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

Abstract

Aims:

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.

Keywords: :

• Asian patients
• DPP-4 inhibitor
• Linagliptin
• Type 2 diabetes

Transparency

Declaration of funding

This study was sponsored by Boehringer Ingelheim.

Declaration of financial/other relationships

Z.Z. and D.S.C. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article. V.M. has disclosed that he has received consulting honoraria and research grants from Novo Nordisk, LifeScan Johnson & Johnson, MSD Pharmaceuticals, USV, Sanofi Aventis, and Roche Diagnostics. A.E., K.S., Y.G., S.P., and H.-J.W. have disclosed that they are employees of Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany. The authors were fully responsible for all content and editorial decisions, were involved at all stages of manuscript development, and have approved the final version.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

Medical writing assistance, supported financially by Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany, was provided by Mark Poirier of Envision Pharma Group, Southport CT, USA during the preparation of this manuscript.