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Assessment of Intranasal Glucagon in Children and Adolescents With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT01997411
Recruitment Status : Completed
First Posted : November 28, 2013
Results First Posted : March 6, 2017
Last Update Posted : August 29, 2018
Sponsor:
Collaborators:
Jaeb Center for Health Research
Locemia Solutions ULC
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 1
Interventions Drug: Nasal Glucagon
Drug: Intramuscular Glucagon
Enrollment 48
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 4 to<8 Years Old Intramuscular (IM) Glucagon Visit 4 to <8 Years Old NG 2.0 mg 1st Visit/3.0 mg 2nd Visit 4 to <8 Years Old NG 3.0 mg 1st Visit/2.0 mg 2nd Visit 8 to <12 Years Old Intramuscular Glucagon Visit 8 to <12 Years Old NG 2.0 mg 1st Visit/3.0 mg 2nd Visit 8 to <12 Years Old NG 3.0 mg 1st Visit/2.0 mg 2nd Visit 12 to <17 Years Old NG 1st Visit/IM Glucagon 2nd Visit 12 to <17 Years Old IM Glucagon 1st Visit/NG 2nd Visit
Hide Arm/Group Description

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.

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.

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.

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.

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.

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.

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.

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.

Period Title: Overall Study
Started 6 6 6 6 6 6 6 6
Completed 6 6 6 6 6 5 6 6
Not Completed 0 0 0 0 0 1 0 0
Arm/Group Title 4 to <8 Years Old IM Glucagon Cohort 4 to <8 Years Old NG Cohort 8 to <12 Years Old IM Glucagon Cohort 8 to <12 Years Old NG Cohort 12 to <17 Years Old NG/IM Cohort Total
Hide Arm/Group Description 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. 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. 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 6 12 6 12 12 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 6 participants 12 participants 6 participants 12 participants 12 participants 48 participants
6.8
(5.7 to 7.5)
6.8
(5.7 to 7.5)
11.1
(10.5 to 11.8)
11.1
(10.5 to 11.8)
14.5
(13.2 to 15.8)
10.6
(7.4 to 12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 12 participants 6 participants 12 participants 12 participants 48 participants
Female 0 3 3 5 5 16
Male 6 9 3 7 7 32
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 6 participants 12 participants 6 participants 12 participants 12 participants 48 participants
6 12 6 12 12 48
Local HbA1c  
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 6 participants 12 participants 6 participants 12 participants 12 participants 48 participants
7.6  (0.5) 8.3  (0.8) 7.5  (1.1) 8.1  (0.7) 8.2  (1.5) 8.0  (1.0)
Duration of Diabetes  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 6 participants 12 participants 6 participants 12 participants 12 participants 48 participants
3.1
(2.1 to 3.8)
2.7
(1.8 to 3.6)
5.3
(3.9 to 6.3)
4.3
(3.4 to 6.7)
5.9
(3.5 to 8.0)
3.9
(2.6 to 6.0)
1.Primary Outcome
Title Maximum Change From Baseline Concentration (Cmax) of Glucagon
Hide Description [Not Specified]
Time Frame Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 4 to<8 Years Old IM Glucagon Visit 4 to<8 Years Old NG Visit 2.0 mg 4 to<8 Years Old NG Visit 3.0 mg 8 to <12 Years Old IM Glucagon Visit 8 to<12 Years Old NG Visit 2.0 mg 8 to<12 Years Old NG Visit 3.0 mg 12 to <17 Years Old IM Glucagon Visit 12 to<17 Years Old NG Visit 3.0 mg
Hide Arm/Group Description:
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.
NG dose of 2.0 mg for participants 4 to less than 8 years of age.
NG dose of 3.0 mg for participants 4 to less than 8 years of age.
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.
NG dose of 2.0 mg for participants 8 to less than 12 years of age.
NG dose of 3.0 mg for participants 8 to less than 12 years of age.
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.
NG dose of 3.0 mg for participants 12 to less than 17 years of age.
Overall Number of Participants Analyzed 6 11 12 6 11 12 12 12
Mean (Standard Deviation)
Unit of Measure: picograms per millilitre (pg/mL)
6290.33  (2045.96) 3463.55  (1760.28) 3958.58  (2438.60) 4743.00  (3094.61) 2776.27  (979.28) 5664.33  (2114.69) 4277.25  (3774.77) 3103.25  (2302.61)
2.Primary Outcome
Title Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon
Hide Description [Not Specified]
Time Frame Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 4 to<8 Years Old IM Glucagon Visit 4 to<8 Years Old NG Visit 2.0 mg 4 to<8 Years Old NG Visit 3.0 mg 8 to <12 Years Old IM Glucagon Visit 8 to<12 Years Old NG Visit 2.0 mg 8 to<12 Years Old NG Visit 3.0 mg 12 to <17 Years Old IM Glucagon Visit 12 to<17 Years Old NG Visit 3.0 mg
Hide Arm/Group Description:
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.
NG dose of 2.0 mg for participants 4 to less than 8 years of age.
NG dose of 3.0 mg for participants 4 to less than 8 years of age.
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.
NG dose of 2.0 mg for participants 8 to less than 12 years of age.
NG dose of 3.0 mg for participants 8 to less than 12 years of age.
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.
NG dose of 3.0 mg for participants 12 to less than 17 years of age.
Overall Number of Participants Analyzed 6 11 12 6 11 12 12 12
Median (Full Range)
Unit of Measure: hours (hr)
0.29
(0.08 to 0.50)
0.25
(0.17 to 0.33)
0.29
(0.17 to 1.00)
0.29
(0.08 to 0.50)
0.25
(0.17 to 0.33)
0.25
(0.17 to 0.50)
0.29
(0.08 to 0.50)
0.33
(0.25 to 0.50)
3.Primary Outcome
Title Area Under the Curve (AUC0-1.5) of Baseline Adjusted Glucagon
Hide Description [Not Specified]
Time Frame Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 4 to<8 Years Old IM Glucagon Visit 4 to<8 Years Old NG Visit 2.0 mg 4 to<8 Years Old NG Visit 3.0 mg 8 to <12 Years Old IM Glucagon Visit 8 to<12 Years Old NG Visit 2.0 mg 8 to<12 Years Old NG Visit 3.0 mg 12 to <17 Years Old IM Glucagon Visit 12 to<17 Years Old NG Visit 3.0 mg
Hide Arm/Group Description:
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.
NG dose of 2.0 mg for participants 4 to less than 8 years of age.
NG dose of 3.0 mg for participants 4 to less than 8 years of age.
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.
NG dose of 2.0 mg for participants 8 to less than 12 years of age.
NG dose of 3.0 mg for participants 8 to less than 12 years of age.
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.
NG dose of 3.0 mg for participants 12 to less than 17 years of age.
Overall Number of Participants Analyzed 6 11 12 6 11 12 12 12
Mean (Standard Deviation)
Unit of Measure: hour*picogram per millilitre (hr*pg/mL)
4078.68  (2078.89) 1744.36  (978.81) 2472.40  (1435.45) 3635.77  (2069.11) 1506.23  (541.57) 2939.31  (1042.03) 3110.22  (2848.75) 1999.69  (1329.44)
4.Primary Outcome
Title Maximum Concentration (Cmax) of Baseline-Adjusted Glucose
Hide Description [Not Specified]
Time Frame Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 4 to<8 Years Old IM Glucagon Visit 4 to<8 Years Old NG Visit 2.0 mg 4 to<8 Years Old NG Visit 3.0 mg 8 to <12 Years Old IM Glucagon Visit 8 to<12 Years Old NG Visit 2.0 mg 8 to<12 Years Old NG Visit 3.0 mg 12 to <17 Years Old IM Glucagon Visit 12 to<17 Years Old NG Visit 3.0 mg
Hide Arm/Group Description:
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.
NG dose of 2.0 mg for participants 4 to less than 8 years of age.
NG dose of 3.0 mg for participants 4 to less than 8 years of age.
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.
NG dose of 2.0 mg for participants 8 to less than 12 years of age.
NG dose of 3.0 mg for participants 8 to less than 12 years of age.
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.
NG dose of 3.0 mg for participants 12 to less than 17 years of age.
Overall Number of Participants Analyzed 6 11 12 6 11 12 12 12
Mean (Standard Deviation)
Unit of Measure: mg/dL
138.17  (26.57) 118.18  (46.46) 137.50  (42.14) 130.50  (21.81) 125.09  (23.81) 132.82  (30.59) 123.17  (29.58) 102.33  (25.63)
5.Primary Outcome
Title Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose
Hide Description [Not Specified]
Time Frame Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 4 to<8 Years Old IM Glucagon Visit 4 to<8 Years Old NG Visit 2.0 mg 4 to<8 Years Old NG Visit 3.0 mg 8 to <12 Years Old IM Glucagon Visit 8 to<12 Years Old NG Visit 2.0 mg 8 to<12 Years Old NG Visit 3.0 mg 12 to <17 Years Old IM Glucagon Visit 12 to<17 Years Old NG Visit 3.0 mg
Hide Arm/Group Description:
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.
NG dose of 2.0 mg for participants 4 to less than 8 years of age.
NG dose of 3.0 mg for participants 4 to less than 8 years of age.
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.
NG dose of 2.0 mg for participants 8 to less than 12 years of age.
NG dose of 3.0 mg for participants 8 to less than 12 years of age.
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.
NG dose of 3.0 mg for participants 12 to less than 17 years of age.
Overall Number of Participants Analyzed 6 11 12 6 11 12 12 12
Median (Full Range)
Unit of Measure: hours (hr)
1.00
(0.67 to 1.50)
0.67
(0.33 to 1.00)
1.00
(0.50 to 1.50)
1.50
(1.00 to 1.50)
1.00
(0.67 to 1.50)
1.00
(0.50 to 1.50)
1.00
(0.67 to 1.50)
1.00
(0.50 to 1.50)
6.Primary Outcome
Title Area Under the Effect Concentration Time Curve (AUEC0-1.5) of Baseline-Adjusted Glucose From Time Zero up to 90 Minutes
Hide Description [Not Specified]
Time Frame Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 4 to<8 Years Old IM Glucagon Visit 4 to<8 Years Old NG Visit 2.0 mg 4 to<8 Years Old NG Visit 3.0 mg 8 to <12 Years Old IM Glucagon Visit 8 to<12 Years Old NG Visit 2.0 mg 8 to<12 Years Old NG Visit 3.0 mg 12 to <17 Years Old IM Glucagon Visit 12 to<17 Years Old NG Visit 3.0 mg
Hide Arm/Group Description:
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.
NG dose of 2.0 mg for participants 4 to less than 8 years of age.
NG dose of 3.0 mg for participants 4 to less than 8 years of age.
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.
NG dose of 2.0 mg for participants 8 to less than 12 years of age.
NG dose of 3.0 mg for participants 8 to less than 12 years of age.
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.
NG dose of 3.0 mg for participants 12 to less than 17 years of age.
Overall Number of Participants Analyzed 6 11 12 6 11 12 12 12
Mean (Standard Deviation)
Unit of Measure: hr*mg/dL
145.86  (26.94) 118.82  (60.73) 142.38  (51.98) 132.42  (22.14) 128.82  (28.45) 138.12  (35.24) 126.94  (30.40) 101.46  (27.38)
7.Secondary Outcome
Title Nasal and Non-nasal Effects/Symptoms
Hide Description 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).
Time Frame Pre-dose;15, 30, 60 and 90 minutes following glucagon administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 4 to<8 Years Old IM Glucagon Visit 4 to<8 Years Old NG Visit 2.0 mg 4 to<8 Years Old NG Visit 3.0 mg 8 to <12 Years Old IM Glucagon Visit 8 to<12 Years Old NG Visit 2.0 mg 8 to<12 Years Old NG Visit 3.0 mg 12 to <17 Years Old IM Glucagon Visit 12 to<17 Years Old NG Visit 3.0 mg
Hide Arm/Group Description:
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.
NG dose of 2.0 mg for participants 4 to less than 8 years of age.
NG dose of 3.0 mg for participants 4 to less than 8 years of age.
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.
NG dose of 2.0 mg for participants 8 to less than 12 years of age.
NG dose of 3.0 mg for participants 8 to less than 12 years of age.
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.
NG dose of 3.0 mg for participants 12 to less than 17 years of age.
Overall Number of Participants Analyzed 6 12 12 6 11 12 12 12
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
Pre-dose
0.50
(0.00 to 1.00)
0.00
(0.00 to 2.00)
0.00
(0.00 to 1.00)
0.00
(0.00 to 0.00)
0.00
(0.00 to 1.00)
0.00
(0.00 to 0.50)
0.00
(0.00 to 0.50)
0.50
(0.00 to 1.00)
15 minutes post glucagon administration
0.00
(0.00 to 1.00)
1.00
(0.00 to 3.00)
0.50
(0.00 to 2.00)
0.00
(0.00 to 1.00)
3.00
(0.00 to 4.00)
3.00
(1.00 to 4.50)
0.00
(0.00 to 0.00)
2.00
(1.00 to 4.00)
30 minutes post glucagon administration
0.00
(0.00 to 1.00)
1.00
(0.00 to 1.50)
0.50
(0.00 to 1.50)
0.00
(0.00 to 1.00)
2.00
(0.00 to 2.00)
2.50
(0.50 to 3.50)
0.00
(0.00 to 0.00)
1.00
(1.00 to 3.00)
60 minutes post glucagon administration
0.00
(0.00 to 0.00)
0.50
(0.00 to 2.00)
0.00
(0.00 to 1.00)
0.00
(0.00 to 0.00)
0.00
(0.00 to 1.00)
0.50
(0.00 to 1.50)
0.00
(0.00 to 0.00)
1.00
(0.00 to 2.00)
90 minutes post glucagon administration
0.00
(0.00 to 0.00)
0.00
(0.00 to 1.50)
0.00
(0.00 to 0.50)
0.00
(0.00 to 0.00)
0.00
(0.00 to 1.00)
0.00
(0.00 to 1.00)
0.00
(0.00 to 0.00)
1.00
(0.00 to 1.00)
8.Secondary Outcome
Title Number of Participants Achieving at Least a 25 mg/dL Rise in Blood Glucose Above Nadir Level Within 30 Minutes
Hide Description [Not Specified]
Time Frame Pre-dose; 5, 10, 15, 20, and 30 minutes following glucagon administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 4 to<8 Years Old IM Glucagon Visit 4 to<8 Years Old NG Visit 2.0 mg 4 to<8 Years Old NG Visit 3.0 mg 8 to <12 Years Old IM Glucagon Visit 8 to<12 Years Old NG Visit 2.0 mg 8 to<12 Years Old NG Visit 3.0 mg 12 to <17 Years Old IM Glucagon Visit 12 to<17 Years Old NG Visit 3.0 mg
Hide Arm/Group Description:
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.
NG dose of 2.0 mg for participants 4 to less than 8 years of age.
NG dose of 3.0 mg for participants 4 to less than 8 years of age.
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.
NG dose of 2.0 mg for participants 8 to less than 12 years of age.
NG dose of 3.0 mg for participants 8 to less than 12 years of age.
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.
NG dose of 3.0 mg for participants 12 to less than 17 years of age.
Overall Number of Participants Analyzed 6 11 12 6 11 12 12 12
Measure Type: Count of Participants
Unit of Measure: Participants
6 11 12 6 11 12 12 12
9.Secondary Outcome
Title Time to Achieving ≥25 mg/dL Rise in Plasma Glucose Above Nadir Level Within 30 Minutes
Hide Description 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.
Time Frame Pre-dose; 5, 10, 15, 20, and 30 minutes following glucagon administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 4 to<8 Years Old IM Glucagon Visit 4 to<8 Years Old NG Visit 2.0 mg 4 to<8 Years Old NG Visit 3.0 mg 8 to <12 Years Old IM Glucagon Visit 8 to<12 Years Old NG Visit 2.0 mg 8 to<12 Years Old NG Visit 3.0 mg 12 to <17 Years Old IM Glucagon Visit 12 to<17 Years Old NG Visit 3.0 mg
Hide Arm/Group Description:
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.
NG dose of 2.0 mg for participants 4 to less than 8 years of age.
NG dose of 3.0 mg for participants 4 to less than 8 years of age.
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.
NG dose of 2.0 mg for participants 8 to less than 12 years of age.
NG dose of 3.0 mg for participants 8 to less than 12 years of age.
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.
NG dose of 3.0 mg for participants 12 to less than 17 years of age.
Overall Number of Participants Analyzed 6 11 12 6 11 12 12 12
Measure Type: Number
Unit of Measure: minutes
10 20 15 20 20 15 20 20
10.Other Pre-specified Outcome
Title Percentage of Participants With >= 25 mg/dL Rise in Plasma Glucose Within 30 Minutes
Hide Description [Not Specified]
Time Frame Pre-dose; 5, 10,15, 20, and 30 minutes following glucagon administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 4 to<8 Years Old IM Glucagon Visit 4 to<8 Years Old NG Visit 2.0 mg 4 to<8 Years Old NG Visit 3.0 mg 8 to <12 Years Old IM Glucagon Visit 8 to<12 Years Old NG Visit 2.0 mg 8 to<12 Years Old NG Visit 3.0 mg 12 to <17 Years Old IM Glucagon Visit 12 to<17 Years Old NG Visit 3.0 mg
Hide Arm/Group Description:
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.
NG dose of 2.0 mg for participants 4 to less than 8 years of age.
NG dose of 3.0 mg for participants 4 to less than 8 years of age.
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.
NG dose of 2.0 mg for participants 8 to less than 12 years of age.
NG dose of 3.0 mg for participants 8 to less than 12 years of age.
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.
NG dose of 3.0 mg for participants 12 to less than 17 years of age.
Overall Number of Participants Analyzed 6 11 12 6 11 12 12 12
Measure Type: Number
Unit of Measure: percentage of participants
100 100 100 100 100 100 100 100
Time Frame Through study completion, up to 69 days
Adverse Event Reporting Description Included all participants received at least one dose of glucagon.
 
Arm/Group Title 4 to<8 Years Old IM Glucagon Visit 4 to<8 Years Old NG Visit 2.0 mg 4 to<8 Years Old NG Visit 3.0 mg 8 to <12 Years Old IM Glucagon Visit 8 to<12 Years Old NG Visit 2.0 mg 8 to<12 Years Old NG Visit 3.0 mg 12 to <17 Years Old IM Glucagon Visit 12 to<17 Years Old NG Visit 3.0 mg
Hide Arm/Group Description 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. NG dose of 2.0 mg for participants 4 to less than 8 years of age. NG dose of 3.0 mg for participants 4 to less than 8 years of age. 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. NG of 2.0 mg for participants 8 to less than 12 years of age. NG dose of 3.0 mg for participants 8 to less than 12 years of age. 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. NG dose of 3.0 mg for participants 12 to less than 17 years of age.
All-Cause Mortality
4 to<8 Years Old IM Glucagon Visit 4 to<8 Years Old NG Visit 2.0 mg 4 to<8 Years Old NG Visit 3.0 mg 8 to <12 Years Old IM Glucagon Visit 8 to<12 Years Old NG Visit 2.0 mg 8 to<12 Years Old NG Visit 3.0 mg 12 to <17 Years Old IM Glucagon Visit 12 to<17 Years Old NG Visit 3.0 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
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4 to<8 Years Old IM Glucagon Visit 4 to<8 Years Old NG Visit 2.0 mg 4 to<8 Years Old NG Visit 3.0 mg 8 to <12 Years Old IM Glucagon Visit 8 to<12 Years Old NG Visit 2.0 mg 8 to<12 Years Old NG Visit 3.0 mg 12 to <17 Years Old IM Glucagon Visit 12 to<17 Years Old NG Visit 3.0 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/6 (16.67%)   0/12 (0.00%)   0/12 (0.00%)   0/6 (0.00%)   0/11 (0.00%)   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%) 
Endocrine disorders                 
Hypoglycemia  1 [1]  1/6 (16.67%)  0/12 (0.00%)  0/12 (0.00%)  0/6 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
[1]
Experienced a hypoglycemic event after receiving a bolus of insulin with lunch. Received 90 g oral carbohydrates and made a full recovery.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
4 to<8 Years Old IM Glucagon Visit 4 to<8 Years Old NG Visit 2.0 mg 4 to<8 Years Old NG Visit 3.0 mg 8 to <12 Years Old IM Glucagon Visit 8 to<12 Years Old NG Visit 2.0 mg 8 to<12 Years Old NG Visit 3.0 mg 12 to <17 Years Old IM Glucagon Visit 12 to<17 Years Old NG Visit 3.0 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/6 (83.33%)   6/12 (50.00%)   5/12 (41.67%)   6/6 (100.00%)   5/11 (45.45%)   6/12 (50.00%)   7/12 (58.33%)   9/12 (75.00%) 
Cardiac disorders                 
Tachycardia  1  0/6 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Eye disorders                 
Eye irritation  1  0/6 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/6 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Lacrimation increase  1  0/6 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/6 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Ocular discomfort  1  0/6 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/6 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Gastrointestinal disorders                 
Abdominal pain  1  1/6 (16.67%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Diarrhea  1  0/6 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/6 (16.67%)  0/11 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Nausea  1  4/6 (66.67%)  4/12 (33.33%)  2/12 (16.67%)  3/6 (50.00%)  1/11 (9.09%)  1/12 (8.33%)  1/12 (8.33%)  3/12 (25.00%) 
Vomiting  1  1/6 (16.67%)  1/12 (8.33%)  3/12 (25.00%)  3/6 (50.00%)  3/11 (27.27%)  4/12 (33.33%)  5/12 (41.67%)  4/12 (33.33%) 
General disorders                 
Catheter site pain  1  0/6 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  1/6 (16.67%)  0/11 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Injection site discomfort  1  2/6 (33.33%)  0/12 (0.00%)  0/12 (0.00%)  3/6 (50.00%)  0/11 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Nervous system disorders                 
Headache  1  0/6 (0.00%)  2/12 (16.67%)  1/12 (8.33%)  2/6 (33.33%)  2/11 (18.18%)  4/12 (33.33%)  1/12 (8.33%)  4/12 (33.33%) 
Dizziness  1  0/6 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/6 (16.67%)  0/11 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Nasal congestion  1  0/6 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/6 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  2/12 (16.67%) 
Nasal discomfort  1  0/6 (0.00%)  0/12 (0.00%)  2/12 (16.67%)  0/6 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Sneezing  1  0/6 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/6 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Rhinalgia  1  0/6 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/6 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01997411     History of Changes
Other Study ID Numbers: 16418
I8R-MC-IGBB ( Other Identifier: Eli Lilly and Company )
INGluc002 ( Other Identifier: Jaeb Center for Health Research )
AMG103 ( Other Identifier: Locemia )
First Submitted: November 22, 2013
First Posted: November 28, 2013
Results First Submitted: September 2, 2016
Results First Posted: March 6, 2017
Last Update Posted: August 29, 2018