title: Efficacy and safety of combination therapy with vildagliptin and metformin versus metformin up-titration in Chinese patients with type 2 diabetes mellitus: study design and rationale of the vision study.
abstract: OBJECTIVE
  Limitations of the currently recommended stepwise treatment pathway for type 2 diabetes mellitus (T2DM), especially the failure of monotherapies to maintain good glycemic control, have prompted use of early, more aggressive combination therapies.The VISION study is designed to explore the efficacy and safety of vildagliptin as an add-on to metformin therapy compared with up-titration of metformin monotherapy in Chinese patients with T2DM.
  
  
  METHODS
  VISION, a 24-week, phase 4, prospective, randomized, multicenter, open-label, parallel-group study, will include 3312 Chinese T2DM patients aged ≥18 years who are inadequately controlled (6.5% >HbA1c ≤9%) by metformin (750-1000 mg/day). Eligible patients will be randomized to receive either vildagliptin plus metformin or up-titration of metformin monotherapy (5:1). Patients will also be subgrouped (1:1:1:1) based on their age and body mass index (BMI): <60 years and <24 kg/m²; <60 years and ≥24 kg/m²; ≥60 years and <24 kg/m²; and ≥60 years and ≥24 kg/m².
  
  
  CONCLUSIONS
  The VISION study will test the hypothesis that early use of combination therapy with vildagliptin and metformin will provide good glycemic control and will be better tolerated than up-titration of metformin monotherapy. The study will also correlate these benefits with age and BMI.
authors: Peking University People's Hospital, 11 Xizhimen Nan Dajie, Xicheng District, Beijing, China. jilinong@gmail.com.
authors: Li-Nong
authors: LN
authors: Ji
authors: Chang-Yu
authors: CY
authors: Pan
authors: Ju-Ming
authors: JM
authors: Lu
authors: Hong
authors: H
authors: Li
authors: Qiang
authors: Q
authors: Li
authors: Qi-Fu
authors: QF
authors: Li
authors: Yong-De
authors: YD
authors: Peng
authors: Hao-Ming
authors: HM
authors: Tian
authors: Chen
authors: C
authors: Yao
authors: Zhi-Gang
authors: ZG
authors: Zhao
authors: Ru-Ya
authors: RY
authors: Zhang
authors: Xiang-Ling
authors: XL
authors: Wang
authors: Lei
authors: L
authors: Wang
mesh_terms: D000218:Adamantane / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000367:Age Factors; D044466:Asian People; D015415:Biomarkers / Q000097:blood; D015992:Body Mass Index; D002681:China / Q000453:epidemiology; D002985:Clinical Protocols; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000208:ethnology; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008687:Metformin / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D009570:Nitriles / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011759:Pyrrolidines / Q000009:adverse effects / Q000627:therapeutic use*; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome; D000077597:Vildagliptin
chemical_list: D000218:Adamantane; D015415:Biomarkers; D054873:Dipeptidyl-Peptidase IV Inhibitors; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D009570:Nitriles; D011759:Pyrrolidines; D000077597:Vildagliptin; C517652:hemoglobin A1c protein, human
references: Ann Intern Med. 2002 Jul 2;137(1):25-33
references: 12093242
references: Diabetologia. 2012 Jun;55(6):1577-96
references: 22526604
references: Cardiovasc Diabetol. 2012 Aug 06;11:92
references: 22867630
references: Biochem Biophys Res Commun. 2002 Nov 15;298(5):779-84
references: 12419322
references: Vasc Health Risk Manag. 2008;4(4):753-68
references: 19065993
references: Lancet. 1998 Sep 12;352(9131):854-65
references: 9742977
references: Pharmacol Res. 2013 Jul;73:20-6
references: 23624419
references: J Clin Endocrinol Metab. 2009 Jan;94(1):81-8
references: 18957505
references: Diabetes Obes Metab. 2009 May;11 Suppl 2:9-17
references: 19385979
references: World J Diabetes. 2010 Mar 15;1(1):19-26
references: 21537424
references: N Engl J Med. 2010 Mar 25;362(12):1090-101
references: 20335585
references: Diabetes Metab. 2012 Oct;38(4):359-66
references: 22809630
references: J Clin Endocrinol Metab. 2007 Apr;92(4):1249-55
references: 17244786
references: Diabetes Care. 2002 May;25(5):869-75
references: 11978683
references: Curr Med Res Opin. 2005 Dec;21(12):2029-35
references: 16368054
references: J Clin Endocrinol Metab. 2005 Aug;90(8):4888-94
references: 15886245
references: BMJ. 2010 May 20;340:c2181
references: 20488910
references: Diabetes Res Clin Pract. 2007 Apr;76(1):132-8
references: 17223217
references: Diabetes Obes Metab. 2011 Mar;13(3):193-203
references: 21205107
references: Diabetes Technol Ther. 2012 Jun;14(6):475-84
references: 22512264
references: Biochem Biophys Res Commun. 2002 Mar 15;291(5):1302-8
references: 11883961
references: J Obes. 2011;2011:957268
references: 21253513
references: Am J Med. 2011 Jan;124(1 Suppl):S19-34
references: 21194577
references: Diabetes Obes Metab. 2010 Sep;12(9):780-9
references: 20649630
references: N Engl J Med. 2006 Dec 7;355(23):2427-43
references: 17145742
references: JAMA. 1999 Jun 2;281(21):2005-12
references: 10359389
references: Lancet. 1998 Sep 12;352(9131):837-53
references: 9742976
references: Vasc Health Risk Manag. 2008;4(3):481-92
references: 18827867
references: J Assoc Physicians India. 2011 Apr;59:237-45
references: 21755761
references: Lancet. 2011 Jul 9;378(9786):182-97
references: 21705062
references: Diabetes Care. 2005 Aug;28(8):1936-40
references: 16043735
references: Br J Clin Pharmacol. 1994 May;37(5):401-4
references: 8054244
references: Biomed Environ Sci. 2010 Jun;23(3):173-9
references: 20708495
references: Diabetologia. 2007 Jun;50(6):1148-55
references: 17387446
references: Diabetes Care. 2009 Nov;32 Suppl 2:S217-22
references: 19875555
references: Diabetes Obes Metab. 2009 May;11(5):506-15
references: 19320662
references: Cochrane Database Syst Rev. 2008 Apr 16;(2):CD006739
references: 18425967
references: Open Med. 2011;5(1):e35-48
references: 22046219
references: Diabetes Obes Metab. 2008 Nov;10(11):1114-24
references: 18355325
references: J Clin Endocrinol Metab. 2004 May;89(5):2078-84
references: 15126524
references: Nat Rev Endocrinol. 2011 Feb 08;7(7):408-19
references: 21301486
references: Diabetes Care. 2004 Dec;27(12):2874-80
references: 15562200
references: Am J Med. 2000 Apr 17;108 Suppl 6a:15S-22S
references: 10764846
references: Expert Opin Pharmacother. 2012 Dec;13(18):2581-91
references: 23121473
references: Diabet Med. 2007 Apr;24(4):350-8
references: 17335466