title: Efficacy and safety of linagliptin monotherapy in Asian patients with inadequately controlled type 2 diabetes mellitus: A multinational, 24-week, randomized, clinical trial.
abstract: OBJECTIVE
  Asian patients represent a large portion of the global population with type 2 diabetes mellitus, but are underrepresented in trials of glucose-lowering therapies. The present randomized, phase III, placebo-controlled, double-blind, 24-week study evaluated the dipeptidyl peptidase-4 inhibitor, linagliptin, as monotherapy in Asian patients with inadequately controlled type 2 diabetes mellitus.
  
  
  METHODS
  Patients who were treatment naïve or had been treated with one oral antidiabetes drug were randomized to either linagliptin 5 mg daily or a placebo after washout. The primary end-point was a change from baseline in glycated hemoglobin after 24 weeks.
  
  
  RESULTS
  A total of 300 Asian (87% Chinese) patients with type 2 diabetes mellitus were randomized to linagliptin or placebo at a 2:1 ratio. After 24 weeks of treatment, adjusted mean (standard error) glycated hemoglobin decreased by a placebo-corrected -0.50 ± 0.11 (P < 0.0001). In patients with baseline glycated hemoglobin ≥8.5%, the placebo-corrected decrease in glycated hemoglobin was -0.91 ± 0.20% (P < 0.0001). Adverse events occurred in 28.0 and 28.3% of linagliptin and placebo patients, respectively, but few were drug-related (3.0 and 2.0%, respectively). Hypoglycemia was reported by one linagliptin patient and no placebo patients. Treatment with linagliptin was weight neutral.
  
  
  CONCLUSIONS
  In Asian patients with inadequately controlled type 2 diabetes mellitus, linagliptin 5 mg as monotherapy was efficacious and well tolerated over 24 weeks.
authors.affiliation: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai, China.
authors.forename: Yuhong
authors.initials: Y
authors.lastname: Chen
authors.affiliation: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai, China.
authors.forename: Guang
authors.initials: G
authors.lastname: Ning
authors.affiliation: The First Affiliated Hospital of Anhui Medical University Hefei, China.
authors.forename: Changjiang
authors.initials: C
authors.lastname: Wang
authors.affiliation: Boehringer Ingelheim, Pharma GmbH & Co. KG Ingelheim, Germany.
authors.forename: Yan
authors.initials: Y
authors.lastname: Gong
authors.affiliation: Boehringer Ingelheim Ltd Bracknell, UK.
authors.forename: Sanjay
authors.initials: S
authors.lastname: Patel
authors.affiliation: Boehringer Ingelheim International Trading Co., Ltd Shanghai, China.
authors.forename: Candice
authors.initials: C
authors.lastname: Zhang
authors.affiliation: Nippon Boehringer Ingelheim Co., Ltd Tokyo, Japan.
authors.forename: Toshiyasu
authors.initials: T
authors.lastname: Izumoto
authors.affiliation: Boehringer Ingelheim, Pharma GmbH & Co. KG Ingelheim, Germany.
authors.forename: Hans-Juergen
authors.initials: HJ
authors.lastname: Woerle
authors.affiliation: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai, China.
authors.forename: Weiqing
authors.initials: W
authors.lastname: Wang
keywords: Asians; Linagliptin; Monotherapy