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

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