NCT04992312

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 1 Year – 4 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DRUG	Glucagon Nasal Powder [Baqsimi]	Administered intranasally

Timeline

• Start date: 2022-03-24
• Primary completion: 2023-11-05
• Completion: 2023-11-05
• First posted: 2021-08-05
• Last updated: 2024-05-23
• Results posted: 2024-05-23

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study