Dasiglucagon in Children With Congenital Hyperinsulinism Up to 1 Year of Age: Results From a Randomized Clinical Trial
Authors' conclusion
In infants with CHI, dasiglucagon significantly reduced the amount of IV glucose needed to maintain euglycemia compared with placebo. Dasiglucagon represents a promising treatment for the management of CHI.
Study context
- Population
- Children with congenital hyperinsulinism (CHI) aged 7 days to 12 months dependent on IV glucose; 4 centers in Germany, the UK and the United Statescrossover
- Participants
- 12 children
- Comparison
- Dasiglucagon vs placebo
- Primary endpoint
- Mean IV glucose infusion rate (GIR)
- Follow-up
- Last 12 hours of part 1
Methodological detailscrossover, double-blind, placebo-controlled, open-label single-arm part 2, multicentre (4 centers), Randomized June 19, 2020 to February 9, 2022, Part 2: all participants received dasiglucagon for 21 days
- Crossover
- Double-blind
- Placebo-controlled
- Open-label single-arm part 2
- Multicentre (4 centers)
- Randomized June 19, 2020 to February 9, 2022
- Part 2: all participants received dasiglucagon for 21 days
Primary result
As reported in the abstract
IV GIR
P = 0.004
Safety
Adverse events
- Most frequent AEs in both treatment groups were gastrointestinal, dermatological, and metabolism and nutritional disorders
Original publication
Dasiglucagon in Children With Congenital Hyperinsulinism Up to 1 Year of Age: Results From a Randomized Clinical Trial. J Clin Endocrinol Metab. Published 25 November 2024. doi:10.
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