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

A 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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypoglycemia
• Intervention / Treatment: Drug: Dasiglucagon

Detailed Description

This trial will use a single-administration, open-label trial design to assess the ability of a single SC injection of dasiglucagon to increase plasma glucose in pediatric children with T1D with hypoglycemia. A total of 8 children will be included; 4 children receiving a dose of 0.3 mg and 4 children receiving a dose of 0.6 mg. Of the 4 children receiving 0.3 mg, at least 2 children must be below 2 years at screening. The 2 additional children receiving 0.3 mg should weigh below 15 kg at screening and should preferably be below 4 years at screening. For children receiving the 0.6 mg dose, all must be above 2 years at screening. Before an eligible child is dosed, the dose level (0.6 mg or 0.3 mg) must be confirmed by the sponsor. Each child will be dosed after the safety assessment of the preceding child has been completed and assessed by the Trial Safety Group.

The trial will include the following visits

• A screening visit (Visit 1) in the period from Day - 50 to Day - 29 (pre-treatment visit)
• A dosing visit (Visit 2), Day 1 (day of single dosing with investigational medicinal product [IMP])
• A Safety follow-up visit (Visit 3) at Day 29 +5 days (the end-of-trial visit) The primary endpoint of the trial is plasma glucose change from baseline at 30 minutes after IMP injection or at the time of rescue by intravenous glucose. Pharmacodynamics (PD) i.e., plasma glucose will be assessed at baseline and 15 and 30 minutes after dosing, while the glucose levels will be monitored by continuous glucose monitoring and by a plasma glucose analyzer during the dosing visit (Visit 2). Pharmacokinetics (PK) will be assessed throughout a 300-minute period at the dosing visit (Visit 2). Safety will be assessed prior to dosing and throughout a 300-minute period after dosing and again at the follow-up visit.

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Clinical Operations; Phone Number: +45 88 77 36 00; Email: clinicaltrials@zealandpharma.com

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Recruiting
      • Children's Healthcare of Atlanta
      • Contact: Kristina Cossen, MD; Phone Number: 404-785-5437; Email: kristina.cossen@emory.edu
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Not yet recruiting
      • Cook Childrens Health Care System
      • Contact: Paul Thornton, MD; Email: Paul.thornton@cookchildrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 6 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma glucose change from baseline at 30 minutes after IMP injection or at the time of rescue by intravenous (IV) glucose	The primary efficacy endpoint will be summarized using descriptive statistics and a 95% confidence interval.	Measured pre-dose (baseline) and 30 minutes after dosing on Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma glucose change from baseline at 15 minutes after IMP injection or at the time of rescue by IV glucose	Secondary endpoints will be summarized using descriptive statistics	Measured pre-dose (baseline) and 15 minutes after dosing on Day 1

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2023
• Primary Completion (Estimated): March 25, 2024
• Study Completion (Estimated): September 25, 2024

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hypoglycemia
• Other Study ID Numbers: ZP4207-21052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No