Postbariatric Hypoglycemia
Conditions
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.
Interventions
DRUGMizagliflozin
Encapsulated
DRUGPlacebo
Encapsulated
Sponsors
Vogenx, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Roux-en-Y gastric bypass surgery performed \> 6 months prior to enrollment * Diagnosis of PBH
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Through study completion, 43 days | Number of participants with adverse events |
| Vital Signs | Through study completion, 43 days | Number of participants with abnormal vital signs |
| Laboratory Tests | Through study completion, 43 days | Number of participants with abnormal laboratory tests |
| Glucose nadir after dosing | 0-3 hours following liquid meal | Time course of glucose concentrations during MMTT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 time to peak glucose concentration after dosing | 0-3 hours following liquid meal | Time course of glucose concentrations during MMTT |
| 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 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 insulin concentration after dosing | 0-3 hours following liquid meal | Time course of insulin concentrations during MMTT |
Countries
United States
Outcome results
None listed