Trial Outcomes & Findings for A Study to Inv. Safety, Efficacy & PD of Dasiglucagon as Hypoglycemia Rescue Therapy in Children <6 Years With T1D (NCT NCT05378672)
NCT ID: NCT05378672
Last Updated: 2025-07-20
Results Overview
Glucose levels were monitored by continuous glucose monitoring and by a plasma glucose analyzer.
COMPLETED
PHASE3
8 participants
Baseline, 30 minutes after dosing on Day 1
2025-07-20
Participant Flow
This study was conducted at 2 centers in the United States.
A total 10 participants were screened of which 2 were screen failures and 8 were enrolled to receive study treatment.
Participant milestones
| Measure |
Dasiglucagon 0.3 mg
Participants received a single dose of 0.3 milligrams (mg) dasiglucagon subcutaneous (SC) injection on Day 1.
|
Dasiglucagon 0.6 mg
Participants received a single dose of 0.6 mg dasiglucagon SC injection on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Inv. Safety, Efficacy & PD of Dasiglucagon as Hypoglycemia Rescue Therapy in Children <6 Years With T1D
Baseline characteristics by cohort
| Measure |
Dasiglucagon 0.3 mg
n=4 Participants
Participants received a single dose of 0.3 mg dasiglucagon SC injection on Day 1.
|
Dasiglucagon 0.6 mg
n=4 Participants
Participants received a single dose of 0.6 mg dasiglucagon SC injection on Day 1.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
2.5 years
STANDARD_DEVIATION 1.00 • n=5 Participants
|
4.0 years
STANDARD_DEVIATION 0.82 • n=7 Participants
|
3.3 years
STANDARD_DEVIATION 1.16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 30 minutes after dosing on Day 1Population: Full analysis set (FAS) included all participants of the SAF. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Glucose levels were monitored by continuous glucose monitoring and by a plasma glucose analyzer.
Outcome measures
| Measure |
Dasiglucagon 0.3 mg
n=4 Participants
Participants received a single dose of 0.3 mg dasiglucagon SC injection on Day 1.
|
Dasiglucagon 0.6 mg
n=3 Participants
Participants received a single dose of 0.6 mg dasiglucagon SC injection on Day 1.
|
|---|---|---|
|
Change From Baseline in Plasma Glucose Concentration at 30 Minutes After IMP Injection
|
102.3 milligrams per deciliter (mg/dL)
Standard Deviation 10.72
|
104.3 milligrams per deciliter (mg/dL)
Standard Deviation 14.47
|
SECONDARY outcome
Timeframe: Baseline, 15 minutes after dosing on Day 1Population: FAS included all participants of the SAF. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Glucose levels were monitored by continuous glucose monitoring and by a plasma glucose analyzer.
Outcome measures
| Measure |
Dasiglucagon 0.3 mg
n=4 Participants
Participants received a single dose of 0.3 mg dasiglucagon SC injection on Day 1.
|
Dasiglucagon 0.6 mg
n=3 Participants
Participants received a single dose of 0.6 mg dasiglucagon SC injection on Day 1.
|
|---|---|---|
|
Change From Baseline in Plasma Glucose Concentration at 15 Minutes After IMP Injection
|
57.3 mg/dL
Standard Deviation 13.84
|
53.3 mg/dL
Standard Deviation 4.04
|
SECONDARY outcome
Timeframe: From first dose of study drug up to end of follow up (up to Day 29)Population: SAF included all participants who were enrolled and received at least 1 dose of IMP.
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.
Outcome measures
| Measure |
Dasiglucagon 0.3 mg
n=4 Participants
Participants received a single dose of 0.3 mg dasiglucagon SC injection on Day 1.
|
Dasiglucagon 0.6 mg
n=4 Participants
Participants received a single dose of 0.6 mg dasiglucagon SC injection on Day 1.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Within 30 minutes of infusion on Day 1Population: SAF included all participants who were enrolled and received at least 1 dose of IMP.
Outcome measures
| Measure |
Dasiglucagon 0.3 mg
n=4 Participants
Participants received a single dose of 0.3 mg dasiglucagon SC injection on Day 1.
|
Dasiglucagon 0.6 mg
n=4 Participants
Participants received a single dose of 0.6 mg dasiglucagon SC injection on Day 1.
|
|---|---|---|
|
Number of Participants Who Received Rescue Intravenous (IV) Glucose Infusion Administration
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Start of first glucose administration up to 30 minutes post-infusion on Day 1Population: SAF included all participants who were enrolled and received at least 1 dose of IMP. Here, "Overall Number of Participants Analyzed" is '0' because no participants received glucose infusion.
Time to first IV glucose infusion (minutes) was defined as Time of start of first glucose administration - Time of administration of study medication.
Outcome measures
Outcome data not reported
Adverse Events
Dasiglucagon 0.3 mg
Dasiglucagon 0.6 mg
Serious adverse events
| Measure |
Dasiglucagon 0.3 mg
n=4 participants at risk
Participants received a single dose of 0.3 mg dasiglucagon SC injection on Day 1.
|
Dasiglucagon 0.6 mg
n=4 participants at risk
Participants received a single dose of 0.6 mg dasiglucagon SC injection on Day 1.
|
|---|---|---|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/4 • From first dose of study drug up to end of follow up (up to Day 29)
|
25.0%
1/4 • Number of events 1 • From first dose of study drug up to end of follow up (up to Day 29)
|
Other adverse events
| Measure |
Dasiglucagon 0.3 mg
n=4 participants at risk
Participants received a single dose of 0.3 mg dasiglucagon SC injection on Day 1.
|
Dasiglucagon 0.6 mg
n=4 participants at risk
Participants received a single dose of 0.6 mg dasiglucagon SC injection on Day 1.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1 • From first dose of study drug up to end of follow up (up to Day 29)
|
50.0%
2/4 • Number of events 3 • From first dose of study drug up to end of follow up (up to Day 29)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • From first dose of study drug up to end of follow up (up to Day 29)
|
25.0%
1/4 • Number of events 1 • From first dose of study drug up to end of follow up (up to Day 29)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
75.0%
3/4 • Number of events 4 • From first dose of study drug up to end of follow up (up to Day 29)
|
25.0%
1/4 • Number of events 1 • From first dose of study drug up to end of follow up (up to Day 29)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
25.0%
1/4 • Number of events 1 • From first dose of study drug up to end of follow up (up to Day 29)
|
0.00%
0/4 • From first dose of study drug up to end of follow up (up to Day 29)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/4 • From first dose of study drug up to end of follow up (up to Day 29)
|
50.0%
2/4 • Number of events 2 • From first dose of study drug up to end of follow up (up to Day 29)
|
|
Infections and infestations
Gastroenteritis
|
25.0%
1/4 • Number of events 1 • From first dose of study drug up to end of follow up (up to Day 29)
|
0.00%
0/4 • From first dose of study drug up to end of follow up (up to Day 29)
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
25.0%
1/4 • Number of events 1 • From first dose of study drug up to end of follow up (up to Day 29)
|
0.00%
0/4 • From first dose of study drug up to end of follow up (up to Day 29)
|
|
Injury, poisoning and procedural complications
Face injury
|
25.0%
1/4 • Number of events 1 • From first dose of study drug up to end of follow up (up to Day 29)
|
0.00%
0/4 • From first dose of study drug up to end of follow up (up to Day 29)
|
|
General disorders
Application site rash
|
0.00%
0/4 • From first dose of study drug up to end of follow up (up to Day 29)
|
25.0%
1/4 • Number of events 1 • From first dose of study drug up to end of follow up (up to Day 29)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place