NCT02985242

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

SGLT2-inhibition With Empagliflozin Reduces Progression of Diabetic Retinopathy in Patients With High Risk of Diabetic Macular Edema (The SUPER-Trial)

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Hannover Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type II

Interventions

Type	Name	Description
DRUG	Empagliflozin	Empagliflozin film-coated tablet
DRUG	Glimepiride	Glimepiride tablet
DRUG	Empagliflozin placebo	Placebo tablet manufactured to mimic Empagliflozin 25 mg film-coated tablet
DRUG	Glimepiride placebo	Placebo tablet manufactured to mimic Glimepiride 2 mg tablet

Timeline

• Start date: 2017-06-12
• Primary completion: 2018-08-01
• Completion: 2018-08-16
• First posted: 2016-12-07
• Last updated: 2018-09-27

Locations

1 site across 1 country: Germany