Efficacy and safety of empagliflozin twice daily versus once daily in patients with type 2 diabetes inadequately controlled on metformin: A 16-week, randomized, placebo-controlled trial

Abstract

Patients with type 2 diabetes mellitus (T2DM) with a glycated haemoglobin (HbA1c) level ≥7 and ≤10% were randomized to receive empagliflozin 12.5mg twice daily (n=219), 25mg once daily (n=218), 5mg twice daily (n=219) or 10mg once daily (n=220), or placebo (n=107) as add-on to stable-dose metformin immediate release (IR) twice daily for 16weeks. The primary endpoint was change from baseline in HbA1c at week 16. At week 16, change from baseline in HbA1c with empagliflozin twice daily was non-inferior to empagliflozin once daily and vice versa. The adjusted mean (95% confidence interval) difference in change from baseline in HbA1c with empagliflozin 12.5mg twice daily versus 25mg once daily was -0.11% (-0.26, 0.03), and with empagliflozin 5mg twice daily versus 10mg once daily it was -0.02% (-0.16, 0.13). All empagliflozin regimens were well tolerated; thus, when used as add-on to metformin IR in patients with T2DM, the therapeutic effect of empagliflozin twice-daily and once-daily regimens can be considered equivalent.