title: Efficacy and safety of dapagliflozin in Asian patients with type 2 diabetes after metformin failure: A randomized controlled trial.
abstract: BACKGROUND
  Dapagliflozin, a highly selective sodium-glucose cotransporter 2 inhibitor, reduces hyperglycemia, body weight, and blood pressure in patients with type 2 diabetes (T2D).
  
  
  METHODS
  This randomized double-blind placebo-controlled parallel-group 24-week study assessed the efficacy, safety, and tolerability of dapagliflozin added to metformin in Asian patients with inadequately controlled T2D (HbA1c 7.5%-10.5%). Patients were randomized to receive placebo (n = 145) or dapagliflozin 5 (n = 147) or 10 mg (n = 152).
  
  
  RESULTS
  Most participants were Chinese (86.0%), with a mean age of 53.8 years and mean T2D duration of 4.9 years; 92.1% completed the study. Adjusted mean HbA1c changes from baseline at Week 24 (primary endpoint) were -0.23%, -0.82%, and -0.85% in the placebo, dapagliflozin 5 and 10 mg groups, respectively, resulting in dapagliflozin 5 and 10 mg versus placebo differences of -0.59% and -0.62%, respectively (both P < 0.0001). Dapagliflozin 5 and 10 mg differences versus placebo were, respectively: -1.2 and -1.5 mmol/L for fasting plasma glucose; -1.1 and -1.8 kg for weight; and -2.3 and -2.7 mmol/L for 2-h postprandial glucose (all P <0.0001). In the placebo, dapagliflozin 5 and 10 mg groups, respectively: adverse events (AEs) occurred in 52.4%, 52.4%, and 55.3% of patients; serious AEs occurred in 4.1%, 2.0%, and 2.0%; urinary tract infections occurred in 4.8%, 4.1%, and 6.6%; and genital infections occurred in 0%, 2.0%, and 1.3%. No AEs of pyelonephritis or renal failure occurred.
  
  
  CONCLUSIONS
  Dapagliflozin 5 or 10 mg as add-on to metformin was well tolerated in Asian patients with T2D and significantly improved glycemic control with the additional benefit of weight reduction.
authors.affiliation: China-Japan Friendship Hospital, Beijing. ywying_1010@163.com.
authors.forename: Wenying
authors.initials: W
authors.lastname: Yang
authors.affiliation: ShengJing Hospital of China Medical University, Shenyang, China.
authors.forename: Ping
authors.initials: P
authors.lastname: Han
authors.affiliation: Eulji Hospital, Seoul, South Korea.
authors.forename: Kyung-Wan
authors.initials: KW
authors.lastname: Min
authors.affiliation: Bristol-Myers Squibb, Shanghai.
authors.forename: Bei
authors.initials: B
authors.lastname: Wang
authors.affiliation: Bristol-Myers Squibb, Princeton, New Jersey, USA.
authors.forename: Traci
authors.initials: T
authors.lastname: Mansfield
authors.affiliation: Bristol-Myers Squibb, Braine-l'Alleud, Belgium.
authors.forename: Caroline
authors.initials: C
authors.lastname: T'Joen
authors.affiliation: Bristol-Myers Squibb, Princeton, New Jersey, USA.
authors.forename: Nayyar
authors.initials: N
authors.lastname: Iqbal
authors.affiliation: AstraZeneca, Gothenburg, Sweden.
authors.forename: Eva
authors.initials: E
authors.lastname: Johnsson
authors.affiliation: Bristol-Myers Squibb, Princeton, New Jersey, USA.
authors.forename: Agata
authors.initials: A
authors.lastname: Ptaszynska
mesh_terms: D000328:Adult; D001559:Benzhydryl Compounds / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D001786:Blood Glucose / Q000032:analysis; D001794:Blood Pressure / Q000187:drug effects; D001835:Body Weight / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005960:Glucosides / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000627:therapeutic use*; D008875:Middle Aged; D010919:Placebos
chemical_list: D001559:Benzhydryl Compounds; D001786:Blood Glucose; D005960:Glucosides; D007004:Hypoglycemic Agents; D010919:Placebos; C529054:dapagliflozin; D008687:Metformin
keywords: Asian; dapagliflozin; treatment efficacy; 亚洲; 疗效; 达格列净