Evaluation of the Tubular Effects of Dapagliflozin Using 1HNMR Spectroscopy
Status:
Completed
Trial end date:
2018-08-01
Target enrollment:
Participant gender:
Summary
This is a phase IV study that will explore the mechanisms of action of a drug (dapagliflozin)
that is already commercially available in the country where the study will be conducted
(Greece). The drug will be used according to its approved clinical indications (as add-on
treatment in patients failed to achieve glycemic targets on metformin monotherapy) and in the
approved posology (10 mg/day). Additionally, although there is limited data on the
coadministration of dapagliflozin with thiazides, the excellent safety profile of the drug
even when it is used in combination with drugs that induce significant volume depletion (such
as loop diuretics) suggests that, in properly selected patients, the possibility of important
adverse events during the coadministration of dapagliflozin with chlorthalidone is very low.
All patients will give written informed consent prior to their enrollment in the study. The
study protocol will be approved by the scientific committee of the University Hospital of
Ioannina.