title: 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).
abstract: 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.
authors.affiliation: Chinese People's Liberation Army General Hospital, Beijing, China.
authors.forename: Chang
authors.initials: C
authors.lastname: Yu Pan
authors.forename: Ping
authors.initials: P
authors.lastname: Han
authors.forename: Xiaoming
authors.initials: X
authors.lastname: Liu
authors.forename: Shengli
authors.initials: S
authors.lastname: Yan
authors.forename: Ping
authors.initials: P
authors.lastname: Feng
authors.forename: Zhiguang
authors.initials: Z
authors.lastname: Zhou
authors.forename: Xiaofeng
authors.initials: X
authors.lastname: Lv
authors.forename: Hui
authors.initials: H
authors.lastname: Tian
authors.forename: Yang
authors.initials: Y
authors.lastname: Jin Kui
authors.forename: Benli
authors.initials: B
authors.lastname: Su
authors.forename: Shuhua
authors.initials: S
authors.lastname: Shang
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Niemoeller
mesh_terms: D000328:Adult; D002681:China; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000378:metabolism; D004311:Double-Blind Method; D004351:Drug Resistance; D018432:Drug Resistance, Multiple; D004359:Drug Therapy, Combination / Q000009:adverse effects; D005260:Female; D000067757:Glucagon-Like Peptide-1 Receptor; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D006943:Hyperglycemia / Q000517:prevention & control*; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008296:Malaysia; D008297:Male; D008687:Metformin / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D010455:Peptides / Q000009:adverse effects / Q000627:therapeutic use*; D018027:Receptors, Glucagon / Q000819:agonists* / Q000378:metabolism; D013453:Sulfonylurea Compounds / Q000009:adverse effects / Q000627:therapeutic use; D013785:Thailand; D000067758:Glucagon-Like Peptide-2 Receptor
chemical_list: D000067757:Glucagon-Like Peptide-1 Receptor; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D010455:Peptides; D018027:Receptors, Glucagon; D013453:Sulfonylurea Compounds; C000593833:GLP1R protein, human; C517652:hemoglobin A1c protein, human; C479460:lixisenatide; D000067758:Glucagon-Like Peptide-2 Receptor
keywords: Asia; glucagon-like peptide-1 (GLP-1) receptor agonists; lixisenatide; type 2 diabetes mellitus (T2DM)