Individuals with type 1 diabetes (T1D) face daily challenges in achieving optimal glycemic control by reducing hyperglycemia while avoiding hypoglycemia. Optimization is reflected by the High/Low Blood Glucose Indices (HBGI/LBGI) - established metrics using self-monitored blood glucose, or continuous glucose monitoring (CGM) data, to assess glycemic variability (GV) and predict the risks of hyper- and hypoglycemia with intensification of therapy.

In the phase 3 inTandem1 and 2 studies, sotagliflozin (SOTA), a dual SGLT1 and 2 inhibitor used as adjunct to optimized insulin therapy in adults with T1D, reduced HbA1c vs. placebo. Significant improvement of glucose time in range (70-180 mg/dL) without increasing time <70 mg/dL was previously reported in the pooled CGM substudy. In this analysis (N=265), we evaluated hyper- and hypoglycemic risks with SOTA 200 mg and 400 mg, both taken once daily, using LBGI and HBGI computed from CGM data.

Compared with placebo, HBGI values were lower with SOTA 400 mg at study weeks 4, 12, and 24, and SOTA 200 mg at weeks 4 and 12 (p<0.0001) (Figure).

The percentage of adults in moderate (4.5-9) or high-risk (>9) HBGI categories was reduced with SOTA throughout the study for both dosages, and minimal changes were seen in LBGI values and risk categories.

The CGM profile showed that SOTA reduced GV through a favorable impact on HBGI without changing LBGI.


B. Kovatchev: Advisory Panel; Self; Sanofi. Board Member; Self; TypeZero Technologies, Inc. Consultant; Self; Sanofi, Tandem Diabetes Care. Research Support; Self; Dexcom, Inc., Roche Diabetes Care, Tandem Diabetes Care. Speaker's Bureau; Self; Dexcom, Inc. Stock/Shareholder; Self; TypeZero Technologies, Inc. Other Relationship; Self; Johnson & Johnson, Sanofi. S. Wang: Employee; Self; Sanofi US. J.H. Oliveira: Employee; Self; Sanofi. Employee; Spouse/Partner; Sanofi. J.A. Stewart: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. P. Lapuerta: Employee; Self; Lexicon Pharmaceuticals, Inc. Stock/Shareholder; Self; Lexicon Pharmaceuticals, Inc. R. Castro: Employee; Self; Sanofi US.


Lexicon Pharmaceuticals, Inc.; Sanofi

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