NCT03091673

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 27, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

March 27, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2017

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2017

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 16, 2018

Completed
Last Updated

December 11, 2018

Status Verified

November 1, 2018

Enrollment Period

5 months

First QC Date

March 16, 2017

Results QC Date

October 17, 2018

Last Update Submit

November 16, 2018

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Time for Plasma Glucose to Increase by ≥25 mg/dL

    0-90 minutes

  • Plasma Glucagon Area Under the Curve

    0-90 minutes

  • Plasma Glucagon Cmax

    0-180 minutes

  • Plasma Glucagon Tmax

    0-180 minutes

Study Arms (2)

G-Pen (glucagon injection) 0.5 mg

EXPERIMENTAL

A single 0.5 mg subcutaneous (SC) injection of G-Pen (glucagon injection)

Drug: Glucagon

G-Pen (glucagon injection) 1.0 mg

EXPERIMENTAL

A single 1.0 mg subcutaneous (SC) injection of G-Pen (glucagon injection)

Drug: Glucagon

Interventions

GlucagonDRUG

0.5 or 1.0 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector

Also known as: G-Pen (glucagon injection)
G-Pen (glucagon injection) 0.5 mgG-Pen (glucagon injection) 1.0 mg

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Stanford University

Stanford, California, 94305, United States

Location

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, 80045, United States

Location

Yale University

New Haven, Connecticut, 06511, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Iowa

Iowa City, Iowa, 52422, United States

Location

Women & Children's Hospital of Buffalo

Buffalo, New York, 14222, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Glucagon

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ProglucagonPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Martin J. Cummins, VP, Clinical Development
Organization
Xeris Pharmaceuticals, Inc.
mcummins@xerispharma.com
806-282-2120

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2017

First Posted

March 27, 2017

Study Start

March 27, 2017

Primary Completion

September 7, 2017

Study Completion

September 27, 2017

Last Updated

December 11, 2018

Results First Posted

November 16, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(7)