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Ertugliflozin is approved in the US and European Union as a stand-alone product for adults with type 2 diabetes mellitus as once daily (QD) dosing. The approved fixed-dose combination (FDC) of ertugliflozin and immediate-release metformin is dosed twice daily (BID). This study assessed steady-state pharmacokinetics (PK; area under the concentration-time curve over 24 hours (AUC 24 )) and pharmacodynamics (PD; urinary glucose excretion over 24 hours (UGE 24 )) for ertugliflozin 5 and 15 mg total daily doses administered BID or QD.

A PK/PD study comparing twice-daily to once-daily dosing regimens of ertugliflozin in healthy subjects