title: Efficacy and safety of lixisenatide in Japanese patients with type 2 diabetes mellitus inadequately controlled by sulfonylurea with or without metformin: Subanalysis of GetGoal-S.
abstract: OBJECTIVE
  This was a subanalysis of Japanese patients included in the glucagon-like peptide-1 receptor agonist AVE0010 in patients with type 2 diabetes mellitus for glycemic control and safety evaluation (GetGoal-S) study - a 24-week, randomized, placebo-controlled study of lixisenatide in patients with type 2 diabetes mellitus inadequately controlled by sulfonylurea with or without metformin.
  
  
  METHODS
  In GetGoal-S, 127 Japanese patients received the once-daily prandial glucagon-like peptide-1 receptor agonist lixisenatide 20 μg/day or a matching placebo. The primary outcome was change in glycated hemoglobin.
  
  
  RESULTS
  At week 24, lixisenatide significantly reduced mean glycated hemoglobin (least squares mean difference vs the placebo -1.1% [12 mmol/mol, P < 0.0001]), and significantly more lixisenatide patients reached glycated hemoglobin targets of <7% (53 mmol/mol) and ≤6.5% (48 mmol/mol) vs the placebo. Lixisenatide produced statistically significant reductions in 2-h postprandial plasma glucose (least squares mean difference vs the placebo -8.51 mmol/L, P < 0.0001) and glucose excursion vs the placebo, and significantly reduced fasting plasma glucose (least squares mean difference vs the placebo -0.65 mmol/L, P = 0.0454). Bodyweight decreased with both lixisenatide and the placebo (least squares mean change -1.12 kg for lixisenatide, -1.02 kg for placebo). The overall incidence of adverse events was similar for lixisenatide and the placebo (84.2 and 82.4%, respectively), the most frequent being gastrointestinal disorders (52.6% for lixisenatide vs 29.4% for placebo). The incidence of symptomatic hypoglycemia was higher with lixisenatide vs the placebo (17.1 and 9.8%, respectively), with no cases of severe symptomatic hypoglycemia in either group.
  
  
  CONCLUSIONS
  In the Japanese subpopulation of the GetGoal-S study, lixisenatide produced a significant and clinically relevant improvement in glycated hemoglobin, with a pronounced improvement in postprandial plasma glucose, and a good safety and tolerability profile.
authors: The Institute for Adult Disease, Asahi Life Foundation Tokyo, Japan.
authors: Yukiko
authors: Y
authors: Onishi
authors: Sanofi R&D Frankfurt, Germany.
authors: Elisabeth
authors: E
authors: Niemoeller
authors: Sanofi Tokyo, Japan.
authors: Yukio
authors: Y
authors: Ikeda
authors: Sanofi Tokyo, Japan.
authors: Hiroki
authors: H
authors: Takagi
authors: Kansai Electric Power Hospital Osaka, Japan.
authors: Daisuke
authors: D
authors: Yabe
authors: Kansai Electric Power Hospital Osaka, Japan.
authors: Yutaka
authors: Y
authors: Seino
keywords: Glucagon-like peptide-1 receptor; Japanese; Lixisenatide