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

Journal of Diabetes
Weiqing WangGuang Ning

Abstract

Despite the increasing prevalence of type 2 diabetes mellitus (T2DM) in Asia, clinical trials for glucose-lowering therapies are often dominated by Caucasian and/or Western populations. The present Phase III randomized placebo-controlled double-blind, 24-week study evaluated the efficacy and safety of the dipeptidyl peptidase-4 inhibitor linagliptin added to metformin in Asian T2DM patients. In all, 306 patients (n = 265 Chinese; n = 24 Malaysian; n = 17 Filipino), aged 18-80 years with HbA1c between ≥7.0 and ≤10.0% and on metformin therapy were randomized (2:1) to either linagliptin 5 mg daily or placebo added to metformin. Antidiabetes drugs other than metformin were washed out prior to randomization. The primary endpoint was change in mean HbA1c from baseline after 24 weeks. Baseline characteristics were well-matched between the groups (overall mean [±SD] HbA1c 8.0 ± 0.8%). Adjusted mean (±SE) HbA1c decreased in the linagliptin and placebo groups by -0.66 ± 0.05 and -0.14 ± 0.07%, respectively (placebo-corrected difference -0.52 ± 0.09%; 95% confidence interval [CI] -0.70, -0.34; P < 0.0001). In patients with baseline HbA1c ≥8.5%, the placebo-corrected decrease in HbA1c was -0.89 ± 0.17% (P < 0.0001). Adverse events occurred...Continue Reading

References

Dec 1, 1999·International Journal of Obesity and Related Metabolic Disorders : Journal of the International Association for the Study of Obesity·G T KoJ Woo
Aug 30, 2011·Diabetes Research and Clinical Practice·Wenying YangIngrid Gause-Nilsson
Mar 1, 2012·Diabetes, Obesity & Metabolism·C PanUNKNOWN Institution Investigators
May 10, 2012·Clinical Pharmacokinetics·Ulrike Graefe-ModyChristian Friedrich
Apr 5, 2013·Annals of the New York Academy of Sciences·Ronald C W Ma, Juliana C N Chan

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Citations

Sep 10, 2015·Medical Science Monitor : International Medical Journal of Experimental and Clinical Research·Wenjun WuXuemei Gu
Dec 6, 2016·Diabetes Technology & Therapeutics·Xiaoling CaiLinong Ji
Mar 26, 2019·Diabetes/metabolism Research and Reviews·Weiping JiaUNKNOWN Chinese Diabetes Society
Nov 23, 2016·American Journal of Cardiovascular Drugs : Drugs, Devices, and Other Interventions·Islam Y ElgendyAnthony A Bavry
Dec 15, 2020·Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders·Dominik LautschSwapnil Rajpathak

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