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

I8R-MC-IGBO -

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.

Trial Summary

Age Range
1 year - 4 years
Conditions the trial is for
Type 1 Diabetes
What the trial is testing?
Glucagon Nasal Powder, Baqsimi, LY900018
Could I receive a Placebo?
No
Enrollment Goal
7
Trial Dates
Mar 24, 2022 - Nov 3, 2023
How long will I be in the trial?
Your participation could last up to 9 days (excluding the screening period) and include 2 telephone follow up calls
Trial Phase
I

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • Participants must have type 1 diabetes for at least 6 months

  • Participants must be taking insulin through injection or by insulin pump<

  • Participants must be able to tolerate removal of blood from vein by use of catheter during the dosing visit

  • Participants must have general good health

  • Participants must have parents/guardian who are able to measure blood glucose using a blood glucose meter or report measurements from a continuous glucose monitor on the night before and morning of the dosing visit

Participants Must Not:

  • Participants must not have allergy or very sensitive to glucagon or other drug allergies

  • Participants must not have nutritional disorders or other illness that limits their ability to eat carbohydrates (foods with sugar)

  • Participants must not have nasal obstruction or structural nasal restriction

  • Participants must not have laryngopharyngeal reflux

  • Participants must not have a history of epilepsy or seizures

  • Participants must not have a recent history of very low blood glucose level

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Clinical Trial Resources

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Clinical Trial Participation: What to Expect

A clinical trial is a scientific study. It helps us learn if a new medicine or treatment works and how it works. Clinical trials can also be called clinical research studies. Learn more about clinical research studies and what to expect when taking part in a clinical trial.