NCT05469659

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Shinshu University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Eligible participants will be randomly assigned (1:1) to tofogliflozin or metformin with stratification based on UACR (\<300 mg/gCr，≧300mg/gCr), an estimated glomerular filtration rate (eGFR) (\<60mL/min/1.73m2, ≧60 mL/min/1.73m2), and age (\<65 years old, ≧65 years old). The primary end point is change in urine albumin-to-creatinine ratio (UACR) from baseline after 52 weeks treatment. Changes in eGFR, HbA1c, body weight, systolic blood pressure, diastolic blood pressure, total serum proteins, serum albumin, uric acid, hematocrit, hemoglobin, red blood cell count, pulse rate, triglyceride, low-density lipoprotein, high-density lipoprotein and albuminuria class transition rate will also be evaluated.

Conditions

• T2DM (Type 2 Diabetes Mellitus)
• Metformin
• SGLT2-Inhibitors

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-09-22
• Primary completion: 2025-10-30
• Completion: 2026-10-30
• First posted: 2022-07-22
• Last updated: 2022-07-22

Locations

1 site across 1 country: Japan