CompletedPhase 3Results posted

A Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Type 1 Diabetes Subjects

A Phase 3, Randomized, Double-blind, Parallel Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in Rescue Treatment of Hypoglycemia in Subjects With Type 1 Diabetes Mellitus Compared to Placebo and With Reference to GlucaGen

Lead sponsor

Zealand Pharma

Asset

Dasiglucagon

Subcutaneous · Glucagon receptor agonist

Listed sites

Recruiting sites

Actual enrollment

170

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 IDNCT03378635

Org study IDZP4207-16137

Timeline

Milestones

Study start2017-12-07actual

Study first posted2017-12-20actual

Primary completion2018-04-27actual

Study completion2018-05-25actual

Results first posted2021-05-10actual

Last update posted2021-06-10actual

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 type 1 diabetes mellitus (T1DM) for at least 1 year, diagnostic criteria as defined by the American Diabetes Association

•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%

Exclusion criteria

•Previously treated with dasiglucagon (previously referred to as ZP4207)

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

•Females who are pregnant according to a positive pregnancy test, are actively attempting to get pregnant, or are lactating.

•History of hypoglycemic events associated with seizures in the last year prior to screening

•History of severe hypoglycemia in the last month prior to screening

•Active malignancy within the last 5 years

•Current bleeding disorder, including anti-coagulant treatment

•Known presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma (i.e. insulin secreting pancreas tumor)

•Use of a daily systemic beta-blocker drug, indomethacin, warfarin or anticholinergic drugs in the previous 28 days before Day 1 of this trial

•Clinically significant abnormal ECG at screening as judged by the investigator

•Donation of blood or plasma in the past month, or in excess of 500 mL within 12 weeks prior to screening

•Surgery or trauma with significant blood loss within the last 2 months prior to screening

•A positive result in the alcohol and/or urine drug screen at the screening visit. Significant history of alcoholism or drug abuse as judged by the investigator or consuming more than 24 g alcohol per day for men, or more than 12 g alcohol per day for women

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

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

Group	Median · minutes	95% CI
Dasiglucagon 0.6 mg	10	10 - 10
Placebo	40	30 - 40
GlucaGen® 1.0 mg	12	10 - 12

p<0.001Log Rank

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

Group	Participants	95% CI
Dasiglucagon 0.6 mgGlucose recovery at 30 minutes	82	-
Glucose recovery at 20 minutes	81	-
Glucose recovery at 15 minutes	81	-
Glucose recovery at 10 minutes	53	-
PlaceboGlucose recovery at 30 minutes	20	-
Glucose recovery at 20 minutes	6	-
Glucose recovery at 15 minutes	1	-
Glucose recovery at 10 minutes	0	-
GlucaGen® 1.0 mgGlucose recovery at 30 minutes	43	-
Glucose recovery at 20 minutes	42	-
Glucose recovery at 15 minutes	41	-
Glucose recovery at 10 minutes	21	-

p<0.001Fisher Exact

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

Group	Mean · mg/dL	95% CI
Dasiglucagon 0.6 mgAt 30 minutes	90.9	-
At 20 minutes	59.7	-
At 15 minutes	43.5	-
At 10 minutes	23.9	-
PlaceboAt 30 minutes	19.1	-
At 20 minutes	8.7	-
At 15 minutes	6.65	-
At 10 minutes	-0.14	-
GlucaGen® 1.0 mgAt 30 minutes	88.5	-
At 20 minutes	58.4	-
At 15 minutes	44.1	-
At 10 minutes	22.0	-

p<0.001ANCOVA

Secondary/protocol endpoint

Rescue Infusion of IV Glucose During the Hypoglycemic Clamp Procedure

Time frame:0-45 minutes after dosing

descriptive

Secondary/registry result

Rescue Infusion of IV Glucose During the Hypoglycemic Clamp Procedure

Time frame:0-45 minutes after dosing

descriptive

Posted result

Group	Participants	95% CI
Dasiglucagon 0.6 mg	0	-
Placebo	0	-
GlucaGen® 1.0 mg	0	-

Secondary/protocol endpoint

Time to First Rescue Infusion of IV Glucose

Time frame:0-45 minutes after dosing

time to event, event

Secondary/registry result

Time to First Rescue Infusion of IV Glucose

Time frame:0-45 minutes after dosing

time to event, event

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 · pmol*h/L	95% CI
Dasiglucagon 0.6 mg	1430	-
GlucaGen® 1.0 mg	1300	-

Mean difference (net)0.9195% CI0.801 - 1.033p0.144ANCOVA

Least square mean ratio for GlucaGen: dasiglucagon

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 · pmol*h/L	95% CI
Dasiglucagon 0.6 mg	1770	-
GlucaGen® 1.0 mg	1490	-

Mean difference (net)0.84495% CI0.749 - 0.951p0.006ANCOVA

Least square mean ratio for GlucaGen: dasiglucagon

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	1280	-
GlucaGen® 1.0 mg	1490	-

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 · hours	95% CI
Dasiglucagon 0.6 mg	0.670	0.250 - 1.00
GlucaGen® 1.0 mg	0.250	0.230 - 0.670

Secondary/protocol endpoint

Immunogenicity - Occurence of Anti-drug Antibodies

Time frame:28 days

descriptive

Secondary/registry result

Immunogenicity - Occurence of Anti-drug Antibodies

Time frame:28 days

descriptive

Posted result

Group	Participants	95% CI
Dasiglucagon 0.6 mgAnti-drug antibodies at follow-up day 28	1	-
Anti-drug antibodies at second follow up	0	-
GlucaGen® 1.0 mgAnti-drug antibodies at follow-up day 28	0	-
Anti-drug antibodies at second follow up	0	-

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

Time to Target

Time frame:0-45 minutes after dosing

time to event, event

Secondary/registry result/low confidence

Time to Target

Time frame:0-45 minutes after dosing

time to event, event

Posted result

Group	Median · minutes	95% CI
Dasiglucagon 0.6 mg	8	8 - 8
Placebo	25	20 - 30
GlucaGen® 1.0 mg	8	8 - 10

p<0.001Log Rank

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 · mg*h/dL	95% CI
Dasiglucagon 0.6 mg	21.0	-
Placebo	3.57	-
GlucaGen® 1.0 mg	20.4	-

Mean difference (net)0.13195% CI0.1 - 0.171p<0.001ANCOVA

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Pieber TR, Aronson R, Hovelmann U, Willard J, Plum-Morschel L, Knudsen KM, Bandak B, Tehranchi R. Dasiglucagon-A Next-Generation Glucagon Analog for Rapid and Effective Treatment of Severe Hypoglycemia: Results of Phase 3 Randomized Double-Blind Clinical Trial. Diabetes Care. 2021 Jun 1;44(6):1361-1367. doi: 10.2337/dc20-2995.
PMID35239971via clinicaltrials gov reference derived

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.