Effect of Tofogliflozin on UACR Compared to Metformin Hydrochloride in Diabetic Kidney Disease (TRUTH-DKD)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| Shinshu University | Matsumoto | Nagano | Recruiting |
On this site
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Other trials for the same condition
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