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

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Empagliflozin; Drug: Placebo

• Registration Number: NCT02890745
• Lead Sponsor: Henrik Enghusen Poulsen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-31
• Study First Submitted QC: 2016-08-31
• Study First Posted: 2016-09-07
• Study Start: 2016-11
• Primary Completion: 2020-01-22
• Study Completion: 2020-01-22
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-09
• Last Update Posted: 2021-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Empagliflozin	Empagliflozin	One tablet 25 mg empagliflozin every morning for 14 days
Placebo	Placebo	One tablet placebo every morning for 14 days

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Center for Diabetes Research, Gentofte Hospital; 🇩🇰 Hellerup, Denmark