Phase 3
Completed N=12
Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
Congenital Hyperinsulinism
Source: ClinicalTrials.gov NCT04172441 ↗
Enrolled (actual)
12
Serious AEs
4.1%
Results posted
Mar 2025
Primary outcomePrimary: Mean Intravenous Glucose Infusion Rate — 4.33; 9.51 mg/kg/minute — p=0.0037
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Intravenous Glucose Infusion Rate |
6.9; 10.4 | — |
| SECONDARY Carbohydrates Administered |
91.03; 75.09; 80.73; 87.37 | — |
| SECONDARY Mean Intravenous Glucose Infusion Rate |
6.9; 10.4 | — |
| SECONDARY Mean Intravenous Glucose Infusion Rate Below 10 mg/kg/Minute |
9; 6; 3; 6 | — |
| SECONDARY Time to Complete Weaning Off Intravenous Glucose |
5.8 | — |
| SECONDARY Hypoglycemia Event Rate in Part 2 |
8.50; 6.0; 3.79; 6.04 | — |
| SECONDARY Clinically Significant Hypoglycemia Events in Part 2 |
1.67; 1.00; 2.92; 1.67 | — |
| SECONDARY Time to Actual Hospital Discharge |
NA | — |
| SECONDARY Time to Pancreatic Surgery |
NA | — |
| SECONDARY Carbohydrates Administered Intravenously |
41.35; 2.12; 0.35; 22.60 | — |
| SECONDARY Carbohydrates Administered Parenterally |
— | — |
| SECONDARY Carbohydrates Administered Orally |
19.57; 0.37; 0.23; 13.38 | — |
| SECONDARY Carbohydrates Administered Via Gastric Feed |
34.43; 52.87; 57.90; 43.96 | — |
| SECONDARY Time in Range in Part 2 |
86.69; 87.87; 91.42; 88.35 | — |
| SECONDARY Time in Hypoglycemia in Part 2 |
7.20; 8.82; 5.73; 6.67 | — |
| SECONDARY Time in Clinically Significant Hypoglycemia in Part 2 |
2.07; 2.20; 0.88; 1.75 | — |
| SECONDARY Hypoglycemia Episodes in Part 2 |
25.00; 26.50; 18.63; 18.54 | — |
| SECONDARY Clinically Significant Hypoglycemia Episodes in Part 2 |
5.00; 8.50; 2.67; 5.00 | — |
| SECONDARY Extent of Hypoglycemia in Part 2 |
0.87; 0.97; 0.59; 0.89 | — |
| SECONDARY Extent of Clinically Significant Hypoglycemia in Part 2 |
0.14; 0.13; 0.12; 0.14 | — |
| SECONDARY Time in Hyperglycemia in Part 2 |
1.74; 0.81; 0.32; 1.48 | — |
Eligibility Criteria
Inclusion Criteria
- CHI diagnosis established based on the following:
- Hyperinsulinemia: plasma insulin above the limit of detection of the assay documented during an event of hypoglycemia, and/or
- Hypofattyacidemia: plasma free fatty acid 30 mg/dL (1.7 mmol/L) after 1 mg IV or intramuscular (IM) glucagon administration
- Male or female, age ≥7 days and 20 mg/m^2 body surface area or equivalent within 5 days before screening
- Prior use of lanreotide, sirolimus (mechanistic target of rapamycin [mTOR] inhibitors), anti-inflammatory biological agents, or other immune modulating agents. Prior use of octreotide is allowed after a minimum of 48 hour washout before randomization.
- Any clinically significant abnormality identified on echocardiogram that in the opinion of the investigator would affect the subject's ability to participate in the trial
- Any recognized clotting or bleeding disorder
- The use of prescription or non-prescription medications known to cause QT prolongation
Data sourced from ClinicalTrials.gov (NCT04172441). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.