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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 8
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
3 milligram (mg) Nasal Glucagon
Participants received a single dose of 3 mg glucagon powder administered intranasally on day 1.
干预措施: Glucagon Nasal Powder [Baqsimi] (Drug)
结局指标
主要结局
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
时间窗: Baseline to Day 9
A TEAE is defined as an adverse event which occurs post-dose or which is present prior to dosing and becomes more severe post-dose. An SAE is any AE from the study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (i.e., immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. The number of participants with one or more TEAEs, SAEs considered by the investigator to be related to study drug administration is reported here. A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record.
次要结局
- PD: Area Under the Concentration Versus Time Curve (AUC) of Blood Glucose(Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose))
- Pharmacodynamics (PD): Change From Baseline in Maximum Observed Blood Glucose (BGmax)(Baseline, Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose))
- PD: Absolute BGmax of Nasal Glucagon(Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose))
- PD: Time of Maximum Observed Blood Glucose (TBGmax) of Nasal Glucagon(Day 1 (pre-dose, 10, 30, 60, 90 minutes post-dose))
- Pharmacokinetics (PK): AUC of Nasal Glucagon(Day 1 (10, 30, 60 minutes post-dose))