Evaluation of the Tubular Effects of Dapagliflozin Using 1HNMR Spectroscopy

Sponsor
University of Ioannina
Study ID
NCT02798757
Phase
PHASE4
Status
Completed

Conditions

  • Diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Urine samples will be collected for 1HNMR spectroscopies

Study Details

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.

Key Dates

Start date
Jun 30, 2016
Status verified
Oct 2017
Primary completion
Aug 31, 2018
Completion
Aug 31, 2018

Study Design

Enrollment
50 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin
    All patients will take dapagliflozin, the intervention does not refer to a drug or device but to the specific 1HNMR test spectroscopy

Primary Outcome Measure

Composite outcome measure. % change to the concentrations of specific metabolites. [ Time Frame: 6 months ]

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