Effect of Tofogliflozin on UACR Compared to Metformin Hydrochloride in Diabetic Kidney Disease (TRUTH-DKD)
Recruiting · NCT05469659 · Interventional (participants receive a specific treatment) · Lead sponsor: Shinshu University
View the official record on ClinicalTrials.gov →Interventions studied
MetforminTofogliflozin
What this trial is about
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).
Who can take part
Age range
20 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Shinshu University - Matsumoto, Nagano, Japan