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

• Status: Completed
• Trial end date: 2019-07-29
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zealand Pharma

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