PMID- 25861982
OWN - NLM
STAT- MEDLINE
DCOM- 20150910
LR  - 20221207
IS  - 1744-7666 (Electronic)
IS  - 1465-6566 (Linking)
VI  - 16
IP  - 7
DP  - 2015 May
TI  - Safety and efficacy of teneligliptin in Japanese patients with type 2 diabetes 
      mellitus: a pooled analysis of two Phase III clinical studies.
PG  - 971-81
LID - 10.1517/14656566.2015.1032249 [doi]
AB  - OBJECTIVE: To assess the safety and efficacy of long-term administration of 
      teneligliptin alone and in combination with oral antidiabetic drugs in Japanese 
      type 2 diabetes mellitus (T2DM) patients with insufficient glycemic control. 
      METHODS: This post-hoc pooled analysis used data from two Phase III clinical 
      studies involving 702 Japanese patients. We evaluated teneligliptin as 
      monotherapy and combined with a sulfonylurea, glinide, biguanide, or 
      alpha-glucosidase inhibitor. Safety measures included adverse events (AEs), adverse 
      reactions and hypoglycemia. The main efficacy measure was the change in glycated 
      hemoglobin (HbA1c) from baseline. RESULTS: Incidences of AEs and adverse 
      reactions were similar among the teneligliptin monotherapy group and all 
      combination therapy groups except the combination with sulfonylurea. Hypoglycemia 
      was more frequent in the sulfonylurea combination therapy group than in other 
      groups. Teneligliptin administered once daily as monotherapy or combination 
      therapy resulted in a decrease in HbA1c, which was maintained for 52 weeks. 
      Bodyweight showed no change or a slight increase at the end of 52 weeks in all 
      groups. CONCLUSIONS: This pooled analysis provides evidence for the safety and 
      efficacy of long-term use of teneligliptin as monotherapy or combination therapy 
      in Japanese T2DM patients.
FAU - Kadowaki, Takashi
AU  - Kadowaki T
AD  - The University of Tokyo, Graduate School of Medicine, Department of Metabolic 
      Disease , Tokyo , Japan.
FAU - Marubayashi, Fuyuhiko
AU  - Marubayashi F
FAU - Yokota, Shoko
AU  - Yokota S
FAU - Katoh, Makoto
AU  - Katoh M
FAU - Iijima, Hiroaki
AU  - Iijima H
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
DEP - 20150410
PL  - England
TA  - Expert Opin Pharmacother
JT  - Expert opinion on pharmacotherapy
JID - 100897346
RN  - 0 
      (3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine)
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Pyrazoles)
RN  - 0 (Thiazolidines)
SB  - IM
MH  - Asian People
MH  - Blood Glucose/metabolism
MH  - Clinical Trials, Phase III as Topic
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Drug Therapy, Combination
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Hypoglycemia/chemically induced
MH  - Hypoglycemic Agents/adverse effects/*therapeutic use
MH  - Pyrazoles/adverse effects/*therapeutic use
MH  - Thiazolidines/adverse effects/*therapeutic use
OTO - NOTNLM
OT  - Japanese
OT  - Phase III
OT  - co-administration
OT  - pooled analysis
OT  - teneligliptin
OT  - type 2 diabetes
EDAT- 2015/04/12 06:00
MHDA- 2015/09/12 06:00
CRDT- 2015/04/12 06:00
PHST- 2015/04/12 06:00 [entrez]
PHST- 2015/04/12 06:00 [pubmed]
PHST- 2015/09/12 06:00 [medline]
AID - 10.1517/14656566.2015.1032249 [doi]
PST - ppublish
SO  - Expert Opin Pharmacother. 2015 May;16(7):971-81. doi: 
      10.1517/14656566.2015.1032249. Epub 2015 Apr 10.