Phase 3 N=31 Treatment

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

Diabetes Mellitus, Type 1

Bottom Line

View on ClinicalTrials.gov: NCT03091673 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2018

Primary outcome: Primary: Change in Plasma Glucose — 81.4; 84.2; 54.0 mg/dL — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Glucagon (Drug)
Age: Pediatric · 2+ yrs
Sex: All
Sponsor: Xeris Pharmaceuticals
Primary completion: Sep 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Plasma Glucose	81.4; 84.2; 54.0	<0.001 sig
SECONDARY Time for Plasma Glucose to Increase by ≥25 mg/dL	16.4; 16.2; 26.6	—
SECONDARY Plasma Glucagon Area Under the Curve	14440.8; 14392.3; 13105.5	—
SECONDARY Plasma Glucagon Cmax	202.3; 216.3; 199.0	—
SECONDARY Plasma Glucagon Tmax	66.6; 68.5; 81.2	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03091673). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.