Clinical Trial Results:
A Phase 3, Single-Administration, Open-label Trial to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Dasiglucagon When Administered as a Rescue Therapy for Severe Hypoglycemia in Pediatric Patients Below 6 Years of Age With Type 1 Diabetes (T1D)
|
Summary
|
|
EudraCT number |
2025-000121-13 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
03 Dec 2024
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
14 Jun 2025
|
First version publication date |
14 Jun 2025
|
Other versions |
|
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
ZP4207-21052
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT05378672 | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
Zealand Pharma A/S
|
||
Sponsor organisation address |
CVR No. DK 2004 5078, Sydmarken 11, Søborg, Denmark, DK-2860
|
||
Public contact |
Clinical Operations, Zealand Pharma A/S, +45 88 77 36 00, clinicaltrials@zealandpharma.com
|
||
Scientific contact |
Clinical Operations, Zealand Pharma A/S, +45 88 77 36 00, clinicaltrials@zealandpharma.com
|
||
|
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
|
||
EMA paediatric investigation plan number(s) |
EMEA-002233-PIP01-17 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
17 Jan 2025
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
03 Dec 2024
|
||
Was the trial ended prematurely? |
No
|
||
|
General information about the trial
|
|||
Main objective of the trial |
To assess the efficacy of dasiglucagon injection in children less than (<) 6 years of age with T1D.
|
||
Protection of trial subjects |
The trial was conducted in accordance with the ethical principles set forth in the Declaration of Helsinki.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
09 May 2023
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
Yes
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
United States: 8
|
||
Worldwide total number of subjects |
8
|
||
EEA total number of subjects |
0
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
1
|
||
Children (2-11 years) |
7
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
0
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
||
|
||||||||||
|
Recruitment
|
||||||||||
Recruitment details |
This study was conducted at 2 centers in the United States. | |||||||||
|
Pre-assignment
|
||||||||||
Screening details |
A total 10 subjects were screened of which 2 were screen failures and 8 were enrolled to receive study treatment. | |||||||||
|
Period 1
|
||||||||||
Period 1 title |
Overall Study (overall period)
|
|||||||||
Is this the baseline period? |
Yes | |||||||||
Allocation method |
Non-randomised - controlled
|
|||||||||
Blinding used |
Not blinded | |||||||||
|
Arms
|
||||||||||
Are arms mutually exclusive |
Yes
|
|||||||||
|
Arm title
|
Dasiglucagon 0.3 mg | |||||||||
Arm description |
Subjects received a single dose of 0.3 milligrams (mg) dasiglucagon subcutaneous (SC) injection on Day 1. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Dasiglucagon
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Solution for injection in pre-filled syringe
|
|||||||||
Routes of administration |
Injection , Subcutaneous use
|
|||||||||
Dosage and administration details |
Dasiglucagon administered as SC injection.
|
|||||||||
|
Arm title
|
Dasiglucagon 0.6 mg | |||||||||
Arm description |
Subjects received a single dose of 0.6 mg dasiglucagon SC injection on Day 1. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Dasiglucagon
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Solution for injection in pre-filled syringe
|
|||||||||
Routes of administration |
Injection , Subcutaneous use
|
|||||||||
Dosage and administration details |
Dasiglucagon administered as SC injection.
|
|||||||||
|
||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Dasiglucagon 0.3 mg
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects received a single dose of 0.3 milligrams (mg) dasiglucagon subcutaneous (SC) injection on Day 1. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Dasiglucagon 0.6 mg
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects received a single dose of 0.6 mg dasiglucagon SC injection on Day 1. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
Dasiglucagon 0.3 mg
|
||
Reporting group description |
Subjects received a single dose of 0.3 milligrams (mg) dasiglucagon subcutaneous (SC) injection on Day 1. | ||
Reporting group title |
Dasiglucagon 0.6 mg
|
||
Reporting group description |
Subjects received a single dose of 0.6 mg dasiglucagon SC injection on Day 1. | ||
|
|||||||||||||
End point title |
Change From Baseline in Plasma Glucose Concentration at 30 Minutes After Investigational Medicinal Product (IMP) Injection [1] | ||||||||||||
End point description |
Glucose levels were monitored by continuous glucose monitoring and by a plasma glucose analyzer. Full analysis set (FAS) included all subjects of the safety analysis set (SAF). Here, “Number of Subjects Analyzed” signifies subjects who were evaluable for this endpoint.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Baseline, 30 minutes after dosing on Day 1
|
||||||||||||
| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive data analysis was planned. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Change From Baseline in Plasma Glucose Concentration at 15 Minutes After IMP Injection | ||||||||||||
End point description |
Glucose levels were monitored by continuous glucose monitoring and by a plasma glucose analyzer. FAS included all subjects of the SAF. Here, “Number of Subjects Analyzed” signifies subjects who were evaluable for this endpoint.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, 15 minutes after dosing on Day 1
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
||||||||||
End point title |
Number of Subjects Who Received Rescue Intravenous (IV) Glucose Infusion Administration | |||||||||
End point description |
SAF included all subjects who were enrolled and received at least 1 dose of IMP.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
Within 30 minutes of infusion on Day 1
|
|||||||||
|
||||||||||
| No statistical analyses for this end point | ||||||||||
|
||||||||||
End point title |
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | |||||||||
End point description |
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 subject, 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. SAF included all subjects who were enrolled and received at least 1 dose of IMP.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
From first dose of study drug up to end of follow up (up to Day 29)
|
|||||||||
|
||||||||||
| No statistical analyses for this end point | ||||||||||
|
|||||||||||||
End point title |
Time to First IV Glucose Infusion Following Treatment With Dasiglucagon | ||||||||||||
End point description |
Time to first IV glucose infusion (minutes) was defined as Time of start of first glucose administration - Time of administration of study medication. SAF included all subjects who were enrolled and received at least 1 dose of IMP.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Start of first glucose administration up to 30 minutes post-infusion on Day 1
|
||||||||||||
|
|||||||||||||
| Notes [2] - Here, “Number of Subjects Analyzed” is ‘0’ because no subjects received glucose infusion. [3] - Here, “Number of Subjects Analyzed” is ‘0’ because no subjects received glucose infusion. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
From first dose of study drug up to end of follow up (up to Day 29)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
24.1
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Dasiglucagon 0.3 mg
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects received a single dose of 0.3 mg dasiglucagon SC injection on Day 1. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Dasiglucagon 0.6 mg
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects received a single dose of 0.6 mg dasiglucagon SC injection on Day 1. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
14 Oct 2022 |
Protocol V.2.0:
-Synopsis, 6.1 Trial Interventions Administered: Injection site was changed from abdomen to buttocks.
-10.1.4 Data Protection text was changed.
|
||
12 Dec 2022 |
Protocol V.3.0
-Added 0.6 mg Dasiglucagon for children with T1D in the age range >=2 and <6 years and of 0.3 mg Dasiglucagon for children with T1D below 2 years of age.
-Updated trial population and references.
-Blood volume updated to reflect changes in blood volume needed for the individual samples and for children over a range of body weights.
- Added texts to allow sharing of relevant medical records which might be examined by Clinical Quality Assurance auditors or other authorized personnel appointed by the sponsor, including relevant partners, by appropriate IRB/IEC members, and by inspectors from regulatory authorities.
|
||
09 Mar 2023 |
Protocol V.4.0:
-Updated texts to support approval of the 0.3 mg dose and expanded indication down to birth.
-Added new inclusion criteria for body weight.
-Added texts to allow for some flexibility for the sites to select a solution that is the least stressful for the children.
-Blood volumes (table 6-3) updated to ensure more flexibility in case of potential challenges with supply of the tubes with the desired volume.
|
||
01 Nov 2023 |
Protocol V.5.0:
-Updated texts to broaden the recruitment for the study.
|
||
12 Jul 2024 |
Protocol V.6.0:
-Updated texts to allow for more flexibility in recruiting children eligible for 0.3 mg dose by removing upper limit for body weight of 15 kg.
|
||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
