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

Phase 3

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
G-Pen (glucagon injection) 0.5 mg	Glucagon	A single 0.5 mg subcutaneous (SC) injection of G-Pen (glucagon injection)
G-Pen (glucagon injection) 1.0 mg	Glucagon	A single 1.0 mg subcutaneous (SC) injection of G-Pen (glucagon injection)

Primary Outcome Measures

Name	Time	Method
Change in Plasma Glucose	0-30 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Time for Plasma Glucose to Increase by ≥25 mg/dL	0-90 minutes	Time for plasma glucose to increase by ≥25 mg/dL from baseline will be analyzed descriptively for each age cohort.
Plasma Glucagon Area Under the Curve	0-90 minutes	Plasma glucagon area under the curve (AUC) for each age cohort will be analyzed descriptively.
Plasma Glucagon Cmax	0-180 minutes	Plasma glucagon maximum concentration for each age cohort will be analyzed descriptively.
Plasma Glucagon Tmax	0-180 minutes	Plasma glucagon time to maximum concentration for each age cohort will be analyzed descriptively.

Locations (7): University of Florida
🇺🇸
Gainesville, Florida, United States
University of Iowa
🇺🇸
Iowa City, Iowa, United States
Indiana University
🇺🇸
Indianapolis, Indiana, United States
Stanford University
🇺🇸
Stanford, California, United States
Yale University
🇺🇸
New Haven, Connecticut, United States
Barbara Davis Center for Childhood Diabetes
🇺🇸
Aurora, Colorado, United States
Women & Children's Hospital of Buffalo
🇺🇸
Buffalo, New York, United States