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Diabetol Metab Syndr. 2016 Jun 01;8:36. doi: 10.1186/s13098-016-0151-7. eCollection 2016.

Lixisenatide improves glycemic outcomes of Japanese patients with type 2 diabetes: a meta-analysis.

Diabetology & metabolic syndrome

Hiroaki Seino, Yukiko Onishi, Yusuke Naito, Mitsuhisa Komatsu

Affiliations

  1. Seino Internal Medicine Clinic, Fukushima, 9638851 Japan.
  2. Division of Clinical Trials, Division of Diabetes and Metabolism, The Institute for Adult Diseases, Asahi Life Foundation, Tokyo, Japan.
  3. Medical Affairs, Sanofi K.K., Tokyo, Japan.
  4. Division of Diabetes, Endocrinology and Metabolism, Department of Internal Medicine, Shinshu University School of Medicine, Nagano, Japan.

PMID: 27252787 PMCID: PMC4888474 DOI: 10.1186/s13098-016-0151-7

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.

Keywords: GLP-1 receptor agonists; Lixisenatide; Type 2 diabetes

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