A Study of Nasal Glucagon (LY900018) in Pediatric Participants With Type 1 Diabetes

Phase 1

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Have a Type 1 Diabetes diagnosis for at least 6 months
Have been receiving insulin therapy via multiple daily injections or using an insulin pump and have been stable for at least 3 months prior to screening
Have a HbA1c level of ≤ 9.5% at screening
Have sufficient venous access for collection of blood samples
Have good general health, apart from their Type 1 diabetes, with no prior history of choanal atresia, nasal/pharyngeal blockage or nasal anomaly

Exclusion Criteria

Have a presence or history of glucagon hypersensitivity
Have a history of pheochromocytoma
Have a history of epilepsy or seizure disorder
Have 1 or more congenital anomalies to the anatomy of the nose, or require changes to the anatomy of the nose
Are using closed-loop insulin therapy, unless such a device is set to 'open loop/manual' mode on the day of the dosing visit
Have an episode of severe hypoglycemia or have had glucagon administered , during the 3 months prior to the screening visit and no severe hypoglycemia between the screening and dosing visit

Arm && Interventions

Group	Intervention	Description
3 milligram (mg) Nasal Glucagon	Glucagon Nasal Powder [Baqsimi]	Participants received a single dose of 3 mg glucagon powder administered intranasally on day 1.

Primary Outcome Measures

Name	Time	Method
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	Baseline to Day 9	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.

Secondary Outcome Measures

Name	Time	Method
PD: Area Under the Concentration Versus Time Curve (AUC) of Blood Glucose	Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)	AUC from time 0 to the last measured concentration of blood glucose at 90 minutes \[AUC(0-90)\] is reported.
Pharmacodynamics (PD): Change From Baseline in Maximum Observed Blood Glucose (BGmax)	Baseline, Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)	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.
PD: Absolute BGmax of Nasal Glucagon	Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)	PD: Absolute BGmax of Nasal Glucagon
PD: Time of Maximum Observed Blood Glucose (TBGmax) of Nasal Glucagon	Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)	PD: TBGmax of Nasal Glucagon
Pharmacokinetics (PK): AUC of Nasal Glucagon	Day 1 (10, 30, 60 minutes post-dose)	PK: AUC of Nasal Glucagon

Locations (8): St. Luke's Regional Medical Center
🇺🇸
Boise, Idaho, United States
Riley Hospital for Children
🇺🇸
Indianapolis, Indiana, United States
Children's Hospital of Philadelphia
🇺🇸
Philadelphia, Pennsylvania, United States
Cincinnati Childrens Hospital Medical Center
🇺🇸
Cincinnati, Ohio, United States
Nemours Childrens Clinic
🇺🇸
Jacksonville, Florida, United States
University of Minnesota Medical School
🇺🇸
Minneapolis, Minnesota, United States
Children's Mercy Hospital
🇺🇸
Kansas City, Missouri, United States
UBMD Pediatrics
🇺🇸
Buffalo, New York, United States