We have reported top-line results from a number of Phase 3 clinical trials of sotagliflozin in adults living with type 2 diabetes.

SOTA-MET Clinical Trial

We reported preliminary top-line results in July 2019 from our SOTA-MET Phase 3 clinical trial. SOTA-MET enrolled 518 patients with type 2 diabetes and inadequate blood sugar control on background metformin therapy in a randomized, double-blind, placebo-controlled study of a 400mg once daily dose of sotagliflozin over a 26-week core treatment period, followed by a 53-week extension treatment period. The primary efficacy endpoint under evaluation in the trial was the reduction of A1C versus placebo at 26 weeks. Preliminary results from the study showed that patients treated with sotagliflozin experienced a statistically significant reduction in A1C at 26 weeks versus placebo, meeting the study's primary efficacy endpoint. Sotagliflozin was generally well-tolerated in the trial, with similar overall incidences of serious adverse events in patients treated with sotagliflozin and placebo.

SOTA-CKD3 Clinical Trial

We reported preliminary top-line results in July 2019 from our SOTA-CKD3 Phase 3 clinical trial. SOTA-CKD3 enrolled 787 patients with type 2 diabetes and moderate, or stage 3, chronic kidney disease in a randomized, double-blind, placebo-controlled study of 200mg and 400mg once daily doses of sotagliflozin over a 26-week core treatment period, followed by a 26-week extension period. The primary efficacy endpoint under evaluation in the trial was the reduction of A1C versus placebo at 26 weeks in the overall population of patients with stage 3 chronic kidney disease and in each of the subpopulations of patients with stage 3a and 3b chronic kidney disease. Preliminary results from the study showed that patients in the overall stage 3 population and patients with stage 3a chronic kidney disease who were treated with the 400mg dose of sotagliflozin experienced a statistically significant reduction in A1C at 26 weeks versus placebo. Although sotagliflozin demonstrated numerical improvement on A1C at 26 weeks, a statistically significant reduction in A1C at 26 weeks versus placebo was not achieved in patients with stage 3b chronic kidney disease. Sotagliflozin was generally well-tolerated in the trial, with similar overall incidences of serious adverse events in patients treated with sotagliflozin and placebo.

SOTA-CKD4 Clinical Trial

We reported preliminary top-line results in July 2019 from our SOTA-CKD4 Phase 3 clinical trial. SOTA-CKD4 enrolled 277 patients with type 2 diabetes and severe, or stage 4, chronic kidney disease in a randomized, double-blind, placebo-controlled study of 200mg and 400mg once daily doses of sotagliflozin over a 26-week core treatment period, followed by a 26-week extension period. The primary efficacy endpoint under evaluation in the trial was the reduction of A1C versus placebo at 26 weeks. Preliminary results from the study showed that patients treated with the 400mg dose of sotagliflozin experienced a clinically meaningful reduction in A1C at 26 weeks that narrowly missed statistical significance versus placebo and achievement of the primary efficacy endpoint. Sotagliflozin was generally well-tolerated in the trial, with similar overall incidences of serious adverse events in patients treated with sotagliflozin and placebo.

SOTA-EMPA Clinical Trial

We reported top-line results in December 2019 from our SOTA-EMPA Phase 3 clinical trial. SOTA-EMPA enrolled 770 type 2 diabetes patients on dipeptidyl peptidase-4 inhibitors, with or without metformin therapy, in a randomized, double-blind, placebo-controlled study of a 400mg once daily dose of sotagliflozin and a 25mg once daily dose of empagliflozin over a 26-week treatment period. The primary efficacy endpoint under evaluation in the trial was the reduction of A1C versus placebo at 26 weeks. Data from the study showed that patients treated with sotagliflozin experienced a statistically significant reduction in A1C at 26 weeks versus placebo, meeting the study's primary efficacy endpoint. The trial also achieved a key secondary endpoint of noninferiority of sotagliflozin versus empagliflozin on A1C reduction at 26 weeks. Sotagliflozin was generally well-tolerated in the trial, with safety results comparable to previously reported safety results in type 2 diabetes.

SOTA-MONO Clinical Trial

We reported preliminary top-line results in July 2020 in the Phase 3, multicenter, randomized, double-blind, placebo-controlled SOTA-MONO study. Sotagliflozin 400 mg and 200 mg as monotherapy was tested for superiority versus placebo in reducing A1C after 26 weeks of treatment in patients with type 2 diabetes and inadequate glycemic control. The study enrolled 142 patients on sotagliflozin 400 mg, 107 patients on sotagliflozin 200 mg and 150 patients on placebo. The study met its primary endpoint, demonstrating that sotagliflozin 400 mg and 200 mg significantly reduced A1C in patients with type 2 diabetes and inadequate glycemic control on diet and exercise alone. Safety results were similar to those in other studies of sotagliflozin in type 2 diabetes, with similar incidences of hypoglycemia on sotagliflozin and placebo.

SOTA-SU Clinical Trial

We reported preliminary top-line results in July 2020 in the Phase 3, multicenter, randomized, double-blind, placebo-controlled SOTA-SU study. SOTA-SU was a 507-patient, randomized, double-blind, placebo-controlled, parallel group, multicenter Phase 3 study that evaluated the efficacy and safety of sotagliflozin 400 mg added to a sulfonylurea, alone or in combination with metformin, in patients with type 2 diabetes who had inadequate glycemic control on a sulfonylurea or metformin alone. The primary endpoint was the change in A1C from baseline to Week 26. Patients were followed for a total of 79 weeks. The study met its primary endpoint, demonstrating that sotagliflozin 400 mg significantly reduced A1C in patients with type 2 diabetes who were on sulfonylurea alone or in combination with metformin with inadequate glycemic control on a sulfonylurea or metformin alone at Week 26. Importantly, A1C reduction persisted through 79 weeks. Safety results were similar to those in other studies of sotagliflozin in type 2 diabetes. Mean estimated glomerular filtration rate was estimated at Week 79, and was similar for sotagliflozin and placebo. Despite the presence of sulfonylurea background therapy, the incidences of hypoglycemia were similar on sotagliflozin and placebo.

SOTA-GLIM Clinical Trial

We reported preliminary top-line results in July 2020 in the Phase 3, multicenter, randomized, double-blind, placebo-controlled SOTA-GLIM study. SOTA-GLIM was a 954-patient, randomized, double-blind, double-dummy, active- and placebo-controlled, parallel group, multicenter Phase 3 study that evaluated the efficacy and safety of sotagliflozin 400 mg compared to glimepiride or placebo added to metformin in patients with type 2 diabetes who had inadequate glycemic control with metformin therapy. The primary objective of the study was to demonstrate the non-inferiority of sotagliflozin 400 mg compared to glimepiride on A1C at Week 52. Patients were followed for a total of 52 weeks. The study met its primary objective, as the change from baseline in A1C reduction to Week 52 was the same on sotagliflozin 400 mg and glimepiride, and the 95% confidence interval excluded the pre-specified margin (0.3%) of non-inferiority. Safety results were similar to those in other studies of sotagliflozin in type 2 diabetes, with less hypoglycemia on sotagliflozin than glimepiride.

SOTA-INS Clinical Trial

We reported preliminary top-line results in July 2020 in the Phase 3, multicenter, randomized, double-blind, placebo-controlled SOTA-INS study. SOTA-INS was a 571-patient, randomized, double-blind, placebo-controlled, parallel group, multicenter, 52-week Phase 3 study that evaluated the efficacy and safety of sotagliflozin 400 mg and 200 mg or placebo in patients with type 2 diabetes who had inadequate glycemic control on basal insulin alone or in addition to oral antidiabetic agents. The primary endpoint was a change in A1C from baseline to Week 18. Patients were followed for a total of 52 weeks. The study met its primary endpoint, demonstrating that sotagliflozin 400 mg and 200 mg significantly reduced A1C in patients with type 2 diabetes who had inadequate glycemic control on basal insulin alone or in addition to oral antidiabetic agents. Importantly, A1C reduction persisted at the same magnitude at 52 weeks. Safety results were similar to those in other studies of sotagliflozin in type 2 diabetes. Despite the presence of background insulin therapy, the incidences of hypoglycemia were similar on sotagliflozin and placebo.