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

Type 1 Diabetes Clinical Trial

— RescuiNGkids  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04992312
• Other study ID #: 17449
• Secondary ID: I8R-MC-IGBO2021-
• Status: Completed
• Phase: Phase 1
• Start date: March 24, 2022
• Est. completion date: November 5, 2023

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: November 5, 2023
• Est. primary completion date: November 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 4 Years

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• Glucagon Nasal Powder [Baqsimi]
Administered intranasally

Locations

Country	Name	City	State
United States	St. Luke's Regional Medical Center	Boise	Idaho
United States	UBMD Pediatrics	Buffalo	New York
United States	Cincinnati Childrens Hospital Medical Center	Cincinnati	Ohio
United States	Riley Hospital for Children	Indianapolis	Indiana
United States	Nemours Childrens Clinic	Jacksonville	Florida
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	University of Minnesota Medical School	Minneapolis	Minnesota
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline to Day 9
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.	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	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	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.	Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)
Secondary	Pharmacokinetics (PK): AUC of Nasal Glucagon	PK: AUC of Nasal Glucagon	Day 1 (10, 30, 60 minutes post-dose)

External Links

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