OR08-04 Efficacy and Safety of the SGLT1 Inhibitor Mizagliflozin in Patients with Post-Bariatric Hypoglycemia
Abstract
Abstract Disclosure: H.M. Lawler: None. T.L. McLaughlin: None. M. Fasen: None. A. Champakanath: None. V. Singh: None. N. Turk: None. K. Carswell: None. S. Walker: None. B. Cheatham: None. W.O. Wilkison: None. Post-bariatric hypoglycemia (PBH) is a dangerous condition with no approved medication. Mizagliflozin (Miza) is a novel, first-in-class, orally administered sodium glucose transporter 1 (SGLT1) inhibitor. Miza is minimally absorbed, acting locally in the gastrointestinal tract. This study (NCT05721729) was a randomized, single blind, crossover repeat-dose study to determine Miza’s effect on safety, tolerability and postprandial glucose and insulin. Fifteen participants with PBH (12 female and 3 male, 29-71 years old) were randomized to a treatment arm (5 cohorts, 3 participants per cohort). Each participant received placebo and 2 active doses in a crossover fashion. Mizagliflozin doses (0.5, 1, 2.5, 5, and 10 mg) and placebo were evaluated with once daily (QD), twice daily (BID) or three times a day (TID) during a 7-day treatment period. After each 7-day treatment period, a mixed meal tolerance test (MMTT) was performed and glucose and insulin pharmacodynamic profiles were determined. Primary endpoints were safety and glucose nadir change from placebo. Secondary endpoints included peak plasma glucose and insulin change from placebo. Exploratory endpoints included hypoglycemic events captured by diary and blinded continuous glucose monitor (CGM). Six participants…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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