Clinical Usability of Intranasal Glucagon in Treatment of Hypoglycemia

This study proposes to evaluate the effectiveness of intranasal (IN) glucagon administered
under clinical use conditions in treating episodes of 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.

The study will also generate data on the patients' assessment of local tolerability and
provide information on immunogenicity of AMG504-1 with regards to the potential development
of anti-glucagon antibodies.

Inclusion Criteria:

- Male or Female Person with diabetes (PWD) lives with or is in frequent contact with
one or more caregivers who are available to administer the glucagon in case of an
episode of severe or moderate hypoglycemia

- With a history of type 1 diabetes >1 year

- At least 18 years of age but not older than 75 years

- Body mass index (BMI) greater than or equal to 18.50 and below 35.00 kg/m2.

- PWD will be otherwise healthy according to medical history, general physical
examination (including vital signs), nasal examination, and laboratory tests
(biochemistry, hematology, and urinalysis).

- For female subjects, a urine pregnancy test must be negative.

Exclusion Criteria:

- Presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma.

- Use of a daily systemic beta-blockers, indomethacin, warfarin or anticholinergic
drugs.