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Adding Sotagliflozin to Insulin in T1D Patients
N Engl J Med; 2017 Dec 14; Garg, Henry, et al
Among patients with type 1 diabetes (T1D) receiving insulin, the proportion of patients who achieved a glycated hemoglobin level lower than 7.0% with no severe hypoglycemia or diabetic ketoacidosis was larger in the group that received sotagliflozin compared to placebo; however, the rate of diabetic ketoacidosis was higher in the sotagliflozin group. This according to a phase 3, double-blind clinical trial that randomly assigned 1,402 patients with T1D who were receiving treatment with any insulin therapy to receive sotagliflozin (400 mg per day) or placebo for 24 weeks. The primary end point was a glycated hemoglobin level lower than 7.0% at week 24, with no episodes of severe hypoglycemia or diabetic ketoacidosis after randomization. Researchers found:
- A significantly larger proportion of patients in the sotagliflozin group vs the placebo group achieved the primary end point (28.6% vs 15.2%).
- The least-squares mean change from baseline was significantly greater in the sotagliflozin group vs the placebo groups for glycated hemoglobin, weight, systolic blood pressure, and mean daily bolus dose of insulin.
- The rate of severe hypoglycemia was similar in the sotagliflozin group and the placebo group.
- The rate of diabetic ketoacidosis was higher in the sotagliflozin group vs the placebo group (3.0% vs 0.6%).
Garg SK, Henry RR, Banks P, et al. Effects of sotagliflozin added to insulin in patients with type 1 diabetes. N Engl J Med. 2017;377:2337-2348. doi:10.1056/NEJMoa1708337.
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The context in which sotagliflozin (not currently FDA approved) is being studied is that there are no oral medications approved as adjunctive therapy with insulin for patients with type 1 diabetes, and only a third of patients with type 1 diabetes have an A1c lower than 7.0%.1 Sotagliflozin is one of a new class of anti-glycemic agents, dual SGLT-1 and SGLT-2 inhibitors. We are familiar with SGLT-2 inhibitors which interfere with glucose reabsorption in the renal tubule and so lead to a decrease in serum glucose along with weight loss and a low incidence of hypoglycemia. SGLT-1 inhibition reduces glucose absorption in the proximal intestine, and by so doing decreases and delays postprandial hyperglycemia. The efficacy of sotagliflozin in lowering A1c, in addition to insulin, was significant, with about twice as many people achieving the target A1c of <7.0%. This was done along with weight loss and a low incidence of hypoglycemia, though there was an increase in the incidence of diabetic ketoacidosis. —Neil Skolnik, MD