Population Pharmacokinetics and Exposure-Response (Efficacy and Safety/Tolerability) of Empagliflozin in Patients with Type 2 Diabetes.

ABSTRACT:

Introduction

The aim of the analysis was to characterize the population pharmacokinetics (PKs) and exposure-response (E-R) for efficacy (fasting plasma glucose, glycated hemoglobin) and safety/tolerability [hypoglycemia, genital infections, urinary tract infection (UTI), and volume depletion] of the sodium glucose cotransporter 2 inhibitor, empagliflozin, in patients with type 2 diabetes mellitus. This study extends the findings of previous analyses which described the PK and pharmacodynamics (PD) using early clinical studies of up to 12 weeks in duration.

Methods

Population pharmacokinetic and E-R models were developed based on two Phase I, four Phase II, and four Phase III studies.

Results

Variability in empagliflozin exposure was primarily affected by estimated glo

SUBMITTER: Baron KT 

PROVIDER: S-EPMC5014782 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature