Abstract
BACKGROUND: The GetGoal-L-Asia and -S trials were multi-center trials conducted in 4 and 16 countries, respectively including Japan that evaluated the efficacy and safety of lixisenatide add-on treatment vs. placebo among patients with type 2 diabetes. The aims of this study were to determine the efficacy and safety of lixisenatide add-on treatment among Japanese patient groups. METHODS: All Japanese intent-to-treat patients with baseline and endpoint HbA1c measurements were included in the meta-analyses. Subgroup analyses were carried out for patients with low (<8 %) and high (≥8 %) baseline HbA1c levels, low (<25 kg/m(2)) and high (≥25 kg/m(2)) baseline body mass index (BMI), short (<10 years) and long (≥10 years) durations of diabetes, and for those <65 and ≥65 years of age. RESULTS: The overall study population of Japanese type 2 diabetes patients included 143 patients (mean age: 59.0 years; 35 % female) treated with lixisenatide and 136 patients treated with placebo (mean age: 57.8 years; 32 % female). Among the subgroups, lixisenatide treatment vs. placebo was associated with greater change in HbA1c (Low HbA1c -0.80 %, p < 0.0001; High HbA1c -1.19 %, p < 0.0001; low BMI -0.88 %, p < 0.0001; high BMI -1.28 %, p < 0.0001; short diabetes duration -1.28 %, p < 0.0001; long diabetes duration -0.93 %, p < 0.0001; <65 years: -1.00 %, p < 0.0001; ≥65 years -1.24 %, p < 0.0001). Additionally, among the subgroups, lixisenatide treatment vs. placebo was associated with greater change in post-prandial glucose. CONCLUSIONS: For Japanese type 2 diabetes patients lixisenatide may be an efficacious and safe add-on therapy leading to improved glycemic outcomes. GetGoal-L-Asia NCT01169779 GetGoal-S NCT00713830.