Effect of race and ethnicity on vildagliptin efficacy: A pooled analysis of phase II and III studies

Abstract

Aims: To determine the impact of race and ethnicity on the efficacy, body weight and hypoglycaemia incidence with vildagliptin treatment in patients with type 2 diabetes mellitus using patient-level data from the vildagliptin clinical trial programme. Methods: Data from 22 randomized, placebo-controlled global and local (Japan, China) registration studies of vildagliptin (50 mg once-daily or twice-daily) of ≥12-week duration were analysed by race (Caucasian [n = 2764] and Asian [n = 2232]) and by ethnicity (Japanese, Chinese, and Indian). The placebo-subtracted differences in the change in glycated haemoglobin (HbA1c) and body weight from baseline to week 12 or week 24 were evaluated by race or ethnicity using repeated measure analysis of unstructured covariance. Hypoglycaemia incidences were summarized using descriptive statistics. Results: The HbA1c reduction from baseline with vildagliptin was similar across the racial/ethnic subgroups (−0.83% ± 0.02% to −1.01% ± 0.05%). Placebo-corrected HbA1c reduction was similar between Caucasian (−0.68% ± 0.03%) and Asian (−0.80% ± 0.03%) patients (P value for interaction =.56); analysis by race and ethnicity showed better efficacy (P