NCT04992312CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 23 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 7 (actual)
- First submitted
- 4 Aug 2021
- Start date
- 24 Mar 2022
- Primary completion date
- 5 Nov 2023
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Type 1 diabetes
- NCT number
- NCT04992312
- EudraCT number
- 2021-006088-61
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 7
- From 24 Mar 2022 to the primary completion date, 5 Nov 2023
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Have a presence or history of glucagon hypersensitivity
- Have a history of pheochromocytoma
- Have a history of epilepsy or seizure disorder
Other
- Have 1 or more congenital anomalies to the anatomy of the nose, or require changes to the anatomy of the nose
Who the study is looking for
- 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
Age in the registry: 1 year to 4 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Luke's Regional Medical Center Coordinator of this site? Confirm its status | Boise | United States | Unknown status |
| UBMD Pediatrics Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| Cincinnati Childrens Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Riley Hospital for Children Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Nemours Childrens Clinic Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Children's Mercy Hospital Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| University of Minnesota Medical School Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.