G-Pen™ (Glucagon Injection) for Induced Hypoglycemia Rescue in Adult Patients With T1D
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Number of Subjects With Plasma Glucose > 70 mg/dL at 30 Minutes Post-treatment
研究概览
简要总结
This is an open-label, exploratory pilot study in patients with T1D. The study will involve two daytime clinical research center visits 7-14 days apart. Subjects will receive a single injection of G-Pen™ (glucagon injection) at each visit.
详细描述
Following eligibility confirmation, each study participant will undergo two episodes of insulin-induced hypoglycemia with plasma glucose < 50 mg/dL. Both episodes will be treated with a single subcutaneous injection of G-Pen™ glucagon. For the first treatment visit, all subjects will receive a 1 mg dose of G-Pen™ glucagon. The investigator will have discretion to repeat this same dose at the second treatment visit or give a 0.5 mg dose of G-Pen™ glucagon. A follow-up phone call will be conducted 3-7 days following administration of the final dose of study drug as a safety check.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes mellitus for at least 24 months
排除标准
- •Pregnant or Lactating
- •HbA1c >10.5% at screening
- •Use of > 2.0 U/kg total insulin dose per day
- •Inadequate bilateral venous access in both arms
- •Renal insufficiency
- •Congestive heart failure, NYHA class II, III or IV
- •Active malignancy within 5 years from screening
- •Major surgical operation within 30 days prior to screening
- •Seizure or bleeding disorder
- •Glycogen storage disease
- •Active substance or alchohol abuse
研究组 & 干预措施
Glucagon
1 mg G-Pen™ (glucagon injection) first, followed by 0.5 mg
干预措施: Glucagon (Drug)
结局指标
主要结局
Number of Subjects With Plasma Glucose > 70 mg/dL at 30 Minutes Post-treatment
时间窗: 0-90 minutes
For 90 minutes following treatment, plasma glucose was measured every 5 minutes, with an increase in plasma glucose to \>70 mg/dL within 30 minutes of treatment being considered a positive response.
次要结局
- Time to Plasma Glucose > 70 mg/dL(0-90 minutes)
- Time to Resolution of Induced Hypoglycemia Symptoms(0-30 minutes)