Open AccessEfficacy and safety of linagliptin monotherapy in Asian patients with inadequately controlled type 2 diabetes mellitus: A multinational, 24‐week, randomized, clinical trial
Author(s) -
Chen Yuhong,
Ning Guang,
Wang Changjiang,
Gong Yan,
Patel Sanjay,
Zhang Candice,
Izumoto Toshiyasu,
Woerle HansJuergen,
Wang Weiqing
Publication year - 2015
Publication title -
journal of diabetes investigation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.089
H-Index - 50
eISSN - 2040-1124
pISSN - 2040-1116
DOI - 10.1111/jdi.12346
Subject(s) - linagliptin , medicine , glycated hemoglobin , placebo , dipeptidyl peptidase 4 inhibitor , diabetes mellitus , type 2 diabetes mellitus , type 2 diabetes , clinical endpoint , randomized controlled trial , gastroenterology , adverse effect , endocrinology , alternative medicine , pathology
Aims/Introduction 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. Materials and 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.