Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children
Condition: Hypoglycemia
MeSH terms: Hypoglycemia
Intervention: dasiglucagon; placebo; GlucaGen HypoKit
Intervention description: glucagon analog; placebo for dasiglucagon; 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: 42.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Glucagon; Dasiglucagon

Summary:

      A phase 3, randomized, double-blind, placebo- and active-controlled, parallel-arm trial to
      assess the efficacy, safety, and pharmacokinetics of dasiglucagon relative to placebo and
      GlucaGen® when administered as a rescue therapy for severe hypoglycemia in children with type
      1 diabetes mellitus (T1DM) treated with insulin
    

Eligibility criteria:

        Inclusion Criteria:

          1. Following receipt of verbal and written information about the trial, patient,
             parent(s) or guardian(s) of the patient must provide signed informed consent before
             any trial-related activity is carried out

          2. Female or male patients with T1DM for at least 1 year, diagnostic criteria as defined
             by the American Diabetes Association; and receiving daily insulin

          3. At least 6.0 years of age (inclusive) and less than 18.0 years

          4. Body weight ≥20 kg

          5. Female patients must meet one of the following criteria:

             a. Participant is of childbearing potential and agrees to use one of the accepted
             contraceptive regimens throughout the entire duration of the trial from screening
             until last follow-up visit. An acceptable method of contraception includes at least
             one of the following: i. Abstinence from heterosexual intercourse ii. Systemic
             contraceptives (birth control pills, injectable/implant/ insertable hormonal birth
             control products, transdermal patch); if the participant is using systemic
             contraceptives, she must use an additional form of acceptable contraception (iii or
             iv, below) iii. Intrauterine device (with and without hormones) iv. Condom with
             spermicide or b. Participant is of non-childbearing potential due to pre-puberty
             status or a medical condition confirmed by the investigator

          6. Male patients must meet the following criteria: If sexually active, uses condom and
             partner practices contraception during the trial from screening and until last
             follow-up visit

          7. Willingness to adhere to the protocol requirements

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             Exclusion Criteria:

        1. Females who are pregnant according to a positive urine pregnancy test, actively
        attempting to get pregnant, or are lactating 2. Known or suspected allergy to trial
        product(s) or related products 3. History of anaphylaxis or symptoms of severe systemic
        allergy (such as angioedema) 4. Previous randomization in this trial 5. History of an
        episode of severe hypoglycemia that required a third party assistance within a month prior
        to screening visit 6. History of hypoglycemic events associated with seizures or
        hypoglycemia unawareness in the last year prior to screening 7. History of epilepsy or
        seizure disorder 8. Receipt of any investigational drug within 3 months prior to screening
        9. Active malignancy within the last 5 years 10. Congestive heart failure, New York Heart
        Association class II-IV 11. Current bleeding disorder, including anti-coagulant treatment
        12. Known presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma
        (i.e. insulin secreting pancreas tumor) 13. Use of a daily systemic beta-blocker drug,
        indomethacin, warfarin or anticholinergic drugs in the previous 28 days before Day 1 of
        this trial 14. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 ×
        the upper limit of the normal range (ULN), bilirubin >1.5 × ULN, estimated glomerular
        filtration rate <30 mL/min/1.73 m2 according to the Modification of Diet in Renal Disease
        study definition, or altered electrolyte values of clinical relevance for cardiac
        conduction, as judged by the investigator 15. Clinically significant abnormal
        electrocardiogram (ECG) at screening as judged by the investigator 16. Clinically
        significant illness within 4 weeks before screening, as judged by the investigator 17.
        Surgery or trauma with significant blood loss within the last 2 months prior to screening
        18. Patients with mental incapacity or language barriers which preclude adequate
        understanding or cooperation, who are unwilling to participate in the trial, or who in the
        opinion of the investigator should not participate in the trial 19. Any condition
        interfering with trial participation or evaluation or that could be hazardous to the
        patient 20. The use of prescription or non-prescription medications known to cause QT
        prolongation

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