Many adults with T1D are not at glycemic goal and are overweight or obese and this trend appears to be worsening. SGLT inhibitors have been shown to improve metabolic outcomes in T1D. However, the glycemic efficacy of selective SGLT2 inhibitors depends on the amount of glucose filtered in the glomerulus and as such efficacy attenuates as renal function declines. The mechanism of action of sotagliflozin (SOTA) involves inhibition of SGLT2 in the kidney and SGLT1 in the gastrointestinal tract. This post-hoc analysis evaluated the efficacy and safety of SOTA by baseline eGFR (45-<60 [N = 71]; 60-<90 [N = 774]; ≥90 mL/min/1.73 m² [N = 730]) using pooled results in 1575 adults with T1D from the inTandem1 and 2 studies. Baseline A1C and body weight (BW) were not different among groups and baseline systolic blood pressure (SBP) tended to be higher in those with eGFR<60 mL/min/1.73 m². Placebo-adjusted reduction in A1C and BW at Week 24 with SOTA was consistent across eGFR subgroups (Table). The safety profile of SOTA was consistent with results published for entire population, with a higher incidence of DKA and a lower incidence of severe hypoglycemia for sotagliflozin vs. placebo. There was no increase in renal-related adverse events or acute kidney injury with SOTA. The efficacy and safety profile of SOTA was generally similar across adults with T1D and varying degrees of renal function.


Y. Handelsman: Advisory Panel; Self; Amgen, Applied Therapeutics, AstraZeneca. Consultant; Self; Applied Therapeutics, Boehringer Ingelheim Pharmaceuticals, Inc. Research Support; Self; Amgen, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc. Speaker’s Bureau; Self; Amarin Corporation, Amgen, AstraZeneca. A. Giaccari: Speaker’s Bureau; Self; Amgen, AstraZeneca, Eli Lilly and Company, Merck Sharp & Dohme Corp., Mundipharma, Novo Nordisk A/S, Sanofi-Aventis. S. Sawhney: None. P.L. Banks: Employee; Self; Lexicon Pharmaceuticals, Inc. M.J. Davies: Employee; Self; Lexicon Pharmaceuticals, Inc. P. Lapuerta: Employee; Self; Lexicon Pharmaceuticals, Inc. Stock/Shareholder; Self; Lexicon Pharmaceuticals, Inc.

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