Efficacy and safety of twice-daily treatment with canagliflozin, a sodium glucose co-transporter 2 inhibitor, added on to metformin monotherapy in patients with type 2 diabetes mellitus

摘要

Aim To evaluate the efficacy/safety of canagliflozin twice daily (BID) compared with placebo in patients with type 2 diabetes mellitus (T2DM) on metformin. Methods In this 18-week, randomized, double-blind, placebo-controlled study, patients ( N ?=?279) at 60 centers in 7 countries received canagliflozin 50 or 150?mg or placebo BID. The pre-specified primary endpoint was change from baseline in HbA 1c at Week 18. Pre-specified secondary endpoints included proportion of patients reaching HbA 1c <7.0%, change in fasting plasma glucose (FPG), and percent change in body weight; changes in systolic blood pressure (BP) and fasting plasma lipids were also evaluated. Adverse events (AEs) were recorded throughout the study. Results From a mean baseline HbA 1c of 7.6% (60?mmol/mol), canagliflozin 50 and 150?mg BID significantly reduced HbA 1c compared with placebo at Week 18 (?0.45%,??0.61%,??0.01% [?5,??7,??0.1?mmol/mol], respectively; P ?