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Aims  To assess the effects of renal impairment (RI)  on the efficacy and safety of ipragliflozin in patients with type 2 diabetes mellitus (T2DM).    Methods  A cohort of Japanese patients with T2DM and mild to moderate  RI  and poor glycaemic control, despite diet/exercise therapy alone or diet/exercise therapy in combination with an oral hypoglycaemic agent (an α‐glucosidase inhibitor, a sulfonylurea, or pioglitazone), were randomized in a double‐blind manner to 50 mg ipragliflozin or placebo once daily for 24 weeks. The patients continued open‐label ipragliflozin for a 28‐week extension period (total treatment duration: 52 weeks).    Results  Ipragliflozin significantly decreased glycated haemoglobin (HbA1c) and fasting plasma glucose ( FPG ) levels and body weight from baseline to week 24 (last observation carried forward) compared with placebo in all patients with  RI . The decreases in  HbA1c  and  FPG  levels were statistically significant in patients with mild  RI , but not in patients with moderate  RI . Ipragliflozin significantly reduced body weight in both  RI  groups. The improvements in glycaemic control were maintained in the 28‐week extension period. Ipragliflozin was associated with no clinically significant safety concerns, and its safety profiles were not influenced by the severity of  RI .    Conclusions  Ipragliflozin significantly improved glycaemic control and body weight in patients with T2DM with mild  RI , but did not improve glycaemic control in patients with moderate  RI . Ipragliflozin is a valid treatment option for patients with mild  RI  but not those with moderate  RI .

diabetes, obesity and metabolism

A randomized, double‐blind, placebo‐controlled study on long‐term efficacy and safety of ipragliflozin treatment in patients with type 2 diabetes mellitus and renal impairment: results of the Long‐Term  ASP1941  Safety Evaluation in Patients with Type 2 Diabetes with Renal Impairment (LANTERN) study