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

PHASE2RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

September 22, 2021

Primary Completion Date

October 30, 2025

Study Completion Date

October 30, 2026

Conditions
T2DM (Type 2 Diabetes Mellitus)MetforminSGLT2-Inhibitors
Interventions
DRUG

Tofogliflozin

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

DRUG

Metformin

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.

Trial Locations (1)

390-8621

RECRUITING

Shinshu University, Matsumoto

All Listed Sponsors
collaborator

Kowa Company, Ltd.

INDUSTRY

lead

Shinshu University

OTHER