A Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Type 1 Diabetes Subjects
Condition: Hypoglycemia; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Intervention: Dasiglucagon; GlucaGen; Placebo
Intervention description: Glucagon analog; Native glucagon; Placebo for dasiglucagon
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: 170.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Dasiglucagon; Glucagon analog

Summary:

      The objective of the trial is to demonstrate superiority of dasiglucagon compared to placebo
      following a single subcutaneous dose administered to subjects with type 1 diabetes mellitus
      (T1DM) with insulin-induced hypoglycemia. Additionally to compare the glycemic response
      observed after administration dasiglucagon with that of GlucaGen®.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female or male subjects with type 1 diabetes mellitus (T1DM) for at least 1 year,
             diagnostic criteria as defined by the American Diabetes Association

          -  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%

        Exclusion Criteria:

          -  Previously treated with dasiglucagon (previously referred to as ZP4207)

          -  Known or suspected allergy to trial product(s) or related products

          -  Females who are pregnant according to a positive pregnancy test, are actively
             attempting to get pregnant, or are lactating.

          -  History of hypoglycemic events associated with seizures in the last year prior to
             screening

          -  History of severe hypoglycemia in the last month prior to screening

          -  Active malignancy within the last 5 years

          -  Current bleeding disorder, including anti-coagulant treatment

          -  Known presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma
             (i.e. insulin secreting pancreas tumor)

          -  Use of a daily systemic beta-blocker drug, indomethacin, warfarin or anticholinergic
             drugs in the previous 28 days before Day 1 of this trial

          -  Clinically significant abnormal ECG at screening as judged by the investigator

          -  Donation of blood or plasma in the past month, or in excess of 500 mL within 12 weeks
             prior to screening

          -  Surgery or trauma with significant blood loss within the last 2 months 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