Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Subjects With T1DM

• Status: Completed
• Trial end date: 2019-03-11
• Target enrollment: 0
• Participant gender: All

Summary

A randomized, double-blind, parallel-group trial to confirm the clinical efficacy and safety of dasiglucagon in the rescue treatment of hypoglycemia in subjects with type 1 diabetes mellitus (T1DM) compared to placebo

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

Details

• Lead Sponsor: Zealand Pharma

Criteria

Inclusion Criteria:

• Female or male subjects with T1DM for at least 1 year; diagnostic criteria as defined by the American Diabetes Association (3).

• Treated with insulin for T1DM for at least 1 year and with stable insulin treatment (defined as no more than a 10-unit daily variation in total daily insulin dose) 30 days prior to screening

• Hemoglobin A1c <10%.

• Aged between 18 and 75 years, both inclusive.

Exclusion Criteria:

• Previous participation in a clinical trial within the dasiglucagon in the rescue treatment of hypoglycemia program.

• Known or suspected allergy to trial drug(s) or related products.

• History of anaphylaxis or symptoms of severe systemic allergy (such as angioedema).

• Previous participation in this trial. Participation being defined by signing the informed consent document.