title: Efficacy, safety, and tolerability of ipragliflozin in Asian patients with type 2 diabetes mellitus and inadequate glycemic control with metformin: Results of a phase 3 randomized, placebo-controlled, double-blind, multicenter trial.
abstract: To determine the efficacy and safety of ipragliflozin in combination with metformin in Asian patients with type 2 diabetes mellitus.
  
  
  
  This phase 3, multicenter, placebo-controlled, double-blind, parallel-group study was carried out at 18 sites in Korea and 12 sites in Taiwan. After an 8-week washout period for patients using drugs other than metformin and a 2-week run-in period, patients were randomized to either 50 mg ipragliflozin or a placebo for 24 weeks while continuing metformin. Efficacy outcomes included the changes in hemoglobin A1c, fasting plasma glucose (FPG) and bodyweight from baseline to the end of treatment (with last observation carried forward). Safety outcomes included treatment-emergent adverse events.
  
  
  
  Between November 2011 and January 2013, 171 patients were randomized to and administered ipragliflozin (n = 87) or a placebo (n = 83). The mean changes (standard deviation) in hemoglobin A1c were -0.94% (0.75%) and -0.47% (0.81%) in the ipragliflozin and placebo groups, respectively (between-group difference -0.46%, P < 0.001). The changes in fasting plasma glucose and bodyweight were also significantly greater in the ipragliflozin group, with between-group differences of -14.1 mg/dL and -1.24 kg, respectively (both P < 0.001). The most common treatment-emergent adverse events (ipragliflozin vs placebo) were upper respiratory tract infection (9.2% vs 12.0%) and urinary tract infection (6.9% vs 2.4%).
  
  
  
  These results show that ipragliflozin is effective and well tolerated when used in combination with metformin in Asian patients with type 2 diabetes mellitus.
authors.affiliation: Department of Internal Medicine Ditmanson Medical Foundation Chiayi Christian Hospital Chiayi City Taiwan; College of Management Department of Business Administration National Chung Cheng University Chia-yi County Taiwan; Department of Nursing and Health Management Da-Yeh University Changhua County Taiwan.
authors.forename: Chieh-Hsiang
authors.initials: CH
authors.lastname: Lu
authors.affiliation: Department of Internal Medicine Eulji General Hospital Seoul Korea.
authors.forename: Kyung Wan
authors.initials: KW
authors.lastname: Min
authors.affiliation: Department of Internal Medicine National Taiwan University Hospital Taipei Taiwan.
authors.forename: Lee-Ming
authors.initials: LM
authors.lastname: Chuang
authors.affiliation: Astellas Pharma Inc. Tokyo Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Kokubo
authors.affiliation: Astellas Pharma Inc. Tokyo Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Yoshida
authors.affiliation: Division of Endocrinology and Metabolism Department of Internal Medicine Yonsei University College of Medicine Seoul Korea.
authors.forename: Bong-Soo
authors.initials: BS
authors.lastname: Cha
mesh_terms: D044466:Asian People; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000009:adverse effects; D005260:Female; D005960:Glucosides / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008687:Metformin / Q000009:adverse effects / Q000627:therapeutic use*; D013876:Thiophenes / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D005960:Glucosides; D013876:Thiophenes; C572941:ipragliflozin; D008687:Metformin
keywords: Asia; Ipragliflozin; Type 2 diabetes mellitus