Rationale, design and baseline characteristics of the effect of canagliflozin in patients with type 2 diabetes and microalbuminuria in the Japanese population: The CANPIONE study

AIM: To evaluate the effect of canagliflozin, a sodium‐glucose co‐transporter‐2 (SGLT2) inhibitor, on albuminuria and the decline of estimated glomerular filtration rate (eGFR) in participants with type 2 diabetes and microalbuminuria. METHODS: The CANPIONE study is a multicentre, randomized, parallel‐group and open‐labelled study consisting of a unique 24‐week preintervention period, during which the rate of eGFR decline before intervention is estimated, followed by a 52‐week intervention and a 4‐week washout period. Participants with a geometric mean urinary albumin‐to‐creatinine ratio (UACR) of 50 and higher and less than 300 mg/g in two consecutive first‐morning voids at two different time points, and an eGFR of 45 ml/min/1.73m(2) or higher, are randomly assigned to receive canagliflozin 100 mg daily or to continue guideline‐recommended treatment, except for SGLT2 inhibitors. The first primary outcome is the change in UACR, and the second primary outcome is the change in eGFR slope. RESULTS: A total of 258 participants were screened and 98 were randomized at 21 sites in Japan from August 2018 to May 2021. The mean baseline age was 61.4 years and 25.8% were female. The mean HbA1c was 7.9%, mean eGFR was 74.1 ml/min/1.73m(2) and median UACR was 104.2 mg/g. CONCLUSIONS: The CANPIONE study will determine whether the SGLT2 inhibitor canagliflozin can reduce albuminuria and slow eGFR decline in participants with type 2 diabetes and microalbuminuria.