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

Phase 3

Completed

Conditions: Type 1 Diabetes
Hypoglycemia

Interventions: Drug: Dasiglucagon

Registration Number: NCT05378672

Lead Sponsor: Zealand Pharma

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.

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, 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 8

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dasiglucagon 0.6 mg	Dasiglucagon	Participants will receive a single dose of 0.6 mg dasiglucagon.
Dasiglucagon 0.3 mg	Dasiglucagon	Participants will receive a single dose of 0.3 mg dasiglucagon.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)	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.
Change From Baseline in Plasma Glucose Concentration at 15 Minutes After IMP Injection	Baseline, 15 minutes after dosing on Day 1	Glucose levels were monitored by continuous glucose monitoring and by a plasma glucose analyzer.
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	Time to first IV glucose infusion (minutes) was defined as Time of start of first glucose administration - Time of administration of study medication.

Trial Locations

Locations (2): Children's Healthcare of Atlanta
🇺🇸
Atlanta, Georgia, United States
Cook Childrens Health Care System
🇺🇸
Fort Worth, Texas, United States
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
Kristina Cossen, MD
Principal Investigator
Xiaomiao Lanpidhainy
Contact
404-727-0637
xlanpid@emory.edu