Clinical trial

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

Name

ZP4207-17084

Description

A 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 (T1DM)

Trial arms

Trial start

2019-03-26

Estimated PCD

2019-07-30

Trial end

2019-07-30

Status

Completed

Phase

Early phase I

Treatment

dasiglucagon

Glucagon analogue

Arms:

Dasiglucagon batch A crossover to dasiglucagon batch B, Dasiglucagon batch B crossover to dasiglucagon batch A

Other names:

ZP4207

Size

Primary endpoint

Time to plasma glucose recovery

0-45 minutes after dosing

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 92, 'type': 'ACTUAL'}}

Updated at

2023-02-21

1 organization

1 product

3 indications

Organization

Product

Indication

Indication

Indication