An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Single dose Part 1 - Change from baseline in glucose levels
研究概览
简要总结
The purpose of this study is to evaluate the safety and clinical pharmacology of XOMA 358 in patients with hypoglycemia after gastric bypass surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged at least 18 years of age
- •Body Mass Index < 35 kg/m2 at baseline, unless discussed with Medical Monitor and patients with higher body mass index do not have significant medical co-morbidities that would confound ability to assess safety and efficacy of study drug.
- •Received gastric bypass surgery more than 1 year before dosing
- •Occurrence of postprandial hypoglycemia (blood glucose less than 60mg/dL) during the Baseline provocation assessments and/or by continuous glucose monitoring, as defined in the protocol.
排除标准
- •History of type 1 diabetes
- •Planned use of the following medications on or after Day -3 (Part 1):
- •Any agent for hypoglycemia, such as diazoxide or octreotide
- •Antihyperglycemic agents, including subcutaneous insulin therapy, sulfonylureas, SGLT2 inhibitors, and GLP-1 agonists
- •Systemic glucocorticoids or β agonists that may affect glucose metabolism
- •Long-acting somatostatin analogs or glucose-affecting medications
- •During Part 2, the following therapies are prohibited as specified below:
- •Tramadol and any other medications not used in the treatment of post-bariatric surgery hypoglycemia that may cause hypoglycemia or fluctuations in blood glucose levels.
- •Acetaminophen-containing products during periods of continuous glucose monitoring.
- •Medications such as tramadol may cause hypoglycemia or fluctuations in blood glucose levels and, as such, use of such medications is subject to the restrictions as described above during the study. Acetaminophen can interfere with the accuracy of the glucose sensor of the continuous glucose monitoring system and is, therefore, prohibited during continuous glucose monitoring.
- •Major general surgery within 3 months before study entry or anticipated during the study period
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Part 1 - single dose
Cohorts A, B, and C
干预措施: XOMA 358 single dose level C (Drug)
Part 1 - single dose
Cohorts A, B, and C
干预措施: XOMA 358 single dose level A (Drug)
Part 1 - single dose
Cohorts A, B, and C
干预措施: XOMA 358 single dose level B (Drug)
Part 2 - multiple doses
Cohort 1
干预措施: XOMA 358 multiple dose level 1 (Drug)
结局指标
主要结局
Single dose Part 1 - Change from baseline in glucose levels
时间窗: Baseline and 22 days
Glucose measured using a continuous glucose monitor
Multiple dose Part 2 - Change from baseline of duration of glucose by CGM at various levels as specified in the protocol
时间窗: 28 days
Glucose measured by continuous glucose monitoring every 5 min
Single dose Part 1 and Multiple dose Part 2 - Incidence of treatment-emergent adverse events -
时间窗: 42 days
Safety assessed by treatment-emergent adverse events
Single dose Part 1 - Blood glucose levels
时间窗: Daily through Day 11 and at Day 22
Assessment of blood glucose with a bedside meter at multiple time points specified in the protocol
Multiple dose Part 2 - Change from baseline of number of episodes and percent of episodes of hypoglycemia per day with glucose by CGM at various levels as defined in the protocol
时间窗: 28 days
次要结局
未报告次要终点