PMID- 24205974
OWN - NLM
STAT- MEDLINE
DCOM- 20150123
LR  - 20221207
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Linking)
VI  - 16
IP  - 5
DP  - 2014 May
TI  - Efficacy and safety of teneligliptin added to glimepiride in Japanese patients 
      with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled 
      study with an open-label, long-term extension.
PG  - 418-25
LID - 10.1111/dom.12235 [doi]
AB  - AIMS: To assess the efficacy and safety of teneligliptin in combination with 
      glimepiride in Japanese patients with type 2 diabetes mellitus (T2DM) 
      inadequately controlled with glimepiride monotherapy. METHODS: In the initial 
      12-week, double-blind, placebo-controlled, parallel-group period, 194 patients 
      [haemoglobin A1c (HbA1c): 8.4 +/- 0.8%; fasting plasma glucose (FPG): 
      164.2 +/- 28.1 mg/dl] were randomized to either teneligliptin 20 mg or placebo once 
      daily while continuing stable glimepiride therapy. This randomized period was 
      then followed by a 40-week, open-label period, where all patients received 
      teneligliptin once daily. The primary endpoint was the change in HbA1c from 
      baseline to week 12. RESULTS: Teneligliptin reduced HbA1c significantly compared 
      with placebo at week 12. The placebo-subtracted change in HbA1c was -1.0 +/- 0.1% 
      [least-squares (LS) mean +/- s.e., p < 0.001]. Teneligliptin also significantly 
      reduced FPG and 2-h postprandial glucose (PPG) as compared with placebo at week 
      12; the placebo-subtracted changes were -27.1 +/- 3.2 and -49.1 +/- 6.2 mg/dl (LS 
      mean +/- s.e., both p < 0.001), respectively. The blood glucose-lowering effects 
      were sustained throughout the 40-week open-label period. The incidence rates of 
      adverse events and adverse drug reactions, including hypoglycaemia, during the 
      double-blind randomized period were similar in both groups. Therefore, 
      teneligliptin was generally well tolerated when used in combination with 
      glimepiride. CONCLUSIONS: The addition of teneligliptin was effective and 
      generally well tolerated in Japanese patients with T2DM inadequately controlled 
      with glimepiride monotherapy. The improvements in glycaemic control were 
      maintained for up to 52 weeks.
CI  - (c) 2013 John Wiley & Sons 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
SI  - ClinicalTrials.gov/NCT00971243
SI  - ClinicalTrials.gov/NCT01026194
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20131210
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 (Hypoglycemic Agents)
RN  - 0 (Pyrazoles)
RN  - 0 (Sulfonylurea Compounds)
RN  - 0 (Thiazolidines)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 6KY687524K (glimepiride)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Asian People
MH  - Blood Glucose/drug effects/metabolism
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy/epidemiology
MH  - Dipeptidyl-Peptidase IV Inhibitors/therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination
MH  - Fasting
MH  - Glycated Hemoglobin/drug effects/metabolism
MH  - Humans
MH  - Hypoglycemia/blood/*chemically induced/epidemiology
MH  - Hypoglycemic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Japan/epidemiology
MH  - Male
MH  - Middle Aged
MH  - Postprandial Period
MH  - Pyrazoles/administration & dosage/adverse effects/*therapeutic use
MH  - Sulfonylurea Compounds/*therapeutic use
MH  - Thiazolidines/administration & dosage/adverse effects/*therapeutic use
MH  - Treatment Outcome
OTO - NOTNLM
OT  - DPP-4 inhibitor
OT  - HbA1c
OT  - Japanese
OT  - glimepiride
OT  - teneligliptin
OT  - type 2 diabetes mellitus
EDAT- 2013/11/12 06:00
MHDA- 2015/01/24 06:00
CRDT- 2013/11/12 06:00
PHST- 2013/05/15 00:00 [received]
PHST- 2013/06/19 00:00 [revised]
PHST- 2013/11/02 00:00 [accepted]
PHST- 2013/11/12 06:00 [entrez]
PHST- 2013/11/12 06:00 [pubmed]
PHST- 2015/01/24 06:00 [medline]
AID - 10.1111/dom.12235 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2014 May;16(5):418-25. doi: 10.1111/dom.12235. Epub 2013 Dec 
      10.