Dasiglucagon for the Treatment of Congenital Hyperinsulinism: A Randomized Phase 3 Trial in Infants and Children
Primary result · SMPG-detected hypoglycemia episodes/weekResult — go to the resultEvent rate ratio 0.85 CI 0.54–1.36Authors' conclusion
Clinically meaningful reductions in all CGM-recorded measures of hypoglycemia support using dasiglucagon as a potential treatment for CHI.
Study context
- Population
- Children with congenital hyperinsulinism (CHI) and persistent hypoglycemia (0.6–10.9 years)randomized 1:1
- Participants
- 32 children
- Comparison
- Dasiglucagon + standard of care (SoC) vs SoC alone
- Dasiglucagon + SoCn = 16
- SoCn = 16reference
- Primary endpoint
- Average number of SMPG-detected hypoglycemia episodes/week (SMPG <3.9 mmol/L)
- Follow-up
- Weeks 2 to 4
Methodological detailsopen-label, add-on to standard of care, In the following 4 weeks, all patients received dasiglucagon + SoC
- Open-label
- Add-on to standard of care
- In the following 4 weeks, all patients received dasiglucagon + SoC
Primary result
SMPG-detected hypoglycemia episodes/week
Event rate ratio
0.85
CI 0.54–1.36
P = 0.5028
Dasiglucagon + SoCvs SoC
event rate ratio 0.85 (CI 0.54–1.36); P = 0.5028
As reported in the abstract
Further findings
| Outcome | Event rate ratio (CI) | P value | |
|---|---|---|---|
| CGM-detected hypoglycemia (<3.9 mmol/L) · Weeks 2 to 4Post hoc analysis | 0.57 (0.39–0.83) | P = 0.0029 | |
| 0.20.5125Event rate ratio (log scale) |
- Continuous glucose monitoring (CGM)-detected hypoglycemia (<3.9 mmol/L) — Reduction in CGM-detected hypoglycemia with dasiglucagon vs SoC alone
- 43%
All other CGM measures of hypoglycemia, incl. extent and percent time in hypoglycemia
- Reductions with dasiglucagon vs SoC alone
- 37% to 61%
- Post hoc analyses
Safety
Safety and tolerability
- Dasiglucagon appeared safe and well tolerated
- Skin and gastrointestinal events more frequent with dasiglucagon + SoC than SoC only
Original publication
Dasiglucagon for the Treatment of Congenital Hyperinsulinism: A Randomized Phase 3 Trial in Infants and Children. J Clin Endocrinol Metab. Published 1 November 2023. doi:10.
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