Clinical trial NCT04992312: A Study of Nasal Glucagon (LY900018) in Pediatric Participants With Type 1 Diabetes
Official title: An Open-Label, Multi-Center, Single-Dose Study to Assess the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Nasal Glucagon in Pediatric Patients With Type 1 Diabetes Aged 1 to <4 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 1 Diabetes
Keywords: Severe Hypoglycemia
Nasal Powder
Hypoglycemia Rescue Therapy
Ready to use Glucagon
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-08-05
Enrollment: 7
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline to Day 9
Secondary outcomes:
measure: Pharmacodynamics (PD): Change From Baseline in Maximum Observed Blood Glucose (BGmax)
timeFrame: Baseline, Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)
measure: PD: Absolute BGmax of Nasal Glucagon
timeFrame: Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)
measure: PD: Time of Maximum Observed Blood Glucose (TBGmax) of Nasal Glucagon
timeFrame: Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)
measure: PD: Area Under the Concentration Versus Time Curve (AUC) of Blood Glucose
timeFrame: Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)
measure: Pharmacokinetics (PK): AUC of Nasal Glucagon
timeFrame: Day 1 (10, 30, 60 minutes post-dose)
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Nemours Childrens Clinic
state: Florida
city: Boise
country: United States
facility: St. Luke's Regional Medical Center
state: Idaho
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Minneapolis
country: United States
facility: University of Minnesota Medical School
state: Minnesota
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Buffalo
country: United States
facility: UBMD Pediatrics
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: