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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03091673
Enrollment
31
Registered
2017-03-27
Start date
2017-03-27
Completion date
2017-09-27
Last updated
2018-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

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.

Interventions

DRUGGlucagon

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

Sponsors

The Emmes Company, LLC
CollaboratorINDUSTRY
Xeris Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Plasma Glucose0-30 minutesThe 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

MeasureTime frameDescription
Time for Plasma Glucose to Increase by ≥25 mg/dL0-90 minutesTime for plasma glucose to increase by ≥25 mg/dL from baseline will be analyzed descriptively for each age cohort.
Plasma Glucagon Area Under the Curve0-90 minutesPlasma glucagon area under the curve (AUC) for each age cohort will be analyzed descriptively.
Plasma Glucagon Cmax0-180 minutesPlasma glucagon maximum concentration for each age cohort will be analyzed descriptively.
Plasma Glucagon Tmax0-180 minutesPlasma glucagon time to maximum concentration for each age cohort will be analyzed descriptively.

Countries

United States

Participant flow

Participants by arm

ArmCount
Subjects 2 to <6 Years of Age
Study subjects at least 2, but less than 6 years of age at the time of dosing
7
Subjects 6 to <12 Years of Age
Study subjects at least 6, but less than 12 years of age at the time of dosing
13
Subjects 12 to <18 Years of Age
Study subjects at least 12, but less than 18 years of age at the time of dosing
11
Total31

Baseline characteristics

CharacteristicSubjects 2 to <6 Years of AgeTotalSubjects 12 to <18 Years of AgeSubjects 6 to <12 Years of Age
Age, Continuous4.96 years
STANDARD_DEVIATION 1.1
10.79 years
STANDARD_DEVIATION 4.41
15.48 years
STANDARD_DEVIATION 1.58
9.95 years
STANDARD_DEVIATION 2.25
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
7 Participants31 Participants11 Participants13 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
2 Participants3 Participants0 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
5 Participants28 Participants11 Participants12 Participants
Region of Enrollment
United States
7 participants31 participants11 participants13 participants
Sex: Female, Male
Female
5 Participants16 Participants6 Participants5 Participants
Sex: Female, Male
Male
2 Participants15 Participants5 Participants8 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 70 / 130 / 11
other
Total, other adverse events
5 / 712 / 138 / 11
serious
Total, serious adverse events
0 / 70 / 130 / 11

Outcome results

Primary

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.

Time frame: 0-30 minutes

Population: All enrolled subjects.

ArmMeasureValue (MEAN)Dispersion
Subjects 2 to <6 Years of AgeChange in Plasma Glucose81.4 mg/dLStandard Deviation 18.3
Subjects 6 to <12 Years of AgeChange in Plasma Glucose84.2 mg/dLStandard Deviation 25.3
Subjects 12 to <18 Years of AgeChange in Plasma Glucose54.0 mg/dLStandard Deviation 27.3
p-value: <0.001t-test, 2 sided
Secondary

Plasma Glucagon Area Under the Curve

Plasma glucagon area under the curve (AUC) for each age cohort will be analyzed descriptively.

Time frame: 0-90 minutes

ArmMeasureValue (MEAN)Dispersion
Subjects 2 to <6 Years of AgePlasma Glucagon Area Under the Curve14440.8 min*mg/dLStandard Deviation 2114.9
Subjects 6 to <12 Years of AgePlasma Glucagon Area Under the Curve14392.3 min*mg/dLStandard Deviation 2698.4
Subjects 12 to <18 Years of AgePlasma Glucagon Area Under the Curve13105.5 min*mg/dLStandard Deviation 13105.45
Secondary

Plasma Glucagon Cmax

Plasma glucagon maximum concentration for each age cohort will be analyzed descriptively.

Time frame: 0-180 minutes

ArmMeasureValue (MEAN)Dispersion
Subjects 2 to <6 Years of AgePlasma Glucagon Cmax202.3 mg/dLStandard Deviation 35.9
Subjects 6 to <12 Years of AgePlasma Glucagon Cmax216.3 mg/dLStandard Deviation 51.2
Subjects 12 to <18 Years of AgePlasma Glucagon Cmax199.0 mg/dLStandard Deviation 57
Secondary

Plasma Glucagon Tmax

Plasma glucagon time to maximum concentration for each age cohort will be analyzed descriptively.

Time frame: 0-180 minutes

ArmMeasureValue (MEAN)Dispersion
Subjects 2 to <6 Years of AgePlasma Glucagon Tmax66.6 minutesStandard Deviation 10.5
Subjects 6 to <12 Years of AgePlasma Glucagon Tmax68.5 minutesStandard Deviation 15.3
Subjects 12 to <18 Years of AgePlasma Glucagon Tmax81.2 minutesStandard Deviation 14.9
Secondary

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.

Time frame: 0-90 minutes

ArmMeasureValue (MEAN)Dispersion
Subjects 2 to <6 Years of AgeTime for Plasma Glucose to Increase by ≥25 mg/dL16.4 minutesStandard Deviation 3.78
Subjects 6 to <12 Years of AgeTime for Plasma Glucose to Increase by ≥25 mg/dL16.2 minutesStandard Deviation 4.63
Subjects 12 to <18 Years of AgeTime for Plasma Glucose to Increase by ≥25 mg/dL26.6 minutesStandard Deviation 9.51

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026