Effect of Tofogliflozin on UACR Compared to Metformin Hydrochloride in Diabetic Kidney Disease (TRUTH-DKD)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20+
SponsorShinshu University
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Tofogliflozin
- Metformin
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Shinshu University
Lead sponsor
Kowa Company, Ltd.
Collaborator
Source ClinicalTrials.gov