title: Efficacy and safety of canagliflozin monotherapy in Japanese patients with type 2 diabetes inadequately controlled with diet and exercise: a 24-week, randomized, double-blind, placebo-controlled, Phase III study.
abstract: OBJECTIVE
  To examine the efficacy and safety of canagliflozin monotherapy, a sodium/glucose co-transporter 2 inhibitor, in Japanese type 2 diabetes patients.
  
  
  METHODS
  In this double-blind, multi-centre Phase III study, patients aged ≥ 20 years with hemoglobin A1c (HbA1c) 7.0-10.0% on diet/exercise therapy alone received placebo or canagliflozin (100 or 200 mg) once daily for 24 weeks. The main outcome measure was the change in HbA1c from baseline to Week 24.
  
  
  RESULTS
  The changes in HbA1c (-0.74 and -0.76 vs + 0.29%), fasting plasma glucose (1 mg/dl = 0.0555 mmol/l; -31.6 and -31.9 vs + 3.7 mg/dl), 2-h plasma glucose after 75-g glucose load (-84.9 and -79.0 vs -0.5 mg/dl), body weight (percent change: -3.76 and -4.02 vs -0.76%) and systolic blood pressure (-7.88 and -6.24 vs -2.72 mmHg) were significantly greater with 100 and 200 mg canagliflozin than with placebo (all, p < 0.05). Genital infections in females (6.5, 6.3 and 0%) and asymptomatic hypoglycemia (4.4, 5.6 and 2.2%), but not symptomatic hypoglycemia (2.2, 1.1 and 1.1%), were more frequent in the 100- and 200-mg groups than in the placebo group.
  
  
  CONCLUSIONS
  Canagliflozin significantly improved glycemic control and was well tolerated.
authors.affiliation: Kyoto University Graduate School of Medicine, Department of Diabetes, Endocrinology and Nutrition , Kyoto , Japan.
authors.forename: Nobuya
authors.initials: N
authors.lastname: Inagaki
authors.forename: Kazuoki
authors.initials: K
authors.lastname: Kondo
authors.forename: Toru
authors.initials: T
authors.lastname: Yoshinari
authors.forename: Nahoko
authors.initials: N
authors.lastname: Takahashi
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Susuta
authors.forename: Hideki
authors.initials: H
authors.lastname: Kuki
mesh_terms: D000368:Aged; D001786:Blood Glucose; D001794:Blood Pressure / Q000187:drug effects; D000068896:Canagliflozin; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000178:diet therapy / Q000188:drug therapy*; D004311:Double-Blind Method; D005081:Exercise Therapy; D005260:Female; D005960:Glucosides / Q000009:adverse effects / Q000627:therapeutic use*; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007564:Japan; D007657:Ketone Bodies / Q000097:blood; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D013876:Thiophenes / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D015431:Weight Loss
chemical_list: D001786:Blood Glucose; D000068896:Canagliflozin; D005960:Glucosides; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007657:Ketone Bodies; D008055:Lipids; D013876:Thiophenes; C517652:hemoglobin A1c protein, human
keywords: canagliflozin; hemoglobin A1c; sodium/glucose co-transporter 2 inhibitor; type 2 diabetes