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Recruiting Phase 2

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

NCT05469659 · tracked via the Priya Life Science Japan tracker
Phase
Phase 2
Started
2021-09-22
Last updated
2022-07-22

Condition(s) studied

T2DM (Type 2 Diabetes Mellitus)MetforminSGLT2-Inhibitors

Investigational drug(s) / intervention(s)

TofogliflozinMetformin →

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

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.

Study 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

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Urine albumin-to-creatinine ratio (UACR) — Up to 52 weeks
    Change from baseline in urine albumin-to-creatinine ratio (UACR) after 52 weeks treatment.

Trial sites (1)

FacilityCityRegionStatus
Shinshu University Matsumoto Nagano Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05469659 on ClinicalTrials.gov ↗ ← All trials in Japan