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

• Status: Completed
• Trial end date: 2020-01-22
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henrik Enghusen Poulsen
• Collaborators: University Hospital, Gentofte, Copenhagen; University of Copenhagen
• Treatments: Empagliflozin

Criteria

Inclusion Criteria:

• Diagnosed with type 2 diabetes

• HbA1c: 6.5-9.0%

• Capable of understanding oral- and written information

• Caucasian

Exclusion Criteria:

• Estimated glomerular filtration rate (eGFR) < 60 mL/hour/1.73 m2

• 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