Researchers have recently found out that Sotagliflozin plus insulin was generally well tolerated without any episodes of diabetic ketoacidosis, as published in the Diabetes Technology and Therapeutics Journal.
Young adults with type 1 diabetes (T1D) tend to have higher A1C than older adults and are at increased risk for diabetic ketoacidosis (DKA). Oral adjuncts to insulin have not been previously studied in this population.
Hence, Bruce W Bode and colleagues from the Atlanta Diabetes Associates, Atlanta, Georgia, USA conducted the present study to assess the effects of Sotagliflozin Combined with Intensive Insulin Therapy in Young Adults with Poorly Controlled Type 1 Diabetes.
The authors carried out a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study on adults aged 18-30 years with T1D and A1C ≥9.0%, all of whom were randomly assigned to placebo (n = 42) or sotagliflozin 400 mg (n = 43), in addition to insulin for 12 weeks. Insulin doses were adjusted to meet glucose targets (preprandial 80-130 mg/dL, postprandial <180 mg/dL). The primary endpoint changed from baseline in A1C at week 12.
The following key findings were seen-
a. From a baseline of 9.8%, mean A1C decreased by 1.0% with placebo and 1.3% with sotagliflozin (-0.4% [95% confidence interval (CI): -0.8 to 0.1]; P = 0.10 vs. placebo).
b. In the prespecified A1C ≤10.0% subgroup, the treatment difference was -0.8% (-1.3 to -0.2; P = 0.006), favoring sotagliflozin.
c. Overall, relative to placebo, postprandial glucose (PPG) decreased by 56.6 mg/dL (-89.7 to -23.6; P < 0.001) and weight decreased by 2.37 kg (-3.5 to -1.2; P < 0.001).
d. More patients achieved an A1C <7.0% with sotagliflozin (16.3%) than placebo (2.4%; P = 0.026).
e. Rates of documented hypoglycemia and severe hypoglycemia were similar between groups.
f. One DKA event occurred with placebo, and none occurred with sotagliflozin.
Therefore, in young adults with T1D and suboptimal glycemic control, sotagliflozin plus insulin for 12 weeks numerically improved A1C and significantly improved A1C goal attainment, PPG, and body weight. Sotagliflozin plus insulin was generally well tolerated without any episodes of DKA, the authors concluded.