title: Randomized trial assessing the safety and efficacy of sitagliptin in Chinese patients with type 2 diabetes mellitus inadequately controlled on sulfonylurea alone or combined with metformin.
abstract: BACKGROUND
  Type 2 diabetes mellitus (T2DM) is a significant burden in China, where approximately 114 million patients have been diagnosed with diabetes. Chinese patients present with prominent β-cell failure, with resulting deficiency in insulin secretion, particularly early phase insulin secretion leading to postprandial hyperglycemia. Sitagliptin, a selective once-daily oral dipeptidyl peptidase-4 inhibitor, has been shown to improve glycemic control as monotherapy and in combination with other antihyperglycemic agents, including sulfonylureas and metformin.
  
  
  METHODS
  This was a multicenter randomized double-blind placebo-controlled study conducted in China. The study assessed the safety and efficacy of the addition of sitagliptin 100 mg once daily versus placebo on changes from baseline at Week 24 in HbA1c, fasting plasma glucose (FPG) and 2-h post-meal glucose (PMG). Patients were aged 18-79 years, had T2DM with inadequate glycemic control, and were taking a sulfonylurea, with or without metformin.
  
  
  RESULTS
  After 24 weeks, sitagliptin reduced HbA1c, FPG, and 2-h PMG significantly more than placebo (between-treatment differences: -0.61 %, -16.8 mg/dL, and -32.9 mg/dL, respectively; P < 0.001 for all). The addition of sitagliptin was generally well tolerated, with a comparable incidence of adverse events and drug-related adverse events in both treatment groups. The sitagliptin group had a higher incidence of symptomatic hypoglycemia than the placebo group (25/248 [10.1 %] vs 13/249 [5.2 %], respectively; P = 0.042).
  
  
  CONCLUSIONS
  Sitagliptin 100 mg once daily significantly improved glycemic control in Chinese patients with T2DM who had inadequate glycemic control with sulfonylurea, with or without metformin therapy. The addition of sitagliptin was generally well tolerated. (clinicaltrials.gov: NCT01590771).
authors: Chinese PLA General Hospital, Beijing, China.
authors: Jianming
authors: J
authors: Ba
authors: Shengjing Hospital of China Medical University, Liaoning, China.
authors: Ping
authors: P
authors: Han
authors: Affiliated Hospital of Jiangsu University, Zhenjiang, China.
authors: Guoyue
authors: G
authors: Yuan
authors: Xiangya Hospital of Central South, Hunan, China.
authors: Zhaohui
authors: Z
authors: Mo
authors: Chinese PLA General Hospital, Beijing, China.
authors: Changyu
authors: C
authors: Pan
authors: Merck & Co. Inc., Kenilworth, New Jersey, USA.
authors: Fan
authors: F
authors: Wu
authors: Merck & Co. Inc., Kenilworth, New Jersey, USA.
authors: Lei
authors: L
authors: Xu
authors: Merck & Co. Inc., Kenilworth, New Jersey, USA.
authors: Mary E
authors: ME
authors: Hanson
authors: Merck & Co. Inc., Kenilworth, New Jersey, USA.
authors: Samuel S
authors: SS
authors: Engel
authors: Merck & Co. Inc., Kenilworth, New Jersey, USA.
authors: R Ravi
authors: RR
authors: Shankar
mesh_terms: D000368:Aged; D044466:Asian People; D001786:Blood Glucose / Q000378:metabolism; D002318:Cardiovascular Diseases / Q000139:chemically induced; D002681:China; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000208:ethnology; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D008297:Male; D008687:Metformin / Q000627:therapeutic use*; D008875:Middle Aged; D000068900:Sitagliptin Phosphate / Q000009:adverse effects / Q000627:therapeutic use*; D013453:Sulfonylurea Compounds / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D054873:Dipeptidyl-Peptidase IV Inhibitors; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D000068900:Sitagliptin Phosphate; D013453:Sulfonylurea Compounds
keywords: China; HbA1c; hypoglycemia; sitagliptin; sulfonylurea; 中国; 低血糖; 磺脲类; 西格列汀