AIMS: Empagliflozin is a selective sodium glucose cotransporter 2 (SGLT2) 
inhibitor that inhibits renal glucose reabsorption and is being investigated for 
the treatment of type 2 diabetes mellitus (T2DM).
METHODS: In this open-label study, the effect of renal impairment on the 
pharmacokinetics, pharmacodynamics and safety of a 50 mg dose of empagliflozin 
was investigated in 40 subjects, grouped according to estimated glomerular 
filtration rate (eGFR).
RESULTS: Maximum empagliflozin plasma concentrations were similar in subjects 
with normal renal function and renal impairment. Area under the empagliflozin 
concentration-time curve (AUC0 -∞ ) values increased by approximately 18, 20, 66 
and 48% in subjects with mild, moderate, severe renal impairment and renal 
failure/end stage renal disease (ESRD), respectively, in comparison to healthy 
subjects. This was attributed to decreased renal clearance (CLR ). Urinary 
glucose excretion (UGE) decreased with increasing renal impairment and 
correlated with decreased eGFR and CLR . Empagliflozin was well tolerated, with 
no increase in adverse events associated with renal impairment.
CONCLUSIONS: Renal insufficiency resulted in decreased CLR of empagliflozin, 
moderately increased systemic exposure and decreased UGE. A single 50 mg dose of 
empagliflozin was well tolerated in subjects with normal renal function and any 
degree of renal impairment. The pharmacokinetic results of this study indicate 
that no dose adjustment of empagliflozin is required in patients with renal 
impairment.