Phase 1
Completed N=7
A Study of Nasal Glucagon (LY900018) in Pediatric Participants With Type 1 Diabetes
Source: ClinicalTrials.gov NCT04992312 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
May 2024
Primary outcomePrimary: 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 — 5; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
5; 0 | — |
| SECONDARY Pharmacodynamics (PD): Change From Baseline in Maximum Observed Blood Glucose (BGmax) |
132.4 | — |
| SECONDARY PD: Absolute BGmax of Nasal Glucagon |
242.1 | — |
| SECONDARY PD: Time of Maximum Observed Blood Glucose (TBGmax) of Nasal Glucagon |
55.6 | — |
| SECONDARY PD: Area Under the Concentration Versus Time Curve (AUC) of Blood Glucose |
18200 | — |
| SECONDARY Pharmacokinetics (PK): AUC of Nasal Glucagon |
1560 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04992312). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.