Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea: a randomised trial

Summary Aims Canagliflozin is a sodium glucose co‐transporter 2 inhibitor developed for the treatment of type 2 diabetes mellitus (T2DM). This randomised, double‐blind, placebo‐controlled, Phase 3 study evaluated the efficacy and safety of canagliflozin as an add‐on to metformin plus sulphonylurea in patients with T2DM. Methods Patients (N = 469) received canagliflozin 100 or 300 mg or placebo once daily during a 26‐week core period and a 26‐week extension. Prespecified primary end‐point was change in HbA1c at 26 weeks. Secondary end‐points included change in HbA1c at week 52 as well as proportion of patients achieving HbA1c