Effect of canagliflozin on the disposition index, a marker of pancreatic beta-cell function: a randomized controlled study

INTERVENTION: Canagliflozin arm: Canagliflozin (100 mg/day) and glimepiride (0‐4 mg/day, adjusted by the prescribed algorithm), for 24 weeks Glimepiride arm: Glimepiride (0‐4 mg/day, adjusted by the prescribed algorithm), for 24 weeks CONDITION: Type 2 diabetes mellitus PRIMARY OUTCOME: Change in disposition index, calculated using blood glucose and insulin values, from baseline to at 1‐week after the end of the treatment SECONDARY OUTCOME: Changes in ; (1) DI‐related outcomes ; (2) DI using C‐peptide ; (3) HbA1c, fasting glucose, fasting insulin ; (4) Body weight ; (5) CGM glucose levels ; (6) HOMA2‐%B, iHOMA2 (‐%B, ‐%S) ; (7) HOMA2‐%S ; (8) Dose of glimepiride INCLUSION CRITERIA: 1) Type 2 diabetic outpatients giving written informed consent for the study participation 2) Aged 20‐75 years at informed consent 3) Not achieving the individual glycemic target, according to Treatment Guide for Diabetes 2016‐2017, by Japan Diabetes Society 4) Undergoing unchanged diet and exercise therapy over 12 weeks 5) Treated with a constant dose of teneligliptin (20 mg/day) over 12 weeks 6) Treated with a constant dose of glimepiride (0.5‐2 mg/day) over 12 weeks 7) Treated with a constant dose of metformin over 12 weeks (or treated with a constant dose of teneligliptin and glimepiride over 12 weeks, having reasonable reason for not taking metformin) 8) Not taking prohibited concomitant medications over 12 weeks