A Phase 3 Study to Evaluate the Glucose Response of G-Pen (Glucagon Injection) in Pediatric Patients With Type 1 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 7
- 主要终点
- Change in Plasma Glucose
研究概览
简要总结
This is a sequential efficacy and safety study in pediatric patients with type 1 diabetes. Subjects will be administered insulin to induce a low normal glycemic state and will then receive an age-appropriate dose of G-Pen (glucagon injection) in a clinical research center (CRC) or comparable setting.
详细描述
This is an open-label, Phase 3 sequential efficacy and safety study in pediatric patients ages 2-17 with type 1 diabetes. Patients will complete the screening procedures up to 30 days before dosing to determine eligibility before enrollment to the treatment phase.
The procedure to evaluate the efficacy of G-Pen (glucagon injection) consists of inducing a low normal glycemic state by administration of insulin. Subjects ages 2-11 will then be given a 0.5 mg dose of G-Pen, while subjects ages 12-17 will receive a 1 mg dose of G-Pen. Subjects ages 12-17 will return for a second visit 1-4 weeks later and will receive a 0.5 mg dose of G-Pen when in a low normal glycemic stare. Plasma glucose and glucagon levels will be monitored for 90 and 180 minutes post-dosing, respectively, at all visits.
A follow-up phone call as a safety check will be conducted 3 - 14 days following administration of the final dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with T1D for at least 6 months at Screening.
- •current usage of daily insulin treatment.
排除标准
- •pregnant or nursing
- •renal insufficiency
- •hepatic synthetic insufficiency
- •aspartate or alanine aminotransferase > 3 times the upper limit of normal
- •hematocrit less than or equal to 30%
- •use of > 2.0 U/kg total insulin dose per day
- •inadequate venous access
- •current seizure disorder
- •history of pheochromocytoma or disorder with increased risk of pheochromocytoma
- •history of insulinoma
- •history of glycogen storage disease.
- •active use of alcohol or drugs of abuse
- •administration of glucagon within 14 days of the first treatment visit
- •participation in other studies involving an investigational drug or device within 30 days
研究组 & 干预措施
G-Pen (glucagon injection) 0.5 mg
A single 0.5 mg subcutaneous (SC) injection of G-Pen (glucagon injection)
干预措施: Glucagon (Drug)
G-Pen (glucagon injection) 1.0 mg
A single 1.0 mg subcutaneous (SC) injection of G-Pen (glucagon injection)
干预措施: Glucagon (Drug)
结局指标
主要结局
Change in Plasma Glucose
时间窗: 0-30 minutes
The primary endpoint for this study is an evaluation of change in plasma glucose following treatment with G-Pen, with an emphasis on the increase from baseline to 30 minutes post-dosing.
次要结局
- Time for Plasma Glucose to Increase by ≥25 mg/dL(0-90 minutes)
- Plasma Glucagon Area Under the Curve(0-90 minutes)
- Plasma Glucagon Cmax(0-180 minutes)
- Plasma Glucagon Tmax(0-180 minutes)