PMID- 23958390
OWN - NLM
STAT- MEDLINE
DCOM- 20140507
LR  - 20240506
IS  - 1475-2840 (Electronic)
IS  - 1475-2840 (Linking)
VI  - 12
DP  - 2013 Aug 19
TI  - 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.
PG  - 118
LID - 10.1186/1475-2840-12-118 [doi]
AB  - BACKGROUND AND AIM: 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/m(2); <60 years and >/=24 kg/m(2); >/=60 years and <24 kg/m(2); 
      and >/=60 years and >/=24 kg/m(2). CONCLUSION: 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.
FAU - Ji, Li-Nong
AU  - Ji LN
AD  - Peking University People's Hospital, 11 Xizhimen Nan Dajie, Xicheng District, 
      Beijing, China. jilinong@gmail.com.
FAU - Pan, Chang-Yu
AU  - Pan CY
FAU - Lu, Ju-Ming
AU  - Lu JM
FAU - Li, Hong
AU  - Li H
FAU - Li, Qiang
AU  - Li Q
FAU - Li, Qi-Fu
AU  - Li QF
FAU - Peng, Yong-De
AU  - Peng YD
FAU - Tian, Hao-Ming
AU  - Tian HM
FAU - Yao, Chen
AU  - Yao C
FAU - Zhao, Zhi-Gang
AU  - Zhao ZG
FAU - Zhang, Ru-Ya
AU  - Zhang RY
FAU - Wang, Xiang-Ling
AU  - Wang XL
FAU - Wang, Lei
AU  - Wang L
CN  - VISION Study Group
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130819
PL  - England
TA  - Cardiovasc Diabetol
JT  - Cardiovascular diabetology
JID - 101147637
RN  - 0 (Biomarkers)
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Nitriles)
RN  - 0 (Pyrrolidines)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 9100L32L2N (Metformin)
RN  - I6B4B2U96P (Vildagliptin)
RN  - PJY633525U (Adamantane)
SB  - IM
MH  - Adamantane/adverse effects/*analogs & derivatives/therapeutic use
MH  - Age Factors
MH  - Asian People
MH  - Biomarkers/blood
MH  - Body Mass Index
MH  - China/epidemiology
MH  - Clinical Protocols
MH  - Diabetes Mellitus, Type 2/blood/diagnosis/*drug therapy/ethnology
MH  - Dipeptidyl-Peptidase IV Inhibitors/adverse effects/*therapeutic use
MH  - Drug Therapy, Combination
MH  - Female
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Hypoglycemic Agents/adverse effects/*therapeutic use
MH  - Male
MH  - Metformin/adverse effects/*therapeutic use
MH  - Middle Aged
MH  - Nitriles/adverse effects/*therapeutic use
MH  - Prospective Studies
MH  - Pyrrolidines/adverse effects/*therapeutic use
MH  - *Research Design
MH  - Time Factors
MH  - Treatment Outcome
MH  - Vildagliptin
PMC - PMC3766124
EDAT- 2013/08/21 06:00
MHDA- 2014/05/08 06:00
PMCR- 2013/08/19
CRDT- 2013/08/21 06:00
PHST- 2013/05/02 00:00 [received]
PHST- 2013/08/13 00:00 [accepted]
PHST- 2013/08/21 06:00 [entrez]
PHST- 2013/08/21 06:00 [pubmed]
PHST- 2014/05/08 06:00 [medline]
PHST- 2013/08/19 00:00 [pmc-release]
AID - 1475-2840-12-118 [pii]
AID - 10.1186/1475-2840-12-118 [doi]
PST - epublish
SO  - Cardiovasc Diabetol. 2013 Aug 19;12:118. doi: 10.1186/1475-2840-12-118.