CompletedPhase 2, PHASE3Results posted

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

A Randomized Trial in 2 Parts: Double-Blind, Placebo-Controlled, Crossover Part 1 and Open-label Part 2, Evaluating the Efficacy and Safety of Dasiglucagon for the Treatment of Children With Congenital Hyperinsulinism

Lead sponsor

Zealand Pharma

Asset

Dasiglucagon

Subcutaneous · Glucagon receptor agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Prediabetes / glucose intolerance

Eligibility highlights

Primary endpoint

•Mean Intravenous Glucose Infusion Rate

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04172441

Org study IDZP4207-17103

Secondary ID2017

Secondary ID2017-004545-24

Timeline

Milestones

Study first posted2019-11-21actual

Study start2020-06-19actual

Primary completion2022-02-17actual

Study completion2022-03-07actual

Last update posted2025-03-14actual

Results first posted2025-03-14actual

Assets

Investigational agents

Dasiglucagon

Who this study enrolls

Prediabetes / glucose intolerance

Who can enroll

Minimum age7 Days

Maximum age364 Days

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•CHI diagnosis established based on the following:

1. Hyperinsulinemia: plasma insulin above the limit of detection of the assay documented during an event of hypoglycemia, and/or

2. Hypofattyacidemia: plasma free fatty acid <1.7 mmol/L, and/or

3. Hypoketonemia: Beta-hydroxybutyrate <1.8 mmol/L, and/or

4. 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

•Male or female, age ≥7 days and <12 months at screening

•Body weight of ≥2.0 kg (4.4 lbs.)

•Continuous IV glucose requirement to prevent hypoglycemia

Exclusion criteria

•Is suspected of having a transient form of CHI (e.g., transient hyperinsulinism due to maternal diabetes or perinatal stress)

•Was born preterm below 34 weeks of gestational age

•Presence of hypertension or hypotension, including circulatory instability requiring supportive medication or presence of pheochromocytoma

•Known or suspected presence of severe brain damage

•Evidence of metabolic, endocrine, or syndromic causes of hypoglycemia not due to hyperinsulinism

•Use of systemic corticosteroids, e.g., hydrocortisone >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

Endpoints (44)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Safety / tolerability / PK

Glycemic / diabetes

10 endpoints

Primary/protocol endpoint

Mean Intravenous Glucose Infusion Rate

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

descriptive

Primary/registry result

Mean Intravenous Glucose Infusion Rate

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

descriptive

Posted result

Group	Mean · mg/kg/minute	95% CI
Dasiglucagon	4.33	-
Placebo	9.51	-

Difference in ls means-5.2195% CI-8.29 - -2.13p0.0037Mixed Models Analysis

Null hypothesis: weighted mean IV GIR in the last 12 hours of treatment with dasiglucagon = weighted mean IV GIR in the last 12 hours of treatment with placebo

Secondary/protocol endpoint

Mean Intravenous Glucose Infusion Rate

Time frame:48 hours after initiation of trial drug (Part 1)

descriptive

Secondary/registry result

Mean Intravenous Glucose Infusion Rate

Time frame:48 hours after initiation of trial drug (Part 1)

descriptive

Posted result

Group	Mean · mg/kg/minute	95% CI
Dasiglucagon	6.9	-
Placebo	10.4	-

Secondary/protocol endpoint

Mean Intravenous Glucose Infusion Rate Below 10 mg/kg/Minute

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

descriptive

Secondary/registry result

Mean Intravenous Glucose Infusion Rate Below 10 mg/kg/Minute

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

descriptive

Posted result

Group	Participants	95% CI
Dasiglucagon	9	-
	3	-
Placebo	6	-
	6	-

Secondary/protocol endpoint

Time to Complete Weaning Off Intravenous Glucose

Time frame:Days 5 to 25 (Part 2)

time to event, event

Secondary/registry result

Time to Complete Weaning Off Intravenous Glucose

Time frame:Days 5 to 25 (Part 2)

time to event, event

Posted result

Group	Median · days	95% CI
Dasiglucagon (Part 2)	5.8	1.0 - 7.9

Secondary/protocol endpoint

Time in Range in Part 2

Time frame:Days 5 to 25

descriptive

Secondary/registry result

Time in Range in Part 2

Time frame:Days 5 to 25

descriptive

Posted result

Group	Median · percent time	95% CI
Dasiglucagon (Part 2)Week 1 (Days 5 to 11)	86.69	34.5 - 94.3
Week 2 (Days 12 to 18)	87.87	51.0 - 95.9
Week 3 (Days 19 to 25)	91.42	36.3 - 100.0
Weeks 1 to 3 (Days 5 to 25)	88.35	42.5 - 100.0

Safety / tolerability / PK

16 endpoints

Secondary/protocol endpoint

Hypoglycemia Event Rate in Part 2

Time frame:Days 5 to 25

descriptive

Secondary/registry result

Hypoglycemia Event Rate in Part 2

Time frame:Days 5 to 25

descriptive

Posted result

Group	Median · episodes per week	95% CI
Dasiglucagon (Part 2)Week 1 (Days 5 to 11)	8.50	0.0 - 29.0
Week 2 (Days 12 to 18)	6.0	0.0 - 37.3
Week 3 (Days 19 to 25)	3.79	0.0 - 15.2
Weeks 1 to 3 (Days 5 to 25)	6.04	1.7 - 33.2

Secondary/protocol endpoint

Clinically Significant Hypoglycemia Events in Part 2

Time frame:Days 5 to 25

descriptive

Secondary/registry result

Clinically Significant Hypoglycemia Events in Part 2

Time frame:Days 5 to 25

descriptive

Posted result

Group	Median · episodes per week	95% CI
Dasiglucagon (Part 2)Week 1 (Days 5 to 11)	1.67	0.0 - 11.0
Week 2 (Days 12 to 18)	1.00	0.0 - 16.3
Week 3 (Days 19 to 25)	2.92	0.0 - 4.0
Weeks 1 to 3 (Days 5 to 25)	1.67	0.3 - 13.7

Secondary/protocol endpoint

Time in Hypoglycemia in Part 2

Time frame:Days 5 to 25

descriptive

Secondary/registry result

Time in Hypoglycemia in Part 2

Time frame:Days 5 to 25

descriptive

Posted result

Group	Median · percent time	95% CI
Dasiglucagon (Part 2)Week 1 (Days 5 to 11)	7.20	1.0 - 24.5
Week 2 (Days 12 to 18)	8.82	0.6 - 49.0
Week 3 (Days 19 to 25)	5.73	0.0 - 22.1
Weeks 1 to 3 (Days 5 to 25)	6.67	0.0 - 30.0

Secondary/protocol endpoint

Time in Clinically Significant Hypoglycemia in Part 2

Time frame:Days 5 to 25

descriptive

Secondary/registry result

Time in Clinically Significant Hypoglycemia in Part 2

Time frame:Days 5 to 25

descriptive

Posted result

Group	Median · percent time	95% CI
Dasiglucagon (Part 2)Week 1 (Days 5 to 11)	2.07	0.2 - 6.0
Week 2 (Days 12 to 18)	2.20	0.0 - 20.4
Week 3 (Days 19 to 25)	0.88	0.0 - 6.8
Weeks 1 to 3 (Days 5 to 25)	1.75	0.0 - 9.2

Secondary/protocol endpoint

Hypoglycemia Episodes in Part 2

Time frame:Days 5 to 25

event count, event

Secondary/registry result

Hypoglycemia Episodes in Part 2

Time frame:Days 5 to 25

event count, event

Posted result

Group	Median · episodes per week	95% CI
Dasiglucagon (Part 2)Week 1 (Days 5 to 11)	25.00	3.0 - 58.0
Week 2 (Days 12 to 18)	26.50	3.0 - 74.7
Week 3 (Days 19 to 25)	18.63	0.0 - 58.3
Weeks 1 to 3 (Days 5 to 25)	18.54	0.0 - 66.3

Secondary/protocol endpoint

Clinically Significant Hypoglycemia Episodes in Part 2

Time frame:Days 5 to 25

event count, event

Secondary/registry result

Clinically Significant Hypoglycemia Episodes in Part 2

Time frame:Days 5 to 25

event count, event

Posted result

Group	Median · episodes per week	95% CI
Dasiglucagon (Part 2)Week 1 (Days 5 to 11)	5.00	1.0 - 23.0
Week 2 (Days 12 to 18)	8.50	0.0 - 46.7
Week 3 (Days 19 to 25)	2.67	0.0 - 18.7
Weeks 1 to 3 (Days 5 to 25)	5.00	0.0 - 34.8

Secondary/protocol endpoint

Extent of Hypoglycemia in Part 2

Time frame:Days 5 to 25

descriptive

Secondary/registry result

Extent of Hypoglycemia in Part 2

Time frame:Days 5 to 25

descriptive

Posted result

Group	Median · mg/dL/hour	95% CI
Dasiglucagon (Part 2)Week 1 (Days 5 to 11)	0.87	0.1 - 2.7
Week 2 (Days 12 to 18)	0.97	0.0 - 8.9
Week 3 (Days 19 to 25)	0.59	0.1 - 2.6
Weeks 1 to 3 (Days 5 to 25)	0.89	0.1 - 4.3

Secondary/protocol endpoint

Extent of Clinically Significant Hypoglycemia in Part 2

Time frame:Days 5 to 25

descriptive

Secondary/registry result

Extent of Clinically Significant Hypoglycemia in Part 2

Time frame:Days 5 to 25

descriptive

Posted result

Group	Median · mg/dL/hour	95% CI
Dasiglucagon (Part 2)Week 1 (Days 5 to 11)	0.14	0.0 - 0.4
Week 2 (Days 12 to 18)	0.13	0.0 - 2.1
Week 3 (Days 19 to 25)	0.12	0.0 - 0.4
Weeks 1 to 3 (Days 5 to 25)	0.14	0.0 - 0.8

Other (unclassified)

18 endpoints

Secondary/protocol endpoint/low confidence

Carbohydrates Administered

Time frame:0 to 48 hours after initiation of trial drug

descriptive

Secondary/registry result/low confidence

Carbohydrates Administered

Time frame:0 to 48 hours after initiation of trial drug

descriptive

Posted result

Group	Mean · g/day	95% CI
Dasiglucagon	106.7	-
Placebo	139.1	-

Difference in ls means-30.9395% CI-56.80 - -5.05p0.0238Mixed Models Analysis

Secondary/protocol endpoint/low confidence

Time to Actual Hospital Discharge

Time frame:Days 5 to 25

time to event, event

Secondary/registry result/low confidence

Time to Actual Hospital Discharge

Time frame:Days 5 to 25

time to event, event

Posted result

Group	Median · days	95% CI
Dasiglucagon (Part 2)	NA	11.7 - NA

Secondary/protocol endpoint/low confidence

Time to Pancreatic Surgery

Time frame:Days 5 to 25

time to event, event

Secondary/registry result/low confidence

Time to Pancreatic Surgery

Time frame:Days 5 to 25

time to event, event

Posted result

Group	Median · days	95% CI
Dasiglucagon (Part 2)	NA	NA - NA

Secondary/protocol endpoint/low confidence

Carbohydrates Administered

Time frame:Days 5 to 25

descriptive

Secondary/registry result/low confidence

Carbohydrates Administered

Time frame:Days 5 to 25

descriptive

Posted result

Group	Median · g/day	95% CI
Dasiglucagon (Part 2)Week 1 (Days 5 to 11)	91.03	57.6 - 190.8
Week 2 (Days 12 to 18)	75.09	29.8 - 218.3
Week 3 (Days 19 to 25)	80.73	0.0 - 222.1
Weeks 1 to 3 (Days 5 to 25)	87.37	39.5 - 195.9

Secondary/protocol endpoint/low confidence

Carbohydrates Administered Intravenously

Time frame:Days 5 to 25

descriptive

Secondary/registry result/low confidence

Carbohydrates Administered Intravenously

Time frame:Days 5 to 25

descriptive

Posted result

Group	Median · g/day	95% CI
Dasiglucagon (Part 2)Week 1 (Days 5 to 11)	41.35	3.6 - 118.8
Week 2 (Days 12 to 18)	2.12	0.0 - 82.2
Week 3 (Days 19 to 25)	0.35	0.0 - 119.0
Weeks 1 to 3 (Days 5 to 25)	22.60	1.2 - 88.5

Secondary/protocol endpoint/low confidence

Carbohydrates Administered Parenterally

Time frame:Days 5 to 25

descriptive

Secondary/registry result/low confidence

Carbohydrates Administered Parenterally

Time frame:Days 5 to 25

descriptive

Secondary/protocol endpoint/low confidence

Carbohydrates Administered Orally

Time frame:Days 5 to 25

descriptive

Secondary/registry result/low confidence

Carbohydrates Administered Orally

Time frame:Days 5 to 25

descriptive

Posted result

Group	Median · g/day	95% CI
Dasiglucagon (Part 2)Week 1 (Days 5 to 11)	19.57	0.0 - 67.5
Week 2 (Days 12 to 18)	0.37	0.0 - 88.9
Week 3 (Days 19 to 25)	0.23	0.0 - 53.8
Weeks 1 to 3 (Days 5 to 25)	13.38	0.0 - 63.4

Secondary/protocol endpoint/low confidence

Carbohydrates Administered Via Gastric Feed

Time frame:Days 5 to 25

descriptive

Secondary/registry result/low confidence

Carbohydrates Administered Via Gastric Feed

Time frame:Days 5 to 25

descriptive

Posted result

Group	Median · g/day	95% CI
Dasiglucagon (Part 2)Week 1 (Days 5 to 11)	34.43	0.0 - 88.7
Week 2 (Days 12 to 18)	52.87	9.0 - 92.8
Week 3 (Days 19 to 25)	57.90	0.0 - 76.1
Weeks 1 to 3 (Days 5 to 25)	43.96	0.0 - 85.0

Secondary/protocol endpoint/low confidence

Time in Hyperglycemia in Part 2

Time frame:Days 5 to 25

descriptive

Secondary/registry result/low confidence

Time in Hyperglycemia in Part 2

Time frame:Days 5 to 25

descriptive

Posted result

Group	Median · percent time	95% CI
Dasiglucagon (Part 2)Week 1 (Days 5 to 11)	1.74	0.0 - 64.5
Week 2 (Days 12 to 18)	0.81	0.0 - 45.0
Week 3 (Days 19 to 25)	0.32	0.0 - 62.7
Weeks 1 to 3 (Days 5 to 25)	1.48	0.0 - 56.6

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.