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

Launched by SHINSHU UNIVERSITY · Jul 21, 2022

Keywords

ClinConnect Summary

The TRUTH-DKD clinical trial is studying a medication called tofogliflozin to see how well it works in reducing the levels of protein in urine, a sign of kidney function, in people with type 2 diabetes and chronic kidney disease. This study is comparing tofogliflozin to metformin, another common diabetes medication. The goal is to find out if tofogliflozin can help improve kidney health in patients who are dealing with both diabetes and kidney issues.

To participate in this trial, you need to be at least 20 years old, have type 2 diabetes, and have certain levels of blood sugar and kidney function. Specifically, you should have a urine test showing a moderate level of protein and have been using certain heart medicines for at least four weeks. Participants will receive either tofogliflozin or metformin and will be monitored for changes in their kidney health over time. This study is currently recruiting participants and aims to help improve treatment options for people facing these health challenges.

Gender

ALL

Eligibility criteria

• 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