A Trial to Evaluate the Immunogenicity of Dasiglucagon and GlucaGen in Patients With Type 1 Diabetes Mellitus

• Status: Completed
• Trial end date: 2018-02-13
• Target enrollment: 0
• Participant gender: All

Summary

The trial's objective is to evaluate the immunogenicity of repeated single doses of dasiglucagon* and GlucaGen following subcutaneous (SC) administration in patients with type 1 diabetes mellitus (T1DM) and further to evaluate the safety and tolerability of dasiglucagon and GlucaGen.

*dasiglucagon is the proposed International Nonproprietary Name (pINN) for ZP4207

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

Details

• Lead Sponsor: Zealand Pharma
• Collaborator: SynteractHCR
• Treatments: Glucagon

Criteria

Inclusion Criteria:

• Informed consent obtained before any trial-related activities (trial-related activities are any procedure that would not have been performed during normal management of the patient)

• Availability for the entire trial period

• Age between 18 and 70 years, both inclusive

• Male or female patients with T1DM for at least 1 year. Diagnostic criteria as defined by the American Diabetes Association

• Hemoglobin A1c (HbA1c) <10%

• Stable anti-diabetic treatment for at least 1 month (e.g. within 10% insulin dose adjustment)

Exclusion Criteria:

• Previous administration of dasiglucagon (previously referred to as ZP4207)

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

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

• Previous participation (randomization) in this trial

• Females who are pregnant according to a positive pregnancy test, actively attempting to get pregnant, or are lactating

• Patients on a closed loop artificial pancreas

• Receipt of any investigational drug within 3 months prior to screening

• Active malignancy within the last 5 years

• Congestive heart failure, New York Heart Association class II-IV

• Inadequately treated blood pressure as defined as systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥90 mmHg at screening

• Current bleeding disorder, including use of anticoagulant treatment

• Known presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma (i.e. insulin-secreting pancreas tumor)

• Known or suspected HIV infection

• Use of a systemic beta-blocker drug, indomethacin, warfarin or anticholinergic drugs in the previous 28 days before Day 1 of this trial

• Use of systemic corticosteroids, anti-inflammatory biological agents, kinase inhibitors or other immune modulating agents within the last 3 months prior to screening

• Donation of blood or plasma in the past month, or in excess of 500 mL within 12 weeks prior to screening

• A positive result in the alcohol and/or urine drug screen at the screening visit. Significant history of alcoholism or drug abuse as judged by the investigator or consuming more than 24 g alcohol per day for men, or more than 12 g alcohol per day for women.

• Surgery or trauma with significant blood loss within the last 2 months prior to screening

• Use of prescription or non-prescription medications known to cause QT prolongation