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Clinical Trial Results:
Assessment of Intranasal Glucagon in Children and Adolescents with Type 1 Diabetes

Summary
EudraCT number	2015-003252-40
Trial protocol	Outside EU/EEA
Global end of trial date	13 Jan 2015

Results information
Results version number	v2(current)
This version publication date	04 Jul 2018
First version publication date	22 Oct 2017
Other versions	v1
Version creation reason	Correction of full data set Data Correction

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

16418

ISRCTN number

US NCT number

NCT01997411

WHO universal trial number (UTN)

Other trial identifiers

Trial Alias: I8R-MC-IGBB, Additional Trial Identifier: AMG103

Sponsor organisation name

Eli Lilly and Company

Sponsor organisation address

Lilly Corporate Center, Indianapolis, IN, United States, 46285

Public contact

Available Mon - Fri 9 AM - 5 PM EST , Eli Lilly and Company, 1 877-CTLilly,

Scientific contact

Available Mon - Fri 9 AM - 5 PM EST , Eli Lilly and Company, 1 877-285-4559,

Is trial part of an agreed paediatric investigation plan (PIP)

Yes

EMA paediatric investigation plan number(s)

EMEA-001657-PIP01-14

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

13 Jan 2015

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

13 Jan 2015

Was the trial ended prematurely?

Main objective of the trial

The purpose of this study was to assess how glucagon administered nasally, using a nasal dosing delivery device, works in children and adolescents compared with commercially-available glucagon given by injection. In addition, the safety and tolerability of glucagon given nasally was evaluated.

Protection of trial subjects

Guidelines as drawn up by the institutional review board were followed with regard to the treatment of human subjects in the study. These guidelines meet the requirements of the Declaration of Helsinki; they also meet the requirements of the United States Code of Federal Regulations (Title 21, Part 56), the Directive 2001/20/EC (Europe) and the Tri-Council Policy Statement (Canada). This study was performed in compliance with Good Clinical Practice.

Background therapy

Evidence for comparator

Actual start date of recruitment

12 Dec 2013

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 48

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

No Text Entered

Screening details

No Text Entered

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Blinding implementation details

IM and NG arms are open labeled. NG cohorts, 2mg and 3mg, are double blinded.

Are arms mutually exclusive

4 to<8 Years Old Intramuscular (IM) Glucagon Visit

Arm description

This was completed at one visit and was the only visit for this cohort.

Arm type

Active comparator

Investigational medicinal product name

Intramuscular Glucagon

Investigational medicinal product code

Other name

Glucagon, GlucaGen HypoKit

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

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 lbs, IM glucagon dosed with 0.5 mg.

4 to <8 Years Old NG 2.0 mg 1st Visit/3.0 mg 2nd Visit

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Nasal Glucagon (NG)

Investigational medicinal product code

Other name

Dry-Mist nasal glucagon, AMG504-1, LY900018

Pharmaceutical forms

Nasal powder

Routes of administration

Nasal use

Dosage and administration details

NG doses of 2.0 mg and 3.0 mg for participants 4 to less than 8 years of age were administered in a nostril with a prefilled delivery device that delivered a single dose upon activation.

4 to <8 Years Old NG 3.0 mg 1st Visit/2.0 mg 2nd Visit

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Nasal Glucagon (NG)

Investigational medicinal product code

Other name

Dry-Mist nasal glucagon, AMG504-1, LY900018

Pharmaceutical forms

Nasal powder

Routes of administration

Nasal use

Dosage and administration details

NG doses of 3.0 mg and 2.0 mg for participants 4 to less than 8 years of age were administered in a nostril with a prefilled delivery device that delivered a single dose upon activation.

8 to <12 Years Old Intramuscular Glucagon Visit

Arm description

This was completed at one visit and was the only “dosing” visit for this cohort.

Arm type

Active comparator

Investigational medicinal product name

Intramuscular Glucagon

Investigational medicinal product code

Other name

Glucagon, GlucaGen HypoKit

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 lbs, IM glucagon dosed with 0.5 mg.

8 to <12 Years Old NG 2.0 mg 1st Visit/3.0 mg 2nd Visit

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Nasal Glucagon (NG)

Investigational medicinal product code

Other name

Dry-Mist nasal glucagon, AMG504-1, LY900018

Pharmaceutical forms

Nasal powder

Routes of administration

Nasal use

Dosage and administration details

NG doses of 2.0 mg and 3.0 mg for participants 8 to less than 12 years of age were administered in a nostril with a prefilled delivery device that delivered a single dose upon activation.

8 to <12 Years Old NG 3.0 mg 1st Visit/2.0 mg 2nd Visit

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Nasal Glucagon (NG)

Investigational medicinal product code

Other name

Dry-Mist nasal glucagon, AMG504-1, LY900018

Pharmaceutical forms

Nasal powder

Routes of administration

Nasal use

Dosage and administration details

NG doses of 3.0 mg and 2.0 mg for participants 8 to less than 12 years of age were administered in a nostril with a prefilled delivery device that delivered a single dose upon activation.

12 to <17 Years Old NG 3.0 mg 1st Visit/IM Glucagon 2nd Visit

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Nasal Glucagon (NG)

Investigational medicinal product code

Other name

Dry-Mist nasal glucagon, AMG504-1, LY900018

Pharmaceutical forms

Nasal powder

Routes of administration

Nasal use

Dosage and administration details

NG doses of 3.0 mg for those 12 to less than 17 years of age were administered in a nostril with a prefilled delivery device that delivered a single dose upon activation.

Investigational medicinal product name

Intramuscular Glucagon

Investigational medicinal product code

Other name

Glucagon, GlucaGen HypoKit

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 lbs, IM glucagon dosed with 0.5 mg.

12 to <17 Years Old IM Glucagon 1st Visit/NG 3.0 mg 2nd Visit

Arm description

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.

Arm type

Active comparator

Investigational medicinal product name

Intramuscular Glucagon

Investigational medicinal product code

Other name

Glucagon, GlucaGen HypoKit

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Participants who weighed at least 25 kg/55 lbs were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 lbs, IM glucagon dosed with 0.5 mg.

Investigational medicinal product name

Nasal Glucagon (NG)

Investigational medicinal product code

Other name

Dry-Mist nasal glucagon, AMG504-1, LY900018

Pharmaceutical forms

Nasal powder

Routes of administration

Nasal use

Dosage and administration details

NG doses of 3.0 mg for those 12 to less than 17 years of age were administered in a nostril with a prefilled delivery device that delivered a single dose upon activation.

Number of subjects in period 1	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 3.0 mg 1st Visit/IM Glucagon 2nd Visit	12 to <17 Years Old IM Glucagon 1st Visit/NG 3.0 mg 2nd Visit
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
Consent withdrawn by subject	-	-	-	-	-	1	-	-

Baseline characteristics

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Reporting group title

Overall Study

Reporting group description

Reporting group values	Overall Study	Total
Number of subjects	48	48
Age categorical
Units: Subjects
Age Continuous
Units: years
median (inter-quartile range (Q1-Q3))	10.6 (7.4 to 12.2)	-
Gender, Male/Female
Units:
Female	16	16
Male	32	32
Region of Enrollment
Units: Subjects
United States	48	48
Duration of Diabetes
Units: years
median (inter-quartile range (Q1-Q3))	3.9 (2.6 to 6)	-
Local HbA1c (glycated haemoglobin)
Units: Percentage
arithmetic mean (standard deviation)	8 ± 1	-

Subject analysis set title

4 to <8 Years Old IM Glucagon Cohort

Subject analysis set type

Full analysis

Subject analysis set 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.

Subject analysis set title

4 to <8 Years Old NG Cohort

Subject analysis set type

Full analysis

Subject analysis set description

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.

Subject analysis set title

8 to <12 Years Old IM Glucagon Cohort

Subject analysis set type

Full analysis

Subject analysis set description

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.

Subject analysis set title

8 to <12 Years Old NG Cohort

Subject analysis set type

Full analysis

Subject analysis set description

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.

Subject analysis set title

12 to <17 Years Old NG/IM Cohort

Subject analysis set type

Full analysis

Subject analysis set description

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.

Subject analysis set title

4 to<8 Years Old IM Glucagon Visit

Subject analysis set type

Sub-group analysis

Subject analysis set 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.

Subject analysis set title

4 to<8 Years Old NG Visit 2.0 mg

Subject analysis set type

Sub-group analysis

Subject analysis set description

NG dose of 2.0 mg for participants 4 to less than 8 years of age.

Subject analysis set title

4 to<8 Years Old NG Visit 3.0 mg

Subject analysis set type

Sub-group analysis

Subject analysis set description

NG dose of 3.0 mg for participants 4 to less than 8 years of age.

Subject analysis set title

8 to <12 Years Old IM Glucagon Visit

Subject analysis set type

Sub-group analysis

Subject analysis set 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.

Subject analysis set title

8 to<12 Years Old NG Visit 2.0 mg

Subject analysis set type

Sub-group analysis

Subject analysis set description

NG of 2.0 mg for participants 8 to less than 12 years of age.

Subject analysis set title

8 to<12 Years Old NG Visit 3.0 mg

Subject analysis set type

Sub-group analysis

Subject analysis set description

NG dose of 3.0 mg for participants 8 to less than 12 years of age.

Subject analysis set title

12 to <17 Years Old IM Glucagon Visit

Subject analysis set type

Sub-group analysis

Subject analysis set 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.

Subject analysis set title

12 to<17 Years Old NG Visit 3.0 mg

Subject analysis set type

Sub-group analysis

Subject analysis set description

NG dose of 3.0 mg for participants 12 to less than 17 years of age.

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

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

Number of subjects

Units: Subjects

Units: years

median (inter-quartile range (Q1-Q3))

6.8 (5.7 to 7.5)

11.1 (10.5 to 11.8)

14.5 (13.2 to 15.8)

Units:

Female

Male

Units: Subjects

United States

Units: years

median (inter-quartile range (Q1-Q3))

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)

Units: Percentage

arithmetic mean (standard deviation)

7.6 ± 0.5

8.3 ± 0.8

7.5 ± 1.1

8.1 ± 0.7

8.2 ± 1.5

End points

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Reporting group title

4 to<8 Years Old Intramuscular (IM) Glucagon Visit

Reporting group description

This was completed at one visit and was the only visit for this cohort.

Reporting group title

4 to <8 Years Old NG 2.0 mg 1st Visit/3.0 mg 2nd Visit

Reporting group description

Reporting group title

4 to <8 Years Old NG 3.0 mg 1st Visit/2.0 mg 2nd Visit

Reporting group description

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.

Reporting group title

8 to <12 Years Old Intramuscular Glucagon Visit

Reporting group description

This was completed at one visit and was the only “dosing” visit for this cohort.

Reporting group title

8 to <12 Years Old NG 2.0 mg 1st Visit/3.0 mg 2nd Visit

Reporting group description

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.

Reporting group title

8 to <12 Years Old NG 3.0 mg 1st Visit/2.0 mg 2nd Visit

Reporting group description

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.

Reporting group title

12 to <17 Years Old NG 3.0 mg 1st Visit/IM Glucagon 2nd Visit

Reporting group description

Reporting group title

12 to <17 Years Old IM Glucagon 1st Visit/NG 3.0 mg 2nd Visit

Reporting group description

Subject analysis set title

4 to <8 Years Old IM Glucagon Cohort

Subject analysis set type

Full analysis

Subject analysis set 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.

Subject analysis set title

4 to <8 Years Old NG Cohort

Subject analysis set type

Full analysis

Subject analysis set description

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.

Subject analysis set title

8 to <12 Years Old IM Glucagon Cohort

Subject analysis set type

Full analysis

Subject analysis set description

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.

Subject analysis set title

8 to <12 Years Old NG Cohort

Subject analysis set type

Full analysis

Subject analysis set description

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.

Subject analysis set title

12 to <17 Years Old NG/IM Cohort

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

4 to<8 Years Old IM Glucagon Visit

Subject analysis set type

Sub-group analysis

Subject analysis set 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.

Subject analysis set title

4 to<8 Years Old NG Visit 2.0 mg

Subject analysis set type

Sub-group analysis

Subject analysis set description

NG dose of 2.0 mg for participants 4 to less than 8 years of age.

Subject analysis set title

4 to<8 Years Old NG Visit 3.0 mg

Subject analysis set type

Sub-group analysis

Subject analysis set description

NG dose of 3.0 mg for participants 4 to less than 8 years of age.

Subject analysis set title

8 to <12 Years Old IM Glucagon Visit

Subject analysis set type

Sub-group analysis

Subject analysis set 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.

Subject analysis set title

8 to<12 Years Old NG Visit 2.0 mg

Subject analysis set type

Sub-group analysis

Subject analysis set description

NG of 2.0 mg for participants 8 to less than 12 years of age.

Subject analysis set title

8 to<12 Years Old NG Visit 3.0 mg

Subject analysis set type

Sub-group analysis

Subject analysis set description

NG dose of 3.0 mg for participants 8 to less than 12 years of age.

Subject analysis set title

12 to <17 Years Old IM Glucagon Visit

Subject analysis set type

Sub-group analysis

Subject analysis set 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.

Subject analysis set title

12 to<17 Years Old NG Visit 3.0 mg

Subject analysis set type

Sub-group analysis

Subject analysis set description

NG dose of 3.0 mg for participants 12 to less than 17 years of age.

Primary: Maximum Change from Baseline Concentration (Cmax) of Glucagon

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End point title

Maximum Change from Baseline Concentration (Cmax) of Glucagon ^[1]

End point description

Change from baseline to maximum glucagon concentration within 90 minutes post glucagon administration. 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.

End point type

Primary

End point timeframe

Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration.

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Inferential statistics were exploratory only per protocol.

End point values	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
Number of subjects analysed	6	11	12	6	11	12	12	12
Units: picogram per milliliter (pg/mL)
arithmetic mean (standard deviation)	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

No statistical analyses for this end point

Primary: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon

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End point title

Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon ^[2]

End point description

Time to the change from baseline to maximum glucagon concentration within 90 minutes post glucagon administration. 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.

End point type

Primary

End point timeframe

Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Inferential statistical analyses were not performed

End point values	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
Number of subjects analysed	6	11	12	6	11	12	12	12
Units: hours
median (full range (min-max))	0.29 (0.08 to 0.50)	0.25 (0.17 to 0.333)	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)

No statistical analyses for this end point

Primary: Area Under the Curve (AUC0-1.5) of Baseline Adjusted Glucagon

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End point title

Area Under the Curve (AUC0-1.5) of Baseline Adjusted Glucagon ^[3]

End point description

Area under the curve from pre-dose to the maximum change of glucagon concentration up to 90 minutes post glucagon administration. 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.

End point type

Primary

End point timeframe

Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Inferential statistics were exploratory only per protocol.

End point values	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
Number of subjects analysed	6	11	12	6	11	12	12	12
Units: hour (hr).pg/mL
arithmetic mean (standard deviation)	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

No statistical analyses for this end point

Primary: Maximum Concentration (Cmax) of Baseline-Adjusted Glucose

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End point title

Maximum Concentration (Cmax) of Baseline-Adjusted Glucose ^[4]

End point description

The change from baseline to maximum glucose concentration within 90 minutes post glucagon administration. 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.

End point type

Primary

End point timeframe

Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration.

Notes
[4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Inferential statistics were exploratory only per protocol.

End point values	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
Number of subjects analysed	6	11	12	6	11	12	12	12
Units: mg/dL
arithmetic mean (standard deviation)	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

No statistical analyses for this end point

Primary: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose

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End point title

Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose ^[5]

End point description

Time to the change from baseline to maximum glucose concentration within 90 minutest post glucagon administration. 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.

End point type

Primary

End point timeframe

Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration.

Notes
[5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Inferential statistical analyses were not performed

End point values	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
Number of subjects analysed	6	11	12	6	11	12	12	12
Units: hours
median (full range (min-max))	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)

No statistical analyses for this end point

Primary: Area Under the Effect Concentration Time Curve (AUEC0-1.5) of Baseline- Adjusted Glucose From Time Zero up to 90 Minutes

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End point title

Area Under the Effect Concentration Time Curve (AUEC0-1.5) of Baseline- Adjusted Glucose From Time Zero up to 90 Minutes ^[6]

End point description

Area under the effect from pre-dose to the maximum change of glucose concentration up to 90 minutest post glucagon administration. 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.

End point type

Primary

End point timeframe

Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration.

Notes
[6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Inferential statistics were exploratory only per protocol.

End point values	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
Number of subjects analysed	6	11	12	6	11	12	12	12
Units: hr.mg/dL
arithmetic mean (standard deviation)	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

No statistical analyses for this end point

Secondary: Nasal and Non-nasal Effects/Symptoms

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End point title

Nasal and Non-nasal Effects/Symptoms

End point 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).

End point type

Secondary

End point timeframe

Pre-dose;15, 30, 60 and 90 minutes following glucagon administration. Population: 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.

End point values	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
Number of subjects analysed	6	12	12	6	11	12	12	12
Units: units on a scale
median (inter-quartile range (Q1-Q3))
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)

No statistical analyses for this end point

Secondary: Number of Participants Achieving at Least a 25 mg/dL Rise in Blood Glucose Above Nadir Level Within 30 Minutes

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End point title

Number of Participants Achieving at Least a 25 mg/dL Rise in Blood Glucose Above Nadir Level Within 30 Minutes

End point description

Glucose increase of at least 25 mg/dL above nadir within 30 Minutes following glucagon administration. Nadir is defined as the minimum glucose measurement at the time of or within 10 minutes following glucagon administration. 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.

End point type

Secondary

End point timeframe

Pre-dose; 5, 10, 15, 20, and 30 minutes following glucagon administration.

End point values	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
Number of subjects analysed	6	11	12	6	11	12	12	12
Units: Participants
number (not applicable)	6	11	12	6	11	12	12	12

No statistical analyses for this end point

Secondary: Time to Achieving ≥25 mg/dL Rise in Plasma Glucose Above Nadir Level Within 30 Minutes

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End point title

Time to Achieving ≥25 mg/dL Rise in Plasma Glucose Above Nadir Level Within 30 Minutes

End point description

Time (in minutes) when all participants experienced a rise in glucose >=25mg/dL. 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.

End point type

Secondary

End point timeframe

Pre-dose; 5, 10, 15, 20, and 30 minutes following glucagon administration.

End point values	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
Number of subjects analysed	6	11	12	6	11	12	12	12
Units: Minutes
number (not applicable)	10	20	15	20	20	15	20	20

No statistical analyses for this end point

Secondary: Percentage of Participants With >= 25 mg/dL Rise in Plasma Glucose Within 30 Minutes

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End point title

Percentage of Participants With >= 25 mg/dL Rise in Plasma Glucose Within 30 Minutes

End point description

End point type

Secondary

End point timeframe

Pre-dose; 5, 10,15, 20, and 30 minutes following glucagon administration.

End point values	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
Number of subjects analysed	6	11	12	6	11	12	12	12
Units: Percentage of participants
number (not applicable)	100	100	100	100	100	100	100	100

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Entire Study

Adverse event reporting additional description

Included all participants who received at least one dose of glucagon.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

18.1

Reporting group title

4 to<8 Years Old IM Glucagon Visit

Reporting group description

Reporting group title

4 to<8 Years Old NG Visit 2.0 mg

Reporting group description

Reporting group title

4 to<8 Years Old NG Visit 3.0 mg

Reporting group description

Reporting group title

8 to <12 Years Old IM Glucagon Visit

Reporting group description

Reporting group title

8 to<12 Years Old NG Visit 2.0 mg

Reporting group description

Reporting group title

8 to<12 Years Old NG Visit 3.0 mg

Reporting group description

Reporting group title

12 to <17 Years Old IM Glucagon Visit

Reporting group description

Reporting group title

12 to<17 Years Old NG Visit 3.0 mg

Reporting group description

Serious adverse events	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
Total subjects affected by serious adverse events
subjects affected / exposed	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%)
number of deaths (all causes)	0	0	0	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0	0	0	0
Endocrine disorders
Hypoglycemia
Additional description: Experienced a hypoglycemic event after receiving a bolus of insulin with lunch. Received 90 grams oral carbohydrates and made a full recovery.
subjects affected / exposed	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%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	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
Total subjects affected by non serious adverse events
subjects affected / exposed	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
subjects affected / exposed	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%)
occurrences all number	0	1	0	0	0	0	0	0
General disorders and administration site conditions
Catheter site pain
subjects affected / exposed	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%)
occurrences all number	0	1	0	1	0	0	0	0
Injection site discomfort
subjects affected / exposed	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%)
occurrences all number	2	0	0	3	0	0	0	0
Dizziness
subjects affected / exposed	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%)
occurrences all number	0	0	0	1	0	0	0	0
Eye disorders
Eye irritation
subjects affected / exposed	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%)
occurrences all number	0	0	0	0	0	0	0	1
Lacrimation increase
subjects affected / exposed	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%)
occurrences all number	0	0	0	0	1	0	0	0
Ocular discomfort
subjects affected / exposed	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%)
occurrences all number	0	0	0	0	0	0	0	1
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	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%)
occurrences all number	1	1	0	0	0	1	0	0
Diarrhea
subjects affected / exposed	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%)
occurrences all number	0	0	0	1	0	0	0	0
Nausea
subjects affected / exposed	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%)
occurrences all number	4	4	2	3	1	1	1	2
Vomiting
subjects affected / exposed	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%)
occurrences all number	1	1	3	3	3	4	5	4
Respiratory, thoracic and mediastinal disorders
Nasal congestion
subjects affected / exposed	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%)
occurrences all number	0	0	0	0	0	0	0	2
Nasal discomfort
subjects affected / exposed	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%)
occurrences all number	0	0	2	0	0	0	0	1
Sneezing
subjects affected / exposed	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%)
occurrences all number	0	0	0	0	0	1	0	0
Rhinalgia
subjects affected / exposed	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%)
occurrences all number	0	1	0	0	0	0	0	0
Musculoskeletal and connective tissue disorders
Headache
subjects affected / exposed	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%)
occurrences all number	0	2	1	2	2	4	1	4

More information

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Were there any global substantial amendments to the protocol? Yes

15 Oct 2013

The protocol was modified to evaluate both doses (2.0 mg and 3.0 mg) in the age group of 4.0 to <12.0 years. Rather than having participants in this age group complete 3 research dosing visits (2.0 mg intranasal, 3.0 mg intranasal, and intramuscular). The sample size increased to 48 participants.

18 Jun 2014

The minimum weight requirement was removed from the protocol. Clarification was added that the number of blood draws will be reduced for participants who do not weigh enough to collect all blood samples for the study. The maximum amount of blood to be collected will remain at 5% of the participant’s total blood volume.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results:
Assessment of Intranasal Glucagon in Children and Adolescents with Type 1 Diabetes

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Maximum Change from Baseline Concentration (Cmax) of Glucagon

Primary: Maximum Change from Baseline Concentration (Cmax) of Glucagon

Primary: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon

Primary: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon

Primary: Area Under the Curve (AUC0-1.5) of Baseline Adjusted Glucagon

Primary: Area Under the Curve (AUC0-1.5) of Baseline Adjusted Glucagon

Primary: Maximum Concentration (Cmax) of Baseline-Adjusted Glucose

Primary: Maximum Concentration (Cmax) of Baseline-Adjusted Glucose

Primary: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose

Primary: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose

Primary: Area Under the Effect Concentration Time Curve (AUEC0-1.5) of Baseline- Adjusted Glucose From Time Zero up to 90 Minutes

Primary: Area Under the Effect Concentration Time Curve (AUEC0-1.5) of Baseline- Adjusted Glucose From Time Zero up to 90 Minutes

Secondary: Nasal and Non-nasal Effects/Symptoms

Secondary: Nasal and Non-nasal Effects/Symptoms

Secondary: Number of Participants Achieving at Least a 25 mg/dL Rise in Blood Glucose Above Nadir Level Within 30 Minutes

Secondary: Number of Participants Achieving at Least a 25 mg/dL Rise in Blood Glucose Above Nadir Level Within 30 Minutes

Secondary: Time to Achieving ≥25 mg/dL Rise in Plasma Glucose Above Nadir Level Within 30 Minutes

Secondary: Time to Achieving ≥25 mg/dL Rise in Plasma Glucose Above Nadir Level Within 30 Minutes

Secondary: Percentage of Participants With >= 25 mg/dL Rise in Plasma Glucose Within 30 Minutes

Secondary: Percentage of Participants With >= 25 mg/dL Rise in Plasma Glucose Within 30 Minutes

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

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Outside EU/EEA

Clinical trials

Clinical Trial Results: Assessment of Intranasal Glucagon in Children and Adolescents with Type 1 Diabetes

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Maximum Change from Baseline Concentration (Cmax) of Glucagon

Primary: Maximum Change from Baseline Concentration (Cmax) of Glucagon

Primary: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon

Primary: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon

Primary: Area Under the Curve (AUC0-1.5) of Baseline Adjusted Glucagon

Primary: Area Under the Curve (AUC0-1.5) of Baseline Adjusted Glucagon

Primary: Maximum Concentration (Cmax) of Baseline-Adjusted Glucose

Primary: Maximum Concentration (Cmax) of Baseline-Adjusted Glucose

Primary: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose

Primary: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose

Primary: Area Under the Effect Concentration Time Curve (AUEC0-1.5) of Baseline- Adjusted Glucose From Time Zero up to 90 Minutes

Primary: Area Under the Effect Concentration Time Curve (AUEC0-1.5) of Baseline- Adjusted Glucose From Time Zero up to 90 Minutes

Secondary: Nasal and Non-nasal Effects/Symptoms

Secondary: Nasal and Non-nasal Effects/Symptoms

Secondary: Number of Participants Achieving at Least a 25 mg/dL Rise in Blood Glucose Above Nadir Level Within 30 Minutes

Secondary: Number of Participants Achieving at Least a 25 mg/dL Rise in Blood Glucose Above Nadir Level Within 30 Minutes

Secondary: Time to Achieving ≥25 mg/dL Rise in Plasma Glucose Above Nadir Level Within 30 Minutes

Secondary: Time to Achieving ≥25 mg/dL Rise in Plasma Glucose Above Nadir Level Within 30 Minutes

Secondary: Percentage of Participants With >= 25 mg/dL Rise in Plasma Glucose Within 30 Minutes

Secondary: Percentage of Participants With >= 25 mg/dL Rise in Plasma Glucose Within 30 Minutes

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
Assessment of Intranasal Glucagon in Children and Adolescents with Type 1 Diabetes