PMID- 25929739
OWN - NLM
STAT- MEDLINE
DCOM- 20170109
LR  - 20221207
IS  - 1753-0407 (Electronic)
IS  - 1753-0407 (Linking)
VI  - 8
IP  - 3
DP  - 2016 May
TI  - Vildagliptin as add-on therapy to insulin improves glycemic control without 
      increasing risk of hypoglycemia in Asian, predominantly Chinese, patients with 
      type 2 diabetes mellitus.
PG  - 345-53
LID - 10.1111/1753-0407.12303 [doi]
AB  - BACKGROUND: The aim of the present study was to investigate the efficacy and 
      safety of vildagliptin added onto insulin with or without metformin in an Asian, 
      predominantly Chinese, population with type 2 diabetes mellitus (T2DM). METHODS: 
      In this 24-week, multicenter, double-blind, placebo-controlled trial, patients 
      with T2DM inadequately controlled (HbA1c 7.5%-11.0%) on stable therapy with 
      long-acting, intermediate-acting, or premixed insulin, with or without 
      concomitant metformin, were randomized to receive vildagliptin 50 mg b.i.d. or 
      placebo. RESULTS: Of 293 patients randomized, 146 received vildagliptin and 147 
      received placebo treatment. At baseline, the overall mean age of patients was 
      58.1 years, mean T2DM duration was 11.3 years, and mean HbA1c was 8.7%. The 
      adjusted mean (+/-SE) change in HbA1c at Week 24 in the vildagliptin and placebo 
      groups was -1.08 +/- 0.12% and -0.38 +/- 0.12%, respectively (between-treatment 
      difference -0.70 +/- 0.16%; P < 0.001). The between-group difference in fasting 
      plasma glucose was -0.43 +/- 0.38 mmol/L (P = 0.259). Significantly, more patients 
      achieved HbA1c <7.0% with vildagliptin than with placebo (23.6% vs. 11.2%; 
      P = 0.006). The incidence of adverse events in the vildagliptin and placebo 
      groups was 43.8% and 46.3%, whereas that of serious adverse events was 3.4% and 
      6.8%, respectively. The frequency of hypoglycemia was lower in the vildagliptin 
      than placebo group (2.7% vs. 5.4%). CONCLUSION: The addition of vildagliptin 
      50 mg b.i.d. significantly improved glycemic control without an increased risk of 
      hypoglycemia in Asian, predominantly Chinese, patients with T2DM inadequately 
      controlled on insulin, with or without metformin.
CI  - (c) 2016 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and John 
      Wiley Sons Australia, & Ltd.
FAU - Ning, Guang
AU  - Ning G
AD  - Ruijin Hospital, Shanghai, China.
FAU - Wang, Weiqing
AU  - Wang W
AD  - Ruijin Hospital, Shanghai, China.
FAU - Li, Ling
AU  - Li L
AD  - Shengjing Hospital of China Medical University, Shenyang, China.
FAU - Ma, Jianhua
AU  - Ma J
AD  - Nanjing First Hospital, Nanjing, China.
FAU - Lv, Xiaofeng
AU  - Lv X
AD  - General Hospital of Beijing Military Region, Beijing, China.
FAU - Yang, Ming
AU  - Yang M
AD  - Beijing Novartis Pharma, Shanghai, China.
FAU - Wang, Wei
AU  - Wang W
AD  - Beijing Novartis Pharma, Shanghai, China.
FAU - Woloschak, Michael
AU  - Woloschak M
AD  - Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
FAU - Lukashevich, Valentina
AU  - Lukashevich V
AD  - Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
FAU - Kothny, Wolfgang
AU  - Kothny W
AD  - Novartis Pharma AG, Basel, Switzerland.
LA  - eng
SI  - ClinicalTrials.gov/NCT01582230
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
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 (Insulin)
RN  - 0 (Nitriles)
RN  - 0 (Pyrrolidines)
RN  - 9100L32L2N (Metformin)
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  - Asia/epidemiology
MH  - Blood Glucose/analysis
MH  - Diabetes Mellitus, Type 2/*drug therapy/epidemiology
MH  - Dipeptidyl-Peptidase IV Inhibitors/therapeutic use
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Female
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hypoglycemia/chemically induced/*prevention & control
MH  - Hypoglycemic Agents/*therapeutic use
MH  - Insulin/*therapeutic use
MH  - Male
MH  - Metformin/therapeutic use
MH  - Middle Aged
MH  - Nitriles/*therapeutic use
MH  - Pyrrolidines/*therapeutic use
MH  - Vildagliptin
MH  - Young Adult
OTO - NOTNLM
OT  - 2型糖尿病
OT  - add-on insulin
OT  - dipeptidyl peptidase-4
OT  - type 2 diabetes mellitus
OT  - vildagliptin
OT  - 二肽基肽酶-4
OT  - 维格列汀
OT  - 胰岛素基础上添加治疗
EDAT- 2015/05/02 06:00
MHDA- 2017/01/10 06:00
CRDT- 2015/05/02 06:00
PHST- 2015/02/12 00:00 [received]
PHST- 2015/04/16 00:00 [accepted]
PHST- 2015/05/02 06:00 [entrez]
PHST- 2015/05/02 06:00 [pubmed]
PHST- 2017/01/10 06:00 [medline]
AID - 10.1111/1753-0407.12303 [doi]
PST - ppublish
SO  - J Diabetes. 2016 May;8(3):345-53. doi: 10.1111/1753-0407.12303.