Subcutaneous Injection of Exendin (9-39) in Subjects With Hyperinsulinemic Hypoglycemia Post-Bariatric Surgery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Treatment effect on plasma glucose
研究概览
简要总结
This study is designed to evaluate the safety, efficacy, and pharmacokinetic profile of single ascending doses of exendin 9-39 administered by subcutaneous route in subjects with post-bariatric hypoglycemia.
详细描述
Post-Bariatric Hypoglycemia (PBH) is a debilitating rare disease afflicting 0.2-6.9% of post-bariatric patients, characterized by repeated severe hypoglycemic episodes with neuroglycopenic symptoms and marked disability. There are no effective medical therapies.
While the cause is not known, exaggerated postprandial secretion of glucagon-like peptide-1 (GLP-1) as a result of altered nutrient transit likely plays a major role. GLP-1 is an incretin hormone secreted primarily by the distal ileum that contributes to postprandial glucose regulation. Exendin 9-39 (Ex9) is a specific GLP-1 receptor antagonist, that when given via continuous IV infusion, has been shown to effectively prevent postprandial hypoglycemia in patients with PBH. Subcutaneous (SC) injection of Ex9 may represent a safe, effective and practical therapeutic approach to treating PBH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- •Post-bariatric surgery more than 6 months prior to signing the informed consent
- •Reported history of Whipple's triad: the occurrence of hypoglycemic symptoms associated with blood glucose of ≤55 mg/dL, and resolution with glucose or carbohydrate administration.
- •Symptomatic hypoglycemia during the baseline/screening OGTT, as defined by the presence of plasma glucose ≤55 mg/dL with concomitant autonomic and/or neuroglycopenic symptoms.
排除标准
- •Patients currently using sulfonylureas or other medications that may interfere with glucose metabolism within 5 half-lives of drug.
- •Participation in any clinical investigation within 4 weeks prior to dosing
- •History of or current insulinoma
- •Active infection or significant acute illness within 2 weeks prior to dosing
- •Female patients who are pregnant or lactating
- •Women of childbearing potential and not utilizing effective contraceptive methods
- •Inadequate end organ function
研究组 & 干预措施
Dose A
Subcutaneous injection of Dose A of Exendin (9-39)
干预措施: Exendin (9-39) (Drug)
Dose B
Subcutaneous injection of Dose B of Exendin (9-39)
干预措施: Exendin (9-39) (Drug)
Dose C
Subcutaneous injection of Dose C of Exendin (9-39)
干预措施: Exendin (9-39) (Drug)
Dose D
Subcutaneous injection of Dose D of Exendin (9-39)
干预措施: Exendin (9-39) (Drug)
结局指标
主要结局
Treatment effect on plasma glucose
时间窗: 0-180 minutes following initiation of oral glucose tolerance test (OGTT) conducted after treatment.
Magnitude of plasma glucose nadir during repeat OGTT after treatment
次要结局
- Treatment effect on symptoms of hypoglycemia(0-180 minutes following initiation of OGTT)
研究者
Tracey McLaughlin
Associate Professor of Medicine (Endocrinology)
Stanford University