RecruitingPhase 2NCT05469659

Effect of Tofogliflozin on UACR Compared to Metformin Hydrochloride in Diabetic Kidney Disease (TRUTH-DKD)

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

Sponsor

Shinshu University

Enrollment

120 participants

Start Date

Sep 22, 2021

Study Type

INTERVENTIONAL

Conditions

Metformin T2DM (Type 2 Diabetes Mellitus)SGLT2-Inhibitors

Summary

This multicenter, randomized, open-label, controlled study will assess the efficacy of the SGLT2 inhibitor tofogliflozin on Urine Albumin-to-Creatinine Ratio (UACR) compared to metformin in patients with type 2 diabetes with chronic kidney disease (CKD).

Eligibility

Min Age: 20 Years

Inclusion Criteria8

Type 2 diabetic patients
Patients aged 20 years or older at the time of obtaining consent
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)
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.
Patients who have been receiving RAS inhibitors (ARB, ARNI, ACE inhibitors, direct renin inhibitors) for 4 weeks or longer
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)
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)
Patients for whom written consent was obtained based on the patient's free will after receiving sufficient explanation for participation in this study

Exclusion Criteria8

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

Interventions

DRUGTofogliflozin

Tofogliflozin 20 mg is orally administered once daily for 104 weeks before or after breakfast.

DRUGMetformin

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 post-start period. The dose may be adjusted according to the patient's condition, but the maximum daily dose should be 2,250 mg.