A Research Study to Investigate the Safety and Effect of Dasiglucagon as a Hypoglycemia Rescue Therapy and How it Works in the Body of Children Under 6 Years of Age With Type 1 Diabetes

• Sponsor: Zealand Pharma (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05378672
• Collaborator: (none)
• Enrollment: 8
• Arm: 1
• Anticipated Duration (Months): 12

Study Details

Study Description

Brief Summary

This research study will investigate whether dasiglucagon as a rescue therapy for participants between 1 and 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.).

Participants will have 3 visits with the study team. For each participant, the study will last up to 84 days.

Condition or Disease	Intervention/Treatment	Phase
Hypoglycemia	Drug: Dasiglucagon	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Single-arm Open-label Trial to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Dasiglucagon When Administered as a Rescue Therapy for Severe Hypoglycemia in Pediatric Patients Aged From 1 to Less Than 6 Years of Age withType 1 Diabetes (T1D)
• Anticipated Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dasiglucagon 0.6 mg Participants will receive a single dose of dasiglucagon.	Drug: Dasiglucagon; Dasiglucagon, 0.6 mg/0.6 mL will be administered as an under the skin (subcutaneous, s.c.) injection by a prefilled syringe, into the abdominal region.; Other Names: Zegalogue, ZP4207

Outcome Measures

Primary Outcome Measures

1. Plasma glucose change from baseline at 30 minutes after IMP injection or at the time of rescue by intravenous (IV) glucose [Measured pre-dose (baseline) and 30 minutes after dosing on Day 1]

Secondary Outcome Measures

1. Plasma glucose change from baseline at 15 minutes after IMP injection or at the time of rescue by IV glucose [Measured pre-dose (baseline) and 15 minutes after dosing on Day 1]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

• Body weight greater than 8 kg

• 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 (eg prolonged fasting (more than 24 hours) at Visit 2

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

• History of hypoglycemia unawareness

• History of hypoglycemic events associated with seizures

• Further exclusion criteria apply

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Zealand Pharma

Investigators

• Study Director: Clinical Operations, Zealand Pharma A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zealand Pharma
• ClinicalTrials.gov Identifier: NCT05378672
• Other Study ID Numbers: ZP4207-21052
• First Posted: May 18, 2022
• Last Update Posted: Jul 13, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypoglycemia

Study Results

No Results Posted as of Jul 13, 2022