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

17449

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.

2022-03-24

2023-11-03

2023-11-03

Completed

Early phase I

7

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

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2024-01-02