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NCT Number: NCT02890745

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Center for Diabetes Research, Gentofte Hospital

Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Empagliflozin

Drug

Placebo

Drug

Primary outcomes

  1. Urinary excretion of 8-oxo-7,8-dihydro-2'-deoxyguanosine (nmol/24h)

    Time frame: Change from baseline after fourteen days of intervention

  2. Urinary excretion of 8-oxo-7,8-dihydroguanosine (nmol/24h)

    Time frame: Change from baseline after fourteen days of intervention

Secondary outcomes

  1. Plasma levels of malondialdehyde

    Time frame: Change from baseline after fourteen days of intervention

  2. Plasma levels of iron, ferritin, transferrin and transferrin saturation

    Time frame: Measured at baseline and after intervention

Sponsors and collaborators

Lead sponsor

Henrik Enghusen Poulsen

Other

Collaborators

  • University Hospital, Gentofte, Copenhagen
  • University of Copenhagen

Registry information

Official study title

EMPOX - A Randomised, Double-blinded, Placebo Controlled Study That Evaluates the Effect of Empagliflozin on Oxidative Stress in Patients With Type 2 Diabetes

Acronym: EMPOX

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Sep 7, 2016
Registry last updated
Jun 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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