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| ID | Type | Description | Link |
|---|---|---|---|
| I8R-MC-IGBO | Other Identifier | Eli Lilly and Company | |
| 2021-006088-61 | EudraCT Number |
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The main purpose of this study is to evaluate the safety and tolerability of a study drug called nasal glucagon (Baqsimi) in pediatric participants with type 1 diabetes (T1D) aged 1 to less than 4 years. Blood tests will be performed to check how much nasal glucagon gets into the bloodstream. Blood sugar will also be measured to understand the effect of the drug on blood sugar levels. The study consists of a screening period up to 35 days before dosing, 1 day when a dose of nasal glucagon will be given and then 2 telephone follow up calls; first follow-up call on the day after the nasal glucagon was given and second call about one week after nasal glucagon was given. The study will last up to 9 days, not including the screening period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 milligram (mg) Nasal Glucagon | Experimental | Participants received a single dose of 3 mg glucagon powder administered intranasally on day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucagon Nasal Powder [Baqsimi] | Drug | Administered intranasally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A TEAE is defined as an adverse event which occurs post-dose or which is present prior to dosing and becomes more severe post-dose. An SAE is any AE from the study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (i.e., immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. The number of participants with one or more TEAEs, SAEs considered by the investigator to be related to study drug administration is reported here. A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record. | Baseline to Day 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics (PD): Change From Baseline in Maximum Observed Blood Glucose (BGmax) | Change from baseline in BGmax was measured to investigate the PD effect of nasal glucagon on blood glucose level following 3 mg nasal glucagon administration on day 1. Baseline is defined as Day 1 pre-dose. The BGmax on Day 1 was determined using plasma samples collected pre-dose, 10, 30, 60, and 90 minutes post nasal glucagon dose. |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|---|---|---|---|---|
| Nemours Childrens Clinic | Jacksonville | Florida | 32207 | United States | ||
| St. Luke's Regional Medical Center |
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| Label | URL |
|---|---|
| A Study of Nasal Glucagon (LY900018) in Pediatric Participants With Type 1 Diabetes (RescuiNGkids) | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 3 Milligram (mg) Nasal Glucagon | Participants received a single dose of 3 mg glucagon powder administered intranasally on day 1. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 3 mg Nasal Glucagon | Participants received a single dose of 3 mg glucagon powder administered intranasally on day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With One or More Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A TEAE is defined as an adverse event which occurs post-dose or which is present prior to dosing and becomes more severe post-dose. An SAE is any AE from the study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (i.e., immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. The number of participants with one or more TEAEs, SAEs considered by the investigator to be related to study drug administration is reported here. A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record. | All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Baseline to Day 9 |
Baseline to Day 9
All participants who received at least one dose of study drug.
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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 | 3 mg Nasal Glucagon | Participants received a single dose of 3 mg glucagon powder administered intranasally on day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye pruritus | Eye disorders | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 28, 2022 | Mar 18, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 20, 2021 | Mar 18, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Baseline, Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose) |
| PD: Absolute BGmax of Nasal Glucagon | PD: Absolute BGmax of Nasal Glucagon | Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose) |
| PD: Time of Maximum Observed Blood Glucose (TBGmax) of Nasal Glucagon | PD: TBGmax of Nasal Glucagon | Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose) |
| PD: Area Under the Concentration Versus Time Curve (AUC) of Blood Glucose | AUC from time 0 to the last measured concentration of blood glucose at 90 minutes [AUC(0-90)] is reported. | Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose) |
| Pharmacokinetics (PK): AUC of Nasal Glucagon | PK: AUC of Nasal Glucagon | Day 1 (10, 30, 60 minutes post-dose) |
| Boise |
| Idaho |
| 83712 |
| United States |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| University of Minnesota Medical School | Minneapolis | Minnesota | 55454 | United States |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| UBMD Pediatrics | Buffalo | New York | 14203 | United States |
| Cincinnati Childrens Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
|
| ID | Title | Description |
|---|---|---|
| OG000 | 3 mg Nasal Glucagon | Participants received a single dose of 3 mg glucagon powder administered intranasally on day 1. |
|
|
| Secondary | Pharmacodynamics (PD): Change From Baseline in Maximum Observed Blood Glucose (BGmax) | Change from baseline in BGmax was measured to investigate the PD effect of nasal glucagon on blood glucose level following 3 mg nasal glucagon administration on day 1. Baseline is defined as Day 1 pre-dose. The BGmax on Day 1 was determined using plasma samples collected pre-dose, 10, 30, 60, and 90 minutes post nasal glucagon dose. | All participants who received at least one dose of study drug and had evaluable PD data. | Posted | Mean | Standard Deviation | milligrams per deciliter (mg/dL) | Baseline, Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose) |
|
|
|
| Secondary | PD: Absolute BGmax of Nasal Glucagon | PD: Absolute BGmax of Nasal Glucagon | All participants who received at least one dose of study drug and had evaluable PD data. | Posted | Mean | Standard Deviation | mg/dL | Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose) |
|
|
|
| Secondary | PD: Time of Maximum Observed Blood Glucose (TBGmax) of Nasal Glucagon | PD: TBGmax of Nasal Glucagon | All participants who received at least one dose of study drug and had evaluable PD data. | Posted | Mean | Standard Deviation | minutes | Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose) |
|
|
|
| Secondary | PD: Area Under the Concentration Versus Time Curve (AUC) of Blood Glucose | AUC from time 0 to the last measured concentration of blood glucose at 90 minutes [AUC(0-90)] is reported. | All participants who received at least one dose of study drug and had evaluable PD data. | Posted | Mean | Standard Deviation | milligram*minute per deciliter (mg*m/dL) | Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose) |
|
|
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| Secondary | Pharmacokinetics (PK): AUC of Nasal Glucagon | PK: AUC of Nasal Glucagon | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | picogram*hour per milliliter (pg*hr/mL) | Day 1 (10, 30, 60 minutes post-dose) |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 5 |
| 7 |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Post-tussive vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |