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Aims  To assess the effects of 16 weeks of tofogliflozin (sodium‐glucose co‐transporter‐2 [ SGLT2 ] inhibitor) treatment vs placebo on glycated haemoglobin ( HbA1c ) levels in Japanese patients with type 2 diabetes mellitus ( T2DM ) inadequately controlled with insulin monotherapy or insulin plus a dipeptidyl peptidase‐4 ( DPP ‐4) inhibitor.    Methods  The study comprised a 16‐week, multicentre, double‐blind, placebo‐controlled period and a 36‐week extension ( NCT02201004 ). Men and women (aged ≥20 and ≤75 years) with  T2DM  ( HbA1c  ≥7.5% and ≤10.5%) were randomized 2:1 to tofogliflozin 20 mg once/day or placebo. The primary endpoint was change in  HbA1c  from baseline. Insulin reduction was not permitted during this study.    Results  A total of 211 patients were randomized (141 tofogliflozin, 70 placebo). Addition of tofogliflozin to insulin therapy was significantly superior to placebo for lowering  HbA1c  (−0.59 vs +0.48%;   P   < .0001), fasting plasma glucose (−27.2 vs +5.3 mg/ dL ;   P   < .0001), postprandial plasma glucose (−65.0 vs +3.2 mg/ dL ;  P  < 0.0001), serum uric acid (−0.18 vs +0.07 mg/ dL ;   P   = .0062), body weight (−1.34 vs +0.03 kg;   P   < .0001) and daily insulin dose (−1.3 vs −0.2 U,   P   = .0152). Hypoglycaemia occurred in 30.7% of patients receiving tofogliflozin vs 21.4% for placebo. Two patients treated with tofogliflozin each had a genital or urinary tract infection.    Conclusions  This 16‐week double‐blind study indicated that, in patients with  T2DM  whose  HbA1c  levels were poorly controlled with insulin monotherapy or insulin plus a  DPP ‐4 inhibitor, addition of tofogliflozin was an effective treatment option with an acceptable safety profile.

diabetes, obesity and metabolism

Efficacy and safety of tofogliflozin in  J apanese patients with type 2 diabetes mellitus with inadequate glycaemic control on insulin therapy ( J‐STEP / INS ): Results of a 16‐week randomized, double‐blind, placebo‐controlled multicentre trial