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RECRUITING
NCT05469659
PHASE2

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

Sponsor: Shinshu University

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2021-09-22

Completion Date

2026-10-30

Last Updated

2022-07-22

Healthy Volunteers

No

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.

Locations (1)

Shinshu University

Matsumoto, Nagano, Japan