Clinical trial NCT02890745: The Effect Effect of Empagliflozin on Oxidative Stress in Patients With Type 2 Diabetes
Official title: EMPOX - A Randomised, Double-blinded, Placebo Controlled Study That Evaluates the Effect of Empagliflozin on Oxidative Stress in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: Empagliflozin
Oxidative stress
Oxidative nucleic acid modifications
8-oxo-7,8-dihydro-2'-deoxyguanosine
8-oxo-7,8-dihydroguanosine
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: University Hospital, Gentofte, Copenhagen
name: University of Copenhagen
First posted: 2016-09-07
Enrollment: 31
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Urinary excretion of 8-oxo-7,8-dihydro-2'-deoxyguanosine (nmol/24h)
timeFrame: Change from baseline after fourteen days of intervention
measure: Urinary excretion of 8-oxo-7,8-dihydroguanosine (nmol/24h)
timeFrame: Change from baseline after fourteen days of intervention
Secondary outcomes:
measure: Plasma levels of malondialdehyde
timeFrame: Change from baseline after fourteen days of intervention
measure: Plasma levels of iron, ferritin, transferrin and transferrin saturation
timeFrame: Measured at baseline and after intervention
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Center for Diabetes Research, Gentofte Hospital
Study officials:
References:
citation: 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.