title: Efficacy and safety of luseogliflozin monotherapy in Japanese patients with type 2 diabetes mellitus: a 12-week, randomized, placebo-controlled, phase II study.
abstract: OBJECTIVE
  Luseogliflozin is a novel sodium glucose cotransporter 2 inhibitor for type 2 diabetes mellitus (T2DM) treatment. An exploratory Phase II study was conducted to assess the efficacy and safety of several doses of luseogliflozin in Japanese T2DM patients.
  
  
  METHODS
  Japanese T2DM patients aged 20-74 years with hemoglobin A1c (HbA1c) of 6.9-10.5%, fasting plasma glucose (FPG) ≥126 mg/dL and on diet therapy were randomized in a double-blind manner to receive luseogliflozin (0.5, 2.5, or 5 mg) or placebo once daily for 12 weeks (n = 61, 61, 61, and 56, respectively). The primary endpoint was the change in HbA1c from baseline to end of treatment. Other endpoints included FPG, 2 h postprandial plasma glucose (PPG) in a meal tolerance test (MTT), and body weight. Drug safety was also assessed.
  
  
  BACKGROUND
  Japan Pharmaceutical Information Center (identifier: JapicCTI-090908).
  
  
  RESULTS
  Changes in HbA1c from baseline to end of treatment were -0.36, -0.62, and -0.75% in the 0.5, 2.5, and 5 mg luseogliflozin groups, respectively, versus +0.06% in the placebo group (all P < 0.001). The reductions in FPG and 2 h-PPG in the MTT were also significantly greater in the luseogliflozin groups (all P < 0.01) without increases in insulin levels from baseline. Luseogliflozin reduced body weight at all doses. There were no significant differences in the incidences of adverse events among groups. Most adverse events were mild in severity. There were no serious adverse events.
  
  
  CONCLUSIONS
  Although this was a small-scale study with a short duration, all tested doses of luseogliflozin significantly improved glycemic control, reduced body weight, and were well tolerated in Japanese T2DM patients over the 12-week treatment period.
authors.affiliation: Kansai Electric Power Hospital , Osaka , Japan.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Seino
authors.forename: Takashi
authors.initials: T
authors.lastname: Sasaki
authors.forename: Atsushi
authors.initials: A
authors.lastname: Fukatsu
authors.forename: Soichi
authors.initials: S
authors.lastname: Sakai
authors.forename: Yoshishige
authors.initials: Y
authors.lastname: Samukawa
mesh_terms: D000328:Adult; D000368:Aged; D044466:Asian People; D015415:Biomarkers / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000208:ethnology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007564:Japan; D008297:Male; D008875:Middle Aged; D013012:Sorbitol / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome; D015431:Weight Loss
chemical_list: D015415:Biomarkers; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D013012:Sorbitol; C517652:hemoglobin A1c protein, human; C549343:1,5-anhydro-1-(5-(4-ethoxybenzyl)-2-methoxy-4-methylphenyl)-1-thioglucitol
keywords: Japanese; Luseogliflozin; Monotherapy; Phase II clinical study; Placebo; Sodium glucose cotransporter 2 (SGLT2) inhibitor; Type 2 diabetes mellitus