CompletedPhase 3Results posted

A Study to Inv. Safety, Efficacy & PD of Dasiglucagon as Hypoglycemia Rescue Therapy in Children <6 Years With T1D

Phase 3, Single-administration, Open-label Trial to Assess the Efficacy, Safety, PK, and PD of Dasiglucagon When Administered as a Rescue Therapy for Severe Hypoglycemia in Pediatric Patients Below 6 Years of Age With Type 1 Diabetes (T1D)

Lead sponsor

Zealand Pharma

Asset

Dasiglucagon

Subcutaneous · Glucagon receptor agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Prediabetes / glucose intolerance, Type 1 diabetes

Eligibility highlights

•Age ≤5

Primary endpoint

•Plasma Glucose Concentration at 30 Minutes After IMP Injection

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 IDNCT05378672

Org study IDZP4207-21052

Timeline

Milestones

Study first posted2022-05-18actual

Study start2023-05-09actual

Primary completion2024-10-29actual

Study completion2024-12-03actual

Last update posted2025-07-20actual

Results first posted2025-07-20actual

Assets

Investigational agents

Dasiglucagon

Who this study enrolls

Prediabetes / glucose intoleranceType 1 diabetes

Who can enroll

Maximum age5 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Participants who are confirmed as having T1D based on medical history and are receiving daily insulin therapy via insulin pump or MDI

•Body weight greater than 8 kg

•Child must be <6 years of age at the time of screening

•Further inclusion criteria apply

Exclusion criteria

•Known or suspected allergy to the IMP or related products

•Any condition that in the investigators opinion may result in diminished hepatic glycogen stores (e.g., prolonged fasting (more than 24 hours) at Visit 2

•History of anaphylaxis or symptoms of severe systemic allergy (such as angioedema)

•History of hypoglycemic events associated with seizures

•Further exclusion criteria apply

Endpoints (10)

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

Glycemic / diabetes

Safety / tolerability / PK

Glycemic / diabetes

8 endpoints

Primary/protocol endpoint

Change From Baseline in Plasma Glucose Concentration at 30 Minutes After IMP Injection

Time frame:Baseline, 30 minutes after dosing on Day 1

change from baseline, improvement

Primary/registry result

Change From Baseline in Plasma Glucose Concentration at 30 Minutes After IMP Injection

Time frame:Baseline, 30 minutes after dosing on Day 1

change from baseline, improvement

Posted result

Group	Mean · milligrams per deciliter (mg/dL)	95% CI
Dasiglucagon 0.3 mg	102.3	-
Dasiglucagon 0.6 mg	104.3	-

Secondary/protocol endpoint

Change From Baseline in Plasma Glucose Concentration at 15 Minutes After IMP Injection

Time frame:Baseline, 15 minutes after dosing on Day 1

change from baseline, improvement

Secondary/registry result

Change From Baseline in Plasma Glucose Concentration at 15 Minutes After IMP Injection

Time frame:Baseline, 15 minutes after dosing on Day 1

change from baseline, improvement

Posted result

Group	Mean · mg/dL	95% CI
Dasiglucagon 0.3 mg	57.3	-
Dasiglucagon 0.6 mg	53.3	-

Secondary/protocol endpoint

Number of Participants Who Received Rescue Intravenous (IV) Glucose Infusion Administration

Time frame:Within 30 minutes of infusion on Day 1

event count, event

Secondary/registry result

Number of Participants Who Received Rescue Intravenous (IV) Glucose Infusion Administration

Time frame:Within 30 minutes of infusion on Day 1

event count, event

Posted result

Group	Participants	95% CI
Dasiglucagon 0.3 mg	0	-
Dasiglucagon 0.6 mg	0	-

Secondary/protocol endpoint

Time to First IV Glucose Infusion Following Treatment With Dasiglucagon

Time frame:Start of first glucose administration up to 30 minutes post-infusion on Day 1

time to event, event

Secondary/registry result

Time to First IV Glucose Infusion Following Treatment With Dasiglucagon

Time frame:Start of first glucose administration up to 30 minutes post-infusion on Day 1

time to event, event

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Time frame:From first dose of study drug up to end of follow up (up to Day 29)

event count, event

Secondary/registry result

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Time frame:From first dose of study drug up to end of follow up (up to Day 29)

event count, event

Posted result

Group	Participants	95% CI
Dasiglucagon 0.3 mg	3	-
Dasiglucagon 0.6 mg	4	-

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.