NCT03091673

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Xeris Pharmaceuticals · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	Glucagon	0.5 or 1.0 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector

Timeline

• Start date: 2017-03-27
• Primary completion: 2017-09-07
• Completion: 2017-09-27
• First posted: 2017-03-27
• Last updated: 2018-12-11
• Results posted: 2018-11-16

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study