PMID- 24604395
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20140622
LR  - 20211021
IS  - 1869-6953 (Print)
IS  - 1869-6961 (Electronic)
IS  - 1869-6961 (Linking)
VI  - 5
IP  - 1
DP  - 2014 Jun
TI  - Efficacy and Safety of Vildagliptin as Add-on to Metformin in Japanese Patients 
      with Type 2 Diabetes Mellitus.
PG  - 169-81
LID - 10.1007/s13300-014-0059-x [doi]
AB  - INTRODUCTION: The objective of this study was to evaluate the efficacy and safety 
      of vildagliptin, a potent dipeptidyl peptidase-4 inhibitor, as an add-on to 
      metformin in Japanese patients with type 2 diabetes mellitus (T2DM). METHODS: 
      This multicenter, 12-week, randomized, double-blind, placebo-controlled, 
      parallel-arm study compared vildagliptin 50 mg bid with placebo in T2DM patients 
      who were inadequately controlled [glycosylated hemoglobin (HbA1c) 7.0-10.0%] on a 
      stable daily dose of metformin monotherapy (250 mg bid or 500 mg bid). RESULTS: A 
      total of 139 patients were randomized to receive either vildagliptin (n = 69) or 
      placebo (n = 70). Patient demographics were comparable between the groups at 
      baseline. After 12 weeks of treatment, adjusted mean change in HbA1c was -1.1% in 
      the vildagliptin group (baseline 8.0%) and -0.1% in the placebo group (baseline 
      8.0%), with a between-treatment difference of -1.0% (P < 0.001). Vildagliptin 
      showed a similar reduction in HbA1c of -1.1% for both the subpopulations of 
      patients receiving metformin 250 mg bid or 500 mg bid (P < 0.001 vs. baseline). 
      Significantly more patients in the vildagliptin group achieved an HbA1c target of 
      </=6.5% (30.9%) and <7.0% (64.1%) compared with the placebo group (P < 0.001). The 
      between-treatment difference in adjusted mean change in fasting plasma glucose 
      was -1.6 mmol/L (P < 0.001) in favor of vildagliptin. Patients in the 
      vildagliptin and placebo groups reported comparable incidences of adverse events 
      (44.1% vs. 41.4%). No deaths or hypoglycemic events were reported in the study. 
      CONCLUSIONS: Vildagliptin 50 mg bid added to metformin improved glycemic control 
      without any tolerability issues and hypoglycemia in Japanese patients with T2DM 
      inadequately controlled on metformin monotherapy.
FAU - Odawara, Masato
AU  - Odawara M
AD  - The Third Department of Internal Medicine, Tokyo Medical University, Tokyo, 
      Japan, odawara@tokyo-med.ac.jp.
FAU - Hamada, Izumi
AU  - Hamada I
FAU - Suzuki, Manabu
AU  - Suzuki M
LA  - eng
PT  - Journal Article
DEP - 20140307
PL  - United States
TA  - Diabetes Ther
JT  - Diabetes therapy : research, treatment and education of diabetes and related 
      disorders
JID - 101539025
PMC - PMC4065285
EDAT- 2014/03/08 06:00
MHDA- 2014/03/08 06:01
PMCR- 2014/03/07
CRDT- 2014/03/08 06:00
PHST- 2014/01/23 00:00 [received]
PHST- 2014/03/08 06:00 [entrez]
PHST- 2014/03/08 06:00 [pubmed]
PHST- 2014/03/08 06:01 [medline]
PHST- 2014/03/07 00:00 [pmc-release]
AID - 59 [pii]
AID - 10.1007/s13300-014-0059-x [doi]
PST - ppublish
SO  - Diabetes Ther. 2014 Jun;5(1):169-81. doi: 10.1007/s13300-014-0059-x. Epub 2014 
      Mar 7.