INTRODUCTION: To evaluate the pharmacodynamics, pharmacokinetics, safety and 
tolerability of empagliflozin in Japanese patients with type 2 diabetes 
mellitus.
MATERIALS AND METHODS: In this 4-week, multiple dose, randomized, 
parallel-group, double-blind, placebo-controlled trial, patients (n = 100) were 
randomized to receive 1, 5, 10 or 25 mg of empagliflozin, or placebo once daily. 
Key end-points were urinary glucose excretion (UGE), fasting plasma glucose 
(FPG) and eight-point glucose profile.
RESULTS: Data are presented for 1, 5, 10, 25 mg of empagliflozin and placebo 
groups, respectively. Adjusted mean changes from baseline to day 27 in UGE were 
40.8, 77.1, 80.9, 93.0 and -2.1 g (P < 0.0001 for all empagliflozin groups vs 
placebo). Adjusted mean changes from baseline to day 28 in FPG were -1.56, 
-1.96, -2.31, -2.37 and -0.86 mmol/L (P < 0.01 for all empagliflozin groups vs 
placebo). Adjusted mean changes from baseline to day 27 in eight-point glucose 
profile were -1.96, -2.21, -2.42, -2.54 and -0.97 mmol/L (P < 0.01 for all 
empagliflozin groups vs placebo). Empagliflozin reached peak plasma 
concentration 1.5-2 h after dosing. Mean steady state terminal elimination 
half-lives ranged from 13.2 to 18.0 h. Of 100 patients, 25 experienced an 
adverse event, occurring more frequently for empagliflozin (29.1%) than placebo 
(9.5%); frequency was not dose related.
CONCLUSIONS: In Japanese patients with type 2 diabetes mellitus, empagliflozin 
at doses up to 25 mg once daily for 4 weeks was well tolerated and resulted in 
significant improvements in glycemic control compared with placebo. This trial 
was registered with ClinicalTrials.gov (no. NCT00885118).