COMET Trial

Not Applicable

• Conditions: diabetic macular edema, diabetes mellitus; 043, 025

• Registration Number: JPRN-jRCTs031180210
• Lead Sponsor: Yokote Koutaro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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
10)Patients with history of bone fracture due to osteoporosis
11) Patients who were treated by thiazolidine, SGLT2 inhibitors, sulfonylurea or glinide within 8 weeks before the screening test
12)Patients who were treated by fibrate or diuretic agents and who changed the usage or dose of them within 8 weeks before the screening test
13)Patients who had systemic administration of steroid within 8 weeks before the screening test
14)Patients with history of cerebrovascular impairment or myocardial infarction within 48 weeks before the screening test
15)Patients with poorly controlled hypertension (clinic blood pressure measured in sitting position is 180 mmHg of higher in systolic blood pressure or 100 mmHg or higher in diastolic blood pressure)

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
21)Patients with iris neovessel, vitreous hemorrhage, or traction retinal detachment in the study eye
22)Patients with epi-retinal membrane in the study eye, which affect macular area
23)Patients with morphological impairment at the central area of macula lutea in the study eye, which can affect the improvement of visual acuity after the disappearance of macular edema, such as atrophy of retinal pigment epithelium, fibrogenesis or scarring under the retina, severe retina ischemia or structural hard exudate
24)Patients with history of cataract surgery or other intraocular surgeries to the study eye within 12 weeks before the screening test
25)Patients with history of laser panretinal or macular photocoagulation to the study eye within 12 weeks before the screening test
26)Patients with history of YAG laser posterior capsulotomy to the study eye within 4 weeks before the screening test
27)Patients who received steroid to the study eye or the surrounding of the study eye within 16 weeks before the screening test
28)Patients who received angiogenic inhibitor (pegaptanib, bevacizumab, ranibizumab, aflibercept and others) to any eyes within 12 weeks before the screening test
2

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intergroup difference in number of anti-VEGF intravitreal injection to the study eye from baseline to week 48