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

Henrik Enghusen Poulsen

Status and phase

Completed

Phase 2

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Placebo

Drug: Empagliflozin

Study type

Interventional

Funder types

Other

Identifiers

NCT02890745

2016-100

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

Male

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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