Clinical Usability of Nasal Glucagon in Treatment of Hypoglycemia in Children and Adolescents

This study is designed to evaluate the effectiveness of nasal glucagon (NG) administered
under clinical use conditions in treating episodes of moderate or severe hypoglycemia in
persons with T1D.

This study also aims to assess the ease with which caregivers can administer the experimental
medication in treatment of hypoglycemic events.

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.