Sotagliflozin (SOTA) is a dual SGLT1 and SGLT2 inhibitor in development as an adjunct to insulin in T1D. This was a pooled analysis of the inTandem1 (NCT02384941) and inTandem2 (NCT02421510) trials in adults with T1D treated with multiple daily insulin injections or pump therapy who were randomized 1:1:1 to placebo, SOTA 200 mg or SOTA 400 mg once daily after 6 weeks of insulin optimization. Of these, 278 patients participated in a blinded continuous glucose monitoring (CGM) sub-study. The primary endpoint of this sub-study was the percentage of time in the target glucose range (70 mg/dL-180 mg/dL). Mean daily glucose and amplitude of all glycemic excursions (MAGE) of <70 and >180 mg/dL were also assessed. Baseline characteristics were similar among groups. Compared with placebo, treatment with SOTA 200 and 400 mg significantly increased the time in range (+1.3 and +2.8 hours/day, respectively) and reduced MAGE at Week 24, while SOTA 400 mg also significantly reduced mean daily glucose (Table). In conclusion, when used adjunctively in T1D, SOTA improved the time in target glucose range compared with placebo, demonstrating efficacy in glycemic control beyond a reduction in HbA1c.

INCREASED TIME IN RANGE WITH SOTAGLIFLOZIN AS ADJUNCT THERAPY TO INSULIN IN ADULTS WITH TYPE 1 DIABETES DEMONSTRATED BY 24-WEEK CONTINUOUS GLUCOSE MONITORING (INTANDEM1, INTANDEM2)