Phase 2 Crossover, Randomized, Placebo-Controlled, Single-Blind, Repeat Dose Study in Post-Bariatric Hypoglycemia Subjects to Determine the Effect of Mizagliflozin on Adverse Events and Postprandial Glucose Excursions
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Vogenx, Inc.
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Laboratory Tests
研究概览
简要总结
This is a phase 2 crossover, randomized, placebo-controlled, single-blind, repeat dose study in PBH subjects to determine the effect of mizagliflozin on adverse events and postprandial glucose excursions.
详细描述
This is a phase 2 crossover, randomized, placebo-controlled, single-blind, repeat dose study in PBH subjects to determine the effect of mizagliflozin on adverse events and postprandial glucose excursions. This study will examine repeat doses of mizagliflozin and placebo while also evaluating dosing regimen. Up to 15 subjects are expected to complete the study. Subjects will be randomly assigned to a treatment arm within a cohort. Each subject should receive placebo and 2 active dose regimens in a crossover fashion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Roux-en-Y gastric bypass surgery performed > 6 months prior to enrollment
- •Diagnosis of PBH
排除标准
- •History of current medical conditions (other than PBH) which may result in hypoglycemia such as insulinoma, adrenal insufficiency, insulin autoimmune hypoglycemia, congenital hyperinsulinemia.
- •Current use of insulin or insulin secretagogues
- •History of current fasting hypoglycemia
- •Pregnancy and/or lactation: For women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 2 weeks after participating in the study
研究组 & 干预措施
Cohort 2
Subjects will receive placebo and two doses of encapsulated mizagliflozin over three dosing periods. Twice and three times daily dosing will be examined.
干预措施: Placebo (Drug)
Cohort 1
Subjects will receive placebo and two doses of encapsulated mizagliflozin over three dosing periods. Once and twice daily dosing will be examined.
干预措施: Mizagliflozin (Drug)
Cohort 1
Subjects will receive placebo and two doses of encapsulated mizagliflozin over three dosing periods. Once and twice daily dosing will be examined.
干预措施: Placebo (Drug)
Cohort 2
Subjects will receive placebo and two doses of encapsulated mizagliflozin over three dosing periods. Twice and three times daily dosing will be examined.
干预措施: Mizagliflozin (Drug)
结局指标
主要结局
Laboratory Tests
时间窗: Through study completion, 43 days
Number of participants with abnormal laboratory tests
Vital Signs
时间窗: Through study completion, 43 days
Number of participants with abnormal vital signs
Adverse Events
时间窗: Through study completion, 43 days
Number of participants with adverse events
Glucose nadir after dosing
时间窗: 0-3 hours following liquid meal
Time course of glucose concentrations during MMTT
次要结局
- MMTT peak glucose concentration after dosing(0-3 hours following liquid meal)
- MMTT insulin concentration(0-3 hours following liquid meal)
- MMTT glucose concentration(0-3 hours following liquid meal)
- MMTT peak insulin concentration after dosing(0-3 hours following liquid meal)
- MMTT time to peak glucose concentration after dosing(0-3 hours following liquid meal)
- MMTT time to peak insulin concentration after dosing(0-3 hours following liquid meal)