diabetic macular edema, diabetes mellitus
Conditions
Interventions
SGLT2 inhibitor (luseogliflozin) treatment group
Control (glimepiride treatment) group
Sponsors
Chiba University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria are included in this study. 1) Patients with type 2 diabetes mellitus who are aged of 20 years or older and younger than 75 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 10.0% 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
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>
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intergroup difference in number of anti-VEGF intravitreal injection to the study eye from baseline to week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| [Efficacy secondary endpoints] (1) Change and percent change of following items from baseline to each observation point (every 4 weeks up to week 48) and intergroup difference of them. 1. Proportion of patients who require additional anti-VEGF intravitreal injections to the study eye after the initial anti-VEGF intravitreal injection 2. Proportion of patients who do not require additional anti-VEGF intravitreal injections to the study eye between 4 weeks after the initial anti-VEGF intravitreal injection to each observation point (every 4 weeks up to week 48) 3. Number of retinal microaneurysm photocoagulation (MAPC) to retinal arteriolar macroaneurysm of the study eye from baseline to week 48 4. Central retina thickness of the study eye at each observation point measured by optical coherence tomography (OCT) 5. Corrected visual acuity of the study eye at each observation point converted to logarithm of minimam angle of resolution (logMAR) 6. Presence or absence of hemorrhage at macular area or hard exudate in the study eye at each observation point measured by opthalmoscopy 7. Presence or absence of active leakage from blood vessels surrounding the macula area of the study eye measured by fluorescein angiography 8. Morphology of acular edema and visual acuity, central retina thickness, number of injections of the study eye at each observation point 9. Body weight, body mass index (BMI), blood pressure, pulse, HbA1c, plasma glucose, eGFR and Hct <Due to the word limit in the UMIN-CTR, other secondary and exploratory endpoints are described in the attached protocol> | — |
Countries
Japan
Contacts
Public ContactHiroki Takayama
Soiken Inc. Clinical Study Support Division
Outcome results
None listed