Clinical Trial Details

NCT ID: NCT03091673
Date Last Changed: May 8, 2017

Overview

Research Study Summary

A clinical trial to evaluate treatments using Glucagon for patients with Diabetes Mellitus, Type 1

Research Study Title

A Phase 3 Study to Evaluate the Glucose Response of G-Pen™ (Glucagon Injection) in Pediatric Patients With Type 1 Diabetes

Purpose

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.

To Learn more

Recruitment Details

Phase
3
Gender
All
Age
2 to 17 Years
Overall Status
Recruiting
Lead Sponsor
Xeris Pharmaceuticals
Duration
5 Months
Facility Type
N/A
Compensation

Eligibility

All ages 2 Years to 17 Years

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

Site Locations (8)

Country State City Zip Facility and Contact
United States California Stanford 94305 Stanford University
Bruce Buckingham, MD
650-725-6549
bbendo@stanford.edu

Bruce Buckingham, MD
Principal Investigator
United States Colorado Aurora 80045 Barbara Davis Center for Childhood Diabetes
Isabel Weber
303-724-8095
isabel.weber@ucdenver.edu

Paul Wadwa, MD
Principal Investigator
United States Connecticut New Haven 06511 Yale University
Carria Lori
203-737-3595
lori.carria@yale.edu

Jennifer Sherr, MD
Principal Investigator
United States Florida Gainesville 32611 University of Florida
Michael Haller, MD
352-273-9264
hallemj@peds.ufl.edu

Michael Haller, MD
Principal Investigator
United States Florida Jacksonville 32207 Nemours
Nicole Johnson
904-697-3026
nicole.m.johnson@nemours.org

Larry Fox, MD
Principal Investigator
United States Indiana Indianapolis 46202 Indiana University
Devyn Purtlebaugh
317-274-2583
drpurtle@iu.edu

Stephanie Woerner, MSN, FNP-C, CDE
Principal Investigator
United States Iowa Iowa City 52422 University of Iowa
Joanne Cabbage
319-335-7434
joanne-cabbage@uiowa.edu

Eva Tsalikian, MD
Principal Investigator
United States New York Buffalo 14222 Women & Children's Hospital of Buffalo
Emily Gorman
716-878-7289
egorman@upa.chob.edu

Kathleen Bethin, MD
Principal Investigator

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