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CompletedPhase 3Results posted

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

Zealand Pharma

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

NCT IDNCT03667053
Org study IDZP4207-17086

Timeline

Milestones

Study first posted2018-09-12actual
Study start2018-09-28actual
Primary completion2019-06-28actual
Study completion2019-06-28actual
Results first posted2021-05-10actual
Last update posted2021-06-30actual

Assets

Investigational agents

Who this study enrolls

Prediabetes / glucose intolerance

Who can enroll

Minimum age6 Years
Maximum age17 Years
SexAll
Healthy volunteersNot accepted

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:

i.Abstinence from heterosexual intercourse
ii.Systemic contraceptives (birth control pills, injectable/implant/ insertable hormonal birth control products, transdermal patch); if the participant is using systemic contraceptives, she must use an additional form of acceptable contraception (iii or iv, below)
iii.Intrauterine device (with and without hormones)
iv.Condom with spermicide or b. Participant is of non-childbearing potential due to pre-puberty status or a medical condition confirmed by the investigator

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

Safety / tolerability / PK
20
Glycemic / diabetes
10
Other (unclassified)
2

Glycemic / diabetes

10 endpoints
Primary/protocol endpoint

Time to Plasma Glucose Recovery

Time frame:0-45 minutes after dosing

time to event, event

Primary/registry result

Time to Plasma Glucose Recovery

Time frame:0-45 minutes after dosing

time to event, event

Posted result

GroupMedian · minutes95% CI
Dasiglucagon 0.6 mg10.008.00 - 12.00
Placebo30.0020.00 - 45.00
GlucaGen® 1.0 mg10.008.00 - 12.00
p<0.001Log Rank

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.

Secondary/protocol endpoint

Plasma Glucose Recovery

Time frame:0-30 minutes after dosing: assessed at 10, 15, 20 and 30 minutes after study drug injection

concentration, descriptive

Secondary/registry result

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

GroupParticipants95% CI
Dasiglucagon 0.6 mgGlucose recovery at 30 minutes20-
Glucose recovery at 20 minutes20-
Glucose recovery at 15 minutes19-
Glucose recovery at 10 minutes13-
PlaceboGlucose recovery at 30 minutes6-
Glucose recovery at 20 minutes2-
Glucose recovery at 15 minutes0-
Glucose recovery at 10 minutes0-
GlucaGen® 1.0 mgGlucose recovery at 30 minutes10-
Glucose recovery at 20 minutes10-
Glucose recovery at 15 minutes10-
Glucose recovery at 10 minutes6-
p0.0073Cochran-Mantel-Haenszel
Secondary/protocol endpoint

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

Secondary/registry result

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

GroupMean · mg/dL95% CI
Dasiglucagon 0.6 mgAt 30 minutes98.459-
At 20 minutes65.369-
At 15 minutes45.342-
At 10 minutes27.225-
PlaceboAt 30 minutes17.510-
At 20 minutes7.322-
At 15 minutes0.835-
At 10 minutes-3.405-
GlucaGen® 1.0 mgAt 30 minutes85.225-
At 20 minutes58.000-
At 15 minutes40.631-
At 10 minutes20.919-
p<0.0001ANOVA
Secondary/protocol endpoint

Administration of Rescue IV Glucose Infusion After IMP Injection

Time frame:0-45 minutes

ratio, improvement

Secondary/registry result

Administration of Rescue IV Glucose Infusion After IMP Injection

Time frame:0-45 minutes

ratio, improvement

Posted result

GroupParticipants95% CI
Dasiglucagon 0.6 mg0-
Placebo1-
GlucaGen® 1.0 mg0-
Secondary/protocol endpoint

Time to First IV Glucose Infusion After IMP Administration

Time frame:0-45 minutes

time to event, event

Secondary/registry result

Time to First IV Glucose Infusion After IMP Administration

Time frame:0-45 minutes

time to event, event

Posted result

GroupNumber · minutes95% CI
Placebo12-

Safety / tolerability / PK

20 endpoints
Secondary/protocol endpoint

Pharmacokinetics: AUC0-30 Min

Time frame:0-30 minutes

descriptive

Secondary/registry result

Pharmacokinetics: AUC0-30 Min

Time frame:0-30 minutes

descriptive

Posted result

GroupGeometric mean · h*pmol/L95% CI
Dasiglucagon 0.6 mg376-
GlucaGen® 1.0 mg376-
Secondary/protocol endpoint

Pharmacokinetics: AUC0-300min

Time frame:0-300 minutes

descriptive

Secondary/registry result

Pharmacokinetics: AUC0-300min

Time frame:0-300 minutes

descriptive

Posted result

GroupGeometric mean · h*pmol/L95% CI
Dasiglucagon 0.6 mg1810-
GlucaGen® 1.0 mg1370-
Secondary/protocol endpoint

Pharmacokinetics: AUC0-inf

Time frame:0-300 minutes

descriptive

Secondary/registry result

Pharmacokinetics: AUC0-inf

Time frame:0-300 minutes

descriptive

Posted result

GroupGeometric mean · h*pmol/L95% CI
Dasiglucagon 0.6 mg1850-
GlucaGen® 1.0 mg1530-
Secondary/protocol endpoint

Pharmacokinetics: Cmax

Time frame:0-300 minutes

concentration, descriptive

Secondary/registry result

Pharmacokinetics: Cmax

Time frame:0-300 minutes

concentration, descriptive

Posted result

GroupGeometric mean · pmol/L95% CI
Dasiglucagon 0.6 mg1160-
GlucaGen® 1.0 mg1120-
Secondary/protocol endpoint

Pharmacokinetics: Tmax

Time frame:0-300 minutes

concentration, descriptive

Secondary/registry result

Pharmacokinetics: Tmax

Time frame:0-300 minutes

concentration, descriptive

Posted result

GroupMedian · hours95% CI
Dasiglucagon 0.6 mg0.350.167 - 1.5
GlucaGen® 1.0 mg0.3330.167 - 0.5
Secondary/protocol endpoint

Pharmacokinetics: λz

Time frame:0-300 minutes

descriptive

Secondary/registry result

Pharmacokinetics: λz

Time frame:0-300 minutes

descriptive

Posted result

GroupGeometric least squares mean · 1/hour95% CI
Dasiglucagon 0.6 mg1.11-
GlucaGen® 1.0 mg0.504-
Secondary/protocol endpoint

Pharmacokinetics: t½

Time frame:0-300 minutes

descriptive

Secondary/registry result

Pharmacokinetics: t½

Time frame:0-300 minutes

descriptive

Posted result

GroupGeometric mean · hours95% CI
Dasiglucagon 0.6 mg0.623-
GlucaGen® 1.0 mg1.38-
Secondary/protocol endpoint

Pharmacokinetics: CL/f

Time frame:0-300 minutes

descriptive

Secondary/registry result

Pharmacokinetics: CL/f

Time frame:0-300 minutes

descriptive

Posted result

GroupGeometric mean · L/h95% CI
Dasiglucagon 0.6 mg96.1-
GlucaGen® 1.0 mg188-
Secondary/protocol endpoint

Pharmacokinetics: Vz/f

Time frame:0-300 minutes

descriptive

Secondary/registry result

Pharmacokinetics: Vz/f

Time frame:0-300 minutes

descriptive

Posted result

GroupGeometric least squares mean · litres95% CI
Dasiglucagon 0.6 mg86.4-
GlucaGen® 1.0 mg373-
Secondary/protocol endpoint

Pharmacokinetics: MRT

Time frame:0-300 minutes

descriptive

Secondary/registry result

Pharmacokinetics: MRT

Time frame:0-300 minutes

descriptive

Posted result

GroupGeometric mean · hours95% CI
Dasiglucagon 0.6 mg1.27-
GlucaGen® 1.0 mg1.86-

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Pharmacodynamics - Area Under the Effect Curve (0-30 Minutes)

Time frame:0-30 minutes

descriptive

Secondary/registry result/low confidence

Pharmacodynamics - Area Under the Effect Curve (0-30 Minutes)

Time frame:0-30 minutes

descriptive

Posted result

GroupMean · mmol*h/L95% CI
Dasiglucagon 0.6 mg22.83-
Placebo1.81-
GlucaGen® 1.0 mg19.66-

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

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.