Clinical trial NCT05469659: Effect of Tofogliflozin on UACR Compared to Metformin Hydrochloride in Diabetic Kidney Disease (TRUTH-DKD)
Official title: Effect of Tofogliflozin on Urine Albumin-to-Creatinine Ratio Compared to Metformin Hydrochloride in Diabetic Kidney Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: T2DM (Type 2 Diabetes Mellitus)
Metformin
SGLT2-Inhibitors
Lead sponsor: Shinshu University
Sponsor class: OTHER
Collaborators: name: Kowa Company, Ltd.
First posted: 2022-07-22
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: Eligible participants will be randomly assigned (1:1) to tofogliflozin or metformin with stratification based on UACR (\<300 mg/gCr，≧300mg/gCr), an estimated glomerular filtration rate (eGFR) (\<60mL/min/1.73m2, ≧60 mL/min/1.73m2), and age (\<65 years old, ≧65 years old). The primary end point is change in urine albumin-to-creatinine ratio (UACR) from baseline after 52 weeks treatment. Changes in eGFR, HbA1c, body weight, systolic blood pressure, diastolic blood pressure, total serum proteins, serum albumin, uric acid, hematocrit, hemoglobin, red blood cell count, pulse rate, triglyceride, low-density lipoprotein, high-density lipoprotein and albuminuria class transition rate will also be evaluated.

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

Primary outcomes:
measure: Urine albumin-to-creatinine ratio (UACR)
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Urine albumin-to-creatinine ratio (UACR)
timeFrame: Up to 26 and 104 weeks
measure: Urine albumin-to-creatinine ratio (UACR)
timeFrame: Up to 26, 52 and 104 weeks
measure: Change slope in eGFR
timeFrame: Up to 52 and 104 weeks
measure: HbA1c
timeFrame: Up to 52 and 104 weeks
measure: Body weight
timeFrame: Up to 52 and 104 weeks
measure: Systolic / diastolic blood pressure
timeFrame: Up to 52 and 104 weeks
measure: Total serum proteins
timeFrame: Up to 52 and 104 weeks
measure: Serum albumin
timeFrame: Up to 52 and 104 weeks
measure: Uric acid
timeFrame: Up to 52 and 104 weeks
measure: Hematocrit
timeFrame: Up to 52 and 104 weeks
measure: Hemoglobin
timeFrame: Up to 52 and 104 weeks
measure: Red blood cell count
timeFrame: Up to 52 and 104 weeks
measure: Pulse rate
timeFrame: Up to 52 and 104 weeks
measure: Triglyceride
timeFrame: Up to 52 and 104 weeks
measure: Low-density lipoprotein
timeFrame: Up to 52 and 104 weeks
measure: High-density lipoprotein
timeFrame: Up to 52 and 104 weeks
measure: Albuminuria class
timeFrame: Up to 104 weeks
Other outcomes:
Locations:
city: Matsumoto
country: Japan
facility: Shinshu University
state: Nagano
Study officials:
affiliation: Shinshu University School of Medicine
name: Koichiro Kuwahara, MD, PhD
role: STUDY_CHAIR
References: