Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children
Phase 3, Randomized, Double-blind, Placebo/Active-controlled, Parallel-arm Trial to Assess Efficacy, Safety, and Pharmacokinetics of Dasiglucagon Relative to Placebo/GlucaGen® as Rescue Therapy for Severe Hypoglycemia in Children With T1DM Treated With Insulin
Lead sponsor
Asset
Dasiglucagon
Subcutaneous · Glucagon receptor agonist
Listed sites
5
Recruiting sites
-
Actual enrollment
42
Study population
Prediabetes / glucose intolerance
Eligibility highlights
•Age 6-17
Primary endpoint
•Plasma Glucose Recovery
Registered trial locations
Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
Inclusion criteria
1. Following receipt of verbal and written information about the trial, patient, parent(s) or guardian(s) of the patient must provide signed informed consent before any trial-related activity is carried out
2. Female or male patients with T1DM for at least 1 year, diagnostic criteria as defined by the American Diabetes Association; and receiving daily insulin
3. At least 6.0 years of age (inclusive) and less than 18.0 years
4. Body weight ≥20 kg
5. Female patients must meet one of the following criteria:
a. Participant is of childbearing potential and agrees to use one of the accepted contraceptive regimens throughout the entire duration of the trial from screening until last follow-up visit. An acceptable method of contraception includes at least one of the following:
6. Male patients must meet the following criteria: If sexually active, uses condom and partner practices contraception during the trial from screening and until last follow-up visit
7. Willingness to adhere to the protocol requirements
Exclusion criteria
1. Females who are pregnant according to a positive urine pregnancy test, actively attempting to get pregnant, or are lactating 2. Known or suspected allergy to trial product(s) or related products 3. History of anaphylaxis or symptoms of severe systemic allergy (such as angioedema) 4. Previous randomization in this trial 5. History of an episode of severe hypoglycemia that required a third party assistance within a month prior to screening visit 6. History of hypoglycemic events associated with seizures or hypoglycemia unawareness in the last year prior to screening 7. History of epilepsy or seizure disorder 8. Receipt of any investigational drug within 3 months prior to screening 9. Active malignancy within the last 5 years 10. Congestive heart failure, New York Heart Association class II-IV 11. Current bleeding disorder, including anti-coagulant treatment 12. Known presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma (i.e. insulin secreting pancreas tumor) 13. Use of a daily systemic beta-blocker drug, indomethacin, warfarin or anticholinergic drugs in the previous 28 days before Day 1 of this trial 14. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 × the upper limit of the normal range (ULN), bilirubin >1.5 × ULN, estimated glomerular filtration rate <30 mL/min/1.73 m2 according to the Modification of Diet in Renal Disease study definition, or altered electrolyte values of clinical relevance for cardiac conduction, as judged by the investigator 15. Clinically significant abnormal electrocardiogram (ECG) at screening as judged by the investigator 16. Clinically significant illness within 4 weeks before screening, as judged by the investigator 17. Surgery or trauma with significant blood loss within the last 2 months prior to screening 18. Patients with mental incapacity or language barriers which preclude adequate understanding or cooperation, who are unwilling to participate in the trial, or who in the opinion of the investigator should not participate in the trial 19. Any condition interfering with trial participation or evaluation or that could be hazardous to the patient 20. The use of prescription or non-prescription medications known to cause QT prolongation
Endpoints (32)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Glycemic / diabetes
10 endpointsTime to Plasma Glucose Recovery
Time frame:0-45 minutes after dosing
time to event, event
Time to Plasma Glucose Recovery
Time frame:0-45 minutes after dosing
time to event, event
Posted result
| Group | Median · minutes | 95% CI |
|---|---|---|
| Dasiglucagon 0.6 mg | 10.00 | 8.00 - 12.00 |
| Placebo | 30.00 | 20.00 - 45.00 |
| GlucaGen® 1.0 mg | 10.00 | 8.00 - 12.00 |
The treatment group difference between dasiglucagon and placebo was evaluated inferentially using a pairwise two-sided log rank test stratified by injection site and age group.
Plasma Glucose Recovery
Time frame:0-30 minutes after dosing: assessed at 10, 15, 20 and 30 minutes after study drug injection
concentration, descriptive
Plasma Glucose Recovery
Time frame:0-30 minutes after dosing: assessed at 10, 15, 20 and 30 minutes after study drug injection
concentration, descriptive
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| Dasiglucagon 0.6 mgGlucose recovery at 30 minutes | 20 | - |
| Glucose recovery at 20 minutes | 20 | - |
| Glucose recovery at 15 minutes | 19 | - |
| Glucose recovery at 10 minutes | 13 | - |
| PlaceboGlucose recovery at 30 minutes | 6 | - |
| Glucose recovery at 20 minutes | 2 | - |
| Glucose recovery at 15 minutes | 0 | - |
| Glucose recovery at 10 minutes | 0 | - |
| GlucaGen® 1.0 mgGlucose recovery at 30 minutes | 10 | - |
| Glucose recovery at 20 minutes | 10 | - |
| Glucose recovery at 15 minutes | 10 | - |
| Glucose recovery at 10 minutes | 6 | - |
Plasma Glucose Changes From Baseline
Time frame:0-30 minutes after dosing: assessed at 10, 15, 20 and 30 minutes after study drug injection
concentration, descriptive
Plasma Glucose Changes From Baseline
Time frame:0-30 minutes after dosing: assessed at 10, 15, 20 and 30 minutes after study drug injection
concentration, descriptive
Posted result
| Group | Mean · mg/dL | 95% CI |
|---|---|---|
| Dasiglucagon 0.6 mgAt 30 minutes | 98.459 | - |
| At 20 minutes | 65.369 | - |
| At 15 minutes | 45.342 | - |
| At 10 minutes | 27.225 | - |
| PlaceboAt 30 minutes | 17.510 | - |
| At 20 minutes | 7.322 | - |
| At 15 minutes | 0.835 | - |
| At 10 minutes | -3.405 | - |
| GlucaGen® 1.0 mgAt 30 minutes | 85.225 | - |
| At 20 minutes | 58.000 | - |
| At 15 minutes | 40.631 | - |
| At 10 minutes | 20.919 | - |
Administration of Rescue IV Glucose Infusion After IMP Injection
Time frame:0-45 minutes
ratio, improvement
Administration of Rescue IV Glucose Infusion After IMP Injection
Time frame:0-45 minutes
ratio, improvement
Posted result
| Group | Participants | 95% CI |
|---|---|---|
| Dasiglucagon 0.6 mg | 0 | - |
| Placebo | 1 | - |
| GlucaGen® 1.0 mg | 0 | - |
Time to First IV Glucose Infusion After IMP Administration
Time frame:0-45 minutes
time to event, event
Time to First IV Glucose Infusion After IMP Administration
Time frame:0-45 minutes
time to event, event
Posted result
| Group | Number · minutes | 95% CI |
|---|---|---|
| Placebo | 12 | - |
Safety / tolerability / PK
20 endpointsPharmacokinetics: AUC0-30 Min
Time frame:0-30 minutes
descriptive
Pharmacokinetics: AUC0-30 Min
Time frame:0-30 minutes
descriptive
Posted result
| Group | Geometric mean · h*pmol/L | 95% CI |
|---|---|---|
| Dasiglucagon 0.6 mg | 376 | - |
| GlucaGen® 1.0 mg | 376 | - |
Pharmacokinetics: AUC0-300min
Time frame:0-300 minutes
descriptive
Pharmacokinetics: AUC0-300min
Time frame:0-300 minutes
descriptive
Posted result
| Group | Geometric mean · h*pmol/L | 95% CI |
|---|---|---|
| Dasiglucagon 0.6 mg | 1810 | - |
| GlucaGen® 1.0 mg | 1370 | - |
Pharmacokinetics: AUC0-inf
Time frame:0-300 minutes
descriptive
Pharmacokinetics: AUC0-inf
Time frame:0-300 minutes
descriptive
Posted result
| Group | Geometric mean · h*pmol/L | 95% CI |
|---|---|---|
| Dasiglucagon 0.6 mg | 1850 | - |
| GlucaGen® 1.0 mg | 1530 | - |
Pharmacokinetics: Cmax
Time frame:0-300 minutes
concentration, descriptive
Pharmacokinetics: Cmax
Time frame:0-300 minutes
concentration, descriptive
Posted result
| Group | Geometric mean · pmol/L | 95% CI |
|---|---|---|
| Dasiglucagon 0.6 mg | 1160 | - |
| GlucaGen® 1.0 mg | 1120 | - |
Pharmacokinetics: Tmax
Time frame:0-300 minutes
concentration, descriptive
Pharmacokinetics: Tmax
Time frame:0-300 minutes
concentration, descriptive
Posted result
| Group | Median · hours | 95% CI |
|---|---|---|
| Dasiglucagon 0.6 mg | 0.35 | 0.167 - 1.5 |
| GlucaGen® 1.0 mg | 0.333 | 0.167 - 0.5 |
Pharmacokinetics: λz
Time frame:0-300 minutes
descriptive
Pharmacokinetics: λz
Time frame:0-300 minutes
descriptive
Posted result
| Group | Geometric least squares mean · 1/hour | 95% CI |
|---|---|---|
| Dasiglucagon 0.6 mg | 1.11 | - |
| GlucaGen® 1.0 mg | 0.504 | - |
Pharmacokinetics: t½
Time frame:0-300 minutes
descriptive
Pharmacokinetics: t½
Time frame:0-300 minutes
descriptive
Posted result
| Group | Geometric mean · hours | 95% CI |
|---|---|---|
| Dasiglucagon 0.6 mg | 0.623 | - |
| GlucaGen® 1.0 mg | 1.38 | - |
Pharmacokinetics: CL/f
Time frame:0-300 minutes
descriptive
Pharmacokinetics: CL/f
Time frame:0-300 minutes
descriptive
Posted result
| Group | Geometric mean · L/h | 95% CI |
|---|---|---|
| Dasiglucagon 0.6 mg | 96.1 | - |
| GlucaGen® 1.0 mg | 188 | - |
Pharmacokinetics: Vz/f
Time frame:0-300 minutes
descriptive
Pharmacokinetics: Vz/f
Time frame:0-300 minutes
descriptive
Posted result
| Group | Geometric least squares mean · litres | 95% CI |
|---|---|---|
| Dasiglucagon 0.6 mg | 86.4 | - |
| GlucaGen® 1.0 mg | 373 | - |
Pharmacokinetics: MRT
Time frame:0-300 minutes
descriptive
Pharmacokinetics: MRT
Time frame:0-300 minutes
descriptive
Posted result
| Group | Geometric mean · hours | 95% CI |
|---|---|---|
| Dasiglucagon 0.6 mg | 1.27 | - |
| GlucaGen® 1.0 mg | 1.86 | - |
Other (unclassified)
2 endpointsPharmacodynamics - Area Under the Effect Curve (0-30 Minutes)
Time frame:0-30 minutes
descriptive
Pharmacodynamics - Area Under the Effect Curve (0-30 Minutes)
Time frame:0-30 minutes
descriptive
Posted result
| Group | Mean · mmol*h/L | 95% CI |
|---|---|---|
| Dasiglucagon 0.6 mg | 22.83 | - |
| Placebo | 1.81 | - |
| GlucaGen® 1.0 mg | 19.66 | - |
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.