Open AccessEfficacy and safety of linagliptin in A sian patients with type 2 diabetes mellitus inadequately controlled by metformin: A multinational 24‐week, randomized clinical trial
Author(s) -
Wang Weiqing,
Yang Jinkui,
Yang Gangyi,
Gong Yan,
Patel Sanjay,
Zhang Candice,
Izumoto Toshiyasu,
Ning Guang
Publication year - 2016
Publication title -
journal of diabetes
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.949
H-Index - 43
eISSN - 1753-0407
pISSN - 1753-0393
DOI - 10.1111/1753-0407.12284
Subject(s) - linagliptin , medicine , metformin , placebo , dipeptidyl peptidase 4 inhibitor , diabetes mellitus , clinical endpoint , type 2 diabetes , randomized controlled trial , type 2 diabetes mellitus , randomization , adverse effect , gastroenterology , endocrinology , insulin , alternative medicine , pathology
Background Despite the increasing prevalence of type 2 diabetes mellitus ( T2DM ) in A sia, clinical trials for glucose‐lowering therapies are often dominated by C aucasian and/or W estern 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 A sian T2DM patients. Methods In all, 306 patients ( n = 265 C hinese; n = 24 M alaysian; n = 17 F ilipino), 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. Results 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 in similar proportions in the linagliptin and placebo patients (27.3% and 28.0%, respectively) and few were considered drug‐related (2.4% and 0.0%, respectively). Hypoglycemia occurred in 1.0% of patients in both groups. Linagliptin therapy was weight neutral. Conclusions Linagliptin 5 mg was efficacious and well tolerated over 24 weeks in A sian patients with T2DM inadequately controlled by metformin.