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

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

Inclusion Criteria:

* 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 Criteria:

* 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

Conditions4

Browse More Trials