title: Sitagliptin added to stable insulin therapy with or without metformin in Chinese patients with type 2 diabetes.
abstract: BACKGROUND
  We evaluated the tolerability and efficacy of the addition of sitagliptin in Chinese patients with type 2 diabetes mellitus receiving stable insulin therapy alone or in combination with metformin.
  
  
  METHODS
  A total of 467 patients with inadequate glycemic control on insulin (glycated hemoglobin [HbA1c] ≥7.5% and ≤11%) were randomized 1:1 to receive sitagliptin 100 mg once daily or a matching placebo for 24 weeks. Randomization was stratified based on metformin use (on or not on metformin) and type of insulin (pre-mixed vs intermediate-/long-acting) at screening. The primary end-point was the change from baseline at week 24 in HbA1c.
  
  
  RESULTS
  The addition of sitagliptin led to a significantly (P < 0.001) greater week 24 HbA1c reduction (0.7%) compared with the reduction (0.3%) with placebo. A significantly (P = 0.013) greater proportion of patients taking sitagliptin (16%) had an HbA1c of <7.0% at week 24 compared with placebo (8%). The addition of sitagliptin significantly (P < 0.001) reduced 2-h post-meal glucose by 26.5 mg/dL (1.5 mmol/L) relative to placebo. Reductions from baseline in fasting plasma glucose were observed in both the sitagliptin (14.4 mg/dL reduction) and placebo (10.7 mg/dL reduction) groups; the between-group difference was not significant. A total of 64 (27.4%) patients taking sitagliptin and 51 (21.9%) taking placebo experienced adverse events of hypoglycemia (symptomatic or asymptomatic). Neither group had a significant change from baseline in bodyweight.
  
  
  CONCLUSIONS
  After 24 weeks, sitagliptin added to stable insulin therapy (±metformin) was generally well tolerated and improved glycemic control in Chinese patients with type 2 diabetes mellitus.
authors.affiliation: Merck & Co., Inc., Kenilworth, New Jersey, USA.
authors.forename: R Ravi
authors.initials: RR
authors.lastname: Shankar
authors.affiliation: Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai.
authors.forename: Yuqian
authors.initials: Y
authors.lastname: Bao
authors.affiliation: Shengjing Hospital of China Medical University, Shenyang.
authors.forename: Ping
authors.initials: P
authors.lastname: Han
authors.affiliation: The Second Affiliated Hospital of Soochow University, Suzhou.
authors.forename: Ji
authors.initials: J
authors.lastname: Hu
authors.affiliation: Nanjing First Hospital Affiliated to Nanjing Medical University, Nanjing.
authors.forename: Jianhua
authors.initials: J
authors.lastname: Ma
authors.affiliation: Shanghai First People's Hospital affiliated to Shanghai Jiaotong University, Shanghai.
authors.forename: Yongde
authors.initials: Y
authors.lastname: Peng
authors.affiliation: MSD China, Beijing, China.
authors.forename: Fan
authors.initials: F
authors.lastname: Wu
authors.affiliation: Merck & Co., Inc., Kenilworth, New Jersey, USA.
authors.forename: Lei
authors.initials: L
authors.lastname: Xu
authors.affiliation: Merck & Co., Inc., Kenilworth, New Jersey, USA.
authors.forename: Samuel S
authors.initials: SS
authors.lastname: Engel
authors.affiliation: Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai.
authors.forename: Weiping
authors.initials: W
authors.lastname: Jia
mesh_terms: D044466:Asian People; D002681:China; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007328:Insulin / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000627:therapeutic use*; D008875:Middle Aged; D000068900:Sitagliptin Phosphate / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D008687:Metformin; D000068900:Sitagliptin Phosphate; C517652:hemoglobin A1c protein, human
keywords: Insulin; Sitagliptin; Type 2 diabetes mellitus