Trial Outcomes & Findings for Glucose Response of G-Pen (Glucagon Injection) in Pediatric T1D Patients (NCT NCT03091673)
NCT ID: NCT03091673
Last Updated: 2018-12-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
31 participants
Primary outcome timeframe
0-30 minutes
Results posted on
2018-12-11
Participant Flow
Participant milestones
| Measure |
G-Pen (Glucagon Injection) 0.5 mg
A single 0.5 mg subcutaneous (SC) injection of G-Pen (glucagon injection)
Glucagon: 0.5 or 1.0 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector
|
G-Pen (Glucagon Injection) 1.0 mg
A single 1.0 mg subcutaneous (SC) injection of G-Pen (glucagon injection)
Glucagon: 0.5 or 1.0 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector
|
|---|---|---|
|
First Dose
STARTED
|
31
|
0
|
|
First Dose
COMPLETED
|
31
|
0
|
|
First Dose
NOT COMPLETED
|
0
|
0
|
|
Second Dose
STARTED
|
0
|
11
|
|
Second Dose
COMPLETED
|
0
|
11
|
|
Second Dose
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Glucose Response of G-Pen (Glucagon Injection) in Pediatric T1D Patients
Baseline characteristics by cohort
| Measure |
Subjects 2 to <6 Years of Age
n=7 Participants
Study subjects at least 2, but less than 6 years of age at the time of dosing
|
Subjects 6 to <12 Years of Age
n=13 Participants
Study subjects at least 6, but less than 12 years of age at the time of dosing
|
Subjects 12 to <18 Years of Age
n=11 Participants
Study subjects at least 12, but less than 18 years of age at the time of dosing
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
4.96 years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
9.95 years
STANDARD_DEVIATION 2.25 • n=7 Participants
|
15.48 years
STANDARD_DEVIATION 1.58 • n=5 Participants
|
10.79 years
STANDARD_DEVIATION 4.41 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
13 participants
n=7 Participants
|
11 participants
n=5 Participants
|
31 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 0-30 minutesPopulation: All enrolled subjects.
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.
Outcome measures
| Measure |
Subjects 2 to <6 Years of Age
n=7 Participants
Study subjects at least 2, but less than 6 years of age at the time of receiving a 0.5 mg dose of G-Pen.
|
Subjects 6 to <12 Years of Age
n=13 Participants
Study subjects at least 6, but less than 12 years of age at the time of receiving a 0.5 mg dose of G-Pen.
|
Subjects 12 to <18 Years of Age
n=11 Participants
Study subjects at least 12, but less than 18 years of age at the time of receiving a 1 mg dose of G-Pen.
|
|---|---|---|---|
|
Change in Plasma Glucose
|
81.4 mg/dL
Standard Deviation 18.3
|
84.2 mg/dL
Standard Deviation 25.3
|
54.0 mg/dL
Standard Deviation 27.3
|
SECONDARY outcome
Timeframe: 0-90 minutesTime for plasma glucose to increase by ≥25 mg/dL from baseline will be analyzed descriptively for each age cohort.
Outcome measures
| Measure |
Subjects 2 to <6 Years of Age
n=7 Participants
Study subjects at least 2, but less than 6 years of age at the time of receiving a 0.5 mg dose of G-Pen.
|
Subjects 6 to <12 Years of Age
n=13 Participants
Study subjects at least 6, but less than 12 years of age at the time of receiving a 0.5 mg dose of G-Pen.
|
Subjects 12 to <18 Years of Age
n=11 Participants
Study subjects at least 12, but less than 18 years of age at the time of receiving a 1 mg dose of G-Pen.
|
|---|---|---|---|
|
Time for Plasma Glucose to Increase by ≥25 mg/dL
|
16.4 minutes
Standard Deviation 3.78
|
16.2 minutes
Standard Deviation 4.63
|
26.6 minutes
Standard Deviation 9.51
|
SECONDARY outcome
Timeframe: 0-90 minutesPlasma glucagon area under the curve (AUC) for each age cohort will be analyzed descriptively.
Outcome measures
| Measure |
Subjects 2 to <6 Years of Age
n=7 Participants
Study subjects at least 2, but less than 6 years of age at the time of receiving a 0.5 mg dose of G-Pen.
|
Subjects 6 to <12 Years of Age
n=13 Participants
Study subjects at least 6, but less than 12 years of age at the time of receiving a 0.5 mg dose of G-Pen.
|
Subjects 12 to <18 Years of Age
n=11 Participants
Study subjects at least 12, but less than 18 years of age at the time of receiving a 1 mg dose of G-Pen.
|
|---|---|---|---|
|
Plasma Glucagon Area Under the Curve
|
14440.8 min*mg/dL
Standard Deviation 2114.9
|
14392.3 min*mg/dL
Standard Deviation 2698.4
|
13105.5 min*mg/dL
Standard Deviation 13105.45
|
SECONDARY outcome
Timeframe: 0-180 minutesPlasma glucagon maximum concentration for each age cohort will be analyzed descriptively.
Outcome measures
| Measure |
Subjects 2 to <6 Years of Age
n=7 Participants
Study subjects at least 2, but less than 6 years of age at the time of receiving a 0.5 mg dose of G-Pen.
|
Subjects 6 to <12 Years of Age
n=13 Participants
Study subjects at least 6, but less than 12 years of age at the time of receiving a 0.5 mg dose of G-Pen.
|
Subjects 12 to <18 Years of Age
n=11 Participants
Study subjects at least 12, but less than 18 years of age at the time of receiving a 1 mg dose of G-Pen.
|
|---|---|---|---|
|
Plasma Glucagon Cmax
|
202.3 mg/dL
Standard Deviation 35.9
|
216.3 mg/dL
Standard Deviation 51.2
|
199.0 mg/dL
Standard Deviation 57.0
|
SECONDARY outcome
Timeframe: 0-180 minutesPlasma glucagon time to maximum concentration for each age cohort will be analyzed descriptively.
Outcome measures
| Measure |
Subjects 2 to <6 Years of Age
n=7 Participants
Study subjects at least 2, but less than 6 years of age at the time of receiving a 0.5 mg dose of G-Pen.
|
Subjects 6 to <12 Years of Age
n=13 Participants
Study subjects at least 6, but less than 12 years of age at the time of receiving a 0.5 mg dose of G-Pen.
|
Subjects 12 to <18 Years of Age
n=11 Participants
Study subjects at least 12, but less than 18 years of age at the time of receiving a 1 mg dose of G-Pen.
|
|---|---|---|---|
|
Plasma Glucagon Tmax
|
66.6 minutes
Standard Deviation 10.5
|
68.5 minutes
Standard Deviation 15.3
|
81.2 minutes
Standard Deviation 14.9
|
Adverse Events
Subjects 2 to <6 Years of Age
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Subjects 6 to <12 Years of Age
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Subjects 12 to <18 Years of Age
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Subjects 2 to <6 Years of Age
n=7 participants at risk
Study subjects at least 2, but less than 6 years of age at the time of receiving a 0.5 mg dose of G-Pen.
|
Subjects 6 to <12 Years of Age
n=13 participants at risk
Study subjects at least 6, but less than 12 years of age at the time of receiving a 0.5 mg dose of G-Pen.
|
Subjects 12 to <18 Years of Age
n=11 participants at risk
Study subjects at least 12, but less than 18 years of age at the time of receiving a 1 mg dose of G-Pen.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
42.9%
3/7 • Number of events 4 • Adverse events were collected from the signing of informed consent through the follow-up phone call, which was completed 3-14 days after the last dose of treatment. The maximum adverse event (AE) collection period was 44 days for subjects receiving a single dose, and 72 days for subjects receiving 2 doses of G-Pen.
|
53.8%
7/13 • Number of events 7 • Adverse events were collected from the signing of informed consent through the follow-up phone call, which was completed 3-14 days after the last dose of treatment. The maximum adverse event (AE) collection period was 44 days for subjects receiving a single dose, and 72 days for subjects receiving 2 doses of G-Pen.
|
36.4%
4/11 • Number of events 4 • Adverse events were collected from the signing of informed consent through the follow-up phone call, which was completed 3-14 days after the last dose of treatment. The maximum adverse event (AE) collection period was 44 days for subjects receiving a single dose, and 72 days for subjects receiving 2 doses of G-Pen.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the signing of informed consent through the follow-up phone call, which was completed 3-14 days after the last dose of treatment. The maximum adverse event (AE) collection period was 44 days for subjects receiving a single dose, and 72 days for subjects receiving 2 doses of G-Pen.
|
23.1%
3/13 • Number of events 3 • Adverse events were collected from the signing of informed consent through the follow-up phone call, which was completed 3-14 days after the last dose of treatment. The maximum adverse event (AE) collection period was 44 days for subjects receiving a single dose, and 72 days for subjects receiving 2 doses of G-Pen.
|
18.2%
2/11 • Number of events 2 • Adverse events were collected from the signing of informed consent through the follow-up phone call, which was completed 3-14 days after the last dose of treatment. The maximum adverse event (AE) collection period was 44 days for subjects receiving a single dose, and 72 days for subjects receiving 2 doses of G-Pen.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from the signing of informed consent through the follow-up phone call, which was completed 3-14 days after the last dose of treatment. The maximum adverse event (AE) collection period was 44 days for subjects receiving a single dose, and 72 days for subjects receiving 2 doses of G-Pen.
|
7.7%
1/13 • Number of events 1 • Adverse events were collected from the signing of informed consent through the follow-up phone call, which was completed 3-14 days after the last dose of treatment. The maximum adverse event (AE) collection period was 44 days for subjects receiving a single dose, and 72 days for subjects receiving 2 doses of G-Pen.
|
0.00%
0/11 • Adverse events were collected from the signing of informed consent through the follow-up phone call, which was completed 3-14 days after the last dose of treatment. The maximum adverse event (AE) collection period was 44 days for subjects receiving a single dose, and 72 days for subjects receiving 2 doses of G-Pen.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from the signing of informed consent through the follow-up phone call, which was completed 3-14 days after the last dose of treatment. The maximum adverse event (AE) collection period was 44 days for subjects receiving a single dose, and 72 days for subjects receiving 2 doses of G-Pen.
|
53.8%
7/13 • Number of events 7 • Adverse events were collected from the signing of informed consent through the follow-up phone call, which was completed 3-14 days after the last dose of treatment. The maximum adverse event (AE) collection period was 44 days for subjects receiving a single dose, and 72 days for subjects receiving 2 doses of G-Pen.
|
27.3%
3/11 • Number of events 3 • Adverse events were collected from the signing of informed consent through the follow-up phone call, which was completed 3-14 days after the last dose of treatment. The maximum adverse event (AE) collection period was 44 days for subjects receiving a single dose, and 72 days for subjects receiving 2 doses of G-Pen.
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • Adverse events were collected from the signing of informed consent through the follow-up phone call, which was completed 3-14 days after the last dose of treatment. The maximum adverse event (AE) collection period was 44 days for subjects receiving a single dose, and 72 days for subjects receiving 2 doses of G-Pen.
|
15.4%
2/13 • Number of events 2 • Adverse events were collected from the signing of informed consent through the follow-up phone call, which was completed 3-14 days after the last dose of treatment. The maximum adverse event (AE) collection period was 44 days for subjects receiving a single dose, and 72 days for subjects receiving 2 doses of G-Pen.
|
0.00%
0/11 • Adverse events were collected from the signing of informed consent through the follow-up phone call, which was completed 3-14 days after the last dose of treatment. The maximum adverse event (AE) collection period was 44 days for subjects receiving a single dose, and 72 days for subjects receiving 2 doses of G-Pen.
|
Additional Information
Martin J. Cummins, VP, Clinical Development
Xeris Pharmaceuticals, Inc.
Phone: 806-282-2120
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place