A trial that evaluates the effect of empagliflozin on oxidative stress in patients with type 2 diabetes

A randomized, double-blinded, placebo-controlled trial that evaluates the effect of empagliflozin on oxidative stress in patients with type 2 diabetes - EMPOX

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000370-38-DK

Enrollment

Registered

2016-02-10

Start date

2016-05-04

Completion date

Unknown

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes MedDRA version: 20.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861

Interventions

Trade Name: jardiance Pharmaceutical Form: Capsule INN or Proposed INN: Empagliflozin CAS Number: 864070-44-0 Other descriptive name: EMPAGLIFLOZIN Concentration unit: mg milligram(s) Concentration ty

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Male individuals with type 2 diabetes - Age = 18 years and = 75 years - HbA1c > 6.5 % - Capable of understanding oral- and written information Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 14 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: - eGFR < 60 ml/hour/1.73 m2 - Currently in insulin treatment - Coronary artery bypass grafting, percutan coronary intervention, acute coronary syndrome, apoplexy, lung embolism, deep vein thrombosis or transitory cerebral ischemia < 6 months. - Genital infection < 14 days - p-alanin-aminotransferase =3 x upper limit - Psychiatric disorder - Intolerance to empagliflozin or other agents relevant to study - Non-compliance

Design outcomes

Primary

Measure	Time frame
Main Objective: To measure the concentration of 8-oxo-Guanosine and 8-oxo-deoxyGuanosine in 24-hour urine sample before and after treatment with empagliflozin compared to placebo;Secondary Objective: Not applicable;Primary end point(s): The primary outcomes, urinary excretion of 8-oxo-Guanosine and 8-oxo-deoxyGuanosine in 24-hour urine samples are compared to placebo with Mann-Whitney U test.;Timepoint(s) of evaluation of this end point: The trial continues until the last patient last visit - expected 31. August 2016. Analysis of the sample and data evaluation are done afterwards - expected finished 1. December 2016.	—

Measure

Time frame

Main Objective: To measure the concentration of 8-oxo-Guanosine and 8-oxo-deoxyGuanosine in 24-hour urine sample before and after treatment with empagliflozin compared to placebo;Secondary Objective: Not applicable;Primary end point(s): The primary outcomes, urinary excretion of 8-oxo-Guanosine and 8-oxo-deoxyGuanosine in 24-hour urine samples are compared to placebo with Mann-Whitney U test.;Timepoint(s) of evaluation of this end point: The trial continues until the last patient last visit - expected 31. August 2016. Analysis of the sample and data evaluation are done afterwards - expected finished 1. December 2016.

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Denmark

Contacts

Public ContactEmil List Larsen

Rigshospitalet, Klinisk Farmakologisk Afd, Q7642

emil.list.larsen.01@regionh.dk+4535457695

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026