Evaluation of the Tubular Effects of Dapagliflozin Using 1HNMR Spectroscopy

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.

Timeline

Start

2016-06

Primary completion

2018-08

Completion

2018-08

Publications

• Filippas-Ntekouan S, Dimou A, Dafopoulos P, Kostara C, Bairaktari E, Chasapi S, Spyroulias G, Koufakis T, Koutsovasilis A, Tsimihodimos V. Effect of dapagliflozin on the serum metabolome in patients with type 2 diabetes mellitus. J Diabetes Metab Disord. 2024 Dec 16;24(1):4. doi: 10.1007/s40200-024-01508-1. eCollection 2025 Jun.
• Bletsa E, Filippas-Dekouan S, Kostara C, Dafopoulos P, Dimou A, Pappa E, Chasapi S, Spyroulias G, Koutsovasilis A, Bairaktari E, Ferrannini E, Tsimihodimos V. Effect of Dapagliflozin on Urine Metabolome in Patients with Type 2 Diabetes. J Clin Endocrinol Metab. 2021 Apr 23;106(5):1269-1283. doi: 10.1210/clinem/dgab086.

Drugs

Indications