Sotagliflozin added to optimised insulin therapy leads to HbA1c reduction without weight gain in adults with type 1 diabetes: a pooled analysis of inTandem1 and inTandem2.

AIMS Insulin intensification is associated with weight gain, which may negate the benefits of improved glycemic control in adults with type 1 diabetes (T1D). This post hoc analysis evaluated whether the addition of sotagliflozin to optimised insulin significantly increases the proportion of adults with T1D who achieve HbA1c goals without weight gain. MATERIALS AND METHODS In a patient-level pooled analysis (n = 1575) of data from two phase 3, 52-week clinical trials (inTandem1 and inTandem2), the change from baseline in HbA1c and weight as well as the proportion of participants achieving an HbA1c <7% without weight gain were compared between groups treated with placebo, sotagliflozin 200 mg, and sotagliflozin 400 mg. RESULTS From a mean baseline HbA1c of 7.7%, mean HbA1c changes at week 24 were - 0.36% (95% CI -0.44 to -0.29) and - 0.38% (-0.45 to -0.31) with sotagliflozin 200 and 400 mg vs placebo (P = 0.001 for both), respectively, with sustained effects through week 52. Weight significantly decreased at weeks 24 and 52 in both sotagliflozin groups compared with placebo. At week 52, the proportion of patients who achieved a HbA1c <7% without weight gain was 21.8% with sotagliflozin 200 mg, 26.1% with sotagliflozin 400 mg, and 9.1% with placebo (P < 0.001). Other HbA1c, weight, and safety composite variables showed similar significant trends. CONCLUSION When added to optimised insulin therapy, sotagliflozin improved glycaemic control and body weight and enabled more adults with T1D to achieve A1c goals without weight gain over 52 weeks, although there was more DKA relative to placebo. This article is protected by copyright. All rights reserved.