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

• Status: Recruiting
• Trial end date: 2026-10-30
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shinshu University
• Collaborator: Kowa Company, Ltd.
• Treatments: 6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol; Metformin

Criteria

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