Phase 2 Randomized Single Ascending Dose Study in Post-Bariatric Hypoglycemia Subjects to Determine the Effect of Mizagliflozin Formulations on Postprandial Glucose and Insulin Levels
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Vogenx, Inc.
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Glucose Nadir After Mizagliflozin Dosing
研究概览
简要总结
This clinical study will examine the safety and tolerability, as well as the effects of orally administered mizagliflozin on post prandial glucose and insulin levels in subjects diagnosed with post-bariatric hypoglycemia (PBH).
详细描述
This is a Phase 2 randomized, sequential crossover single ascending dose study in PBH subjects to determine the effect of two mizagliflozin formulations This study will examine single doses of mizagliflozin in either a liquid or encapsulated formulation. Subjects will be randomly assigned to one of two treatment arms. Safety, tolerability and pharmacodynamic response to mizagliflozin will be assessed in subjects during a mixed meal tolerance test (MMTT).
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
- None
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 dumping syndrome.
- •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
Treatment Arm A
Subjects will receive two separate single doses (Period 1 and Period 2) of encapsulated mizagliflozin
干预措施: Mizagliflozin (Drug)
Treatment Arm B
Subjects will receive one dose of liquid formulation (Period 1), and one dose (optional) of encapsulated mizagliflozin (Period 2)
干预措施: Mizagliflozin (Drug)
结局指标
主要结局
Glucose Nadir After Mizagliflozin Dosing
时间窗: 0-3 hours following liquid meal
Time course of glucose concentrations during MMTT
次要结局
未报告次要终点