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, 78.4 kg, 77.8 kg, and 79.3 kg in placebo, empagliflozin 10 mg, empagliflozin 25 mg and sitagliptin groups, respectively. Compared with placebo, adjusted mean (95% CI) changes from baseline in HbA1c at week 76 were -0.78% (-0.94, -0.63) and -0.89% (-1.04, -0.73) with empagliflozin 10 mg and 25 mg; both p < 0.001), and in weight were -1.8 kg (-2.4, -1.3) and -2.0 kg (-2.6, -1.5), respectively; both p < 0.001. Compared with sitagliptin, empagliflozin 25 mg reduced HbA1c (-0.22% [-0.38, -0.07]; p < 0.01) and empagliflozin 10 and 25 mg reduced weight (-2.3 kg [-2.9, -1.8] and -2.6 kg [-3.1, -2.0], respectively; both p < 0.001). Adverse events (AEs) were reported in 76.4%, 76.8%, 78.0% and 72.2% of patients on placebo, empagliflozin 10 mg, empagliflozin 25 mg and sitagliptin, respectively. Hypoglycaemic AEs (glucose ≤3.9 mmol/l and/or requiring assistance) were reported in 0.9% of patients in each group; 1 patient (empagliflozin 10 mg) required assistance.

Conclusion: Empagliflozin monotherapy for ≥76 weeks was well tolerated and reduced HbA1c and weight versus placebo.