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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Drug: Glucagon

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Barbara Davis Center for Childhood Diabetes
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale University
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Iowa
    • Iowa City, Iowa, United States, 52422
      • University of Iowa
  • New York
    • Buffalo, New York, United States, 14222
      • Women & Children's Hospital of Buffalo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: G-Pen (glucagon injection) 0.5 mg; A single 0.5 mg subcutaneous (SC) injection of G-Pen (glucagon injection)	Drug: Glucagon; 0.5 or 1.0 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector; Other Names: G-Pen (glucagon injection)
EXPERIMENTAL: G-Pen (glucagon injection) 1.0 mg; A single 1.0 mg subcutaneous (SC) injection of G-Pen (glucagon injection)	Drug: Glucagon; 0.5 or 1.0 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector; Other Names: G-Pen (glucagon injection)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Plasma Glucose	The primary endpoint for this study is an evaluation of change in plasma glucose following treatment with G-Pen, with an emphasis on the increase from baseline to 30 minutes post-dosing.	0-30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time for Plasma Glucose to Increase by ≥25 mg/dL	Time for plasma glucose to increase by ≥25 mg/dL from baseline will be analyzed descriptively for each age cohort.	0-90 minutes
Plasma Glucagon Area Under the Curve	Plasma glucagon area under the curve (AUC) for each age cohort will be analyzed descriptively.	0-90 minutes
Plasma Glucagon Cmax	Plasma glucagon maximum concentration for each age cohort will be analyzed descriptively.	0-180 minutes
Plasma Glucagon Tmax	Plasma glucagon time to maximum concentration for each age cohort will be analyzed descriptively.	0-180 minutes

Collaborators and Investigators

• Sponsor: Xeris Pharmaceuticals
• Collaborators: The Emmes Company, LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 27, 2017
• Primary Completion (ACTUAL): September 7, 2017
• Study Completion (ACTUAL): September 27, 2017

Study Registration Dates

• First Submitted: March 16, 2017
• First Submitted That Met QC Criteria: March 21, 2017
• First Posted (ACTUAL): March 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 11, 2018
• Last Update Submitted That Met QC Criteria: November 16, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Physiological Effects of Drugs; Gastrointestinal Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Glucagon; Glucagon-Like Peptide 1
• Other Study ID Numbers: XSGP-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No