PMID- 25691359
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20150326
LR  - 20200930
IS  - 1869-6953 (Print)
IS  - 1869-6961 (Electronic)
IS  - 1869-6961 (Linking)
VI  - 6
IP  - 1
DP  - 2015 Mar
TI  - Efficacy and safety of a single-pill combination of vildagliptin and metformin in 
      Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, 
      placebo-controlled trial.
PG  - 17-27
LID - 10.1007/s13300-015-0099-x [doi]
AB  - INTRODUCTION: The use of dipeptidyl peptidase-4 inhibitors in combination with 
      metformin is increasing in Japanese patients with type 2 diabetes mellitus 
      (T2DM), but no single-pill combination (SPC) is currently available in Japan. The 
      objective of this study was to assess the efficacy and safety of 
      vildagliptin/metformin SPC in Japanese patients with T2DM inadequately controlled 
      with vildagliptin monotherapy. METHODS: This was a 14-week, randomized, 
      double-blind, parallel-group, placebo-controlled trial. 171 patients with T2DM 
      inadequately controlled [HbA1c (glycosylated hemoglobin) 7.0-10.0%] with 
      vildagliptin 50 mg twice daily (bid) were randomized (2:1) to receive either a 
      vildagliptin/metformin SPC (n = 115) or matching vildagliptin/placebo SPC 
      (n = 56). RESULTS: Baseline demographics and background characteristics were 
      generally comparable between the treatment groups. The change in HbA1c 
      [mean +/- standard error (SE)] was -0.8 +/- 0.1% in the vildagliptin/metformin SPC 
      (baseline HbA1c, 7.9 +/- 0.1%) group and 0.1 +/- 0.1% in the vildagliptin/placebo SPC 
      (baseline HbA1c, 8.0 +/- 0.1%) group, with a between-treatment difference of 
      -1.0 +/- 0.1% (P <0.001) in favor of the vildagliptin/metformin SPC group. The 
      proportion of patients achieving target HbA1c <7.0% was significantly higher with 
      vildagliptin/metformin SPC compared with vildagliptin/placebo SPC (45.8% vs. 
      13.5%, P <0.001). The overall incidences of adverse events (AEs) were 43.5% in 
      the vildagliptin/metformin SPC and 67.9% in the vildagliptin/placebo SPC group. 
      The incidences of serious AEs were low in both the treatment groups (0.9% vs. 
      3.6%, respectively). Body weight remained constant throughout the study in both 
      the treatment groups. There were no deaths or hypoglycemic events during the 
      study. CONCLUSIONS: Switching Japanese patients with T2DM requiring treatment 
      intensification, from vildagliptin monotherapy to a vildagliptin/metformin SPC 
      (50/250 or 50/500 mg) was efficacious and safe, eliciting significant reduction 
      in HbA1c without increased risk of hypoglycemia and weight gain.
FAU - Odawara, Masato
AU  - Odawara M
AD  - The Department of Diabetes, Endocrinology, Metabolism and Rheumatology, Tokyo 
      Medical University, Tokyo, Japan, odawara@tokyo-med.ac.jp.
FAU - Yoshiki, Mika
AU  - Yoshiki M
FAU - Sano, Misako
AU  - Sano M
FAU - Hamada, Izumi
AU  - Hamada I
FAU - Lukashevich, Valentina
AU  - Lukashevich V
FAU - Kothny, Wolfgang
AU  - Kothny W
LA  - eng
PT  - Journal Article
DEP - 20150218
PL  - United States
TA  - Diabetes Ther
JT  - Diabetes therapy : research, treatment and education of diabetes and related 
      disorders
JID - 101539025
PMC - PMC4374075
EDAT- 2015/02/19 06:00
MHDA- 2015/02/19 06:01
PMCR- 2015/02/18
CRDT- 2015/02/19 06:00
PHST- 2014/12/24 00:00 [received]
PHST- 2015/02/19 06:00 [entrez]
PHST- 2015/02/19 06:00 [pubmed]
PHST- 2015/02/19 06:01 [medline]
PHST- 2015/02/18 00:00 [pmc-release]
AID - 99 [pii]
AID - 10.1007/s13300-015-0099-x [doi]
PST - ppublish
SO  - Diabetes Ther. 2015 Mar;6(1):17-27. doi: 10.1007/s13300-015-0099-x. Epub 2015 Feb 
      18.