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

• Status: Completed
• Trial end date: 2017-09-27
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xeris Pharmaceuticals
• Collaborators: The Emmes Company, LLC; The EMMES Corporation
• Treatments: Glucagon; Glucagon-Like Peptide 1

Criteria

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