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

Zealand Pharma

Status and phase: Completed; Phase 3

Conditions: Hypoglycemia; Diabetes Mellitus, Type 1

Treatments: Drug: dasiglucagon

Study type: Interventional

Funder types: Industry

Identifiers

NCT03895697

ZP4207-17084

Details and patient eligibility

About

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)

Full description

This multicenter, double-blind, crossover, randomized clinical trial was designed to evaluate the efficacy and safety of 2 different batches of subcutaneous dasiglucagon in patients with T1DM. Patients were randomly assigned 1:1 to either dasiglucagon Batch A or dasiglucagon Batch B as their initial dose and the other as the second dose. To avoid bias in the evaluation of clinical assessments, the trial was conducted in a double-blinded manner.

Enrollment: 92 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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92 participants in 2 patient groups

Dasiglucagon batch A crossover to dasiglucagon batch B

Experimental group

Description:

V2: Single fixed dose (subcutaneous injection) of dasiglucagon batch A then at V3: Single fixed dose (subcutaneous injection) of dasiglucagon batch B

Treatment:

Drug: dasiglucagon

Dasiglucagon batch B crossover to dasiglucagon batch A

Experimental group

Description:

V2: Single fixed dose (subcutaneous injection) of dasiglucagon batch B then at V3: Single fixed dose (subcutaneous injection) of dasiglucagon batch A

Treatment:

Drug: dasiglucagon