Trial Outcomes & Findings for A Study of Nasal Glucagon (LY900018) in Pediatric Participants With Type 1 Diabetes (NCT NCT04992312)
NCT ID: NCT04992312
Last Updated: 2024-05-23
Results Overview
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.
COMPLETED
PHASE1
7 participants
Baseline to Day 9
2024-05-23
Participant Flow
Participant milestones
| Measure |
3 Milligram (mg) Nasal Glucagon
Participants received a single dose of 3 mg glucagon powder administered intranasally on day 1.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
Received at Least One Dose of Study Drug
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Nasal Glucagon (LY900018) in Pediatric Participants With Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
3 mg Nasal Glucagon
n=7 Participants
Participants received a single dose of 3 mg glucagon powder administered intranasally on day 1.
|
|---|---|
|
Age, Continuous
|
2.98 years
STANDARD_DEVIATION 0.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 9Population: All participants who received at least one dose of study drug.
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.
Outcome measures
| Measure |
3 mg Nasal Glucagon
n=7 Participants
Participants received a single dose of 3 mg glucagon powder administered intranasally on day 1.
|
|---|---|
|
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
TEAEs
|
5 Participants
|
|
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
SAEs
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)Population: All participants who received at least one dose of study drug and had evaluable PD data.
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.
Outcome measures
| Measure |
3 mg Nasal Glucagon
n=7 Participants
Participants received a single dose of 3 mg glucagon powder administered intranasally on day 1.
|
|---|---|
|
Pharmacodynamics (PD): Change From Baseline in Maximum Observed Blood Glucose (BGmax)
|
132.4 milligrams per deciliter (mg/dL)
Standard Deviation 52.4
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)Population: All participants who received at least one dose of study drug and had evaluable PD data.
PD: Absolute BGmax of Nasal Glucagon
Outcome measures
| Measure |
3 mg Nasal Glucagon
n=7 Participants
Participants received a single dose of 3 mg glucagon powder administered intranasally on day 1.
|
|---|---|
|
PD: Absolute BGmax of Nasal Glucagon
|
242.1 mg/dL
Standard Deviation 46
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)Population: All participants who received at least one dose of study drug and had evaluable PD data.
PD: TBGmax of Nasal Glucagon
Outcome measures
| Measure |
3 mg Nasal Glucagon
n=7 Participants
Participants received a single dose of 3 mg glucagon powder administered intranasally on day 1.
|
|---|---|
|
PD: Time of Maximum Observed Blood Glucose (TBGmax) of Nasal Glucagon
|
55.6 minutes
Standard Deviation 20.9
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)Population: All participants who received at least one dose of study drug and had evaluable PD data.
AUC from time 0 to the last measured concentration of blood glucose at 90 minutes \[AUC(0-90)\] is reported.
Outcome measures
| Measure |
3 mg Nasal Glucagon
n=7 Participants
Participants received a single dose of 3 mg glucagon powder administered intranasally on day 1.
|
|---|---|
|
PD: Area Under the Concentration Versus Time Curve (AUC) of Blood Glucose
|
18200 milligram*minute per deciliter (mg*m/dL)
Standard Deviation 3000
|
SECONDARY outcome
Timeframe: Day 1 (10, 30, 60 minutes post-dose)Population: All participants who received at least one dose of study drug and had evaluable PK data.
PK: AUC of Nasal Glucagon
Outcome measures
| Measure |
3 mg Nasal Glucagon
n=7 Participants
Participants received a single dose of 3 mg glucagon powder administered intranasally on day 1.
|
|---|---|
|
Pharmacokinetics (PK): AUC of Nasal Glucagon
|
1560 picogram*hour per milliliter (pg*hr/mL)
Geometric Coefficient of Variation 25.3
|
Adverse Events
3 mg Nasal Glucagon
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
3 mg Nasal Glucagon
n=7 participants at risk
Participants received a single dose of 3 mg glucagon powder administered intranasally on day 1.
|
|---|---|
|
Eye disorders
Eye pruritus
|
14.3%
1/7 • Number of events 1 • Baseline to Day 9
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
14.3%
1/7 • Number of events 1 • Baseline to Day 9
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
1/7 • Number of events 1 • Baseline to Day 9
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Number of events 1 • Baseline to Day 9
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Post-tussive vomiting
|
14.3%
1/7 • Number of events 1 • Baseline to Day 9
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Number of events 1 • Baseline to Day 9
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.3%
1/7 • Number of events 1 • Baseline to Day 9
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
14.3%
1/7 • Number of events 1 • Baseline to Day 9
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
14.3%
1/7 • Number of events 1 • Baseline to Day 9
All participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60