title: Long-term safety and efficacy of tofogliflozin, a selective inhibitor of sodium-glucose cotransporter 2, as monotherapy or in combination with other oral antidiabetic agents in Japanese patients with type 2 diabetes mellitus: multicenter, open-label, randomized controlled trials.
abstract: OBJECTIVE
  To evaluate long-term safety and efficacy of tofogliflozin in Japanese patients with type 2 diabetes as monotherapy or in combination with other oral antidiabetic agents, we conducted 52-week, open-label, randomized controlled trials.
  
  
  METHODS
  The single-agent trial included patients with inadequate glycemic control on diet and exercise, whereas the add-on trial included those uncontrolled with any of the oral antidiabetic agents. In both trials, patients were randomly assigned to receive tofogliflozin 20 or 40 mg once daily orally for 52 weeks.
  
  
  METHODS
  Safety assessments.
  
  
  RESULTS
  A total of 194 patients (65, 20-mg group; 129, 40-mg group) were enrolled into the single-agent trial, whereas 602 (178 and 424, respectively) were enrolled into the add-on trial. Tofogliflozin was well tolerated for 52 weeks in both trials with < 6% of treatment discontinuation because of adverse events in each treatment group. It also reduced hemoglobin A1c. In the single-agent trial, mean reductions at 52 weeks were 0.67 and 0.66% in the 20- and 40-mg groups, respectively. In the add-on trial, mean reductions ranged from 0.71 to 0.93% across the subgroups by dose and background therapy.
  
  
  CONCLUSIONS
  Tofogliflozin was well tolerated and showed sustained efficacy in both trials.
authors: Yamaguchi University Graduate School of Medicine, Division of Endocrinology, Metabolism, Hematological Science and Therapeutics , 1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505 , Japan +81 836 22 2250 (office) ; +81 836 22 2256 ; tanizawa@yamaguchi-u.ac.jp.
authors: Yukio
authors: Y
authors: Tanizawa
authors: Kohei
authors: K
authors: Kaku
authors: Eiichi
authors: E
authors: Araki
authors: Kazuyuki
authors: K
authors: Tobe
authors: Yasuo
authors: Y
authors: Terauchi
authors: Kazunori
authors: K
authors: Utsunomiya
authors: Yasuhiko
authors: Y
authors: Iwamoto
authors: Hirotaka
authors: H
authors: Watada
authors: Wataru
authors: W
authors: Ohtsuka
authors: Daisuke
authors: D
authors: Watanabe
authors: Hideki
authors: H
authors: Suganami
mesh_terms: D000368:Aged; D044466:Asian People; D001559:Benzhydryl Compounds / Q000627:therapeutic use*; D001786:Blood Glucose / Q000032:analysis; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D005960:Glucosides / Q000627:therapeutic use*; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D051297:Sodium-Glucose Transporter 2; D000077203:Sodium-Glucose Transporter 2 Inhibitors
chemical_list: D001559:Benzhydryl Compounds; D001786:Blood Glucose; D005960:Glucosides; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D051297:Sodium-Glucose Transporter 2; D000077203:Sodium-Glucose Transporter 2 Inhibitors; C089180:SLC5A2 protein, human; C575086:6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol