A Phase 2 interventional study of Empagliflozin and Placebo in Diabetes Mellitus, Type 2, sponsored by Henrik Enghusen Poulsen. Completed at 1 site in Denmark. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-06-10.
Sponsored by Henrik Enghusen Poulsen · Phase 2, Interventional, and Treatment
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 31 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Henrik Enghusen Poulsen is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
One tablet 25 mg empagliflozin every morning for 14 days
Drug: Empagliflozin
One tablet placebo every morning for 14 days
Drug: Placebo
Urinary excretion of 8-oxo-7,8-dihydro-2'-deoxyguanosine (nmol/24h)
Time frame: Change from baseline after fourteen days of intervention
Urinary excretion of 8-oxo-7,8-dihydroguanosine (nmol/24h)
Time frame: Change from baseline after fourteen days of intervention
Plasma levels of malondialdehyde
Time frame: Change from baseline after fourteen days of intervention
Plasma levels of iron, ferritin, transferrin and transferrin saturation
Time frame: Measured at baseline and after intervention
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Henrik Enghusen Poulsen