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) - 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)

Chiba University0 sites60 target enrollmentAugust 30, 2018

Overview

Phase: 未知
Intervention: Not specified
Conditions: Not specified
Sponsor: Chiba University
Enrollment: 60
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 30, 2018

End Date

July 31, 2024

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Chiba University

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•Patients who fall into any of the following criteria are excluded from participating in the study. \<internal medicine\> 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 in 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 10\) Patients with history of bone fracture due to osteoporosis and others \<ophthalmology\> 16\) patients with history of retina vitreal surgery or scleral buckling 17\) Patients with history of filtration surgery to the study eye for glaucoma treatment, or patients who are expected to require the filtration surgery in future 18\) Patients with active proliferative diabetic retinopathy in the study eye 19\) Patients with history of idiopathic or autoimmune uveitis in the study eye 20\) Patients with vitreomacular traction syndrome or epi\-retinal membrane in the study eye measured by slit lamp microscope or OCT, which affect the central visual acuity and others \<common\> 35\) Patients with other conditions that the investigator/researcher thinks inappropriate for the study \<Due to the word limit in the UMIN\-CTR, other exclusion criteria are described in the attached protocol\>