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

NCT03091673 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2018-12-11

Study results available
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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.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

Glucagon

0.5 or 1.0 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector

Sponsors & Collaborators

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • Xeris Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-27
Primary Completion
2017-09-07
Completion
2017-09-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03091673 on ClinicalTrials.gov