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

June 9, 2021 updated by: Henrik Enghusen Poulsen

EMPOX - A Randomised, Double-blinded, Placebo Controlled Study That Evaluates the 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hellerup, Denmark, 2900
        • Center for Diabetes Research, Gentofte Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Urinary excretion of 8-oxo-7,8-dihydro-2'-deoxyguanosine (nmol/24h)
Time Frame: Change from baseline after fourteen days of intervention
Change from baseline after fourteen days of intervention
Urinary excretion of 8-oxo-7,8-dihydroguanosine (nmol/24h)
Time Frame: Change from baseline after fourteen days of intervention
Change from baseline after fourteen days of intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma levels of malondialdehyde
Time Frame: Change from baseline after fourteen days of intervention
Change from baseline after fourteen days of intervention
Plasma levels of iron, ferritin, transferrin and transferrin saturation
Time Frame: Measured at baseline and after intervention
Measured at baseline and after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henrik Enghusen Poulsen

Collaborators

University of Copenhagen
University Hospital, Gentofte, Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2016

Primary Completion (ACTUAL)

January 22, 2020

Study Completion (ACTUAL)

January 22, 2020

Study Registration Dates

First Submitted

August 31, 2016

First Submitted That Met QC Criteria

August 31, 2016

First Posted (ESTIMATE)

September 7, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 10, 2021

Last Update Submitted That Met QC Criteria

June 9, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe