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An Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon for the Treatment of Children with Congenital Hyperinsulinism

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514007-34-00
Acronym
ZP4207-17106
Enrollment
7
Registered
2024-08-09
Start date
2020-03-08
Completion date
2024-12-06
Last updated
2024-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children with congenital hyperinsulinism

Brief summary

Adverse events

Detailed description

Total amount of gastric carbohydrates administered (nasogastric [NG] tube or gastrostomy) to treat hypoglycemia, Time to removal of NG tube or gastrostomy, Time to pancreatic surgery (sub-total or total pancreatectomy), CGM percent time <70 mg/dL (3.9 mmol/L), Rate of CGM-detected hypoglycemia episodes <70 mg/dL (3.9 mmol/L) for 15 minutes or more, Rate of clinically significant CGM-detected hypoglycemia episodes <54 mg/dL (3.0 mmol/L) for 15 minutes or more

Interventions

DRUGDasiglucagon 4 mg/ml

Sponsors

Zealand Pharma A/S
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Adverse events

Secondary

MeasureTime frame
Total amount of gastric carbohydrates administered (nasogastric [NG] tube or gastrostomy) to treat hypoglycemia, Time to removal of NG tube or gastrostomy, Time to pancreatic surgery (sub-total or total pancreatectomy), CGM percent time <70 mg/dL (3.9 mmol/L), Rate of CGM-detected hypoglycemia episodes <70 mg/dL (3.9 mmol/L) for 15 minutes or more, Rate of clinically significant CGM-detected hypoglycemia episodes <54 mg/dL (3.0 mmol/L) for 15 minutes or more

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026