Glucose Response of G-Pen (Glucagon Injection) in Pediatric T1D Patients

This is an open-label, Phase 3 sequential efficacy and safety study in pediatric patients
ages 2-17 with type 1 diabetes. Patients will complete the screening procedures up to 30 days
before dosing to determine eligibility before enrollment to the treatment phase.

The procedure to evaluate the efficacy of G-Pen (glucagon injection) consists of inducing a
low normal glycemic state by administration of insulin. Subjects ages 2-11 will then be given
a 0.5 mg dose of G-Pen, while subjects ages 12-17 will receive a 1 mg dose of G-Pen. Subjects
ages 12-17 will return for a second visit 1-4 weeks later and will receive a 0.5 mg dose of
G-Pen when in a low normal glycemic stare. Plasma glucose and glucagon levels will be
monitored for 90 and 180 minutes post-dosing, respectively, at all visits.

A follow-up phone call as a safety check will be conducted 3 - 14 days following
administration of the final dose.

Inclusion Criteria:

- diagnosed with T1D for at least 6 months at Screening.

- current usage of daily insulin treatment.

Exclusion Criteria:

- pregnant or nursing

- renal insufficiency

- hepatic synthetic insufficiency

- aspartate or alanine aminotransferase > 3 times the upper limit of normal

- hematocrit less than or equal to 30%

- use of > 2.0 U/kg total insulin dose per day

- inadequate venous access

- current seizure disorder

- history of pheochromocytoma or disorder with increased risk of pheochromocytoma

- history of insulinoma

- history of glycogen storage disease.

- active use of alcohol or drugs of abuse

- administration of glucagon within 14 days of the first treatment visit

- participation in other studies involving an investigational drug or device within 30
days