CompletedPhase 3Results posted

A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism

A Two-Period, Open-label Trial 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

•Age 3-12

Primary endpoint

•Hypoglycemia Episode 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 IDNCT03777176

Org study IDZP4207-17109

Timeline

Milestones

Study first posted2018-12-17actual

Study start2019-02-07actual

Primary completion2020-08-31actual

Study completion2020-10-05actual

Last update posted2023-12-13actual

Results first posted2023-12-13actual

Assets

Investigational agents

Dasiglucagon

Who this study enrolls

Prediabetes / glucose intolerance

Who can enroll

Minimum age3 Months

Maximum age12 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Established and documented diagnosis of CHI based on standard of care

•Experiencing ≥3 events of hypoglycemia per week (plasma glucose [PG] <70 mg/dL [<3.9 mmol/L]) according to the investigator's evaluation

•Previously undergone near-total pancreatectomy or being treated with a non-surgical approach, having been evaluated as not eligible for pancreatic surgery

•If somatostatin analogues or sirolimus are used, the therapy should be well established as judged by the investigator, especially when considering their biological half-life

Exclusion criteria

•Previous administration of dasiglucagon

•Known or suspected allergy to the trial drug or related products

•Previous participation (randomization) in this trial

•Circulatory instability requiring supportive medication or presence of pheochromocytoma

•Requires exogenous insulin

•Body weight of <4 kg (8.8 lbs.)

•Documented HbA1c ≥7% subsequent to near-total pancreatectomy and within 6 months prior to screening

•Known or suspected presence of significant central nervous system disease/injury such that in the investigator's opinion will affect trial participation

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

Endpoints (30)

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

Safety / tolerability / PK

Other (unclassified)

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Percent Time in Range 70-180 mg/dL

Time frame:Baseline, Week 2-4 (Treatment Period 1)

descriptive

Secondary/registry result

Percent Time in Range 70-180 mg/dL

Time frame:Baseline, Week 2-4 (Treatment Period 1)

descriptive

Posted result

Group	Mean · percent time	95% CI
Standard of Care + DasiglucagonWeek 2-4	75.10	-
Change from Baseline	-0.97	-
Standard of Care OnlyWeek 2-4	72.65	-
Change from Baseline	2.44	-

Mean difference (net)0.1595% CI-6.48 - 6.78p0.9653ANCOVA

Safety / tolerability / PK

22 endpoints

Primary/protocol endpoint

Hypoglycemia Episode Rate

Time frame:Baseline, Week 2-4 (Treatment Period 1)

descriptive

Primary/registry result

Hypoglycemia Episode Rate

Time frame:Baseline, Week 2-4 (Treatment Period 1)

descriptive

Posted result

Group	Mean · episodes per week	95% CI
Standard of Care + DasiglucagonWeekly number of episodes in Weeks 2-4	5.29	-
Change from Baseline	-3.05	-
Standard of Care OnlyWeekly number of episodes in Weeks 2-4	5.85	-
Change from Baseline	-3.15	-

Event rate ratio0.8595% CI0.54 - 1.36p0.5028Negative binomial regression

The primary analysis was performed as a negative binominal regression analysis on the difference of the SMPG-detected hypoglycemia episode rate between treatment groups over the Weeks 2-4.

Secondary/protocol endpoint

Clinically Significant Hypoglycemia Episode Rates

Time frame:Baseline, Week 2-4 (Treatment Period 1)

descriptive

Secondary/registry result

Clinically Significant Hypoglycemia Episode Rates

Time frame:Baseline, Week 2-4 (Treatment Period 1)

descriptive

Posted result

Group	Mean · episodes per week	95% CI
Standard of Care + DasiglucagonWeekly number of episodes in Weeks 2-4	1.77	-
Change from Baseline	-0.51	-
Standard of Care OnlyWeekly number of episodes in Weeks 2-4	1.90	-
Change from Baseline	-0.35	-

Event rate ratio0.9395% CI0.49 - 1.74p0.8114Negative binominal regression

Secondary/protocol endpoint

Total Amount of Gastric Carbohydrates Administered to Treat Hypoglycemia

Time frame:Baseline, Week 2-4 (Treatment Period 1)

descriptive

Secondary/registry result

Total Amount of Gastric Carbohydrates Administered to Treat Hypoglycemia

Time frame:Baseline, Week 2-4 (Treatment Period 1)

descriptive

Posted result

Group	Mean · grams	95% CI
Standard of Care + DasiglucagonWeek 2-4	22.89	-
Change from Baseline	-33.66	-
Standard of Care OnlyWeek 2-4	37.66	-
Change from Baseline	-19.74	-

Secondary/protocol endpoint

Rate of Gastric Carbohydrates Administrations to Treat Hypoglycemia

Time frame:Baseline, Week 2-4 (Treatment Period 1)

ratio, event

Secondary/registry result

Rate of Gastric Carbohydrates Administrations to Treat Hypoglycemia

Time frame:Baseline, Week 2-4 (Treatment Period 1)

ratio, event

Posted result

Group	Mean · number of administrations per week	95% CI
Standard of Care + DasiglucagonWeek 2-4	2.30	-
Change from Baseline	-0.29	-
Standard of Care OnlyWeek 2-4	2.18	-
Change from Baseline	-2.13	-

Secondary/protocol endpoint

Extent of Hypoglycemia

Time frame:Baseline, Week 2-4 (Treatment Period 1)

descriptive

Secondary/registry result

Extent of Hypoglycemia

Time frame:Baseline, Week 2-4 (Treatment Period 1)

descriptive

Posted result

Group	Mean · mmol/L	95% CI
Standard of Care + DasiglucagonWeek 2-4: Extent of Hypoglycemia Below 70 mg/dL (3.9 mmol/L)	0.083	-
Change from Baseline in Extent of Hypoglycemia Below 70 mg/dL (3.9 mmol/L)	-0.062	-
Week 2-4: Extent of Hypoglycemia Below 54 mg/dL (3.0 mmol/L)	0.015	-
Change from Baseline in Extent of Hypoglycemia Below 54 mg/dL (3.0 mmol/L)	-0.008	-
Standard of Care OnlyWeek 2-4: Extent of Hypoglycemia Below 70 mg/dL (3.9 mmol/L)	0.147	-
Change from Baseline in Extent of Hypoglycemia Below 70 mg/dL (3.9 mmol/L)	-0.019	-
Week 2-4: Extent of Hypoglycemia Below 54 mg/dL (3.0 mmol/L)	0.025	-
Change from Baseline in Extent of Hypoglycemia Below 54 mg/dL (3.0 mmol/L)	-0.007	-

Secondary/protocol endpoint

Percent Time in Hypoglycemia

Time frame:Baseline, Week 2-4 (Treatment Period 1)

descriptive

Secondary/registry result

Percent Time in Hypoglycemia

Time frame:Baseline, Week 2-4 (Treatment Period 1)

descriptive

Posted result

Group	Mean · percent time	95% CI
Standard of Care + DasiglucagonWeek 2-4	11.77	-
Change from Baseline	-9.91	-
Standard of Care OnlyWeek 2-4	20.22	-
Change from Baseline	-1.95	-

Secondary/protocol endpoint

Rate of Hypoglycemic Episodes

Time frame:Baseline, Week 2-4 (Treatment Period 1)

event count, event

Secondary/registry result

Rate of Hypoglycemic Episodes

Time frame:Baseline, Week 2-4 (Treatment Period 1)

event count, event

Posted result

Group	Mean · episodes per week	95% CI
Standard of Care + DasiglucagonWeek 2-4	21.71	-
Change from Baseline	-14.37	-
Standard of Care OnlyWeek 2-4	36.88	-
Change from Baseline	-6.28	-

Secondary/protocol endpoint

Percent Time in Hypoglycemia in Treatment Period 2

Time frame:Baseline, Week 6-8 (Treatment Period 2)

descriptive

Secondary/registry result

Percent Time in Hypoglycemia in Treatment Period 2

Time frame:Baseline, Week 6-8 (Treatment Period 2)

descriptive

Posted result

Group	Mean · percent time	95% CI
Standard of Care + Dasiglucagon (Treatment Period 2)Week 6-8	8.64	-
Change from Baseline	-13.27	-

Secondary/protocol endpoint

Rate of Gastric Carbohydrates Administrations to Treat Hypoglycemia in Treatment Period 2

Time frame:Baseline, Week 6-8 (Treatment Period 2)

ratio, event

Secondary/registry result

Rate of Gastric Carbohydrates Administrations to Treat Hypoglycemia in Treatment Period 2

Time frame:Baseline, Week 6-8 (Treatment Period 2)

ratio, event

Posted result

Group	Mean · number of administrations per week	95% CI
Standard of Care + Dasiglucagon (Treatment Period 2)Week 6-8	1.31	-
Change from Baseline	-2.22	-

Secondary/protocol endpoint

Rate of Hypoglycemic Episodes in Treatment Period 2

Time frame:Baseline, Week 6-8 (Treatment Period 2)

event count, event

Secondary/registry result

Rate of Hypoglycemic Episodes in Treatment Period 2

Time frame:Baseline, Week 6-8 (Treatment Period 2)

event count, event

Posted result

Group	Mean · episodes per week	95% CI
Standard of Care + Dasiglucagon (Treatment Period 2)Weekly number of episodes in Weeks 6-8	3.06	-
Change from Baseline	-5.61	-

Secondary/protocol endpoint

Rate of Clinically Significant Hypoglycemia Episodes in Treatment Period 2

Time frame:Baseline, Week 6-8 (Treatment Period 2)

event count, event

Secondary/registry result

Rate of Clinically Significant Hypoglycemia Episodes in Treatment Period 2

Time frame:Baseline, Week 6-8 (Treatment Period 2)

event count, event

Posted result

Group	Mean · episodes per week	95% CI
Standard of Care + Dasiglucagon (Treatment Period 2)Week 6-8	7.78	-
Change from Baseline	-8.51	-

Other (unclassified)

6 endpoints

Secondary/protocol endpoint/low confidence

Increase in Fasting Tolerance

Time frame:Baseline, Week 2-4 (Treatment Period 1)

descriptive

Secondary/registry result/low confidence

Increase in Fasting Tolerance

Time frame:Baseline, Week 2-4 (Treatment Period 1)

descriptive

Posted result

Group	Mean · hours	95% CI
Standard of Care + DasiglucagonEnd of Treatment Period 1	6.13	-
Change from Baseline	1.20	-
Standard of Care OnlyEnd of Treatment Period 1	4.22	-
Change from Baseline	1.27	-

Mean difference (net)0.8495% CI-2.71 - 4.39p0.6433ANCOVA

Secondary/protocol endpoint/low confidence

Amount of Nightly Gastric Carbohydrates Administered

Time frame:Baseline, Week 2-4 (Treatment Period 1)

descriptive

Secondary/registry result/low confidence

Amount of Nightly Gastric Carbohydrates Administered

Time frame:Baseline, Week 2-4 (Treatment Period 1)

descriptive

Posted result

Group	Mean · grams	95% CI
Standard of Care + DasiglucagonWeek 1	95.98	-
Change from Baseline at Week 1	41.64	-
Week 2	77.24	-
Change from Baseline at Week 2	22.90	-
Week 3	67.59	-
Change from Baseline at Week 3	13.24	-
Week 4	63.89	-
Change from Baseline at Week 4	9.55	-
Standard of Care OnlyWeek 1	33.43	-
Change from Baseline at Week 1	3.64	-
Week 2	39.25	-
Change from Baseline at Week 2	9.46	-
Week 3	30.31	-
Change from Baseline at Week 3	0.52	-
Week 4	34.62	-
Change from Baseline at Week 4	4.83	-

Secondary/protocol endpoint/low confidence

Total Amount of Gastric Carbohydrates Administered

Time frame:Baseline, Week 2-4 (Treatment Period 1)

descriptive

Secondary/registry result/low confidence

Total Amount of Gastric Carbohydrates Administered

Time frame:Baseline, Week 2-4 (Treatment Period 1)

descriptive

Posted result

Group	Mean · grams	95% CI
Standard of Care + DasiglucagonWeek 2-4	567.35	-
Change from Baseline	-146.56	-
Standard of Care OnlyWeek 2-4	775.96	-
Change from Baseline	160.44	-

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.