Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT05378672Other idZP4207-21052

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 8 participants (actual)
Sponsor: Zealand Pharma · Industry
Design: Not randomized · Open label (no masking)
Countries: 1 country
United States
Start: 9 May 2023
Primary completion: 29 Oct 2024
Completion: 3 Dec 2024
First posted: 18 May 2022
Last update posted: 20 Jul 2025
Conditions: Hypoglycemia · Type 1 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202320242025

Ph 3
A Study to Inv. Safety, Efficacy & PD of Dasiglucagon as Hypoglycemia Rescue Therapy in Children <6 Years With T1D
NCT05378672
9 May 2023 to 3 Dec 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This research study will investigate whether dasiglucagon as a rescue therapy for participants under 6 years of age works and is safe to use. In addition, the study will investigate how dasiglucagon works in the body (pharmacokinetics and pharmacodynamics). Participants will receive 1 single dose as an injection under the skin (subcutaneous, s.c.) into the buttocks. Participants will have 3 visits with the study team. For each participant, the study will last up to 84 days.

Interventions

DasiglucagonDrug

Arms2

Experimental
Dasiglucagon 0.6 mg
Participants will receive a single dose of 0.6 mg dasiglucagon.
Experimental
Dasiglucagon 0.3 mg
Participants will receive a single dose of 0.3 mg dasiglucagon.

Primary outcomes1

Outcomes the sponsor listed as primary.

Change From Baseline in Plasma Glucose Concentration at 30 Minutes After IMP Injection
Time frame · Baseline, 30 minutes after dosing on Day 1
Registry description
Glucose levels were monitored by continuous glucose monitoring and by a plasma glucose analyzer.

Secondary outcomes(4)

Change From Baseline in Plasma Glucose Concentration at 15 Minutes After IMP Injection
Time frame · Baseline, 15 minutes after dosing on Day 1
Registry description
Glucose levels were monitored by continuous glucose monitoring and by a plasma glucose analyzer.
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)
Registry description
Treatment-emergence was defined as those adverse events (AEs) that occurred after dosing and those existing AEs that worsened during the study. An AE was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the trial intervention.
Number of Participants Who Received Rescue Intravenous (IV) Glucose Infusion Administration
Time frame · Within 30 minutes of infusion on Day 1
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
Registry description
Time to first IV glucose infusion (minutes) was defined as Time of start of first glucose administration - Time of administration of study medication.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline, 30 minutes after dosing on Day 1

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

Group	Value (milligrams per deciliter (mg/dL))	Spread
Dasiglucagon 0.3 mg	102.3	10.72
Dasiglucagon 0.6 mg	104.3	14.47

Secondary and other outcome results(4)

Secondary outcomeMean· Baseline, 15 minutes after dosing on Day 1

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

Group	Value (mg/dL)	Spread
Dasiglucagon 0.3 mg	57.3	13.84
Dasiglucagon 0.6 mg	53.3	4.04

Secondary outcomeCount of participants· From first dose of study drug up to end of follow up (up to Day 29)

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

Group	Value (Participants)
Dasiglucagon 0.3 mg	3
Dasiglucagon 0.6 mg	4

Secondary outcomeCount of participants· Within 30 minutes of infusion on Day 1

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

Group	Value (Participants)
Dasiglucagon 0.3 mg	0
Dasiglucagon 0.6 mg	0

Secondary outcome· Start of first glucose administration up to 30 minutes post-infusion on Day 1

Time to First IV Glucose Infusion Following Treatment With Dasiglucagon

Group	Value
Dasiglucagon 0.3 mg	not posted
Dasiglucagon 0.6 mg	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Dasiglucagon 0.3 mgParticipants received a single dose of 0.3 mg dasiglucagon SC injection on Day 1.	0 / 4	0 / 4	3 / 4
Dasiglucagon 0.6 mgParticipants received a single dose of 0.6 mg dasiglucagon SC injection on Day 1.	0 / 4	1 / 4	3 / 4

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: up to 5 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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