Study Comparing Tofogliflozin and Metformin Effects on Kidney Health in Adults with Type 2 Diabetes

What this Trial Is About

Researchers are evaluating the effects of the drug tofogliflozin on urine albumin-to-creatinine ratio UACR in people with type 2 diabetes who also have chronic kidney disease CKD. This phase 2, multicenter, randomized, open-label study compares tofogliflozin to metformin, a common diabetes medication. The study aims to assess how these treatments affect kidney function and other health markers over time. Participants will be randomly assigned to receive either tofogliflozin or metformin. Tofogliflozin is taken as a 20 mg oral dose once daily, before or after breakfast, for up to 104 weeks. Metformin treatment starts at 500 mg daily, taken in two to three divided doses with meals, with the dose adjusted as needed up to 2,250 mg daily, also for 104 weeks. Randomization considers factors such as UACR level, estimated glomerular filtration rate eGFR, and age. During the study, participants will have regular assessments including UACR, eGFR, blood sugar control HbA1c, body weight, blood pressure, and various blood markers like serum proteins and lipids. These measurements will be taken at multiple time points over 52 to 104 weeks to monitor treatment effects and safety. The primary focus is the change in UACR after 52 weeks, with ongoing monitoring throughout the study period.

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