title: Randomized clinical trial of the safety and efficacy of sitagliptin and metformin co-administered to Chinese patients with type 2 diabetes mellitus.
abstract: BACKGROUND
  The results of a clinical trial to evaluate the efficacy and safety of initial combination therapy with sitagliptin and metformin in Chinese patients with type 2 diabetes and inadequate glycemic control are reported here.
  
  
  METHODS
  This was a multicenter, randomized, double-blind, placebo-controlled, parallel group, 24-week clinical trial carried out in China. Patients (n = 744) with type 2 diabetes and inadequate glycemic control (glycated hemoglobin ≥7.5 and ≤11.0%) who were either drug-naïve or washed out of previous therapy were randomized in equal ratios to sitagliptin 100 mg once daily (q.d.; S100), metformin 500 mg twice daily (b.i.d.; M1000), metformin 850 mg b.i.d. (M1700), sitagliptin 50 mg b.i.d. plus metformin 500 mg b.i.d. (S100/M1000), sitagliptin 50 mg b.i.d. plus metformin 850 mg b.i.d. (S100/M1700), or placebo.
  
  
  RESULTS
  The mean baseline glycated hemoglobin in randomized patients was 8.7%. Least squares mean changes from baseline in glycated hemoglobin were -0.59% (placebo), -0.99% (S100), -1.29% (M1000), -1.56% (M1700), -1.67% (S100/M1000) and -1.83% (S100/M1700) (P < 0.05 for each active group vs placebo, for S100/M1700 and S100/M1000 vs S100, and for S100/M1000 vs M1000). All treatments were generally well-tolerated. The overall incidence of hypoglycemia (symptomatic or asymptomatic) was higher in the two co-administration groups (S100/M1700 and S100/M1000) compared with the placebo. The incidence of symptomatic hypoglycemia was low, and similar, across all treatment groups. The incidences of gastrointestinal adverse events were generally higher in high-dose metformin groups than in the placebo group.
  
  
  CONCLUSIONS
  In Chinese patients with type 2 diabetes, initial combination therapy with sitagliptin and metformin was generally well-tolerated, and provided improvement in glycemic control.
authors.affiliation: Peking University People's Hospital, Beijing, China.
authors.forename: Linong
authors.initials: L
authors.lastname: Ji
authors.affiliation: Shengjing Hospital, China Medical University, Shenyang, China.
authors.forename: Ping
authors.initials: P
authors.lastname: Han
authors.affiliation: The First People's Hospital of Yueyang, Yueyang, China.
authors.forename: Xiaoyue
authors.initials: X
authors.lastname: Wang
authors.affiliation: Jiangxi Province People's Hospital, Nanchang, China.
authors.forename: Jingdong
authors.initials: J
authors.lastname: Liu
authors.affiliation: The Second Hospital of Tianjin Medical University, Tianjin, China.
authors.forename: Shaoxiong
authors.initials: S
authors.lastname: Zheng
authors.affiliation: Merck & Co., Inc, Kenilworth, New Jersey, USA.
authors.forename: Ying-Ming
authors.initials: YM
authors.lastname: Jou
authors.affiliation: Merck & Co., Inc, Kenilworth, New Jersey, USA.
authors.forename: Edward A
authors.initials: EA
authors.lastname: O'Neill
authors.affiliation: Merck & Co., Inc, Kenilworth, New Jersey, USA.
authors.forename: Gregory T
authors.initials: GT
authors.lastname: Golm
authors.affiliation: Merck & Co., Inc, Kenilworth, New Jersey, USA.
authors.forename: Samuel S
authors.initials: SS
authors.lastname: Engel
authors.affiliation: Merck & Co., Inc, Kenilworth, New Jersey, USA.
authors.forename: Keith D
authors.initials: KD
authors.lastname: Kaufman
authors.affiliation: Merck & Co., Inc, Kenilworth, New Jersey, USA.
authors.forename: R Ravi
authors.initials: RR
authors.lastname: Shankar
mesh_terms: D002681:China; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000008:administration & dosage / 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 / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D000068900:Sitagliptin Phosphate / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D054873:Dipeptidyl-Peptidase IV Inhibitors; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D000068900:Sitagliptin Phosphate; C517652:hemoglobin A1c protein, human
keywords: Dipeptidyl peptidase-4 inhibitor; Glycemic control; Incretin therapy