Effect of Mizagliflozin Repeat Dosing on Adverse Events and Postprandial Glucose Excursions
- Conditions
- Postbariatric Hypoglycemia
- Interventions
- Drug: Placebo
- Registration Number
- NCT05721729
- Lead Sponsor
- Vogenx, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 15
- Roux-en-Y gastric bypass surgery performed > 6 months prior to enrollment
- Diagnosis of PBH
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cohort 1 Mizagliflozin Subjects will receive placebo and two doses of encapsulated mizagliflozin over three dosing periods. Once and twice daily dosing will be examined. Cohort 1 Placebo Subjects will receive placebo and two doses of encapsulated mizagliflozin over three dosing periods. Once and twice daily dosing will be examined. Cohort 2 Mizagliflozin Subjects will receive placebo and two doses of encapsulated mizagliflozin over three dosing periods. Twice and three times daily dosing will be examined. Cohort 2 Placebo Subjects will receive placebo and two doses of encapsulated mizagliflozin over three dosing periods. Twice and three times daily dosing will be examined.
- Primary Outcome Measures
Name Time Method Laboratory Tests Through study completion, 43 days Number of participants with abnormal laboratory tests
Vital Signs Through study completion, 43 days Number of participants with abnormal vital signs
Adverse Events Through study completion, 43 days Number of participants with adverse events
Glucose nadir after dosing 0-3 hours following liquid meal Time course of glucose concentrations during MMTT
- Secondary Outcome Measures
Name Time Method MMTT insulin concentration 0-3 hours following liquid meal MMTT insulin area under the curve (AUC0-1, AUC0-2, and AUC0-3) after dosing
MMTT glucose concentration 0-3 hours following liquid meal MMTT glucose area under the curve (AUC0-1, AUC0-2, and AUC0-3) after dosing
MMTT peak glucose concentration after dosing 0-3 hours following liquid meal Time course of glucose concentrations during MMTT
MMTT peak insulin concentration after dosing 0-3 hours following liquid meal Time course of insulin concentrations during MMTT
MMTT time to peak glucose concentration after dosing 0-3 hours following liquid meal Time course of glucose concentrations during MMTT
MMTT time to peak insulin concentration after dosing 0-3 hours following liquid meal Time course of insulin concentrations during MMTT
Trial Locations
- Locations (2)
Stanford
🇺🇸Palo Alto, California, United States
University of Colorado / Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States