1232-P: Predictors of ß-Cell Function Changes: Pooled Analysis from Phase 3 Ertugliflozin Studies

Improving glycemic control generally improves β-cell function in T2DM but the predictors for this effect are unclear. SGLT2 inhibitors improve glycemia and have no known direct effects on β-cell function. Therefore, we aimed to identify predictors of β-cell function changes by treatment with the SGLT2 inhibitor ertugliflozin (ERTU). Data of patients (pts) randomized to ERTU (5 or 15 mg) only or placebo (PBO) only from four phase 3 ERTU studies of the VERTIS clinical program were pooled and analyzed. Change from baseline in β-cell function (fasting homeostatic model assessment beta [HOMA-β] and C-peptide Insulinogenic Index [IGI] at 30 min of a mixed meal tolerance test) at Week 26 was assessed, followed by linear regression analyses to examine the relationship between change in β-cell function versus metabolic and demographic characteristics. ERTU compared with PBO improved β-cell function when assessed by the changes from baseline (95% CIs) in HOMA-β (14.7 [12.3,17.1] versus −0.4 [−3.4, 2.5]) but not IGI. Change in HOMA-β correlated negatively and similarly with change in A1C in both groups (ERTU: r=−0.29; PBO: r=−0.36, both P Disclosure S. Gallo: Employee; Self; Pfizer Inc. Stock/Shareholder; Self; Pfizer Inc. A. Raji: Employee; Self; Merck & Co., Inc. Stock/Shareholder; Self; Merck & Co., Inc. R.A. Calle: Employee; Self; Pfizer Inc. Stock/Shareholder; Self; Pfizer Inc. M.C. Ellison: Employee; Self; Merck & Co., Inc. C. Meyer: Employee; Self; Merck & Co., Inc. Funding Merck Sharp & Dohme Corp; Pfizer Inc.