title: Nateglinide in combination with metformin in Chinese patients with type 2 diabetes mellitus: a post-marketing surveillance study.
abstract: OBJECTIVE
  Diabetes mellitus has become a major public health problem in China. This open-label, prospective, multicentre, post-marketing surveillance study was conducted to investigate the efficacy and safety of nateglinide in combination with metformin in Chinese patients with type 2 diabetes (T2DM).
  
  
  METHODS
  A total of 892 patients with T2DM were included in the study, of whom 361 subjects had been pretreated with metformin and 531 subjects had not previously been treated with any oral antihyperglycaemic agent. All enrolled patients received 120 mg of nateglinide three times daily within 15 minutes before meals together with metformin (with no restrictions on dosage or frequency of administration) for 12 weeks. Physical examination, laboratory tests and relevant tests in terms of efficacy were performed, and adverse events and subject compliance were documented and monitored.
  
  
  RESULTS
  From baseline to week 12, glycosylated haemoglobin (HbA1c) was reduced by 1.52 % ± 1.25 % (mean ± SD), fasting plasma glucose (FPG) by 1.92 ± 1.78 mmol/L, and 2-h post-prandial plasma glucose (2-h PPG) by 4.55 ± 2.93 mmol/L (all p < 0.01); 61.66 % of subjects achieved the HbA1c goals of <7 %. A total adverse events incidence of 2.47 % was observed, including an incidence of 1.68 % treatment-emergent adverse events. The incidence of hypoglycaemia was 1.57 %. Other nateglinide-related adverse events (including gastrointestinal disorders, rash and allergic dermatitis) were also reported. There were no serious adverse effects.
  
  
  CONCLUSIONS
  The combination of nateglinide and metformin is a safe and effective means of achieving glycaemic target in Chinese patients with T2DM.
authors: Department of Endocrinology, Beijing Tongren Hospital, Capital Medical University, Beijing, 100730, China. jinkui.yang@gmail.com
authors: Jin-Kui
authors: JK
authors: Yang
authors: Lei
authors: L
authors: Wang
mesh_terms: D000368:Aged; D001835:Body Weight; D003510:Cyclohexanes / Q000008:administration & dosage / Q000627:therapeutic use*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D000077715:Nateglinide; D010649:Phenylalanine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies
chemical_list: D003510:Cyclohexanes; D007004:Hypoglycemic Agents; D000077715:Nateglinide; D010649:Phenylalanine; D008687:Metformin