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. populace 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. "type":"clinical-trial","attrs":"text":"NCT01169779","term_id":"NCT01169779"NCT01169779 "type":"clinical-trial","attrs":"text":"NCT00713830","term_id":"NCT00713830"NCT00713830 value of 0.05 was used to determine the level of statistical significance. Other summary statistics The summary statistics of patient clinical characteristics as well as efficacy and safety outcomes for each treatment arm within the study groups had been determined. The procedure hands within each subgroup had been compared to one another with p ideals calculated utilizing a Chi rectangular check or ANOVA check where suitable. A p worth of 0.05 was used to look for the degree of statistical significance. All descriptive statistical analyses had been completed using SAS? 9.3 (Cary, NC). Outcomes The overall research human population of Japanese type 2 diabetes individuals included 143 individuals (mean age group: 59.0?years; 35?% woman) treated with lixisenatide and 136 individuals treated with placebo (suggest age group: 57.8?years; 32?% woman). The mean durations of type 2 diabetes had been 11.9 and 12.4?years among individuals Rabbit Polyclonal to CDC7 treated with placebo and lixisenatide, respectively. Lixisenatide treated individuals got higher shifts in HbA1c ( significantly?1.08?%, self-confidence period (CI) ?1.29, ?0.86, p?0.0001) and PPG amounts (?149.8?mg/dL, CI ?170.4, ?129.2, p?0.0001) compared to placebo treated individuals during trial intervals. Lixisenatide treated individuals had a larger probability of having symptomatic hypoglycemia through the trial intervals compared to placebo treated individuals [odds percentage (OR) 3.0, CI 1.4, 6.3, p?=?0.0040]; nevertheless, lixisenatide treated individuals had higher likelihoods of attaining an endpoint HbA1c <7?% (OR 20.3, CI 6.1, 67.8, p?0.0001), as well as the composite endpoints of the HbA1c <7?% no putting on weight (OR 13.5, CI 4.0, 45.6, p?0.0001), an HbA1c?7?% no symptomatic hypoglycemia (OR 18.5, CI 4.3, 78.8, p?0.0001), and an HbA1c <7?% no weight gain no symptomatic hypoglycemia (OR 12.8, CI 2.9, 55.7, p?=?0.0007) compared to placebo treated individuals. Severe hypoglycemia had not been observed among the entire study human population of Japanese type 2 diabetes individuals. Baseline features of research subgroups are shown in Desk?1. Shape?1 presents a forest storyline of mean treatment differences of adjustments in HbA1c during trial intervals of Japan type 2 diabetes individual subgroups. Desk?1 Baseline features of research subgroups Fig.?1 of hba1c treatment variations among Japan type 2 diabetes individual subgroups Subgroups: Japan type 2 diabetes individuals with low (<8?%) and high (8?%) baseline HbA1c amounts A listing of the meta-analysis results of Japanese type 2 diabetes individuals with low (<8?%) and high (8?%) baseline HbA1c amounts placebo is shown in Desk?2. Lixisenatide treated individuals with low (<8?%) baseline HbA1c got Phenacetin manufacture significantly higher adjustments in HbA1c (?0.80?%, CI ?1.18, ?0.43, p?0.0001) and PPG amounts (?132.0?mg/dL, CI ?171.7, ?92.4, p?0.0001) compared to placebo treated individuals with low (<8?%) baseline HbA1c during trial Phenacetin manufacture intervals. The probability of symptomatic hypoglycemia happening during trial intervals was not considerably different among individuals with low (<8?%) baseline HbA1c treated with lixisenatide and placebo. Lixisenatide treated individuals with low (<8?%) baseline HbA1c got higher likelihoods of attaining an endpoint HbA1c <7?% (OR Phenacetin manufacture 25.5, CI 5.2, 124.6, p?0.0001), as well as the composite endpoints of the HbA1c <7?% no putting on weight (OR 15.8, CI 3.3, 75.8, p?=?0.0005), an HbA1c <7?% no symptomatic hypoglycemia (OR 11.8, CI 2.0, 68.7, p?=?0.0060), and an HbA1c <7?% no weight gain no symptomatic hypoglycemia (OR 8.9, CI 1.5, 52.2, p?=?0.0154). Desk?2 Overview of meta-analysis outcomes Phenacetin manufacture for Japanese type 2 diabetes individuals with low (<8?%) and high (8?%) baseline HbA1c amounts Lixisenatide treated individuals Phenacetin manufacture with high (8?%) baseline HbA1c got significantly higher adjustments in HbA1c (?1.19?%, CI ?1.46, ?0.92, p?0.0001), FPG (?14.7?mg/dL, CI ?25.9, ?3.6, p?=?0.0097), and PPG amounts (?162.0?mg/dL, CI ?185.9, ?138.1, p?0.0001).