Evaluation of the effect of dapagliflozin on cardiac repolarization: a thorough QT/QTc study.

ABSTRACT:

Introduction

Dapagliflozin is a first-in-class sodium-glucose transporter 2 (SGLT2) inhibitor under investigation for the treatment of type 2 diabetes mellitus. A thorough QTc study was conducted, according to International Conference on Harmonization E14 guidelines, to characterize the effect of dapagliflozin on cardiac repolarization.

Methods

The present study was a double-blind, four-period, placebo-controlled crossover study at a single-center inpatient clinical pharmacology unit. The study enrolled 50 healthy men who were randomized to receive sequences of single doses of dapagliflozin 150 mg, dapagliflozin 20 mg, moxifloxacin 400 mg, and placebo. The sequences were randomized based on the Williams design for a cross-over study to reduce the "carryover" effects from dru

SUBMITTER: Carlson GF 

PROVIDER: S-EPMC3173598 | biostudies-literature | 2011 Sep

REPOSITORIES: biostudies-literature