title: Empagliflozin monotherapy in Japanese patients with type 2 diabetes mellitus: a randomized, 12-week, double-blind, placebo-controlled, phase II trial.
abstract: BACKGROUND
  This study was designed to determine the efficacy and tolerability of empagliflozin monotherapy in Japanese patients with type 2 diabetes mellitus (T2DM).
  
  
  METHODS
  Patients with glycosylated hemoglobin (HbA1c) ≥ 7.0 - ≤ 10% were randomized via an interactive web response system, and treated double-blind with empagliflozin 5, 10, 25, 50 mg, or placebo once daily for 12 weeks. The primary endpoint was change from baseline in HbA1c at week 12. Other endpoints included percentage of patients with HbA1c <7.0% and changes from baseline in fasting plasma glucose (FPG), body weight, and systolic blood pressure (SBP) at week 12.
  
  
  RESULTS
  A total of 547 patients were randomized and treated with empagliflozin 5 mg (n = 110), 10 mg (n = 109), 25 mg (n = 109), 50 mg (n = 110), or placebo (n = 109) for 12 weeks. Adjusted mean [95% confidence interval (CI)] differences vs. placebo in changes from baseline in HbA1c were -0.72% (-0.87, -0.57) with empagliflozin 5 mg, -0.70% (-0.85, -0.55) with 10 mg, -0.95% (-1.10, -0.80) with 25 mg, and -0.91 (-1.06, -0.76) with 50 mg (all p < 0.001). More patients with HbA1c ≥ 7.0% at baseline reached HbA1c <7.0% with empagliflozin (19-33%) than placebo (3%). Compared with placebo, empagliflozin reduced FPG, body weight (p < 0.001 for all doses for both endpoints) and SBP (p = 0.001, p = 0.014 and p = 0.003 for empagliflozin 10, 25, and 50 mg, respectively). Adverse events were reported by 42% of patients receiving placebo and 33-38% of patients receiving empagliflozin. There were few reports of confirmed hypoglycemic adverse events or events consistent with urinary tract infection or genital infection in any treatment group.
  
  
  CONCLUSIONS
  Empagliflozin monotherapy for 12 weeks in Japanese patients with T2DM reduced HbA1c, FPG, body weight and SBP, and was well tolerated.
authors: Department of Diabetes and Metabolic Diseases, Graduate School of Medicine, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan.
authors: Takashi
authors: T
authors: Kadowaki
authors: Masakazu
authors: M
authors: Haneda
authors: Nobuya
authors: N
authors: Inagaki
authors: Yasuo
authors: Y
authors: Terauchi
authors: Atsushi
authors: A
authors: Taniguchi
authors: Kazuki
authors: K
authors: Koiwai
authors: Henning
authors: H
authors: Rattunde
authors: Hans J
authors: HJ
authors: Woerle
authors: Uli C
authors: UC
authors: Broedl
mesh_terms: D000368:Aged; D001559:Benzhydryl Compounds / Q000008:administration & dosage / Q000009:adverse effects; D001786:Blood Glucose / Q000032:analysis; D001794:Blood Pressure / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D016903:Drug Monitoring / Q000379:methods; D005260:Female; D005960:Glucosides / Q000008:administration & dosage / Q000009:adverse effects; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects; D007564:Japan; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D015431:Weight Loss / Q000187:drug effects
chemical_list: D001559:Benzhydryl Compounds; D001786:Blood Glucose; D005960:Glucosides; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; C570240:empagliflozin