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Empagliflozin Reduces Progression of Diabetic Retinopathy in Patients With High Risk of Diabetic Macular Edema
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.
Details
| Lead sponsor | Hannover Medical School |
|---|---|
| Phase | PHASE4 |
| Status | TERMINATED |
| Enrolment | 6 |
| Start date | Mon Jun 12 2017 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Thu Aug 16 2018 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Diabetes Mellitus, Type II
Interventions
- Empagliflozin
- Glimepiride
- Empagliflozin placebo
- Glimepiride placebo
Countries
Germany