Buse JB, et al. - The efficacy and safety of the dual sodium–glucose cotransporter 1 (SGLT1) and SGLT2 inhibitor sotagliflozin in combination with optimized insulin in type 1 diabetes (T1D) was assessed in this analysis. Researchers reported that sotagliflozin combined with optimized insulin therapy was correlated with sustained HbA_1c reduction, weight loss, lower insulin dose, less episodes of severe hypoglycemia, improved patient-reported outcomes, and more diabetic ketoacidosis (DKA) relative to placebo in a 1-year T1D study.

Methods

• The inTandem1 trial was, a double-blind, 52-week phase 3 trial.
• This trial randomized North American adults with T1D to placebo (n = 268), sotagliflozin 200 mg (n = 263), or sotagliflozin 400 mg (n= 262) after 6 weeks of insulin optimization.
• HbA_1c change from baseline at 24 weeks was the primary end point.
• Through 52 weeks, HbA_1c, as well as weight and safety were also assessed.

Results

• Study results showed that placebo-adjusted HbA_1c reductions were 0.36% and 0.41% with sotagliflozin 200 and 400 mg, respectively, at 24 weeks and 0.25% and 0.31% at 52 weeks (all P < 0.001) from a mean baseline of 7.57%.
• It was observed that an HbA_1c < 7% was achieved by 15.7%, 27.2%, and 40.3% of patients receiving placebo, sotagliflozin 200 mg, and sotagliflozin 400 mg, respectively (P ≤ 0.003 vs placebo) at 24 weeks among patients with a baseline HbA_1c ≥7.0%.
• Findings revealed that mean treatment differences between sotagliflozin 400 mg and placebo were -1.08 mmol/L for fasting plasma glucose, -4.32 kg for weight, and -15.63% for bolus insulin dose and -11.87% for basal insulin dose (all P < 0.001) at 52 weeks.
• At 24 weeks, diabetes treatment satisfaction questionnaire scores increased significantly by 2.5 points with sotagliflozin vs placebo (P < 0.001).
• With sotagliflozin, genital mycotic infections and diarrhea occurred more frequently.
• Data reported that adjudicated diabetic ketoacidosis (DKA) occurred in 9 (3.4%) and 11 (4.2%) subjects receiving sotagliflozin 200 and 400 mg, respectively, and in 1 (0.4%) receiving placebo.
• According to the findings obtained, severe hypoglycemia occurred in 17 (6.5%) subjects from each sotagliflozin group and 26 (9.7%) subjects receiving placebo.