Abstract

Aim: To evaluate the efficacy and safety of administering canagliflozin to Japanese type 2 diabetes mellitus (T2DM) patients and reducing the dosage of their existing regimen of sulfonylurea (SU) by half. Methods: Seventeen Japanese T2DM patients on antidiabetes medication (SU) completed this 12-week prospective single-arm open-label study. First, the dose of SU was reduced by half and a concomitant administration of canagliflozin (100 mg/day) was initiated. Glycemic control and other metabolic parameters were measured at weeks 0, 4, 8 and 12. Results: At 12 weeks, average HbA1c levels had declined from 7.3 ± 0.3% (56 mmol/mol) to 7.1 ± 0.4% (53 mmol/mol) (p < 0.05). Continuous glucose monitoring showed average blood glucose (BG) levels (mg/dl) reduced from 156.8 ± 23.5 to 129.4 ± 10.4 (p < 0.05) with a standard deviation (SD) of from 45.7 ± 12.6 to 32.4 ± 9.0 (NS). Neither severe hypoglycemia nor other serious adverse events developed during the study period. Serum ketone bodies were transiently elevated from 61 ± 47 to 162 ± 140 (p < 0.05) at 4 weeks but were decreased afterward. Conclusion: This study showed that a combination of canagliflozin preceded by a reduced dose of SU resulted in an acceptable short-term tolerability and a significant improvement in glycemic control without increasing the risk of hypoglycemia and severe ketosis.

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