WithdrawnPhase EARLY_1

Micro Glucagon During Exercise in Type 1 Diabetes

Subcutaneous Dasiglucagon Use During Exercise In People With Type 1 Diabetes: Effects On Plasma Glucose And Exercise Metabolism

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Asset

Dasiglucagon

Subcutaneous · Glucagon receptor agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Prediabetes / glucose intolerance, Type 1 diabetes

Eligibility highlights

•HbA1c ≤8%

Primary endpoint

•Hypoglycaemia

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 IDNCT04192019

Org study IDGLU-01

Timeline

Milestones

Study first posted2019-12-10actual

Last update posted2023-09-01actual

Study start2023-04estimated (month precision)

Primary completion2024-04estimated (month precision)

Study completion2024-06estimated (month precision)

Assets

Investigational agents

Dasiglucagon

Who this study enrolls

Prediabetes / glucose intoleranceType 1 diabetes

Who can enroll

Minimum age18 Years

Maximum age45 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•T1D for >1 year

•Male aged 18-45 years old

•HbA1c <8.0% (64 mmol/mol) based on analysis from the central laboratory unit of Bern University Hospital

•Regular physical activity (defined as meeting 150 min moderate-intensity exercise per week)

•Using either continuous subcutaneous insulin infusion or multiple daily injections

•Written informed consent

Exclusion criteria

•Physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the results as judged by the investigator

•Current treatment with drugs known to interfere with metabolism e.g. systemic corticosteroids, statins, SGLT2 inhibitors, GLP1 agonists

•Relevant diabetic complications as judged by the investigator

•Body mass index 30 kg/m2

•Uncontrolled hypertension (>180/100 mmHg)

Endpoints (9)

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

1 endpoint

Secondary/protocol endpoint

Glucose during exercise

Time frame:60 minutes

descriptive

Safety / tolerability / PK

3 endpoints

Primary/protocol endpoint

Time to hypoglycaemia

Time frame:60 minutes

time to event, event

Secondary/protocol endpoint

Hypoglycaemia

Time frame:24 hours

descriptive

Secondary/protocol endpoint

Any adverse events

Time frame:24 hours

descriptive