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

Phase 1

Active, not recruiting

• Conditions: Type 2 diabetes; MedDRA version: 20.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2016-000370-38-DK
• Lead Sponsor: Rigshospitalet, Klinisk Farmakologisk Afd. Q7642

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-10
• Study Completion: 2020-01-22
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Male
• Target Recruitment: 35

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable