Effectiveness and safety of Combination therapy of Ranibizumab and LuseOgliflozin in type 2 diabetes with diabetic Macular Edema, a parallel group comparison with the standard Treatment controlled by Glimepiride, multicenter, randomized, open-label trial - COMET Trial

Yokote Koutaro0 sites60 target enrollmentMarch 7, 2019

Overview

No summary available.

Registry

who.int

Start Date

March 7, 2019

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Yokote Koutaro

•1\) Patients with type 2 diabetes mellitus who are aged of 20 years or older and younger than 80 years when giving their consent
•2\) patients with diabetic macular edema which affects fovea centralis of macula lutea, and with corrected visual acuity of 0\.05 or higher
•3\) patients with retina thickness of study eye measured by OCT is 350 micrometer or more at the screening test. If the retina thickness of both eyes are 350 micrometer of more, the eye with thicker retina is defined as the study eye.
•4\) patients with HbA1c of 6\.5% or higher and less than 12\.0% at the screening test
•5\) patients with BMI of 18\.5 kg/m2 or higher at the screening test
•6\) patients with eGFR of 30 mL/min/1\.73m2 or higher at the screening test
•7\) patients in whom treatment of diabetes mellitus have not been changed in 8 weeks before the screening test
•8\) patients who provide written consent form to participate in this study after full explanation of the study

•Patients who fall into any of the following criteria are excluded from participating in the study.
•1\)patients with type 1 diabetes mellitus
•2\)patients with history of hypersensitivity against SGLT2 inhibitor or glimepiride
•3\)patients with history of coma or precoma due to the diabetes mellitus or hypoglycemia within the 24 weeks before the screening test
•4\)Patients with severe infections, before or after surgery, or severe trauma which require insulin treatment
•5\)Patients with severe renal dysfunction (eGFR \< 30mL/ min/1\.73m2\), or patients who undergo dialysis (including peritoneal dialysis)
•6\)Female patients who are pregnant, possibly pregnant, or planned to be pregnant or breast feeding
•7\)Patients with urinary tract infection or dehydration, or patients who are prone to urinary tract infection or dehydration
•8\)Patients with positive urinary ketone body (urine qualitative of 2\+ or higher)
•9\)Patients with history of leg amputation due to leg gangrene