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Empagliflozin as adjunctive to insulin therapy in type 1 diabetes: The EASE Trials

Diabetes Care Oct 31, 2018

Rosenstock J, et al. - In patients with type 1 diabetes (T1D), researchers assessed the effectiveness and safety of empagliflozin 10- and 25-mg doses plus a unique lower dose (2.5 mg) as adjunct to intensified insulin. In this EASE (Empagliflozin as Adjunctive to inSulin thErapy) program (N = 1,707), two double-blind, placebo-controlled phase 3 trials were included: EASE-2 with empagliflozin 10 mg (n = 243), 25 mg (n = 244), and placebo (n = 243), 52-week treatment; and EASE-3 with empagliflozin 2.5 mg (n = 241), 10 mg (n = 248), 25 mg (n = 245), and placebo (n = 241), 26-week treatment. It was noted that in T1D, empagliflozin did not increase hypoglycemia, and it did improve glycemic control and weight. Outcomes revealed that ketoacidosis rate was similar between empagliflozin 2.5 mg and placebo, but it increased with 10 mg and 25 mg. Study findings suggested that ketone monitoring for early ketoacidosis detection and intervention, as well as lower empagliflozin doses, might lower this risk. They found that genital infections occurred more frequently on empagliflozin.

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