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Hormone Therapy
Nasal Glucagon for Type 1 Diabetes (RescuiNGkids Trial)
Phase 1
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the safety and tolerability of a new diabetes drug for children aged 1-4. It will involve blood tests and measuring blood sugar levels. The study will last up to 9 days.
Who is the study for?
This trial is for young children aged 1 to less than 4 with Type 1 Diabetes. They should have stable diabetes management, no severe hypoglycemia recently, and no nasal blockages or anomalies. Kids on closed-loop insulin therapy must switch to manual mode during the study.
What is being tested?
The trial tests Baqsimi, a nasal glucagon powder, in toddlers with Type 1 Diabetes. It checks safety and how it affects blood sugar levels after one dose followed by two phone check-ins over about a week.
What are the potential side effects?
While not explicitly listed here, common side effects of glucagon may include nausea, vomiting, headache, and reactions at the administration site such as irritation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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
Secondary study objectives
PD: Absolute BGmax of Nasal Glucagon
Blood Glucose
PD: Time of Maximum Observed Blood Glucose (TBGmax) of Nasal Glucagon
+2 moreSide effects data
From 2023 Phase 1 trial • 7 Patients • NCT0499231214%
Eye pruritus
14%
Nasal discomfort
14%
Abdominal discomfort
14%
Dyspepsia
14%
Epistaxis
14%
Sneezing
14%
Nausea
14%
Post-tussive vomiting
14%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
3 mg Nasal Glucagon
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: 3 milligram (mg) Nasal GlucagonExperimental Treatment1 Intervention
Participants received a single dose of 3 mg glucagon powder administered intranasally on day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glucagon Nasal Powder [Baqsimi]
2022
Completed Phase 1
~10
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Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,675 Previous Clinical Trials
3,463,976 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,388 Previous Clinical Trials
427,371 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are using a specific type of insulin therapy device, unless it is set to a different mode on the day of the treatment visit.Your HbA1c level (a measure of blood sugar control) is lower than 9.5%.You were born with nose abnormalities or need surgery to change the shape of your nose.You have a history of epilepsy or seizures.You have been diagnosed with Type 1 Diabetes for at least 6 months.You are allergic to glucagon.You have had a type of tumor called pheochromocytoma in the past.You need to be in good health except for having Type 1 diabetes, and you cannot have a history of certain nose or throat problems.You have been using insulin injections or a pump regularly for at least 3 months before the screening.You had a very low blood sugar episode or needed glucagon in the last 3 months before your screening, and you didn't have another very low blood sugar episode between the screening and dosing visits.You have veins that can be used to draw blood for testing.
Research Study Groups:
This trial has the following groups:- Group 1: 3 milligram (mg) Nasal Glucagon
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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