title: Efficacy and safety of combination therapy with vildagliptin and metformin versus metformin uptitration in Chinese patients with type 2 diabetes inadequately controlled with metformin monotherapy: a randomized, open-label, prospective study (VISION).
abstract: To compare the efficacy and safety of combination of vildagliptin and metformin therapy with metformin uptitration in Chinese patients with type 2 diabetes (T2DM) inadequately controlled with low-dose metformin.
  
  
  
  In this 24-week prospective, randomized, multicentre, open-label study, patients with T2DM inadequately controlled with metformin ≤1000 mg daily were divided 1 : 1 : 1 : 1 into four prespecified subgroups based on age and body mass index (BMI). Patients in each subgroup were randomized 5 : 1 to receive either vildagliptin (50 mg twice daily) plus metformin [500 mg twice daily; vildagliptin and low-dose metformin (VLDM) group] or metformin uptitration [1000 mg twice daily; high-dose metformin (HDM) group]. The primary endpoint was change in glycated haemoglobin (HbA1c) from baseline at week 24. The key secondary endpoints included percentage of patients achieving target HbA1c without adverse gastrointestinal (GI) events and mean change in fasting plasma glucose (FPG) from baseline to week 24.
  
  
  
  A total of 3084 patients were randomized. HbA1c reduction of 0.54% at week 24 in the VLDM group was non-inferior and statistically superior compared with 0.40% in the HDM group (P < 0.0001). VLDM's non-inferiority to HDM was confirmed in the four subgroups and its superiority was shown for all subgroups (p < 0.05) except for the subgroup of patients aged <60 years with a BMI of ≥24 kg/m(2) . Compared with HDM, VLDM significantly increased the percentage of patients achieving HbA1c ≤6.5% and HbA1c ≤6.5% without GI events. FPG levels in the VLDM group were lower at week 24 numerically than in the HDM group. The two treatment arms had similar safety profiles.
  
  
  
  VLDM was non-inferior and statistically superior to HDM in glycaemic control in Chinese patients with T2DM inadequately controlled with low-dose metformin.
authors.affiliation: Department of Endocrinology, Peking University People's Hospital, Beijing, China.
authors.forename: L-N
authors.initials: LN
authors.lastname: Ji
authors.affiliation: Department of Endocrinology, Chinese PLA General Hospital, Beijing, China.
authors.forename: C-Y
authors.initials: CY
authors.lastname: Pan
authors.affiliation: Department of Endocrinology, Chinese PLA General Hospital, Beijing, China.
authors.forename: J-M
authors.initials: JM
authors.lastname: Lu
authors.affiliation: Department of Endocrinology, Sir Run Run Shaw Hospital, Zhejiang University Medical College, Hangzhou, China.
authors.forename: H
authors.initials: H
authors.lastname: Li
authors.affiliation: Department of Endocrinology, Nanjing Drum Tower Hospital, Nanjing University Medical School, Nanjing, China.
authors.forename: D-L
authors.initials: DL
authors.lastname: Zhu
authors.affiliation: Department of Endocrinology and Metabolism, Second Affiliated Hospital of Harbin Medical University, Harbin, China.
authors.forename: Q
authors.initials: Q
authors.lastname: Li
authors.affiliation: Department of Endocrinology, First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
authors.forename: Q-F
authors.initials: QF
authors.lastname: Li
authors.affiliation: Department of Endocrinology, Shanghai First People's Hospital, Shanghai, China.
authors.forename: Y-D
authors.initials: YD
authors.lastname: Peng
authors.affiliation: Department of Endocrinology, West China Hospital, Sichuan University, Chengdu, China.
authors.forename: H-M
authors.initials: HM
authors.lastname: Tian
authors.affiliation: Department of Endocrinology, Peking University First Hospital, Beijing, China.
authors.forename: C
authors.initials: C
authors.lastname: Yao
authors.affiliation: Department of Endocrinology, Zhengzhou Yihe Hospital, Zhengzhou, China.
authors.forename: Z-G
authors.initials: ZG
authors.lastname: Zhao
authors.affiliation: Novartis Pharmaceuticals (China), Shanghai, China.
authors.forename: L
authors.initials: L
authors.lastname: Wang
authors.affiliation: Novartis Pharmaceuticals (China), Shanghai, China.
authors.forename: B-H
authors.initials: BH
authors.lastname: Wang
mesh_terms: D000218:Adamantane / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000368:Aged; D044466:Asian People; D001786:Blood Glucose / Q000378:metabolism; D015992:Body Mass Index; D002681:China; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000378:metabolism; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D008297:Male; D008687:Metformin / Q000008:administration & dosage* / Q000627:therapeutic use; D008875:Middle Aged; D009570:Nitriles / Q000627:therapeutic use*; D011446:Prospective Studies; D011759:Pyrrolidines / Q000627:therapeutic use*; D016896:Treatment Outcome; D000077597:Vildagliptin
chemical_list: D000218:Adamantane; D001786:Blood Glucose; D054873:Dipeptidyl-Peptidase IV Inhibitors; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D009570:Nitriles; D011759:Pyrrolidines; D000077597:Vildagliptin; C517652:hemoglobin A1c protein, human
keywords: Chinese; glycated haemoglobin (HbA1c); metformin; type 2 diabetes; vildagliptin