TY - JOUR T1 - Lixisenatide treatment improves glycaemic control in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin with or without sulfonylurea: a randomized, double-blind, placebo-controlled, 24-week trial (GetGoal-M-Asia). AU - Yu Pan,Chang, AU - Han,Ping, AU - Liu,Xiaoming, AU - Yan,Shengli, AU - Feng,Ping, AU - Zhou,Zhiguang, AU - Lv,Xiaofeng, AU - Tian,Hui, AU - Jin Kui,Yang, AU - Su,Benli, AU - Shang,Shuhua, AU - Niemoeller,Elisabeth, PY - 2013/09/03/received PY - 2014/02/05/revised PY - 2014/02/17/accepted PY - 2014/3/19/entrez PY - 2014/3/19/pubmed PY - 2015/7/15/medline KW - Asia KW - glucagon-like peptide-1 (GLP-1) receptor agonists KW - lixisenatide KW - type 2 diabetes mellitus (T2DM) SP - 726 EP - 35 JF - Diabetes/metabolism research and reviews JO - Diabetes Metab Res Rev VL - 30 IS - 8 N2 - BACKGROUND: This study assessed the efficacy and safety of the once-daily glucagon-like peptide-1 receptor agonist, lixisenatide, in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin ± sulfonylurea. METHODS: In this 24-week, double-blind, placebo-controlled, multinational study, patients were randomized to lixisenatide 20 µg once daily or placebo. The primary endpoint was absolute change in glycated haemoglobin (HbA1c) from baseline to week 24. RESULTS: A total of 391 patients were randomized. Lixisenatide significantly reduced HbA1c levels compared with placebo (LS mean difference: -0.36%, p = 0.0004). A significantly higher proportion of lixisenatide-treated patients achieved HbA1c targets of <7% (p = 0.003) and ≤6.5% (p = 0.001) versus placebo. Lixisenatide was associated with a statistically significant reduction in 2-h postprandial plasma glucose after a standardized breakfast versus placebo (LS mean difference: -4.28 mmol/L, p < 0.0001) and a significant reduction in fasting plasma glucose (p = 0.0109). There was no difference in weight loss versus placebo, with a modest reduction in body weight reported for both groups (lixisenatide: -1.50 kg, placebo: -1.24 kg; p = 0.296). The incidence of treatment-emergent adverse events (TEAEs) was 64.3% with lixisenatide versus 47.4% with placebo, with serious TEAEs reported in 1.5% versus 2.1% of patients, respectively. The most common TEAE in the lixisenatide group was nausea (16.3% vs 2.6% with placebo). The incidence of symptomatic hypoglycaemia was 5.6% with lixisenatide treatment and 2.6% with placebo (p = 0.1321), with no severe symptomatic hypoglycaemia events reported. CONCLUSIONS: In Asian patients with type 2 diabetes mellitus insufficiently controlled on metformin ± sulfonylurea, lixisenatide significantly improved glycaemic control and was well tolerated during the 24-week study. SN - 1520-7560 UR - https://www.unboundmedicine.com/medline/citation/24639432/Lixisenatide_treatment_improves_glycaemic_control_in_Asian_patients_with_type_2_diabetes_mellitus_inadequately_controlled_on_metformin_with_or_without_sulfonylurea:_a_randomized_double_blind_placebo_controlled_24_week_trial__GetGoal_M_Asia__ L2 - https://doi.org/10.1002/dmrr.2541 DB - PRIME DP - Unbound Medicine ER -