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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Hypoglycemia

Intervention / Treatment
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* Drug: Dasiglucagon


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dasiglucagon 0.6 mg<br>Participants will receive a single dose of dasiglucagon. | Drug: Dasiglucagon<br>* 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.<br>* Other names: Zegalogue, ZP4207;|

What is the study measuring?
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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 |