drugset / Trial / NCT02985242

Empagliflozin Reduces Progression of Diabetic Retinopathy in Patients With High Risk of Diabetic Macular Edema

NCT02985242

Phase 4 Terminated 6 enrolled Hannover Medical School
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a prospective, randomized, active control, two-arm parallel, double-blind, monocenter phase IV clinical trial. The trial compares empagliflozin to glimepiride in patients with type 2 diabetes mellitus in addition to standard of care treatment. Patients with type 2 diabetes mellitus who are between 18 and 80 years of age will be recruited for the clinical trial and randomly allocated to either receive empagliflozin or glimepiride. The assumption of the study is that empagliflozin slows down diabetic retinopathy progression rate and thus a lower microaneurysm formation rate compared to subjects treated with glimepiride by substantially decreased cellular glucotoxicity will be achieved.

Timeline

Start
2017-06-12
Primary completion
2018-08-01
Completion
2018-08-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Empagliflozin Small molecule 25 mg Oral
Comparator Glimepiride Small molecule 2 mg Oral