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

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ClinicalTrials.gov Identifier: NCT03091673
Recruitment Status : Completed
First Posted : March 27, 2017
Results First Posted : November 16, 2018
Last Update Posted : December 11, 2018
Sponsor:
Collaborator:
The Emmes Company, LLC
Information provided by (Responsible Party):
Xeris Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: Glucagon Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Study to Evaluate the Glucose Response of G-Pen (Glucagon Injection) in Pediatric Patients With Type 1 Diabetes
Actual Study Start Date : March 27, 2017
Actual Primary Completion Date : September 7, 2017
Actual Study Completion Date : September 27, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Glucagon

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 Name: 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 Name: G-Pen (glucagon injection)




Primary Outcome Measures :
  1. Change in Plasma Glucose [ Time Frame: 0-30 minutes ]
    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.


Secondary Outcome Measures :
  1. Time for Plasma Glucose to Increase by ≥25 mg/dL [ Time Frame: 0-90 minutes ]
    Time for plasma glucose to increase by ≥25 mg/dL from baseline will be analyzed descriptively for each age cohort.

  2. Plasma Glucagon Area Under the Curve [ Time Frame: 0-90 minutes ]
    Plasma glucagon area under the curve (AUC) for each age cohort will be analyzed descriptively.

  3. Plasma Glucagon Cmax [ Time Frame: 0-180 minutes ]
    Plasma glucagon maximum concentration for each age cohort will be analyzed descriptively.

  4. Plasma Glucagon Tmax [ Time Frame: 0-180 minutes ]
    Plasma glucagon time to maximum concentration for each age cohort will be analyzed descriptively.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091673


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
United States, Colorado
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06511
United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52422
United States, New York
Women & Children's Hospital of Buffalo
Buffalo, New York, United States, 14222
Sponsors and Collaborators
Xeris Pharmaceuticals
The Emmes Company, LLC
  Study Documents (Full-Text)

Documents provided by Xeris Pharmaceuticals:
Study Protocol  [PDF] December 6, 2016
Statistical Analysis Plan  [PDF] August 16, 2017


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Responsible Party: Xeris Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03091673     History of Changes
Other Study ID Numbers: XSGP-302
First Posted: March 27, 2017    Key Record Dates
Results First Posted: November 16, 2018
Last Update Posted: December 11, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins