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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.

journal of diabetes investigation

Efficacy and safety of linagliptin monotherapy in Asian patients with inadequately controlled type 2 diabetes mellitus: A multinational, 24‐week, randomized, clinical trial