CompletedPhase 3

A Trial to Compare the Efficacy and Safety of 2 Different Batches of Subcutaneous Dasiglucagon in Patients With T1DM

A Phase 3b, Randomized, Double-blind, Crossover Trial to Compare the Efficacy and Safety of 2 Different Batches of Subcutaneous Dasiglucagon in Patients With Type 1 Diabetes Mellitus

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 IDNCT03895697

Org study IDZP4207-17084

Timeline

Milestones

Study start2019-03-26actual

Study first posted2019-03-29actual

Primary completion2019-07-30actual

Study completion2019-07-30actual

Last update posted2023-02-21actual

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

•Type 1 diabetes mellitus for at least 1 year according to the diagnostic criteria as defined by the American Diabetes Association.

•Hemoglobin A1c <10.0% at screening

•Treated with stable insulin treatment (defined as no more than a 10-unit daily variation in total daily insulin dose) 30 days prior to screening

Exclusion criteria

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

•History of severe hypoglycemia (an episode requiring assistance from another person) in the last month prior to screening

•Previous participation in a clinical trial within the dasiglucagon program

Endpoints (19)

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

Safety / tolerability / PK

Glycemic / diabetes

Other (unclassified)

Glycemic / diabetes

4 endpoints

Primary/protocol endpoint

Time to plasma glucose recovery

Time frame:0-45 minutes after dosing

time to event, event

Secondary/protocol endpoint

Plasma glucose changes from baseline

Time frame:0-30 minutes after dosing

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamics - Maximum plasma glucose concentration

Time frame:0-90 minutes after dosing

concentration, descriptive

Secondary/protocol endpoint

Pharmacodynamics - Time maximum plasma glucose concentration

Time frame:0-90 minutes after dosing

concentration, descriptive

Safety / tolerability / PK

13 endpoints

Secondary/protocol endpoint

Pharmacokinetics - Area under the plasma concentration-time curve 30 min

Time frame:0-30 minutes after dosing

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics - Area under the plasma concentration-time curve 300 min