Clinical trial NCT05721729: Effect of Mizagliflozin Repeat Dosing on Adverse Events and Postprandial Glucose Excursions
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Postbariatric Hypoglycemia
Lead sponsor: Vogenx, Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adverse Events
timeFrame: Through study completion, 43 days
measure: Vital Signs
timeFrame: Through study completion, 43 days
measure: Laboratory Tests
timeFrame: Through study completion, 43 days
measure: Glucose nadir after dosing
timeFrame: 0-3 hours following liquid meal
Secondary outcomes:
measure: MMTT peak glucose concentration after dosing
timeFrame: 0-3 hours following liquid meal
measure: MMTT peak insulin concentration after dosing
timeFrame: 0-3 hours following liquid meal
measure: MMTT time to peak glucose concentration after dosing
timeFrame: 0-3 hours following liquid meal
measure: MMTT time to peak insulin concentration after dosing
timeFrame: 0-3 hours following liquid meal
measure: MMTT glucose concentration
timeFrame: 0-3 hours following liquid meal
measure: MMTT insulin concentration
timeFrame: 0-3 hours following liquid meal
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford
state: California
city: Aurora
country: United States
facility: University of Colorado / Anschutz Medical Campus
state: Colorado
Study officials:
References: