The Effect Effect of Empagliflozin on Oxidative Stress in Patients With Type 2 Diabetes
NCT ID: NCT02890745
Last Updated: 2021-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
31 participants
INTERVENTIONAL
2016-11-30
2020-01-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Empagliflozin
One tablet 25 mg empagliflozin every morning for 14 days
Empagliflozin
Placebo
One tablet placebo every morning for 14 days
Placebo
Interventions
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Empagliflozin
Placebo
Eligibility Criteria
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Inclusion Criteria
* HbA1c: 6.5-9.0%
* Capable of understanding oral- and written information
* Caucasian
Exclusion Criteria
* Currently receiving insulin treatment
* Coronary artery bypass grafting, percutaneous coronary intervention, acute coronary syndrome, stroke, lung embolism, deep vein thrombosis, or transitory cerebral ischemia within 6 months
* Genital infection within 14 days
* Plasma alanine aminotransferase ≥3 times upper normal limit
* Treatment with sodium glucose cotransporter (SGLT) -2 inhibitor within 2 months
* Hyperglycaemic symptoms
* Psychiatric disorder
* Intolerance to empagliflozin or other agents relevant to study
* Non-compliant
18 Years
75 Years
MALE
No
Sponsors
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University Hospital, Gentofte, Copenhagen
OTHER
University of Copenhagen
OTHER
Henrik Enghusen Poulsen
OTHER
Responsible Party
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Henrik Enghusen Poulsen
Professor, DMSc, chief physician
Locations
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Center for Diabetes Research, Gentofte Hospital
Hellerup, , Denmark
Countries
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References
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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.
Other Identifiers
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2016-100
Identifier Type: -
Identifier Source: org_study_id
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