Clinical Usability of Nasal Glucagon in Treatment of Hypoglycemia in Children and Adolescents
Condition: Hypoglycemia; Diabetes Mellitus
MeSH terms: Hypoglycemia
Intervention: Nasal Glucagon
Intervention description: 3 mg nasal glucagon powder
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 4 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      Up to fifty (50) children and adolescents with type 1 diabetes (T1D) aged 4 to ˂18 years at
      time of enrolment will be selected for inclusion in the study. The target is to obtain
      treatment response and user-experience data following use of Nasal Glucagon (LY900018) in
      treating episodes of hypoglycemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Availability for the entire study period.

          -  Motivated Child/Adolescent with diabetes (C/AWD) and caregiver(s) and absence of
             intellectual problems likely to limit the validity of consent to participate in the
             study or the compliance with protocol requirements; ability to cooperate adequately;
             ability to understand and observe the instructions of the qualified investigator or
             designee.

          -  C/AWD lives with one or more caregivers who are available to administer the glucagon
             in case of an episode of severe or moderate hypoglycemia.

          -  Male or female C/AWD with a history of type 1 diabetes >1 year.

          -  C/AWD aged of at least 4 years of age but less than 18 years.

          -  A female C/AWD must meet one of the following criteria:

             a) Participant is of child-bearing potential and agrees to use one of the accepted
             contraceptive regimens throughout the entire duration of the study (from the pre-trial
             evaluation and enrollment visit until study completion). An acceptable method of
             contraception includes one of the following: (i) Abstinence from heterosexual
             intercourse (ii) Systemic contraceptives (birth control pills, injectable/implantable/
             insertable hormonal birth control products, transdermal patch) (iii) Intrauterine
             device (iv) Condom with spermicide, OR b) Participant is of non-child-bearing
             potential, defined as a female who had had a hysterectomy or tubal ligation, is
             clinically considered infertile or has not yet reached menarche.

          -  In good general health with no conditions that could influence the outcome of the
             trial, and in the judgment of the Investigator is a suitable candidate for the study
             based on review of available medical history, physical examination and clinical
             laboratory evaluations.

          -  Willingness to adhere to the protocol requirements.

        Exclusion Criteria:

          -  Females who are pregnant according to a positive urine pregnancy test, actively
             attempting to get pregnant, or lactating.

          -  History of significant hypersensitivity to glucagon, or any related products as well
             as severe hypersensitivity reactions (such as angioedema) to any drugs.

          -  Presence of cardiovascular, gastrointestinal, liver or kidney disease, or any other
             conditions which in the judgment of the investigator could interfere with the
             absorption, distribution, metabolism or excretion of drugs or could potentiate or
             predispose to undesired effects.

          -  Presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma.

          -  Use of daily systemic beta-blockers, indomethacin, warfarin or anticholinergic drugs.

          -  Concomitant maintenance therapy with any drug that would influence the outcome of the
             trial, at the discretion of the Investigator and the Sponsor.

          -  Regular consumption of 3 or more units of alcoholic beverages per day.

          -  Current participation in another clinical trial, intent to enroll in another clinical
             trial during this clinical study or use of an Investigational Product (in another
             clinical trial) within the prior 30 days.