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

NCT05378672 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: ZP4207-21052
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hypoglycemia; Type 1 Diabetes

Keywords

Hypoglycemia; Low Blood Sugar; Type 1 Diabetes; Diabetes; T1D

Outcome Measures

Primary Outcomes (1)

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

  Glucose levels were monitored by continuous glucose monitoring and by a plasma glucose analyzer.

  Baseline, 30 minutes after dosing on Day 1

Secondary Outcomes (4)

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

  Baseline, 15 minutes after dosing on Day 1

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

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

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

  Within 30 minutes of infusion on Day 1

• Time to First IV Glucose Infusion Following Treatment With Dasiglucagon

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

Study Arms (2)

Dasiglucagon 0.6 mg

EXPERIMENTAL

Participants will receive a single dose of 0.6 mg dasiglucagon.

Drug: Dasiglucagon

Dasiglucagon 0.3 mg

EXPERIMENTAL

Participants will receive a single dose of 0.3 mg dasiglucagon.

Drug: Dasiglucagon

Interventions

Dasiglucagon DRUG

Dasiglucagon, 0.6 mg/0.6 mL or 0.3 mg/0.3 mL will be administered as an under the skin (subcutaneous, s.c.) injection by a prefilled syringe, into the buttocks.

Also known as: Zegalogue, ZP4207

Dasiglucagon 0.3 mg; Dasiglucagon 0.6 mg

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand Pharma: lead
• Novo Nordisk A/S: collaborator

Study Sites (2)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30329, United States

Location

Cook Childrens Health Care System

Fort Worth, Texas, 76104, United States

Location

MeSH Terms

Conditions

Hypoglycemia; Diabetes Mellitus, Type 1; Diabetes Mellitus

Interventions

dasiglucagon

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Clinical Operations
• Organization: Zealand Pharma A/S

clinicaltrials@zealandpharma.com

+45 88 77 36 00

Study Officials

• Clinical Operations

  Zealand Pharma A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 18, 2022
• Study Start: May 9, 2023
• Primary Completion: October 29, 2024
• Study Completion: December 3, 2024
• Last Updated: July 20, 2025
• Results First Posted: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)