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CompletedPhase 2

Low-dose Dasiglucagon for Prevention of Insulin-Induced Hypoglycemia in People With Type 1 Diabetes

Asset

Dasiglucagon

Subcutaneous · Glucagon receptor agonist

Listed sites

1

Recruiting sites

-

Actual enrollment

20

Study population

Prediabetes / glucose intolerance, Type 1 diabetes

Eligibility highlights

•HbA1c ≤8%

Primary endpoint

•Difference between study visits in time (min) in hypoglycemia from 0-180

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 IDNCT04449692
Org study IDH-20013256
Secondary ID2020-000551-12

Timeline

Milestones

Study first posted2020-06-29actual
Study start2020-07-02actual
Primary completion2021-01-04actual
Study completion2021-01-04actual
Last update posted2021-02-09actual

Assets

Investigational agents

Dasiglucagon

Who this study enrolls

Prediabetes / glucose intoleranceType 1 diabetes

Who can enroll

Minimum age18 Years
Maximum age64 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Age 18-64 years
•Duration of T1D ≥ 3 years
•Use of CSII or MDI therapy for ≥ 6 months
•Current use of Novorapid (change from another fast-acting insulin to Novorapid prior to study initiation is allowed)
•HbA1c ≤ 8.0%
•Regular use of carbohydrate counting in the judgement of the investigator

Exclusion criteria

•Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
•History of allergy or intolerance to glucagon or glucagon-like products
•Patients with pheochromocytoma
•Clinically significant ECG abnormalities
•Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (sterilization, intrauterine device, contraceptive pill, patch or injection)
•Inability to understand the individual information and to give informed consent
•Current participation in another clinical trial that, in the judgment of the principle investigator, will compromise the results of the study or the safety of the subject
•Other concomitant medical or psychological condition that, according to the investigator's assessment, makes the individual unsuitable for study participation

Endpoints (25)

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
17
Safety / tolerability / PK
4
Other (unclassified)
4

Glycemic / diabetes

17 endpoints
Primary/protocol endpoint

Difference between study visits in time (min) in hypoglycemia (plasma glucose < 3.9 mmol/l) from 0-180 minutes post-intervention

Time frame:Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

concentration, descriptive

Secondary/protocol endpoint

Difference between study visits in incidence rate of hypoglycemia (plasma glucose < 3.9 mmol/l) from 0-180 minutes post-intervention

Time frame:Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

concentration, descriptive

Secondary/protocol endpoint

Difference between study visits in incidence rate of level 2 hypoglycemia (plasma glucose < 3.0 mmol/l) from 0-180 minutes post-intervention

Time frame:Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

concentration, descriptive

Secondary/protocol endpoint

Difference between study visits in incidence rate of rebound hyperglycemia (plasma glucose > 10 mmol/l) from 0-180 minutes post-intervention

Time frame:Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

concentration, descriptive

Secondary/protocol endpoint

Difference between study visits in nadir plasma glucose concentration from 0-180 minutes post-intervention

Time frame:Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

concentration, descriptive

Secondary/protocol endpoint

Difference between study visits in peak plasma glucose concentration from 0-180 minutes post-intervention

Time frame:Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

concentration, descriptive

Secondary/protocol endpoint

Difference between study visits in incremental peak in plasma glucose concentration from 0-180 minutes post-intervention

Time frame:Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

concentration, descriptive

Secondary/protocol endpoint

Difference between study visits in mean plasma glucose concentration from 0-180 minutes post-intervention

Time frame:Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

concentration, descriptive

Secondary/protocol endpoint

Difference between study visits in time (min) from intervention to first increase in plasma glucose concentration of 1.1 mmol/l

Time frame:Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

concentration, descriptive

Secondary/protocol endpoint

Difference between study visits in plasma glucose Area Under the Curve (AUC) from 0-180 minutes post-intervention

Time frame:Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

concentration, descriptive

Secondary/protocol endpoint

Difference between study visits in time (min) to peak plasma glucose concentration from 0-180 minutes post-intervention

Time frame:Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

concentration, descriptive

Secondary/protocol endpoint

Difference between study visits in time (min) in range (plasma glucose ≥ 3.9 mmol/l and 10.0 mmol/l) from 0-180 minutes post-intervention

Time frame:Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

threshold achievement, improvement

Secondary/protocol endpoint

Difference between study visits in time (min) in hyperglycemia (plasma glucose > 10 mmol/l) from 0-180 minutes post-intervention

Time frame:Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

concentration, descriptive

Secondary/protocol endpoint

Difference between study visits in time (%) in hypoglycemia (plasma glucose < 3.9 mmol/l) (per protocol) from 0-180 minutes post-intervention

Time frame:Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

concentration, descriptive

Secondary/protocol endpoint

Difference between study visits in serum insulin concentration at visit start (t = 0) and immediately before administration of the intervention (t-intervention = 0)

Time frame:Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

concentration, descriptive

Secondary/protocol endpoint

Difference between study visits in serum insulin AUC from 0-180 minutes post-intervention

Time frame:Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

concentration, descriptive

Secondary/protocol endpoint

Difference between study visits in dose (units) of insulin bolus at study start (t = 0)

Time frame:Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

descriptive

Safety / tolerability / PK

4 endpoints
Secondary/protocol endpoint

Difference between study visits in plasma dasiglucagon Area Under the Curve (AUC) from 0-180 minutes post-intervention

Time frame:Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

concentration, descriptive

Secondary/protocol endpoint

Difference between study visits in change in Edinburgh Hypoglycemia Symptoms Scale (EHSS) from 0-180 minutes post-intervention

Time frame:Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

change from baseline, event

Secondary/protocol endpoint

Difference between study visits in change in visual analogue scale (VAS) for nausea, headache, stomach ache, injection site pain, palpitations and hunger from 0-180 minutes post-intervention

Time frame:Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

change from baseline, event

Secondary/protocol endpoint

Difference between study visits in incidence rate of vomiting from 0-180 minutes post-intervention

Time frame:Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

descriptive

Other (unclassified)

4 endpoints
Secondary/protocol endpoint/low confidence

Difference between study visits in incidence rate of rescue carbohydrate administration from 0-180 minutes post-intervention

Time frame:Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

ratio, improvement

Secondary/protocol endpoint/low confidence

Difference between study visits in time (min) to rescue carbohydrate administration from 0-180 minutes post-intervention

Time frame:Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

ratio, improvement

Secondary/protocol endpoint/low confidence

Difference between study visits in peak plasma dasiglucagon concentration from 0-180 minutes post-intervention

Time frame:Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

concentration, descriptive

Secondary/protocol endpoint/low confidence

Difference between study visits in time to peak plasma dasiglucagon concentration from 0-180 minutes post-intervention

Time frame:Study visit 1 (day 1), study visit 2 (estimated day 4) and study visit 3 (estimated day 7)

time to event, 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

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.