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 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
15
Encapsulated
Encapsulated
Stanford
Palo Alto, California, United States
University of Colorado / Anschutz Medical Campus
Aurora, Colorado, United States
Adverse Events
Number of participants with adverse events
Time frame: Through study completion, 43 days
Vital Signs
Number of participants with abnormal vital signs
Time frame: Through study completion, 43 days
Laboratory Tests
Number of participants with abnormal laboratory tests
Time frame: Through study completion, 43 days
Glucose nadir after dosing
Time course of glucose concentrations during MMTT
Time frame: 0-3 hours following liquid meal
MMTT peak glucose concentration after dosing
Time course of glucose concentrations during MMTT
Time frame: 0-3 hours following liquid meal
MMTT peak insulin concentration after dosing
Time course of insulin concentrations during MMTT
Time frame: 0-3 hours following liquid meal
MMTT time to peak glucose concentration after dosing
Time course of glucose concentrations during MMTT
Time frame: 0-3 hours following liquid meal
MMTT time to peak insulin concentration after dosing
Time course of insulin concentrations during MMTT
Time frame: 0-3 hours following liquid meal
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MMTT glucose concentration
MMTT glucose area under the curve (AUC0-1, AUC0-2, and AUC0-3) after dosing
Time frame: 0-3 hours following liquid meal
MMTT insulin concentration
MMTT insulin area under the curve (AUC0-1, AUC0-2, and AUC0-3) after dosing
Time frame: 0-3 hours following liquid meal