diabetes

Integrated safety and efficacy analysis of dasiglucagon for the treatment of severe hypoglycaemia in individuals with type 1 diabetes

Diabetes Obes MetabPublished Integrated analysis of pooled clinical trials

Authors' conclusion

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

Study context

Population
Adults with T1D with insulin-induced severe hypoglycaemia
Comparison
Dasiglucagon vs reconstituted glucagon vs placebo
Primary endpoint
Time to plasma glucose recovery from insulin-induced severe hypoglycaemia
Methodological detailsplacebo-controlled pool (2 trials), broad pool (2 placebo-controlled and 4 non-placebo-controlled trials), subgroup analysis
  • Placebo-controlled pool (2 trials)
  • Broad pool (2 placebo-controlled and 4 non-placebo-controlled trials)
  • Subgroup analysis

Primary result

As reported in the abstract

Time to plasma glucose recovery

P < 0.0001

Further findings

Median recovery time across placebo-controlled trial subgroups

Consistent across all placebo-controlled trial subgroups

Safety

Safety and tolerability (placebo-controlled datasets)

Serious adverse events (AEs), AEs leading to withdrawal, or deaths
0
Most common causally related AE: nausea (dasiglucagon)
56.5%
Causally related AE: vomiting (dasiglucagon)
24.6%
Safety and tolerability profile similar to reconstituted glucagon; broad pool showed similar results

Original publication

Integrated safety and efficacy analysis of dasiglucagon for the treatment of severe hypoglycaemia in individuals with type 1 diabetes. Diabetes Obes Metab. Published 14 February 2023. doi:10.1111/dom.14987

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