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| ID | Type | Description | Link |
|---|---|---|---|
| I8R-MC-IGBB | Other Identifier | Eli Lilly and Company | |
| INGluc002 | Other Identifier | Jaeb Center for Health Research | |
| AMG103 | Other Identifier | Locemia |
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| Name | Class |
|---|---|
| Jaeb Center for Health Research | OTHER |
| Locemia Solutions ULC | INDUSTRY |
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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.
This study was conducted to permit determination of appropriate dose level(s) for pediatric use based on the safety observations and results of glucagon and glucose assays.
Each participant 12 to less than 17 years of age underwent two visits in random order and received glucagon nasal powder once and commercially available glucagon (GlucaGen, Novo Nordisk) by intramuscular (IM) injection once. Participants 4 to less than 12 years were randomly assigned to have either 1 visit with commercially available glucagon (GlucaGen, Novo Nordisk) by IM injection OR to have 2 visits with a 2.0 milligram (mg) dose of glucagon nasal powder administered during one visit and a 3.0 mg dose of glucagon nasal powder administered during the other visit. For those randomized to complete two research dosing visits, the dose of glucagon nasal powder given during each visit was masked to the participant and study personnel.
Glucagon was administered after glucose was lowered to <80 mg/dL using insulin if necessary on the dosing day. Participants were treated with either glucagon given nasally (either 2.0 mg or 3.0 mg for participants 4 to less than 12 years of age or 3.0 mg for those 12 to less than 17 years of age) or by intramuscular (IM) injection (1 mg for those 55 pounds [lbs] or more and 0.5 mg for those weighing less than 55 lbs) in the quadriceps muscle of the leg.
Blood glucose levels and adverse events were carefully monitored for 90 minutes post-dosing. After a wash-out period of 7 days or more, participants 12 to less than 17 years of age returned to the clinic and the procedure was repeated with each participant crossed over to the other treatment. Participants 4 to less than 12 years assigned to have 2 dosing visits returned to clinic for repeated procedures and received alternate dose of nasal glucagon (NG). Participants 4 to less than 12 years assigned to a single dosing visit did not return for a second dosing visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal Glucagon (NG) | Experimental | Nasal glucagon (NG) doses of 2.0 mg and 3.0 mg for participants 4 to less than 12 years of age and 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. |
|
| Intramuscular (IM) Glucagon | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal Glucagon | Drug |
|
| |
| Intramuscular Glucagon |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Change From Baseline Concentration (Cmax) of Glucagon | Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration | |
| Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon | Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration | |
| Area Under the Curve (AUC0-1.5) of Baseline Adjusted Glucagon | Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration | |
| Maximum Concentration (Cmax) of Baseline-Adjusted Glucose | Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration | |
| Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose | Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration | |
| Area Under the Effect Concentration Time Curve (AUEC0-1.5) of Baseline-Adjusted Glucose From Time Zero up to 90 Minutes | Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration |
| Measure | Description | Time Frame |
|---|---|---|
| Nasal and Non-nasal Effects/Symptoms | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With >= 25 mg/dL Rise in Plasma Glucose Within 30 Minutes | Pre-dose; 5, 10,15, 20, and 30 minutes following glucagon administration |
Inclusion Criteria:
To be eligible, the following inclusion criteria were met:
History of type 1 diabetes and receiving daily insulin therapy from the time of diagnosis for at least 12 months
At least 4 years of age and less than 17 years
Females must have met one of the following criteria:
In good general health with no conditions that could have influenced the outcome of the trial, and in the judgment of the Investigator was a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations
Willingness to adhere to the study requirements
Exclusion Criteria:
An individual was not eligible if any of the following exclusion criteria were present:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Davis Center for Diabetes | Aurora | Colorado | 80045 | United States | ||
| Yale University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26884472 | Derived | Sherr JL, Ruedy KJ, Foster NC, Piche CA, Dulude H, Rickels MR, Tamborlane WV, Bethin KE, DiMeglio LA, Fox LA, Wadwa RP, Schatz DA, Nathan BM, Marcovina SM, Rampakakis E, Meng L, Beck RW; T1D Exchange Intranasal Glucagon Investigators. Glucagon Nasal Powder: A Promising Alternative to Intramuscular Glucagon in Youth With Type 1 Diabetes. Diabetes Care. 2016 Apr;39(4):555-62. doi: 10.2337/dc15-1606. Epub 2016 Feb 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| FG006 | 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. |
| FG007 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 4 to <8 Years Old IM Glucagon Cohort | 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. |
| BG001 | 4 to <8 Years Old NG Cohort |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Change From Baseline Concentration (Cmax) of Glucagon | 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. | Posted | Mean | Standard Deviation | picograms per millilitre (pg/mL) | Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration |
|
Through study completion, up to 69 days
Included all participants received at least one dose of glucagon.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 4 to<8 Years Old IM Glucagon 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Endocrine disorders | MedDRA 18.1 | Systematic Assessment | Experienced a hypoglycemic event after receiving a bolus of insulin with lunch. Received 90 g oral carbohydrates and made a full recovery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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IM and NG arms are open labeled. NG cohorts, 2mg and 3mg, are quadruple blinded.
| Drug |
|
|
| Pre-dose;15, 30, 60 and 90 minutes following glucagon administration |
| Number of Participants Achieving at Least a 25 mg/dL Rise in Blood Glucose Above Nadir Level Within 30 Minutes | Pre-dose; 5, 10, 15, 20, and 30 minutes following glucagon administration |
| Time to Achieving ≥25 mg/dL Rise in Plasma Glucose Above Nadir Level Within 30 Minutes | 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. | Pre-dose; 5, 10, 15, 20, and 30 minutes following glucagon administration |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| University of Florida | Gainesville | Florida | 32605 | United States |
| Nemours Children's Clinic | Jacksonville | Florida | 32207 | United States |
| Riley Hospital for Children Indiana University Health | Indianapolis | Indiana | 46202 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55454 | United States |
| UPA Buffalo | Buffalo | New York | 14222 | United States |
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.
| BG002 | 8 to <12 Years Old IM Glucagon Cohort | 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. |
| BG003 | 8 to <12 Years Old NG Cohort | 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. |
| BG004 | 12 to <17 Years Old NG/IM Cohort | 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. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Local HbA1c | Mean | Standard Deviation | percent |
|
| Duration of Diabetes | Median | Inter-Quartile Range | years |
|
NG dose of 2.0 mg for participants 4 to less than 8 years of age. |
| OG002 | 4 to<8 Years Old NG Visit 3.0 mg | NG dose of 3.0 mg for participants 4 to less than 8 years of age. |
| OG003 | 8 to <12 Years Old IM Glucagon 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. |
| OG004 | 8 to<12 Years Old NG Visit 2.0 mg | NG dose of 2.0 mg for participants 8 to less than 12 years of age. |
| OG005 | 8 to<12 Years Old NG Visit 3.0 mg | NG dose of 3.0 mg for participants 8 to less than 12 years of age. |
| OG006 | 12 to <17 Years Old IM Glucagon 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. |
| OG007 | 12 to<17 Years Old NG Visit 3.0 mg | NG dose of 3.0 mg for participants 12 to less than 17 years of age. |
|
|
| Primary | Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon | 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. | Posted | Median | Full Range | hours (hr) | Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration |
|
|
|
| Primary | Area Under the Curve (AUC0-1.5) of Baseline Adjusted Glucagon | 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. | Posted | Mean | Standard Deviation | hour*picogram per millilitre (hr*pg/mL) | Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration |
|
|
|
| Primary | Maximum Concentration (Cmax) of Baseline-Adjusted Glucose | 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. | Posted | Mean | Standard Deviation | mg/dL | Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration |
|
|
|
| Primary | Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose | 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. | Posted | Median | Full Range | hours (hr) | Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration |
|
|
|
| Primary | Area Under the Effect Concentration Time Curve (AUEC0-1.5) of Baseline-Adjusted Glucose From Time Zero up to 90 Minutes | 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. | Posted | Mean | Standard Deviation | hr*mg/dL | Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration |
|
|
|
| Secondary | Nasal and Non-nasal Effects/Symptoms | 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). | 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. | Posted | Median | Inter-Quartile Range | units on a scale | Pre-dose;15, 30, 60 and 90 minutes following glucagon administration |
|
|
|
| Secondary | Number of Participants Achieving at Least a 25 mg/dL Rise in Blood Glucose Above Nadir Level Within 30 Minutes | 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. | Posted | Count of Participants | Participants | No | Pre-dose; 5, 10, 15, 20, and 30 minutes following glucagon administration |
|
|
|
| Secondary | Time to Achieving ≥25 mg/dL Rise in Plasma Glucose Above Nadir Level Within 30 Minutes | 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. | 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. | Posted | Number | minutes | Pre-dose; 5, 10, 15, 20, and 30 minutes following glucagon administration |
|
|
|
| Other Pre-specified | Percentage of Participants With >= 25 mg/dL Rise in Plasma Glucose Within 30 Minutes | 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. | Posted | Number | percentage of participants | Pre-dose; 5, 10,15, 20, and 30 minutes following glucagon administration |
|
|
|
| 1 |
| 6 |
| 5 |
| 6 |
| EG001 | 4 to<8 Years Old NG Visit 2.0 mg | NG dose of 2.0 mg for participants 4 to less than 8 years of age. | 0 | 12 | 6 | 12 |
| EG002 | 4 to<8 Years Old NG Visit 3.0 mg | NG dose of 3.0 mg for participants 4 to less than 8 years of age. | 0 | 12 | 5 | 12 |
| EG003 | 8 to <12 Years Old IM Glucagon 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. | 0 | 6 | 6 | 6 |
| EG004 | 8 to<12 Years Old NG Visit 2.0 mg | NG of 2.0 mg for participants 8 to less than 12 years of age. | 0 | 11 | 5 | 11 |
| EG005 | 8 to<12 Years Old NG Visit 3.0 mg | NG dose of 3.0 mg for participants 8 to less than 12 years of age. | 0 | 12 | 6 | 12 |
| EG006 | 12 to <17 Years Old IM Glucagon 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. | 0 | 12 | 7 | 12 |
| EG007 | 12 to<17 Years Old NG Visit 3.0 mg | NG dose of 3.0 mg for participants 12 to less than 17 years of age. | 0 | 12 | 9 | 12 |
|
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Lacrimation increase | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| Ocular discomfort | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Rhinalgia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Injection site discomfort | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| 15 minutes post glucagon administration |
|
| 30 minutes post glucagon administration |
|
| 60 minutes post glucagon administration |
|
| 90 minutes post glucagon administration |
|