title: Efficacy and safety of linagliptin as monotherapy or add-on treatment in Asian patients with suboptimal glycemic control: a pooled analysis.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of the dipeptidyl peptidase (DPP)-4 inhibitor linagliptin in Asian patients with type 2 diabetes mellitus (T2DM), a rapidly increasing population.
  
  
  METHODS
  Data were pooled for Asian patients receiving linagliptin orally once daily, as monotherapy or added to existing oral antidiabetes therapies, in multinational randomized placebo-controlled clinical trials. Efficacy data were taken from four pivotal trials with 24-week durations to allow for robust efficacy assessment. Safety data were pooled from a wider group of 10 trials with varying durations to capture the largest possible incidence of adverse events (AEs). The primary efficacy endpoint was change from baseline to week 24 in HbA1c. AEs were analyzed descriptively.
  
  
  RESULTS
  Mean baseline HbA1c (±SD) in this population was 8.2 ± 0.9%. Placebo-corrected mean change in HbA1c after 24 weeks was -0.79% (95% confidence interval [CI]: -0.92 to -0.67; p < 0.0001). Placebo-corrected mean change in fasting plasma glucose was -17.8 ± 2.4 mg/dL (95% CI: -22.6, -13.0; p < 0.0001). In a small subgroup, mean post-prandial glucose was reduced by a placebo-corrected -56.9 ± 14.0 mg/dL (95% CI: -85.2, -28.5). AEs occurred in 58.0% of linagliptin patients (serious AEs in 2.4%) and 58.2% of placebo patients (serious AEs in 3.0%).
  
  
  CONCLUSIONS
  This study was limited by the post hoc nature of the analysis, and because the pooling did not differentiate between geographically distant Asian regions. Nonetheless, this analysis provides evidence that linagliptin was efficacious and well tolerated as monotherapy or added to other oral antidiabetes therapies in Asian patients with T2DM.
authors.affiliation: Peking Union Medical College Hospital , Beijing , China.
authors.forename: Zhengpei
authors.initials: Z
authors.lastname: Zeng
authors.forename: Dong Seop
authors.initials: DS
authors.lastname: Choi
authors.forename: Viswanathan
authors.initials: V
authors.lastname: Mohan
authors.forename: Angela
authors.initials: A
authors.lastname: Emser
authors.forename: Kamran
authors.initials: K
authors.lastname: Siddiqui
authors.forename: Yan
authors.initials: Y
authors.lastname: Gong
authors.forename: Sanjay
authors.initials: S
authors.lastname: Patel
authors.forename: Hans-Juergen
authors.initials: HJ
authors.lastname: Woerle
mesh_terms: D000328:Adult; D000368:Aged; D044466:Asian People; D001786:Blood Glucose / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000208:ethnology*; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D000069476:Linagliptin; D008297:Male; D008875:Middle Aged; D011687:Purines / Q000008:administration & dosage*; D011799:Quinazolines / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D054873:Dipeptidyl-Peptidase IV Inhibitors; D006442:Glycated Hemoglobin; D000069476:Linagliptin; D011687:Purines; D011799:Quinazolines
keywords: Asian patients; DPP-4 inhibitor; Linagliptin; Type 2 diabetes