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

NCT02985242 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2018-09-27

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Hannover Medical School

    lead OTHER

Principal Investigators

  • Amelie Pielen, MD · Hannover Medical School, University Eye Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02985242 on ClinicalTrials.gov