Glucose Response of G-Pen (Glucagon Injection) in Pediatric T1D Patients
NCT ID: NCT03091673
Last Updated: 2018-12-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
31 participants
INTERVENTIONAL
2017-03-27
2017-09-27
Brief Summary
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Detailed Description
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The procedure to evaluate the efficacy of G-Pen (glucagon injection) consists of inducing a low normal glycemic state by administration of insulin. Subjects ages 2-11 will then be given a 0.5 mg dose of G-Pen, while subjects ages 12-17 will receive a 1 mg dose of G-Pen. Subjects ages 12-17 will return for a second visit 1-4 weeks later and will receive a 0.5 mg dose of G-Pen when in a low normal glycemic stare. Plasma glucose and glucagon levels will be monitored for 90 and 180 minutes post-dosing, respectively, at all visits.
A follow-up phone call as a safety check will be conducted 3 - 14 days following administration of the final dose.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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G-Pen (glucagon injection) 0.5 mg
A single 0.5 mg subcutaneous (SC) injection of G-Pen (glucagon injection)
Glucagon
0.5 or 1.0 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector
G-Pen (glucagon injection) 1.0 mg
A single 1.0 mg subcutaneous (SC) injection of G-Pen (glucagon injection)
Glucagon
0.5 or 1.0 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector
Interventions
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Glucagon
0.5 or 1.0 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* current usage of daily insulin treatment.
Exclusion Criteria
* 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
2 Years
17 Years
ALL
No
Sponsors
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The Emmes Company, LLC
INDUSTRY
Xeris Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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XSGP-302
Identifier Type: -
Identifier Source: org_study_id