PMID- 23464664
OWN - NLM
STAT- MEDLINE
DCOM- 20140311
LR  - 20221207
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Linking)
VI  - 15
IP  - 9
DP  - 2013 Sep
TI  - Efficacy, safety and dose-response relationship of teneligliptin, a dipeptidyl 
      peptidase-4 inhibitor, in Japanese patients with type 2 diabetes mellitus.
PG  - 810-8
LID - 10.1111/dom.12092 [doi]
AB  - AIM: To assess the efficacy, safety and dose-response relationship of once-daily 
      teneligliptin, a novel dipeptidyl peptidase-4 inhibitor, in Japanese patients 
      with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and 
      exercise. METHODS: In this randomized, double-blind, placebo-controlled, 
      parallel-group study, patients (n = 324) were randomized to receive teneligliptin 
      10, 20 or 40 mg, or placebo, once daily before breakfast for 12 weeks. The 
      primary endpoint was the change in haemoglobin (Hb)A1c from baseline to week 12. 
      RESULTS: All teneligliptin-treated groups showed significantly greater reductions 
      in HbA1c and fasting plasma glucose (FPG) than did the placebo group. The 
      differences between the teneligliptin 10, 20 or 40 mg groups and the placebo 
      group for the change in HbA1c were -0.9 [least-squares (LS) mean; 95% confidence 
      interval: -1.0, -0.7], -0.9 (-1.1, -0.7) and -1.0 (-1.2, -0.9)%, respectively 
      (all, p < 0.001). The respective LS means for FPG were -17.8 (-23.4, -12.1), 
      -16.9 (-22.6, -11.2) and -20.0 (-25.7, -14.3) mg/dl (all, p < 0.001). There were 
      no significant differences in HbA1c among the three doses of teneligliptin. The 
      incidence of adverse events and adverse drug reactions was similar in each group. 
      The incidence of hypoglycaemia was not significantly different among the four 
      groups. CONCLUSIONS: Treatment with teneligliptin for 12 weeks provided 
      significant and clinically meaningful reductions in HbA1c and FPG across the dose 
      range studied and was generally well tolerated in Japanese patients with T2DM.
CI  - (c) 2013 Blackwell Publishing Ltd.
FAU - Kadowaki, T
AU  - Kadowaki T
AD  - Department of Metabolic Diseases, Graduate School of Medicine, The University of 
      Tokyo, Tokyo, Japan.
FAU - Kondo, K
AU  - Kondo K
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130407
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
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 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Pyrazoles)
RN  - 0 (Thiazolidines)
RN  - 0 (hemoglobin A1c protein, human)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Area Under Curve
MH  - Asian People/statistics & numerical data
MH  - Blood Glucose/metabolism
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy/epidemiology
MH  - Dipeptidyl-Peptidase IV Inhibitors/administration & dosage/adverse 
      effects/*therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Fasting
MH  - Female
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Japan/epidemiology
MH  - Male
MH  - Middle Aged
MH  - Pyrazoles/administration & dosage/adverse effects/*therapeutic use
MH  - Thiazolidines/administration & dosage/adverse effects/*therapeutic use
MH  - Time Factors
MH  - Treatment Outcome
OTO - NOTNLM
OT  - DPP-4 inhibitor
OT  - HbA1c
OT  - teneligliptin
OT  - type 2 diabetes mellitus
EDAT- 2013/03/08 06:00
MHDA- 2014/03/13 06:00
CRDT- 2013/03/08 06:00
PHST- 2012/08/31 00:00 [received]
PHST- 2012/10/01 00:00 [revised]
PHST- 2013/03/03 00:00 [accepted]
PHST- 2013/03/08 06:00 [entrez]
PHST- 2013/03/08 06:00 [pubmed]
PHST- 2014/03/13 06:00 [medline]
AID - 10.1111/dom.12092 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2013 Sep;15(9):810-8. doi: 10.1111/dom.12092. Epub 2013 Apr 
      7.