Evaluation of the Tubular Effects of Dapagliflozin Using 1HNMR Spectroscopy

• Status: Completed
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Ioannina
• Treatments: Dapagliflozin

Criteria

Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures

2. Female and/or male aged 18-70 years. Women with childbearing potential can only be included in the study if a serological pregnancy test is negative and a safe contraception method is used throughout the study.

3. Uncontrolled type 2 diabetes mellitus (HbA1c > 7%) on metformin monotherapy (≥ 2000 mg qd or maximum tolerated dose)

4. Stage 1 hypertension (BP 140-159/90-99 mmHg)

Exclusion Criteria:

1. Known primary kidney disease (eGFR < 60 ml/min)

2. History of cardiovascular disease

3. Type 1 diabetes

4. History of heart failure

5. Diseases that shorten the life expectancy (cancers, degenerative neurological disorders etc.)

6. Pregnancy-lactation

7. Patients with eGFR values lower than 45 ml/min (on repeated measurements) during the study period will be excluded