Efficacy and safety of linagliptin as monotherapy or add-on treatment in Asian patients with suboptimal glycemic control: a pooled analysis

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). Placebocorrected 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.