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

Sponsor
Hannover Medical School
Study ID
NCT02985242
Phase
PHASE4
Status
Terminated

Conditions

  • Diabetes Mellitus, Type II

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin — DRUG
    Empagliflozin film-coated tablet
  • Glimepiride — DRUG
    Glimepiride tablet
  • Empagliflozin placebo — DRUG
    Placebo tablet manufactured to mimic Empagliflozin 25 mg film-coated tablet
  • Glimepiride placebo — DRUG
    Placebo tablet manufactured to mimic Glimepiride 2 mg tablet

Study Details

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.

Key Dates

Start date
Jun 12, 2017
Status verified
Sep 2018
Primary completion
Aug 1, 2018
Completion
Aug 16, 2018

Study Design

Enrollment
6 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Empagliflozin/glimepiride placebo
    Empagliflozin 25 mg film-coated tablet p.o. daily and glimepiride matching placebo p.o. daily Duration of treatment: 12 months
  • Active Comparator: Glimepiride/empagliflozin placebo
    Glimepiride 2 mg tablet p.o. daily and empagliflozin matching placebo p.o. daily Duration of treatment: 12 months

Primary Outcome Measure

Microaneurysm formation rate over 12 months, i.e. number of newly developed microaneurysms within 12 months [ Time Frame: Weeks 27 and 52 ]