drugset / Trial / NCT02890745
The Effect Effect of Empagliflozin on Oxidative Stress in Patients With Type 2 Diabetes
Phase 2
Completed
31 enrolled
Henrik Enghusen Poulsen
University Hospital, Gentofte, Copenhagen · collabUniversity of Copenhagen · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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.
Timeline
- Start
- 2016-11
- Primary completion
- 2020-01-22
- Completion
- 2020-01-22
Publications
- Larsen EL, Andersen A, Kjaer LK, Eickhoff MK, Frimodt-Moller M, Persson F, Rossing P, Lykkesfeldt J, Knop FK, Vilsboll T, Rungby J, Poulsen HE. Effects of two- and twelve-weeks sodium-glucose cotransporter 2 inhibition on DNA and RNA oxidation: two randomized, placebo-controlled trials. Free Radic Res. 2023 Feb;57(2):140-151. doi: 10.1080/10715762.2023.2213820. Epub 2023 May 19.
- Larsen EL, Cejvanovic V, Kjaer LK, Vilsboll T, Knop FK, Rungby J, Poulsen HE. The effect of empagliflozin on oxidative nucleic acid modifications in patients with type 2 diabetes: protocol for a randomised, double-blinded, placebo-controlled trial. BMJ Open. 2017 May 9;7(5):e014728. doi: 10.1136/bmjopen-2016-014728.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Empagliflozin | Small molecule | 25 mg | Oral |