Effect of Tofogliflozin on Urine Albumin-to-Creatinine Ratio Compared to Metformin Hydrochloride in Diabetic Kidney Disease

JRCT ID: jRCTs031210339

Registered date:22/09/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type 2 Diabetes Mellitus, Chronic Kidney Disease
• Date of first enrollment: 05/11/2021
• Target sample size: 120
• Study type: Interventional

Intervention(s)

Arm A. Tofogliflozin is orally administered once daily for 104 weeks before or after breakfast.
Arm B. Metformin is started at 500 mg daily and orally administered in 2 to 3 divided doses immediately before or after meals.
The dose during the maintenance period is determined by observing the effect, but is usually 750 to 1,500 mg daily. Metformin is orally administered for 104 weeks throughout the post-start period. The dose may be adjusted according to the patient's condition, but the maximum daily dose should be 2,250 mg.
However, the maximum is 750 mg for eGFR 30 or more and less than 45 (mL/ min/1.73 m2), and the maximum is 1500 mg for eGFR 45 or more and less than 60 (mL/ min/1.73 m2). If eGFR is less than 30 (mL/ min/1.73m2) during the course of both groups, in principle, administration should be discontinued, but if it is associated with reversible factors (dehydration, etc.), continuation of administration should be considered at the discretion of the doctor. If eGFR <30 mL / min / 1.73 m2 is confirmed in two consecutive tests, administration should be uniformly discontinued.

Outcome(s)

• Primary Outcome: Amount of changes in urine albumin-to-creatinine ratio

Secondary Outcome

Rate of changes in urine albumin-to-creatinine ratio
Amount of changes in eGFR, HbA1c, body weight, systolic blood pressure, diastolic blood pressure, total serum proteins, serum albumin, Uric acid, Hematocrit, Hemoglobin, Red blood cell count, Pulse rate, Triglyceride, Low-density lipoprotein and high-density lipoprotein.
Albuminuria class transition rate.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who meet all of the following selection criteria are included.
1. Type 2 diabetic patients
2. Patients aged 20 years or older at the time of obtaining consent
3. Patients with HbA1c 6.5 or more and 9.0% or less within 13 weeks before obtaining consent (evaluated by test values after 4 weeks or more without taking SGLT2 inhibitor/metformin)
4. Patients who have been judged by their doctor to need a diabetic drug when they are first seen, or who have already taken a diabetic drug and have decided that it is necessary to add one diabetic drug.
5. Patients who have been receiving RAS inhibitors (ARB, ARNI, ACE inhibitors, direct renin inhibitors) for 4 weeks or longer
6.Patients with eGFR of 30 or more (mL/ min/1.73m2) within 13 weeks before obtaining consent (evaluated by test values after 4 weeks or more without taking SGLT2 inhibitor/metformin)
7. Patients with urinary albumin/creatinine ratio (UACR) of 30 or more and less than 2000 (mg /gCr) (4 weeks or more without taking SGLT2 inhibitor/metformin) within 13 weeks before obtaining consent Evaluate by inspection value)
8. Patients for whom written consent was obtained based on the patient's free will after receiving sufficient explanation for participation in this study

Exclude criteria

1. Patients receiving treatment with SGLT2 inhibitor or metformin within 13 weeks before obtaining consent
2. Dialysis patient
3. Patients with a history of severe hypoglycemia
4. Patients with hypersensitivity to SGLT2 inhibitor or metformin
5. Pregnant women, lactating patients, and patients who wish to raise children
6. Patients with BMI of 35 kg / m2 or more based on the latest measured values within 13 weeks before obtaining consent
7. Patients who are contraindicated for the study drug
8. Other patients who the attending physician deems inappropriate as a subject

Related Information

• Primary Sponsor: Kuwahara Koichiro
• Source(s) of Monetary Support: Kowa Company, Ltd.