A Phase IIb, randomized, placebo-controlled study of the SGLT2 inhibitor empagliflozin in patients with type 2 diabetes

Aim This Phase IIb, randomized, double‐blind, placebo‐controlled trial evaluated the efficacy, safety, tolerability and pharmacokinetics of empagliflozin in patients with type 2 diabetes. Methods Four hundred and eight patients (treatment‐naïve or after a 4‐week wash‐out period) were randomized to receive empagliflozin 5, 10 or 25 mg once daily, placebo or open‐label metformin for 12 weeks. The primary endpoint was change in haemoglobin A1c (HbA1c) after 12 weeks. Results After 12 weeks' treatment, empagliflozin showed dose‐dependent reductions in HbA1c from baseline [5 mg: −0.4%, 10 mg: −0.5%, 25 mg: −0.6%; all doses p