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

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 1

In brief

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.

Key facts

Study ID

NCT03091673

Run by

Xeris Pharmaceuticals

People needed

31

Starts

2017-03-27

Expected to finish

2017-09-27

Last updated by the study team

2018-12-11

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• diagnosed with T1D for at least 6 months at Screening.
• current usage of daily insulin treatment.

You may not qualify if…

• 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

Where it is running

• Stanford University — Stanford, California, United States
• Barbara Davis Center for Childhood Diabetes — Aurora, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• University of Florida — Gainesville, Florida, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• Women & Children's Hospital of Buffalo — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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