Integrated safety and efficacy analysis of dasiglucagon for the treatment of severe hypoglycaemia in individuals with type 1 diabetes
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
Composed by AI from the published abstract and checked against it. How Briefs are made →