A Study to Inv. Safety,Efficacy & PD of Dasiglucagon as Hypoglycemia Rescue Therapy in Children<6 Years With T1D
Primary Purpose
Hypoglycemia
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dasiglucagon
Sponsored by
About this trial
This is an interventional treatment trial for Hypoglycemia
Eligibility Criteria
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
Sites / Locations
- Children's Healthcare of AtlantaRecruiting
- Cook Childrens Health Care System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dasiglucagon 0.6 mg
Arm Description
Participants will receive a single dose of dasiglucagon.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05378672
Brief Title
A Study to Inv. Safety,Efficacy & PD of Dasiglucagon as Hypoglycemia Rescue Therapy in Children<6 Years With T1D
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 9, 2023 (Actual)
Primary Completion Date
March 25, 2024 (Anticipated)
Study Completion Date
September 25, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zealand Pharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoglycemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dasiglucagon 0.6 mg
Arm Type
Experimental
Arm Description
Participants will receive a single dose of dasiglucagon.
Intervention Type
Drug
Intervention Name(s)
Dasiglucagon
Other Intervention Name(s)
Zegalogue, ZP4207
Intervention Description
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.
Primary Outcome Measure Information:
Title
Plasma glucose change from baseline at 30 minutes after IMP injection or at the time of rescue by intravenous (IV) glucose
Description
The primary efficacy endpoint will be summarized using descriptive statistics and a 95% confidence interval.
Time Frame
Measured pre-dose (baseline) and 30 minutes after dosing on Day 1
Secondary Outcome Measure Information:
Title
Plasma glucose change from baseline at 15 minutes after IMP injection or at the time of rescue by IV glucose
Description
Secondary endpoints will be summarized using descriptive statistics
Time Frame
Measured pre-dose (baseline) and 15 minutes after dosing on Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Operations
Phone
+45 88 77 36 00
Email
clinicaltrials@zealandpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Operations
Organizational Affiliation
Zealand Pharma A/S
Official's Role
Study Director
Facility Information:
Facility Name
Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristina Cossen, MD
Phone
404-785-5437
Email
kristina.cossen@emory.edu
Facility Name
Cook Childrens Health Care System
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Thornton, MD
Email
Paul.thornton@cookchildrens.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Inv. Safety,Efficacy & PD of Dasiglucagon as Hypoglycemia Rescue Therapy in Children<6 Years With T1D
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