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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Tofogliflozin 20 mg is orally administered once daily for 104 weeks before or after breakfast.
Metformin is started at 500 mg daily and orally administered in 2 to 3 divided doses immediately before or after meals. The dose during the maintenance period is determined by observing the effect, but is usually 750 to 1,500 mg daily. Metformin is orally administered for 104 weeks throughout post-start period. The dose may be adjusted according to the patient's condition, but the maximum daily dose should be 2,250 mg.
Shinshu University
Matsumoto, Nagano, Japan
RECRUITINGUrine albumin-to-creatinine ratio (UACR)
Change from baseline in urine albumin-to-creatinine ratio (UACR) after 52 weeks treatment.
Time frame: Up to 52 weeks
Urine albumin-to-creatinine ratio (UACR)
Change from baseline in urine albumin-to-creatinine ratio (UACR) after 26 and 104 weeks treatment.
Time frame: Up to 26 and 104 weeks
Urine albumin-to-creatinine ratio (UACR)
Change rates from baseline in urine albumin-to-creatinine ratio (UACR) after 26, 52 and 104weeks treatment.
Time frame: Up to 26, 52 and 104 weeks
Change slope in eGFR
Change slope in eGFR
Time frame: Up to 52 and 104 weeks
HbA1c
Change in HbA1c
Time frame: Up to 52 and 104 weeks
Body weight
Changes in body weight
Time frame: Up to 52 and 104 weeks
Systolic / diastolic blood pressure
Changes in systolic / diastolic blood pressure
Time frame: Up to 52 and 104 weeks
Total serum proteins
Changes in total serum proteins
Time frame: Up to 52 and 104 weeks
Serum albumin
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Changes in serum albumin
Time frame: Up to 52 and 104 weeks
Uric acid
Changes in uric acid
Time frame: Up to 52 and 104 weeks
Hematocrit
Changes in hematocrit
Time frame: Up to 52 and 104 weeks
Hemoglobin
Changes in hemoglobin
Time frame: Up to 52 and 104 weeks
Red blood cell count
Changes in red blood cell count
Time frame: Up to 52 and 104 weeks
Pulse rate
Changes in pulse rate
Time frame: Up to 52 and 104 weeks
Triglyceride
Changes in triglyceride
Time frame: Up to 52 and 104 weeks
Low-density lipoprotein
Changes in low-density lipoprotein
Time frame: Up to 52 and 104 weeks
High-density lipoprotein
Changes in high-density lipoprotein
Time frame: Up to 52 and 104 weeks
Albuminuria class
Transition of albuminuria class
Time frame: Up to 104 weeks