Overview

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