Phase 3
N=32
A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
Congenital Hyperinsulinism
Bottom Line
View on ClinicalTrials.gov: NCT03777176 ↗Enrolled (actual)
32
Serious AEs
7.8%
Results posted
Dec 2023
Primary outcome: Primary: Hypoglycemia Episode Rate — 5.29; 5.85; -3.05; -3.15 episodes per week — p=0.5028
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dasiglucagon (Drug); Standard of Care (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Zealand Pharma
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hypoglycemia Episode Rate |
5.29; 5.85; -3.05; -3.15 | 0.5028 |
| SECONDARY Increase in Fasting Tolerance |
6.13; 4.22; 1.20; 1.27 | 0.6433 |
| SECONDARY Percent Time in Range 70-180 mg/dL |
75.10; 72.65; -0.97; 2.44 | 0.9653 |
| SECONDARY Clinically Significant Hypoglycemia Episode Rates |
1.77; 1.90; -0.51; -0.35 | 0.8114 |
| SECONDARY Total Amount of Gastric Carbohydrates Administered to Treat Hypoglycemia |
22.89; 37.66; -33.66; -19.74 | — |
| SECONDARY Rate of Gastric Carbohydrates Administrations to Treat Hypoglycemia |
2.30; 2.18; -0.29; -2.13 | — |
| SECONDARY Extent of Hypoglycemia |
0.083; 0.147; -0.062; -0.019; 0.015; 0.025 | — |
| SECONDARY Amount of Nightly Gastric Carbohydrates Administered |
95.98; 33.43; 41.64; 3.64; 77.24; 39.25 | — |
| SECONDARY Total Amount of Gastric Carbohydrates Administered |
567.35; 775.96; -146.56; 160.44 | — |
| SECONDARY Percent Time in Hypoglycemia |
11.77; 20.22; -9.91; -1.95 | — |
| SECONDARY Rate of Hypoglycemic Episodes |
21.71; 36.88; -14.37; -6.28 | — |
| SECONDARY Percent Time in Hypoglycemia in Treatment Period 2 |
8.64; -13.27 | — |
| SECONDARY Rate of Gastric Carbohydrates Administrations to Treat Hypoglycemia in Treatment Period 2 |
1.31; -2.22 | — |
| SECONDARY Rate of Hypoglycemic Episodes in Treatment Period 2 |
3.06; -5.61 | — |
| SECONDARY Rate of Clinically Significant Hypoglycemia Episodes in Treatment Period 2 |
7.78; -8.51 | — |
Summary
The objective of the trial is to evaluate the efficacy and safety of dasiglucagon administered as a subcutaneous (SC) infusion in reducing hypoglycemia in children with CHI.
Eligibility Criteria
Inclusion Criteria
- Established and documented diagnosis of CHI based on standard of care
- Experiencing ≥3 events of hypoglycemia per week (plasma glucose [PG] 20 mg/m2 body surface area or equivalent in the 5 days before screening
- Use of anti-inflammatory biological agents, or other immune modulating agents in the 3 months prior to screening
- Any clinically significant abnormality identified on echocardiogram that in the opinion of the investigator would affect the patient's ability to participate in the trial
- Any recognized clotting or bleeding disorders
- Has participated in an interventional clinical trial (investigational or marketed product) within 3 months of screening or 5 half-lives of the drug under investigation (whichever comes first), or plans to participate in another clinical trial.
Data sourced from ClinicalTrials.gov (NCT03777176). 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.