CompletedPhase 3Results posted

Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Subjects With T1DM

A Randomized, Double-blind, Parallel-group Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Rescue Treatment of Hypoglycemia in Subjects With Type 1 Diabetes Mellitus (T1DM) Compared to Placebo

Lead sponsor

Zealand Pharma

Asset

Dasiglucagon

Subcutaneous · Glucagon receptor agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Prediabetes / glucose intolerance, Type 1 diabetes

Eligibility highlights

•HbA1c ≤10%

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 IDNCT03688711

Org study IDZP4207-17145

Timeline

Milestones

Study first posted2018-09-28actual

Study start2018-11-01actual

Primary completion2019-03-11actual

Study completion2019-03-11actual

Last update posted2021-05-19actual

Results first posted2021-05-19actual

Assets

Investigational agents

Dasiglucagon

Who this study enrolls

Prediabetes / glucose intoleranceType 1 diabetes

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Female or male subjects with T1DM for at least 1 year; diagnostic criteria as defined by the American Diabetes Association (3).

•Treated with insulin for T1DM for at least 1 year and with stable insulin treatment (defined as no more than a 10-unit daily variation in total daily insulin dose) 30 days prior to screening

•Hemoglobin A1c <10%.

•Aged between 18 and 75 years, both inclusive.

Exclusion criteria

•Previous participation in a clinical trial within the dasiglucagon in the rescue treatment of hypoglycemia program.

•Known or suspected allergy to trial drug(s) or related products.

•History of anaphylaxis or symptoms of severe systemic allergy (such as angioedema).

•Previous participation in this trial. Participation being defined by signing the informed consent document.

Endpoints (24)

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

Safety / tolerability / PK

Other (unclassified)

Glycemic / diabetes

12 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

Group	Median · minutes	95% CI
Dasiglucagon 0.6 mg	10.0	8.0 - 12.0
Placebo	35.0	20.0 - NA

p<0.0001Log Rank

Secondary/protocol endpoint

Plasma Glucose Recovery After Trial Drug Injection

Time frame:0-30 minutes after dosing

concentration, descriptive

Secondary/registry result

Plasma Glucose Recovery After Trial Drug Injection

Time frame:0-30 minutes after dosing

concentration, descriptive

Posted result

Group	Participants	95% CI
Dasiglucagon 0.6 mgGlucose recovery within 30 minutes	33	-
Glucose recovery within 20 minutes	32	-
Glucose recovery within 15 minutes	30	-
Glucose recovery within 10 minutes	21	-
PlaceboGlucose recovery within 30 minutes	5	-
Glucose recovery within 20 minutes	1	-
Glucose recovery within 15 minutes	0	-
Glucose recovery within 10 minutes	0	-

p0.0012Fisher Exact

p<0.0001Fisher Exact

p0.0006Fisher Exact

Secondary/protocol endpoint

Plasma Glucose Changes From Baseline

Time frame:0-30 minutes after dosing

concentration, descriptive

Secondary/registry result

Plasma Glucose Changes From Baseline

Time frame:0-30 minutes after dosing

concentration, descriptive

Posted result

Group	Mean · mg/dL	95% CI
Dasiglucagon 0.6 mgAt 30 minutes	85.29	-
At 20 minutes	52.95	-
At 15 minutes	41.62	-
At 10 minutes	24.54	-
PlaceboAt 30 minutes	15.14	-
At 20 minutes	9.67	-
At 15 minutes	5.23	-
At 10 minutes	0.62	-

p<0.0001ANCOVA

Secondary/protocol endpoint

Time to Target Plasma Glucose Concentration

Time frame:0-45 minutes after dosing

time to event, event

Secondary/registry result

Time to Target Plasma Glucose Concentration

Time frame:0-45 minutes after dosing

time to event, event

Posted result

Group	Median · minutes	95% CI
Dasiglucagon 0.6 mg	9.0	8.0 - 10.0
Placebo	27.5	12.0 - 40.0

p<0.0001Log Rank

Secondary/protocol endpoint

Rescue Infusions of IV Glucose After Trial Drug Administration

Time frame:0-45 minutes after dosing

ratio, improvement

Secondary/registry result

Rescue Infusions of IV Glucose After Trial Drug Administration

Time frame:0-45 minutes after dosing

ratio, improvement

Posted result

Group	Participants	95% CI
Dasiglucagon 0.6 mg	1	-
Placebo	1	-

Secondary/protocol endpoint

Time to First Rescue Infusion of IV Glucose After Trial Drug Administration

Time frame:0-45 minutes after dosing

time to event, event

Secondary/registry result

Time to First Rescue Infusion of IV Glucose After Trial Drug Administration

Time frame:0-45 minutes after dosing

time to event, event

Posted result

Group	Number · minutes	95% CI
Dasiglucagon 0.6 mg	10	-
Placebo	14	-

Safety / tolerability / PK

10 endpoints

Secondary/protocol endpoint

Pharmacokinetics - Area Under the Plasma Concentration Curve

Time frame:0-90 minutes after dosing

concentration, descriptive

Secondary/registry result

Pharmacokinetics - Area Under the Plasma Concentration Curve

Time frame:0-90 minutes after dosing

concentration, descriptive

Posted result

Group	Geometric mean · hr*pmol/L	95% CI
Dasiglucagon 0.6 mg	1480	-

Secondary/protocol endpoint

Pharmacokinetics - Area Under the Plasma Concentration Curve

Time frame:0-120 minutes after dosing

concentration, descriptive

Secondary/registry result

Pharmacokinetics - Area Under the Plasma Concentration Curve

Time frame:0-120 minutes after dosing

concentration, descriptive

Posted result

Group	Geometric mean · hr*pmol/L	95% CI
Dasiglucagon 0.6 mg	1780	-

Secondary/protocol endpoint

Pharmacokinetics - Maximum Plasma Concentration

Time frame:0-120 minutes after dosing

concentration, descriptive

Secondary/registry result

Pharmacokinetics - Maximum Plasma Concentration

Time frame:0-120 minutes after dosing

concentration, descriptive

Posted result

Group	Geometric mean · pmol/L	95% CI
Dasiglucagon 0.6 mg	1350	-

Secondary/protocol endpoint

Pharmacokinetics - Time to Maximum Plasma Concentration

Time frame:0-120 minutes after dosing

time to event, event

Secondary/registry result

Pharmacokinetics - Time to Maximum Plasma Concentration

Time frame:0-120 minutes after dosing

time to event, event

Posted result

Group	Median · minutes	95% CI
Dasiglucagon 0.6 mg	35	15 - 60

Secondary/protocol endpoint

Immunogenicity - Occurrence of Anti-drug Antibodies

Time frame:58 days

descriptive

Secondary/registry result

Immunogenicity - Occurrence of Anti-drug Antibodies

Time frame:58 days

descriptive

Posted result

Group	Participants	95% CI
Dasiglucagon 0.6 mg	0	-
Placebo	0	-

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Pharmacodynamics - Area Under the Effect Curve

Time frame:0-30 minutes after dosing

descriptive

Secondary/registry result/low confidence

Pharmacodynamics - Area Under the Effect Curve

Time frame:0-30 minutes after dosing

descriptive

Posted result

Group	Mean · hr*mg/dL	95% CI
Dasiglucagon 0.6 mg	19.9	-
Placebo	2.67	-

Odds ratio (or)4.0595% CI2.71 - 6.05p<0.0001ANCOVA

The analysis was an analysis of covariance (ANCOVA) model with treatment group as factor and the baseline of the dependent variable plasma glucose as a covariate.

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.