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

Plain Language Summary

Simplified for easier understanding

This study is comparing the diabetes drug tofogliflozin (an SGLT2 inhibitor) versus metformin to see which better reduces protein in the urine — a sign of kidney damage — in people with type 2 diabetes. **You may be eligible if...** - You have been diagnosed with type 2 diabetes - You have protein in your urine (a condition called albuminuria), which is a sign of early kidney damage - You are not currently well-controlled on your current diabetes medication alone **You may NOT be eligible if...** - You have severe kidney disease (significantly reduced kidney function) - You have a history of recurrent urinary tract infections or certain genital infections - You have type 1 diabetes - You are pregnant or breastfeeding - You have serious heart or liver disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

Locations(1)

Shinshu University

Matsumoto, Nagano, Japan

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