CompletedPhase 2/3

Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism

United States, Germany, Israel12 participantsStarted 2020-06-19

Plain-language summary

The objective of the trial is to evaluate the efficacy of dasiglucagon in reducing glucose requirements in children with persistent congenital hyperinsulinism (CHI) requiring continuous intravenous (IV) glucose administration to prevent/manage hypoglycemia.

Who can participate

Age range7 Days – 364 Days

SexALL

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Inclusion criteria

✓. Hyperinsulinemia: plasma insulin above the limit of detection of the assay documented during an event of hypoglycemia, and/or
✓. Hypofattyacidemia: plasma free fatty acid \<1.7 mmol/L, and/or
✓. Hypoketonemia: Beta-hydroxybutyrate \<1.8 mmol/L, and/or
✓. Glycemic response: an increase in plasma glucose (PG) of \>30 mg/dL (1.7 mmol/L) after 1 mg IV or intramuscular (IM) glucagon administration

What they're measuring

Mean Intravenous Glucose Infusion Rate

Timeframe: Hours 36-48 after initiation of trial drug (Part 1)

Trial details

NCT IDNCT04172441

SponsorZealand Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-02-17

Results submitted2024-12-17

View on ClinicalTrials.gov More Congenital Hyperinsulinism trials