A Trial to Evaluate the Immunogenicity of Dasiglucagon and GlucaGen in Patients With Type 1 Diabetes Mellitus
Condition: Hypoglycemia; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Intervention: dasiglucagon; GlucaGen
Intervention description: Glucagon Analog; Native Glucagon
Intervention MeSH terms: Glucagon
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Glucagon; Dasiglucagon

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
    

Eligibility 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