CompletedPhase 2

Pen-Administered Low-Dose Dasiglucagon for Prevention and Treatment of Hypoglycemia in People With Type 1 Diabetes

Pen-Administered Low-Dose Dasiglucagon for Prevention and Treatment of Hypoglycemia in People With Type 1 Diabetes: A Randomized, Open-Label, Two-Period Crossover Outpatient Study

Lead sponsor

Steno Diabetes Center Copenhagen

Asset

Dasiglucagon

Subcutaneous · Glucagon receptor agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Prediabetes / glucose intolerance, Type 1 diabetes

Eligibility highlights

Primary endpoint

•Percentage of time in range between the two study periods

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 IDNCT04764968

Org study ID77119

Secondary ID2020-005745-16

Secondary IDH-21000002Regional Scientific Ethics Committee

Timeline

Milestones

Study first posted2021-02-21actual

Study start2021-04-27actual

Primary completion2021-12-30actual

Study completion2022-01-28actual

Last update posted2022-09-07actual

Assets

Investigational agents

Dasiglucagon

Who this study enrolls

Prediabetes / glucose intoleranceType 1 diabetes

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age ≥ 18 years

•T1D ≥ 2 years

•Use of insulin pump therapy (without sensor-augmented insulin suspension/adjustment functionality) ≥ 6 months

•Use of CGM (real-time or intermittently scanned) ≥ 3 months and ≥ 70% during the previous 14 days

•HbA1c ≤ 70 mmol/l (8.5%)

•Performs aerobic exercise on a regular basis (≥ 2 times per week; self-reported) and desires to exercise per American Diabetes Association guidelines (150 minutes per week) during the study.

•Use of carbohydrate counting and bolus calculator (self-reported)

•Sensor glucose level < 3.9 mmol/l on ≥ 4/14 previous days assessed by CGM data

Exclusion criteria

•Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period and within 30 days prior to study start

•Known or suspected allergies to glucagon or related products

•History of hypersensitivity or allergic reaction to dasiglucagon or any of the excipients

•Patients with pheochromocytoma or insulinoma

•Hypoglycemia unawareness

•Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods

•Inability to understand the individual information and to give informed consent

•Current participation in another clinical trial that, in the judgment of the investigator, will compromise the results of the study or the safety of the subject

•Concomitant medical or psychological conditions identified through review of medical history, physical examination and clinical laboratory analysis that, according to the investigator's assessment, makes the individual unsuitable for study participation

Endpoints (15)

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

Other (unclassified)

Safety / tolerability / PK

Glycemic / diabetes

Patient-reported / QoL

Glycemic / diabetes

3 endpoints

Primary/protocol endpoint

Difference in percentage of time in range between the two study periods

Time frame:2-week 'usual care' period and 2-week 'dasiglucagon' period

descriptive

Secondary/protocol endpoint

Difference in successful cases (%) of hypoglycemia treatment without subsequent hyperglycemia [sensor glucose level > 10 mmol/l during the first two hours post-treatment] between the two study periods

Time frame:2-week 'usual care' period and 2-week 'dasiglucagon' period

descriptive

Secondary/protocol endpoint

Difference between the average total daily insulin dose between the two study periods

Time frame:2-week 'usual care' period and 2-week 'dasiglucagon' period

descriptive

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Percentage of participants scoring a favorable outcome on the patient-reported outcome questionnaire

Time frame:At the end-of-study visit (estimated week 6)

threshold achievement, improvement

Safety / tolerability / PK

5 endpoints

Secondary/protocol endpoint

Difference in percentage of time in hypoglycemia between the two study periods

Time frame:2-week 'usual care' period and 2-week 'dasiglucagon' period

descriptive

Secondary/protocol endpoint

Difference between successful cases (%) of hypoglycemia treatment between the two study periods

Time frame:2-week 'usual care' period and 2-week 'dasiglucagon' period

descriptive

Secondary/protocol endpoint

Difference in successful cases (%) of hypoglycemia prevention between the two study periods

Time frame:2-week 'usual care' period and 2-week 'dasiglucagon' period

descriptive

Secondary/protocol endpoint

Difference in time from hypoglycemia treatment to euglycemia between the two study periods

Time frame:2-week 'usual care' period and 2-week 'dasiglucagon' period

descriptive

Secondary/protocol endpoint

Difference in the number and intensity of episodes with nausea, headache, stomach-ache, palpitations and injection site pain between the two study periods

Time frame:2-week 'usual care' period and 2-week 'dasiglucagon' period

event count, event

Other (unclassified)

6 endpoints

Secondary/protocol endpoint/low confidence

Difference in percentage of time in hyperglycemia between the two study periods

Time frame:2-week 'usual care' period and 2-week 'dasiglucagon' period

descriptive

Secondary/protocol endpoint/low confidence

Difference in coefficient of variation (%) between the two study periods

Time frame:2-week 'usual care' period and 2-week 'dasiglucagon' period

descriptive

Secondary/protocol endpoint/low confidence

Incidence rate of supplement carbohydrate administration during the first hour following dasiglucagon administration

Time frame:2-week 'dasiglucagon' period

ratio, improvement

Secondary/protocol endpoint/low confidence

Difference between the average daily carbohydrate intake between the two study periods

Time frame:2-week 'usual care' period and 2-week 'dasiglucagon' period

descriptive

Secondary/protocol endpoint/low confidence

Percentage of participants with treatment-induced or treatment-boosted anti-dasiglucagon antibodies

Time frame:Measured 4 weeks after the 'dasiglucagon' period

threshold achievement, improvement

Other/protocol endpoint/low confidence

Number of device failures/malfunctions

Time frame:2-week 'dasiglucagon' period

event count, event

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

Laugesen C, Ranjan AG, Schmidt S, Norgaard K. Pen-administered low-dose dasiglucagon vs usual care for prevention and treatment of non-severe hypoglycaemia in people with type 1 diabetes during free-living conditions: a Phase II, randomised, open-label, two-period crossover trial. Diabetologia. 2023 Jul;66(7):1208-1217. doi: 10.1007/s00125-023-05909-4. Epub 2023 Apr 11.
PMID37037948via 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 tableno registry results posted yet

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.