Long-term efficacy and safety of empagliflozin monotherapy in drug-naïve patients with type 2 diabetes

Aim: Assess long-term safety and efficacy of empagliflozin monotherapy versus placebo and sitagliptin in patients with type 2 diabetes. Methods: Of 899 patients treated with empagliflozin 10 mg, empagliflozin 25 mg, placebo or sitagliptin 100 mg for 24 weeks (EMPA-REG MONO™), 68.4% continued in a Phase-III double-blind extension (EMPA-REG EXTEND™ MONO) for ≥52 weeks (until last patient treated for 76 weeks). Exploratory efficacy endpoints were changes from baseline (of EMPA-REG MONO™) in HbA1c and weight at week 76. Results: At baseline, mean HbA1c was 7.91%, 7.87%, 7.86% and 7.85% and mean weight was 78.2 kg, 7…