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

Zealand Pharma8 enrolled

Overview

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.

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, 2 children should preferably 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

Allocation

NON_RANDOMIZED

Purpose

Conditions

Hypoglycemia Type 1 Diabetes

Interventions

DasiglucagonDRUG

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.

Eligibility

Sex: ALLMax age: 5 Years

Medical Language ↔ Plain English

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

Locations (2)

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Cook Childrens Health Care System

Fort Worth, Texas, United States

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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

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

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

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

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.

Time frame: 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

Time frame: Within 30 minutes of infusion on Day 1

Time to First IV Glucose Infusion Following Treatment With Dasiglucagon

Time to first IV glucose infusion (minutes) was defined as Time of start of first glucose administration - Time of administration of study medication.

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

Data from ClinicalTrials.gov

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