Efficacy and safety of canagliflozin in Japanese patients with type 2 diabetes: A randomized, double-blind, placebo-controlled, 12-week study

Abstract

Aims: We examined the efficacy, safety and tolerability of canagliflozin, a sodium glucose co-transporter 2 inhibitor, in Japanese patients with type 2 diabetes (T2DM) undergoing diet and exercise therapy. Methods: Patients aged 20-80years with T2DM diagnosed ≥3months previously, and HbA1c of 6.9-9.9% were randomized to 50, 100, 200 or 300mg canagliflozin or placebo once daily for 12weeks. The primary and secondary endpoints were changes in HbA1c, fasting plasma glucose (FPG), urinary glucose/creatinine and postprandial glycaemic parameters following a meal test. The safety assessments included adverse events (AEs) and clinical laboratory tests. Results: Overall, 383 patients were randomized to receive either placebo (n=75), or 50mg (n=82), 100mg (n=74), 200mg (n=77) or 300mg canagliflozin (n=75). At week 12, significant reductions in HbA1c were observed in all canagliflozin groups relative to placebo (-0.61, -0.80, -0.79 and -0.88% for 50, 100, 200 and 300mg, respectively, versus +0.11% for placebo; all, p<0.01). FPG and postprandial glycaemic parameters improved significantly in the canagliflozin groups. Body weight was significantly decreased by canagliflozin. No deaths or drug-related serious AEs were reported. There was no dose-dependent increase in the incidence of AEs in the canagliflozin groups. The incidence of hypoglycaemia was low; episodes were not severe or dose dependent. Canagliflozin did not affect serum creatinine levels or the urinary albumin/creatinine ratio. Conclusions: Treatment with canagliflozin for 12weeks significantly improved glycaemic control and reduced body weight in Japanese patients with T2DM. Canagliflozin was well tolerated. © 2013 The Authors. Diabetes, Obesity and Metabolism.