The Effect Effect of Empagliflozin on Oxidative Stress in Patients With Type 2 Diabetes

Sponsor
Henrik Enghusen Poulsen
Study ID
NCT02890745
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to investigate the effect of empagliflozin on oxidative stress in patients with type 2 diabetes. The association is examined by comparing the difference in oxidative modifications before and after 14 days treatment with 25 mg empagliflozin compared to placebo treatment. The study is randomised, double-blinded, and placebo controlled. Each treatment group consists of 17 males with type 2 diabetes. Oxidative modifications are measured by urinary excretion of 8-oxo-7,8-dihydro-2'-deoxyguanosine and 8-oxo-7,8-dihydroguanosine. A student t-test will be performed to compare the drug treatment with placebo. The results will be published in a peer-review journal.

Key Dates

Start date
Nov 30, 2016
Status verified
Jun 2021
Primary completion
Jan 22, 2020
Completion
Jan 22, 2020

Study Design

Enrollment
31 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Empagliflozin
    One tablet 25 mg empagliflozin every morning for 14 days
  • Placebo Comparator: Placebo
    One tablet placebo every morning for 14 days

Primary Outcome Measure

Urinary excretion of 8-oxo-7,8-dihydro-2'-deoxyguanosine (nmol/24h) [ Time Frame: Change from baseline after fourteen days of intervention ]

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