Trial Outcomes & Findings for Assessment of Intranasal Glucagon in Children and Adolescents With Type 1 Diabetes (NCT NCT01997411)
NCT ID: NCT01997411
Last Updated: 2018-08-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
48 participants
Primary outcome timeframe
Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration
Results posted on
2018-08-29
Participant Flow
Participant milestones
| Measure |
4 to<8 Years Old Intramuscular (IM) Glucagon Visit
Participants who weighed at least 25 kilograms (kg)/55 pounds (lbs) were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
This was completed at one visit and was the only visit for this cohort.
|
4 to <8 Years Old NG 2.0 mg 1st Visit/3.0 mg 2nd Visit
At the first visit, a nasal glucagon (NG) dose of 2.0 milligrams (mg) for participants 4 to less than 8 years of age was administered nasally.
At the second visit, NG dose of 3.0 mg was administered nasally.
|
4 to <8 Years Old NG 3.0 mg 1st Visit/2.0 mg 2nd Visit
At the first visit, a NG dose of 3.0 mg for participants 4 to less than 8 years of age was administered nasally.
At the second visit, a NG dose of 2.0 mg was administered nasally.
|
8 to <12 Years Old Intramuscular Glucagon Visit
Participants who weighed at least 25 kilograms kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg. This was completed at one visit and was the only visit for this cohort.
|
8 to <12 Years Old NG 2.0 mg 1st Visit/3.0 mg 2nd Visit
At the first visit, a NG dose of 2.0 mg for participants 8 to less than 12 years of age was administered nasally.
At the second visit, a NG dose of 3.0 mg was administered nasally.
|
8 to <12 Years Old NG 3.0 mg 1st Visit/2.0 mg 2nd Visit
At the first visit, a NG dose of 3.0 mg for participants 8 to less than 12 years of age was administered nasally.
At the second visit, a NG dose of 2.0 mg was administered nasally.
|
12 to <17 Years Old NG 1st Visit/IM Glucagon 2nd Visit
At the first visit, a NG dose of 3.0 mg was administered nasally.
At the second visit, participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
12 to <17 Years Old IM Glucagon 1st Visit/NG 2nd Visit
At the first visit, participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
At the second visit, a NG dose of 3.0 mg was administered nasally.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
5
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessment of Intranasal Glucagon in Children and Adolescents With Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
4 to <8 Years Old IM Glucagon Cohort
n=6 Participants
Participants who were 4 to \< 8 years old at the time of enrollment into the study randomized to receive only the intramuscular glucagon at one visit.
|
4 to <8 Years Old NG Cohort
n=12 Participants
Participants who were 4 to \< 8 years old at the time of enrollment into the study randomized to receive 2.0 or 3.0 mg of nasal glucagon at two separate visits. Order of these visits was randomized.
|
8 to <12 Years Old IM Glucagon Cohort
n=6 Participants
Participants who were 8 to \< 12 years old at the time of enrollment into the study randomized to receive only the intramuscular glucagon at one visit.
|
8 to <12 Years Old NG Cohort
n=12 Participants
Participants who were 8 to \< 12 years old at the time of enrollment into the study randomized to receive 2.0 or 3.0 mg of nasal glucagon at two separate visits. Order of these visits was randomized.
|
12 to <17 Years Old NG/IM Cohort
n=12 Participants
Participants who were 12 to \< 17 years old at the time of enrollment into the study randomized to receive either intramuscular glucagon or nasal glucagon at two separate visits. Order of these visits was randomized.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
6.8 years
n=93 Participants
|
6.8 years
n=4 Participants
|
11.1 years
n=27 Participants
|
11.1 years
n=483 Participants
|
14.5 years
n=36 Participants
|
10.6 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
16 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
32 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
12 Participants
n=36 Participants
|
48 Participants
n=10 Participants
|
|
Local HbA1c
|
7.6 percent
STANDARD_DEVIATION 0.5 • n=93 Participants
|
8.3 percent
STANDARD_DEVIATION 0.8 • n=4 Participants
|
7.5 percent
STANDARD_DEVIATION 1.1 • n=27 Participants
|
8.1 percent
STANDARD_DEVIATION 0.7 • n=483 Participants
|
8.2 percent
STANDARD_DEVIATION 1.5 • n=36 Participants
|
8.0 percent
STANDARD_DEVIATION 1.0 • n=10 Participants
|
|
Duration of Diabetes
|
3.1 years
n=93 Participants
|
2.7 years
n=4 Participants
|
5.3 years
n=27 Participants
|
4.3 years
n=483 Participants
|
5.9 years
n=36 Participants
|
3.9 years
n=10 Participants
|
PRIMARY outcome
Timeframe: Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administrationPopulation: All enrolled participants that completed the required dosing visit(s). One participant in the 4 to \<8 year old 2.0 mg NG group was excluded due to blowing nose after NG administration. One participant in the 8 to \<12 group withdrew after completion of the 3.0 mg NG visit and did not complete the 2.0 mg NG visit.
Outcome measures
| Measure |
4 to<8 Years Old IM Glucagon Visit
n=6 Participants
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
4 to<8 Years Old NG Visit 2.0 mg
n=11 Participants
NG dose of 2.0 mg for participants 4 to less than 8 years of age.
|
4 to<8 Years Old NG Visit 3.0 mg
n=12 Participants
NG dose of 3.0 mg for participants 4 to less than 8 years of age.
|
8 to <12 Years Old IM Glucagon Visit
n=6 Participants
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
8 to<12 Years Old NG Visit 2.0 mg
n=11 Participants
NG dose of 2.0 mg for participants 8 to less than 12 years of age.
|
8 to<12 Years Old NG Visit 3.0 mg
n=12 Participants
NG dose of 3.0 mg for participants 8 to less than 12 years of age.
|
12 to <17 Years Old IM Glucagon Visit
n=12 Participants
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
12 to<17 Years Old NG Visit 3.0 mg
n=12 Participants
NG dose of 3.0 mg for participants 12 to less than 17 years of age.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Change From Baseline Concentration (Cmax) of Glucagon
|
6290.33 picograms per millilitre (pg/mL)
Standard Deviation 2045.96
|
3463.55 picograms per millilitre (pg/mL)
Standard Deviation 1760.28
|
3958.58 picograms per millilitre (pg/mL)
Standard Deviation 2438.60
|
4743.00 picograms per millilitre (pg/mL)
Standard Deviation 3094.61
|
2776.27 picograms per millilitre (pg/mL)
Standard Deviation 979.28
|
5664.33 picograms per millilitre (pg/mL)
Standard Deviation 2114.69
|
4277.25 picograms per millilitre (pg/mL)
Standard Deviation 3774.77
|
3103.25 picograms per millilitre (pg/mL)
Standard Deviation 2302.61
|
PRIMARY outcome
Timeframe: Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administrationPopulation: All enrolled participants that completed the required dosing visit(s). One participant in the 4 to \<8 year old 2.0 mg NG group was excluded due to blowing nose after NG administration. One participant in the 8 to \<12 group withdrew after completion of the 3.0 mg NG visit and did not complete the 2.0 mg NG visit.
Outcome measures
| Measure |
4 to<8 Years Old IM Glucagon Visit
n=6 Participants
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
4 to<8 Years Old NG Visit 2.0 mg
n=11 Participants
NG dose of 2.0 mg for participants 4 to less than 8 years of age.
|
4 to<8 Years Old NG Visit 3.0 mg
n=12 Participants
NG dose of 3.0 mg for participants 4 to less than 8 years of age.
|
8 to <12 Years Old IM Glucagon Visit
n=6 Participants
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
8 to<12 Years Old NG Visit 2.0 mg
n=11 Participants
NG dose of 2.0 mg for participants 8 to less than 12 years of age.
|
8 to<12 Years Old NG Visit 3.0 mg
n=12 Participants
NG dose of 3.0 mg for participants 8 to less than 12 years of age.
|
12 to <17 Years Old IM Glucagon Visit
n=12 Participants
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
12 to<17 Years Old NG Visit 3.0 mg
n=12 Participants
NG dose of 3.0 mg for participants 12 to less than 17 years of age.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon
|
0.29 hours (hr)
Interval 0.08 to 0.5
|
0.25 hours (hr)
Interval 0.17 to 0.33
|
0.29 hours (hr)
Interval 0.17 to 1.0
|
0.29 hours (hr)
Interval 0.08 to 0.5
|
0.25 hours (hr)
Interval 0.17 to 0.33
|
0.25 hours (hr)
Interval 0.17 to 0.5
|
0.29 hours (hr)
Interval 0.08 to 0.5
|
0.33 hours (hr)
Interval 0.25 to 0.5
|
PRIMARY outcome
Timeframe: Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administrationPopulation: All enrolled participants that completed the required dosing visit(s). One participant in the 4 to \<8 year old 2.0 mg NG group was excluded due to blowing nose after NG administration. One participant in the 8 to \<12 group withdrew after completion of the 3.0 mg NG visit and did not complete the 2.0 mg NG visit.
Outcome measures
| Measure |
4 to<8 Years Old IM Glucagon Visit
n=6 Participants
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
4 to<8 Years Old NG Visit 2.0 mg
n=11 Participants
NG dose of 2.0 mg for participants 4 to less than 8 years of age.
|
4 to<8 Years Old NG Visit 3.0 mg
n=12 Participants
NG dose of 3.0 mg for participants 4 to less than 8 years of age.
|
8 to <12 Years Old IM Glucagon Visit
n=6 Participants
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
8 to<12 Years Old NG Visit 2.0 mg
n=11 Participants
NG dose of 2.0 mg for participants 8 to less than 12 years of age.
|
8 to<12 Years Old NG Visit 3.0 mg
n=12 Participants
NG dose of 3.0 mg for participants 8 to less than 12 years of age.
|
12 to <17 Years Old IM Glucagon Visit
n=12 Participants
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
12 to<17 Years Old NG Visit 3.0 mg
n=12 Participants
NG dose of 3.0 mg for participants 12 to less than 17 years of age.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Curve (AUC0-1.5) of Baseline Adjusted Glucagon
|
4078.68 hour*picogram per millilitre (hr*pg/mL)
Standard Deviation 2078.89
|
1744.36 hour*picogram per millilitre (hr*pg/mL)
Standard Deviation 978.81
|
2472.40 hour*picogram per millilitre (hr*pg/mL)
Standard Deviation 1435.45
|
3635.77 hour*picogram per millilitre (hr*pg/mL)
Standard Deviation 2069.11
|
1506.23 hour*picogram per millilitre (hr*pg/mL)
Standard Deviation 541.57
|
2939.31 hour*picogram per millilitre (hr*pg/mL)
Standard Deviation 1042.03
|
3110.22 hour*picogram per millilitre (hr*pg/mL)
Standard Deviation 2848.75
|
1999.69 hour*picogram per millilitre (hr*pg/mL)
Standard Deviation 1329.44
|
PRIMARY outcome
Timeframe: Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administrationPopulation: All enrolled participants that completed the required dosing visit(s). One participant in the 4 to \<8 year old 2.0 mg NG group was excluded due to blowing nose after NG administration. One participant in the 8 to \<12 group withdrew after completion of the 3.0 mg NG visit and did not complete the 2.0 mg NG visit.
Outcome measures
| Measure |
4 to<8 Years Old IM Glucagon Visit
n=6 Participants
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
4 to<8 Years Old NG Visit 2.0 mg
n=11 Participants
NG dose of 2.0 mg for participants 4 to less than 8 years of age.
|
4 to<8 Years Old NG Visit 3.0 mg
n=12 Participants
NG dose of 3.0 mg for participants 4 to less than 8 years of age.
|
8 to <12 Years Old IM Glucagon Visit
n=6 Participants
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
8 to<12 Years Old NG Visit 2.0 mg
n=11 Participants
NG dose of 2.0 mg for participants 8 to less than 12 years of age.
|
8 to<12 Years Old NG Visit 3.0 mg
n=12 Participants
NG dose of 3.0 mg for participants 8 to less than 12 years of age.
|
12 to <17 Years Old IM Glucagon Visit
n=12 Participants
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
12 to<17 Years Old NG Visit 3.0 mg
n=12 Participants
NG dose of 3.0 mg for participants 12 to less than 17 years of age.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Concentration (Cmax) of Baseline-Adjusted Glucose
|
138.17 mg/dL
Standard Deviation 26.57
|
118.18 mg/dL
Standard Deviation 46.46
|
137.50 mg/dL
Standard Deviation 42.14
|
130.50 mg/dL
Standard Deviation 21.81
|
125.09 mg/dL
Standard Deviation 23.81
|
132.82 mg/dL
Standard Deviation 30.59
|
123.17 mg/dL
Standard Deviation 29.58
|
102.33 mg/dL
Standard Deviation 25.63
|
PRIMARY outcome
Timeframe: Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administrationPopulation: All enrolled participants that completed the required dosing visit(s). One participant in the 4 to \<8 year old 2.0 mg NG group was excluded due to blowing nose after NG administration. One participant in the 8 to \<12 group withdrew after completion of the 3.0 mg NG visit and did not complete the 2.0 mg NG visit.
Outcome measures
| Measure |
4 to<8 Years Old IM Glucagon Visit
n=6 Participants
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
4 to<8 Years Old NG Visit 2.0 mg
n=11 Participants
NG dose of 2.0 mg for participants 4 to less than 8 years of age.
|
4 to<8 Years Old NG Visit 3.0 mg
n=12 Participants
NG dose of 3.0 mg for participants 4 to less than 8 years of age.
|
8 to <12 Years Old IM Glucagon Visit
n=6 Participants
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
8 to<12 Years Old NG Visit 2.0 mg
n=11 Participants
NG dose of 2.0 mg for participants 8 to less than 12 years of age.
|
8 to<12 Years Old NG Visit 3.0 mg
n=12 Participants
NG dose of 3.0 mg for participants 8 to less than 12 years of age.
|
12 to <17 Years Old IM Glucagon Visit
n=12 Participants
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
12 to<17 Years Old NG Visit 3.0 mg
n=12 Participants
NG dose of 3.0 mg for participants 12 to less than 17 years of age.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose
|
1.00 hours (hr)
Interval 0.67 to 1.5
|
0.67 hours (hr)
Interval 0.33 to 1.0
|
1.00 hours (hr)
Interval 0.5 to 1.5
|
1.50 hours (hr)
Interval 1.0 to 1.5
|
1.00 hours (hr)
Interval 0.67 to 1.5
|
1.00 hours (hr)
Interval 0.5 to 1.5
|
1.00 hours (hr)
Interval 0.67 to 1.5
|
1.00 hours (hr)
Interval 0.5 to 1.5
|
PRIMARY outcome
Timeframe: Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administrationPopulation: All enrolled participants that completed the required dosing visit(s). One participant in the 4 to \<8 year old 2.0 mg NG group was excluded due to blowing nose after NG administration. One participant in the 8 to \<12 group withdrew after completion of the 3.0 mg NG visit and did not complete the 2.0 mg NG visit.
Outcome measures
| Measure |
4 to<8 Years Old IM Glucagon Visit
n=6 Participants
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
4 to<8 Years Old NG Visit 2.0 mg
n=11 Participants
NG dose of 2.0 mg for participants 4 to less than 8 years of age.
|
4 to<8 Years Old NG Visit 3.0 mg
n=12 Participants
NG dose of 3.0 mg for participants 4 to less than 8 years of age.
|
8 to <12 Years Old IM Glucagon Visit
n=6 Participants
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
8 to<12 Years Old NG Visit 2.0 mg
n=11 Participants
NG dose of 2.0 mg for participants 8 to less than 12 years of age.
|
8 to<12 Years Old NG Visit 3.0 mg
n=12 Participants
NG dose of 3.0 mg for participants 8 to less than 12 years of age.
|
12 to <17 Years Old IM Glucagon Visit
n=12 Participants
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
12 to<17 Years Old NG Visit 3.0 mg
n=12 Participants
NG dose of 3.0 mg for participants 12 to less than 17 years of age.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Effect Concentration Time Curve (AUEC0-1.5) of Baseline-Adjusted Glucose From Time Zero up to 90 Minutes
|
145.86 hr*mg/dL
Standard Deviation 26.94
|
118.82 hr*mg/dL
Standard Deviation 60.73
|
142.38 hr*mg/dL
Standard Deviation 51.98
|
132.42 hr*mg/dL
Standard Deviation 22.14
|
128.82 hr*mg/dL
Standard Deviation 28.45
|
138.12 hr*mg/dL
Standard Deviation 35.24
|
126.94 hr*mg/dL
Standard Deviation 30.40
|
101.46 hr*mg/dL
Standard Deviation 27.38
|
SECONDARY outcome
Timeframe: Pre-dose;15, 30, 60 and 90 minutes following glucagon administrationPopulation: All enrolled participants. One participant in the 8 to \<12 group withdrew from the study after completion of the 3.0 mg NG visit and did not complete the 2.0 mg NG visit.
Symptoms of runny nose, nasal congestion and/or itching, sneezing, watery and/or itchy eyes, redness of eyes, and itching of ears and/or throat were assessed prior to administering glucagon and at 15, 30, 60 and 90 minutes following administration of glucagon. This was done via the "Nasal Non-nasal Score Questionnaire". Each of the 9 symptoms is assigned an integer value from 0 to 3; higher values indicate more severe symptoms (a score of 0 indicates no symptoms). The reported results indicate the cohort median out of a possible maximum value of 27 (summing all 9 questions for each participant and reporting the median/IQR across participants).
Outcome measures
| Measure |
4 to<8 Years Old IM Glucagon Visit
n=6 Participants
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
4 to<8 Years Old NG Visit 2.0 mg
n=12 Participants
NG dose of 2.0 mg for participants 4 to less than 8 years of age.
|
4 to<8 Years Old NG Visit 3.0 mg
n=12 Participants
NG dose of 3.0 mg for participants 4 to less than 8 years of age.
|
8 to <12 Years Old IM Glucagon Visit
n=6 Participants
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
8 to<12 Years Old NG Visit 2.0 mg
n=11 Participants
NG dose of 2.0 mg for participants 8 to less than 12 years of age.
|
8 to<12 Years Old NG Visit 3.0 mg
n=12 Participants
NG dose of 3.0 mg for participants 8 to less than 12 years of age.
|
12 to <17 Years Old IM Glucagon Visit
n=12 Participants
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
12 to<17 Years Old NG Visit 3.0 mg
n=12 Participants
NG dose of 3.0 mg for participants 12 to less than 17 years of age.
|
|---|---|---|---|---|---|---|---|---|
|
Nasal and Non-nasal Effects/Symptoms
Pre-dose
|
0.50 units on a scale
Interval 0.0 to 1.0
|
0.00 units on a scale
Interval 0.0 to 2.0
|
0.00 units on a scale
Interval 0.0 to 1.0
|
0.00 units on a scale
Interval 0.0 to 0.0
|
0.00 units on a scale
Interval 0.0 to 1.0
|
0.00 units on a scale
Interval 0.0 to 0.5
|
0.00 units on a scale
Interval 0.0 to 0.5
|
0.50 units on a scale
Interval 0.0 to 1.0
|
|
Nasal and Non-nasal Effects/Symptoms
15 minutes post glucagon administration
|
0.00 units on a scale
Interval 0.0 to 1.0
|
1.00 units on a scale
Interval 0.0 to 3.0
|
0.50 units on a scale
Interval 0.0 to 2.0
|
0.00 units on a scale
Interval 0.0 to 1.0
|
3.00 units on a scale
Interval 0.0 to 4.0
|
3.00 units on a scale
Interval 1.0 to 4.5
|
0.00 units on a scale
Interval 0.0 to 0.0
|
2.00 units on a scale
Interval 1.0 to 4.0
|
|
Nasal and Non-nasal Effects/Symptoms
30 minutes post glucagon administration
|
0.00 units on a scale
Interval 0.0 to 1.0
|
1.00 units on a scale
Interval 0.0 to 1.5
|
0.50 units on a scale
Interval 0.0 to 1.5
|
0.00 units on a scale
Interval 0.0 to 1.0
|
2.00 units on a scale
Interval 0.0 to 2.0
|
2.50 units on a scale
Interval 0.5 to 3.5
|
0.00 units on a scale
Interval 0.0 to 0.0
|
1.00 units on a scale
Interval 1.0 to 3.0
|
|
Nasal and Non-nasal Effects/Symptoms
60 minutes post glucagon administration
|
0.00 units on a scale
Interval 0.0 to 0.0
|
0.50 units on a scale
Interval 0.0 to 2.0
|
0.00 units on a scale
Interval 0.0 to 1.0
|
0.00 units on a scale
Interval 0.0 to 0.0
|
0.00 units on a scale
Interval 0.0 to 1.0
|
0.50 units on a scale
Interval 0.0 to 1.5
|
0.00 units on a scale
Interval 0.0 to 0.0
|
1.00 units on a scale
Interval 0.0 to 2.0
|
|
Nasal and Non-nasal Effects/Symptoms
90 minutes post glucagon administration
|
0.00 units on a scale
Interval 0.0 to 0.0
|
0.00 units on a scale
Interval 0.0 to 1.5
|
0.00 units on a scale
Interval 0.0 to 0.5
|
0.00 units on a scale
Interval 0.0 to 0.0
|
0.00 units on a scale
Interval 0.0 to 1.0
|
0.00 units on a scale
Interval 0.0 to 1.0
|
0.00 units on a scale
Interval 0.0 to 0.0
|
1.00 units on a scale
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: Pre-dose; 5, 10, 15, 20, and 30 minutes following glucagon administrationPopulation: All enrolled participants that completed the required dosing visit(s). One participant in the 4 to \<8 year old 2.0 mg NG group was excluded due to blowing nose after NG administration. One participant in the 8 to \<12 group withdrew after completion of the 3.0 mg NG visit and did not complete the 2.0 mg NG visit.
Outcome measures
| Measure |
4 to<8 Years Old IM Glucagon Visit
n=6 Participants
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
4 to<8 Years Old NG Visit 2.0 mg
n=11 Participants
NG dose of 2.0 mg for participants 4 to less than 8 years of age.
|
4 to<8 Years Old NG Visit 3.0 mg
n=12 Participants
NG dose of 3.0 mg for participants 4 to less than 8 years of age.
|
8 to <12 Years Old IM Glucagon Visit
n=6 Participants
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
8 to<12 Years Old NG Visit 2.0 mg
n=11 Participants
NG dose of 2.0 mg for participants 8 to less than 12 years of age.
|
8 to<12 Years Old NG Visit 3.0 mg
n=12 Participants
NG dose of 3.0 mg for participants 8 to less than 12 years of age.
|
12 to <17 Years Old IM Glucagon Visit
n=12 Participants
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
12 to<17 Years Old NG Visit 3.0 mg
n=12 Participants
NG dose of 3.0 mg for participants 12 to less than 17 years of age.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Achieving at Least a 25 mg/dL Rise in Blood Glucose Above Nadir Level Within 30 Minutes
|
6 Participants
|
11 Participants
|
12 Participants
|
6 Participants
|
11 Participants
|
12 Participants
|
12 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Pre-dose; 5, 10, 15, 20, and 30 minutes following glucagon administrationPopulation: All enrolled participants that completed the required dosing visit(s). One participant in the 4 to \<8 year old 2.0 mg NG group was excluded due to blowing nose after NG administration. One participant in the 8 to \<12 group withdrew after completion of the 3.0 mg NG visit and did not complete the 2.0 mg NG visit.
Time (in minutes) when all participants experienced a rise in glucose \>=25mg/dL. This is an absolute number and is not a calculated statistic. There is no distribution per cohort.
Outcome measures
| Measure |
4 to<8 Years Old IM Glucagon Visit
n=6 Participants
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
4 to<8 Years Old NG Visit 2.0 mg
n=11 Participants
NG dose of 2.0 mg for participants 4 to less than 8 years of age.
|
4 to<8 Years Old NG Visit 3.0 mg
n=12 Participants
NG dose of 3.0 mg for participants 4 to less than 8 years of age.
|
8 to <12 Years Old IM Glucagon Visit
n=6 Participants
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
8 to<12 Years Old NG Visit 2.0 mg
n=11 Participants
NG dose of 2.0 mg for participants 8 to less than 12 years of age.
|
8 to<12 Years Old NG Visit 3.0 mg
n=12 Participants
NG dose of 3.0 mg for participants 8 to less than 12 years of age.
|
12 to <17 Years Old IM Glucagon Visit
n=12 Participants
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
12 to<17 Years Old NG Visit 3.0 mg
n=12 Participants
NG dose of 3.0 mg for participants 12 to less than 17 years of age.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Achieving ≥25 mg/dL Rise in Plasma Glucose Above Nadir Level Within 30 Minutes
|
10 minutes
|
20 minutes
|
15 minutes
|
20 minutes
|
20 minutes
|
15 minutes
|
20 minutes
|
20 minutes
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose; 5, 10,15, 20, and 30 minutes following glucagon administrationPopulation: All enrolled participants that completed the required dosing visit(s). One participant in the 4 to \<8 year old 2.0 mg NG group was excluded due to blowing nose after NG administration. One participant in the 8 to \<12 group withdrew after completion of the 3.0 mg NG visit and did not complete the 2.0 mg NG visit.
Outcome measures
| Measure |
4 to<8 Years Old IM Glucagon Visit
n=6 Participants
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
4 to<8 Years Old NG Visit 2.0 mg
n=11 Participants
NG dose of 2.0 mg for participants 4 to less than 8 years of age.
|
4 to<8 Years Old NG Visit 3.0 mg
n=12 Participants
NG dose of 3.0 mg for participants 4 to less than 8 years of age.
|
8 to <12 Years Old IM Glucagon Visit
n=6 Participants
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
8 to<12 Years Old NG Visit 2.0 mg
n=11 Participants
NG dose of 2.0 mg for participants 8 to less than 12 years of age.
|
8 to<12 Years Old NG Visit 3.0 mg
n=12 Participants
NG dose of 3.0 mg for participants 8 to less than 12 years of age.
|
12 to <17 Years Old IM Glucagon Visit
n=12 Participants
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
12 to<17 Years Old NG Visit 3.0 mg
n=12 Participants
NG dose of 3.0 mg for participants 12 to less than 17 years of age.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With >= 25 mg/dL Rise in Plasma Glucose Within 30 Minutes
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
Adverse Events
4 to<8 Years Old IM Glucagon Visit
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
4 to<8 Years Old NG Visit 2.0 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
4 to<8 Years Old NG Visit 3.0 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
8 to <12 Years Old IM Glucagon Visit
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
8 to<12 Years Old NG Visit 2.0 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
8 to<12 Years Old NG Visit 3.0 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
12 to <17 Years Old IM Glucagon Visit
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
12 to<17 Years Old NG Visit 3.0 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
4 to<8 Years Old IM Glucagon Visit
n=6 participants at risk
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
4 to<8 Years Old NG Visit 2.0 mg
n=12 participants at risk
NG dose of 2.0 mg for participants 4 to less than 8 years of age.
|
4 to<8 Years Old NG Visit 3.0 mg
n=12 participants at risk
NG dose of 3.0 mg for participants 4 to less than 8 years of age.
|
8 to <12 Years Old IM Glucagon Visit
n=6 participants at risk
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
8 to<12 Years Old NG Visit 2.0 mg
n=11 participants at risk
NG of 2.0 mg for participants 8 to less than 12 years of age.
|
8 to<12 Years Old NG Visit 3.0 mg
n=12 participants at risk
NG dose of 3.0 mg for participants 8 to less than 12 years of age.
|
12 to <17 Years Old IM Glucagon Visit
n=12 participants at risk
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
12 to<17 Years Old NG Visit 3.0 mg
n=12 participants at risk
NG dose of 3.0 mg for participants 12 to less than 17 years of age.
|
|---|---|---|---|---|---|---|---|---|
|
Endocrine disorders
Hypoglycemia
|
16.7%
1/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/11 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
Other adverse events
| Measure |
4 to<8 Years Old IM Glucagon Visit
n=6 participants at risk
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
4 to<8 Years Old NG Visit 2.0 mg
n=12 participants at risk
NG dose of 2.0 mg for participants 4 to less than 8 years of age.
|
4 to<8 Years Old NG Visit 3.0 mg
n=12 participants at risk
NG dose of 3.0 mg for participants 4 to less than 8 years of age.
|
8 to <12 Years Old IM Glucagon Visit
n=6 participants at risk
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
8 to<12 Years Old NG Visit 2.0 mg
n=11 participants at risk
NG of 2.0 mg for participants 8 to less than 12 years of age.
|
8 to<12 Years Old NG Visit 3.0 mg
n=12 participants at risk
NG dose of 3.0 mg for participants 8 to less than 12 years of age.
|
12 to <17 Years Old IM Glucagon Visit
n=12 participants at risk
Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 Ibs, IM glucagon dose was 0.5 mg.
|
12 to<17 Years Old NG Visit 3.0 mg
n=12 participants at risk
NG dose of 3.0 mg for participants 12 to less than 17 years of age.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
8.3%
1/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/11 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
8.3%
1/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
16.7%
2/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
8.3%
1/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
33.3%
2/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
18.2%
2/11 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
33.3%
4/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
8.3%
1/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
33.3%
4/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/11 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
16.7%
2/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
|
Eye disorders
Eye irritation
|
0.00%
0/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/11 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
8.3%
1/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
|
General disorders
Catheter site pain
|
0.00%
0/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
8.3%
1/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
16.7%
1/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/11 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
|
Eye disorders
Lacrimation increase
|
0.00%
0/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
9.1%
1/11 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/11 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
8.3%
1/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
16.7%
1/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/11 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
33.3%
4/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
16.7%
2/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
50.0%
3/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
9.1%
1/11 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
8.3%
1/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
8.3%
1/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
25.0%
3/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
8.3%
1/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
25.0%
3/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
50.0%
3/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
27.3%
3/11 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
33.3%
4/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
41.7%
5/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
33.3%
4/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
16.7%
2/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/11 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
8.3%
1/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/11 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
8.3%
1/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
8.3%
1/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/11 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
|
General disorders
Injection site discomfort
|
33.3%
2/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
50.0%
3/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/11 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
8.3%
1/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/11 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
16.7%
1/6 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/11 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
0.00%
0/12 • Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place