EMPOX: The Effect Effect of Empagliflozin on Oxidative Stress in Patients With Type 2 Diabetes
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Empagliflozin One tablet 25 mg empagliflozin every morning for 14 days |
Drug: Empagliflozin
|
Placebo Comparator: Placebo One tablet placebo every morning for 14 days |
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
- Urinary excretion of 8-oxo-7,8-dihydro-2'-deoxyguanosine (nmol/24h) [Change from baseline after fourteen days of intervention]
- Urinary excretion of 8-oxo-7,8-dihydroguanosine (nmol/24h) [Change from baseline after fourteen days of intervention]
Secondary Outcome Measures
- Plasma levels of malondialdehyde [Change from baseline after fourteen days of intervention]
- Plasma levels of iron, ferritin, transferrin and transferrin saturation [Measured at baseline and after intervention]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosed with type 2 diabetes
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HbA1c: 6.5-9.0%
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Capable of understanding oral- and written information
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Caucasian
Exclusion Criteria:
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Estimated glomerular filtration rate (eGFR) < 60 mL/hour/1.73 m2
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Currently receiving insulin treatment
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Coronary artery bypass grafting, percutaneous coronary intervention, acute coronary syndrome, stroke, lung embolism, deep vein thrombosis, or transitory cerebral ischemia within 6 months
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Genital infection within 14 days
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Plasma alanine aminotransferase ≥3 times upper normal limit
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Treatment with sodium glucose cotransporter (SGLT) -2 inhibitor within 2 months
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Hyperglycaemic symptoms
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Psychiatric disorder
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Intolerance to empagliflozin or other agents relevant to study
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Non-compliant
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Center for Diabetes Research, Gentofte Hospital | Hellerup | Denmark | 2900 |
Sponsors and Collaborators
- Henrik Enghusen Poulsen
- University Hospital, Gentofte, Copenhagen
- University of Copenhagen
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2016-100