PMID- 24823599
OWN - NLM
STAT- MEDLINE
DCOM- 20151029
LR  - 20221207
IS  - 1753-0407 (Electronic)
IS  - 1753-0407 (Linking)
VI  - 7
IP  - 2
DP  - 2015 Mar
TI  - Vildagliptin added to sulfonylurea improves glycemic control without hypoglycemia 
      and weight gain in Chinese patients with type 2 diabetes mellitus.
PG  - 174-81
LID - 10.1111/1753-0407.12169 [doi]
AB  - OBJECTIVE: The aim of the present study was to assess the efficacy and safety of 
      vildagliptin as add-on to sulfonylurea therapy in Chinese patients with type 2 
      diabetes mellitus (T2DM) inadequately controlled on sulfonylurea monotherapy. 
      METHODS: The 24-week randomized double-blind placebo-controlled study compared 
      vildagliptin 50 mg, q.d., with placebo as add-on to glimepiride in T2DM patients 
      who were inadequately controlled (HbA1c 7.5%-11.0% [58-97 mmol/mol]) on a stable 
      dose of sulfonylurea for >/=12 weeks before study entry. RESULTS: In all, 279 
      patients were randomized to receive either vildagliptin (n = 143) or placebo 
      (n = 136). At baseline, overall mean age was 58.5 years, body weight 68.1 kg, 
      duration of diabetes 6.9 years and daily glimepiride dose 3.3 mg. After 24 weeks, 
      the adjusted mean change (AMDelta) in HbA1c was -0.7% (-8 mmol/mol; baseline 8.6%, 
      70 mmol/mol) in the vildagliptin group and -0.2% (-2 mmol/mol; baseline 8.7%, 
      72 mmol/mol) in the placebo group, with a treatment difference of -0.5% 
      (-5 mmol/mol; P < 0.001). The between-group difference in AMDelta in fasting plasma 
      glucose was -0.4 mmol/L (P = 0.160). There was a slight, but not significant, 
      decrease in body weight in both groups. No hypoglycemic events were reported in 
      either group, including those patients reaching HbA1c <7.0%. Patients in the 
      vildagliptin and placebo groups reported low and comparable incidences of adverse 
      events (14.0% vs. 17.8%) and serious adverse events (0.7% in each group). 
      CONCLUSION: Vildagliptin 50 mg, q.d., added to sulfonylurea monotherapy is 
      effective in Chinese patients with T2DM, without increasing the risk of 
      hypoglycemia and weight gain.
CI  - (c) 2014 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and Wiley 
      Publishing Asia Pty Ltd.
FAU - Yang, Wenying
AU  - Yang W
AD  - China-Japan Friendship Hospital, Beijing, China.
FAU - Xing, Xiaoping
AU  - Xing X
FAU - Lv, Xiaofeng
AU  - Lv X
FAU - Li, Yiming
AU  - Li Y
FAU - Ma, Jianhua
AU  - Ma J
FAU - Yuan, Guoyue
AU  - Yuan G
FAU - Sun, Feifei
AU  - Sun F
FAU - Wang, Wei
AU  - Wang W
FAU - Woloschak, Michael
AU  - Woloschak M
FAU - Lukashevich, Valentina
AU  - Lukashevich V
FAU - Kozlovski, Plamen
AU  - Kozlovski P
FAU - Kothny, Wolfgang
AU  - Kothny W
CN  - all investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT01357252
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140729
PL  - Australia
TA  - J Diabetes
JT  - Journal of diabetes
JID - 101504326
RN  - 0 (Blood Glucose)
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Nitriles)
RN  - 0 (Pyrrolidines)
RN  - 0 (Sulfonylurea Compounds)
RN  - 6KY687524K (glimepiride)
RN  - I6B4B2U96P (Vildagliptin)
RN  - PJY633525U (Adamantane)
SB  - IM
MH  - Adamantane/*analogs & derivatives/therapeutic use
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Blood Glucose/analysis/drug effects
MH  - Case-Control Studies
MH  - China
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Dipeptidyl-Peptidase IV Inhibitors/therapeutic use
MH  - Double-Blind Method
MH  - Female
MH  - Follow-Up Studies
MH  - Glycated Hemoglobin/metabolism
MH  - Glycemic Index
MH  - Humans
MH  - Hypoglycemia/*prevention & control
MH  - Hypoglycemic Agents/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Nitriles/*therapeutic use
MH  - Prognosis
MH  - Pyrrolidines/*therapeutic use
MH  - Risk Factors
MH  - Sulfonylurea Compounds/*therapeutic use
MH  - Vildagliptin
MH  - Weight Gain/*drug effects
MH  - Young Adult
OTO - NOTNLM
OT  - Chinese
OT  - dipeptidyl peptidase-4
OT  - glimepiride
OT  - type 2 diabetes mellitus
OT  - vildagliptin
OT  - 关键词：中国人，二肽基肽酶-4，格列美脲，2型糖尿病，维格列汀
FIR - Yang, Wenying
IR  - Yang W
FIR - Guo, Xiaohui
IR  - Guo X
FIR - Xing, Xiaoping
IR  - Xing X
FIR - Lv, Xiaofeng
IR  - Lv X
FIR - Li, Quanmin
IR  - Li Q
FIR - Biao, Yuqian
IR  - Biao Y
FIR - Li, Yiming
IR  - Li Y
FIR - Zhang, Xiuzhen
IR  - Zhang X
FIR - Ma, Jianhua
IR  - Ma J
FIR - Zhu, Dalong
IR  - Zhu D
FIR - Yang, Tao
IR  - Yang T
FIR - Han, Ping
IR  - Han P
FIR - Zheng, Shaoxiong
IR  - Zheng S
FIR - Li, Yukun
IR  - Li Y
FIR - Mo, Zhaohui
IR  - Mo Z
FIR - Yuan, Guoyue
IR  - Yuan G
FIR - Li, Yanbing
IR  - Li Y
FIR - Xiang, Guangda
IR  - Xiang G
EDAT- 2014/05/16 06:00
MHDA- 2015/10/30 06:00
CRDT- 2014/05/15 06:00
PHST- 2014/03/15 00:00 [received]
PHST- 2014/05/07 00:00 [accepted]
PHST- 2014/05/15 06:00 [entrez]
PHST- 2014/05/16 06:00 [pubmed]
PHST- 2015/10/30 06:00 [medline]
AID - 10.1111/1753-0407.12169 [doi]
PST - ppublish
SO  - J Diabetes. 2015 Mar;7(2):174-81. doi: 10.1111/1753-0407.12169. Epub 2014 Jul 29.