Clinical trial NCT03091673: Glucose Response of G-Pen (Glucagon Injection) in Pediatric T1D Patients
Official title: A Phase 3 Study to Evaluate the Glucose Response of G-Pen (Glucagon Injection) in Pediatric Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Xeris Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: The Emmes Company, LLC
First posted: 2017-03-27
Enrollment: 31
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is an open-label, Phase 3 sequential efficacy and safety study in pediatric patients ages 2-17 with type 1 diabetes. Patients will complete the screening procedures up to 30 days before dosing to determine eligibility before enrollment to the treatment phase.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Plasma Glucose
timeFrame: 0-30 minutes
Secondary outcomes:
measure: Time for Plasma Glucose to Increase by ≥25 mg/dL
timeFrame: 0-90 minutes
measure: Plasma Glucagon Area Under the Curve
timeFrame: 0-90 minutes
measure: Plasma Glucagon Cmax
timeFrame: 0-180 minutes
measure: Plasma Glucagon Tmax
timeFrame: 0-180 minutes
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
facility: Barbara Davis Center for Childhood Diabetes
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Buffalo
country: United States
facility: Women & Children's Hospital of Buffalo
state: New York
Study officials:
References: