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

A Phase 3 Study to Evaluate the Glucose Response of G-Pen (Glucagon Injection) in Pediatric Patients With Type 1 Diabetes

This is a sequential efficacy and safety study in pediatric patients with type 1 diabetes. Subjects will be administered insulin to induce a low normal glycemic state and will then receive an age-appropriate dose of G-Pen (glucagon injection) in a clinical research center (CRC) or comparable setting.

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.

The primary endpoint for this study is an evaluation of change in plasma glucose following treatment with G-Pen, with an emphasis on the increase from baseline to 30 minutes post-dosing.

Time for plasma glucose to increase by ≥25 mg/dL from baseline will be analyzed descriptively for each age cohort.

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