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

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).

Timeline

Start

2021-09-22

Primary completion

2025-10-30

Completion

2026-10-30

Publications

• Kimura K, Takagi Y, Harada M, Ueda S, Minamisawa M, Sonoda K, Oiwa A, Yazaki Y, Sakurai S, Tomita T, Kaneko K, Yamamoto K, Takama N, Momose S, Inobe Y, Nogi K, Koshikawa M, Misawa T, Kasai T, Tsutsui H, Watanabe N, Yamazaki K, Miyamoto T, Midorikawa T, Usui T, Saigusa T, Motoki H, Saito Y, Kamijo Y, Komatsu M, Kuwahara K. Effect of Tofogliflozin on Urinary Albumin-to-Creatinine Ratio vs. Metformin in Diabetic Kidney Disease: Rationale and Study Protocol of the TRUTH-DKD Trial. Diabetes Ther. 2026 Jan;17(1):149-163. doi: 10.1007/s13300-025-01822-8. Epub 2025 Nov 18.
• El-Damanawi R, Stanley IK, Staatz C, Pascoe EM, Craig JC, Johnson DW, Mallett AJ, Hawley CM, Milanzi E, Hiemstra TF, Viecelli AK. Metformin for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2024 Jun 4;6(6):CD013414. doi: 10.1002/14651858.CD013414.pub2.

Drugs

Indications