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

Sponsor

Henrik Enghusen Poulsen (Other)

Overall Status

Completed

CT.gov ID

NCT02890745

Collaborator

University Hospital, Gentofte, Copenhagen (Other), University of Copenhagen (Other)

Enrollment

Location

Arms

38.7

Actual Duration (Months)

0.8

Patients Per Site Per Month

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
Diabetes Mellitus, Type 2	Drug: Empagliflozin Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 1, 2016

Actual Primary Completion Date :

Jan 22, 2020

Actual Study Completion Date :

Jan 22, 2020

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

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

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Male

Accepts 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