Clinical Trial Details

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


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


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.

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Recruitment Details

2 to 17 Years
Overall Status
Lead Sponsor
Xeris Pharmaceuticals
5 Months
Facility Type


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

Bruce Buckingham, MD
Principal Investigator
United States Colorado Aurora 80045 Barbara Davis Center for Childhood Diabetes
Isabel Weber

Paul Wadwa, MD
Principal Investigator
United States Connecticut New Haven 06511 Yale University
Carria Lori

Jennifer Sherr, MD
Principal Investigator
United States Florida Gainesville 32611 University of Florida
Michael Haller, MD

Michael Haller, MD
Principal Investigator
United States Florida Jacksonville 32207 Nemours
Nicole Johnson

Larry Fox, MD
Principal Investigator
United States Indiana Indianapolis 46202 Indiana University
Devyn Purtlebaugh

Stephanie Woerner, MSN, FNP-C, CDE
Principal Investigator
United States Iowa Iowa City 52422 University of Iowa
Joanne Cabbage

Eva Tsalikian, MD
Principal Investigator
United States New York Buffalo 14222 Women & Children's Hospital of Buffalo
Emily Gorman

Kathleen Bethin, MD
Principal Investigator

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