PMID- 20537746
OWN - NLM
STAT- MEDLINE
DCOM- 20101123
LR  - 20221207
IS  - 1872-8227 (Electronic)
IS  - 0168-8227 (Linking)
VI  - 89
IP  - 3
DP  - 2010 Sep
TI  - Efficacy and tolerability of vildagliptin as an add-on to glimepiride in Japanese 
      patients with Type 2 diabetes mellitus.
PG  - 216-23
LID - 10.1016/j.diabres.2010.04.017 [doi]
AB  - AIM: To investigate the efficacy and tolerability of vildagliptin, a potent and 
      selective dipeptidyl peptidase-4 inhibitor, as add-on to glimepiride in Japanese 
      patients with Type 2 diabetes mellitus (T2DM) who were inadequately controlled. 
      METHODS: This 12-week, randomized, double-blind, placebo-controlled study 
      compared vildagliptin 50mg twice-daily (n=102) with placebo (n=100) when added to 
      a stable dose of glimepiride (>or=1mg/d). RESULTS: Treatment groups were balanced 
      at baseline (glycosylated hemoglobin [HbA(1c)], 7.9%; fasting plasma glucose, 
      163.8 mg/dL). During treatment HbA(1c) decreased progressively with vildagliptin, 
      but remained unchanged with placebo. The adjusted mean change (AMDelta) at 
      endpoint was -1.0+/-0.1 and -0.1+/-0.1% in vildagliptin- and placebo-treated 
      patients (between-group Delta=-1.0+/-0.1%, P<0.001). A greater proportion of 
      vildagliptin-treated patients had HbA(1c) <or=6.5% compared to placebo-treated 
      patients (45% vs. 3%, P<0.001). The AMDelta FPG was -20.9+/-2.8 mg/dL with 
      vildagliptin compared to 6.3+/-2.8 mg/dL with placebo (between-group 
      Delta=-27.2+/-3.9 mg/dL, P<0.001). Patients in vildagliptin and placebo groups 
      reported similar incidences of adverse events (AEs) (59.8% vs. 57.0%), serious 
      AEs (0% vs. 2.0%), suspected drug-related AEs (21.6% vs. 23.0%), and 
      discontinuation due to AEs (1.0% vs. 3.0%). Hypogylcaemia was reported in two 
      (vildagliptin) and one (placebo) patient. CONCLUSION: Vildagliptin is effective 
      and well tolerated as an add-on to glimepiride in Japanese patients with T2DM.
CI  - Copyright (c) 2010 Elsevier Ireland Ltd. All rights reserved.
FAU - Kikuchi, Masatoshi
AU  - Kikuchi M
AD  - Division of Diabetes and Metabolism, The Institute for Adult Diseases, Asahi Life 
      Foundation, Tokyo, Japan.
FAU - Haneda, Masakazu
AU  - Haneda M
FAU - Koya, Daisuke
AU  - Koya D
FAU - Tobe, Kazuyuki
AU  - Tobe K
FAU - Onishi, Yukiko
AU  - Onishi Y
FAU - Couturier, Andre
AU  - Couturier A
FAU - Mimori, Nobuyuki
AU  - Mimori N
FAU - Inaba, Yoko
AU  - Inaba Y
FAU - Goodman, Matthew
AU  - Goodman M
LA  - eng
SI  - ClinicalTrials.gov/NCT00325117
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - Ireland
TA  - Diabetes Res Clin Pract
JT  - Diabetes research and clinical practice
JID - 8508335
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
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/adverse effects/*analogs & derivatives/therapeutic use
MH  - Aged
MH  - Asian People
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Dipeptidyl-Peptidase IV Inhibitors/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Hypoglycemic Agents/adverse effects/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Nitriles/adverse effects/*therapeutic use
MH  - Pyrrolidines/adverse effects/*therapeutic use
MH  - Sulfonylurea Compounds/adverse effects/*therapeutic use
MH  - Treatment Outcome
MH  - Vildagliptin
EDAT- 2010/06/12 06:00
MHDA- 2010/12/14 06:00
CRDT- 2010/06/12 06:00
PHST- 2009/10/21 00:00 [received]
PHST- 2010/04/21 00:00 [revised]
PHST- 2010/04/26 00:00 [accepted]
PHST- 2010/06/12 06:00 [entrez]
PHST- 2010/06/12 06:00 [pubmed]
PHST- 2010/12/14 06:00 [medline]
AID - S0168-8227(10)00199-3 [pii]
AID - 10.1016/j.diabres.2010.04.017 [doi]
PST - ppublish
SO  - Diabetes Res Clin Pract. 2010 Sep;89(3):216-23. doi: 
      10.1016/j.diabres.2010.04.017.