Abstract
BackgroundThe 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.MethodsAll 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/m2) and high (≥25 kg/m2) baseline body mass index (BMI), short (<10 years) and long (≥10 years) durations of diabetes, and for those <65 and ≥65 years of age.ResultsThe 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.ConclusionsFor Japanese type 2 diabetes patients lixisenatide may be an efficacious and safe add-on therapy leading to improved glycemic outcomes.GetGoal-L-Asia NCT01169779GetGoal-S NCT00713830
Highlights
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 overall study population of Japanese type 2 diabetes patients included 143 patients treated with lixisenatide and 136 patients treated with placebo
Lixisenatide treated patients had a greater likelihood of having symptomatic hypoglycemia during the trial periods in comparison to placebo treated patients [odds ratio (OR) 3.0, confidence intervals (CI) 1.4, 6.3, p = 0.0040]; lixisenatide treated patients had greater likelihoods of achieving an endpoint glycated hemoglobin (HbA1c)
Summary
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 GetGoal-L-Asia (NCT01169779) and -S (NCT00713830) trials were multicenter, multi-country trials that evaluated the efficacy and safety of lixisenatide add-on treatment vs placebo among patients with type 2 diabetes with both trials having the primary endpoint of change in HbA1c [10, 11]. The objectives of this study were to conduct meta-analyses of GetGoal-L-Asia and -S trial data to determine the efficacy and safety of lixisenatide add-on treatment among specific Japanese type 2 diabetes patient groups, including those with low (
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