PMID- 27181910
OWN - NLM
STAT- MEDLINE
DCOM- 20170227
LR  - 20221207
IS  - 1744-7666 (Electronic)
IS  - 1465-6566 (Linking)
VI  - 17
IP  - 10
DP  - 2016 Jul
TI  - The efficacy and safety of teneligliptin added to ongoing metformin monotherapy 
      in patients with type 2 diabetes: a randomized study with open label extension.
PG  - 1309-16
LID - 10.1080/14656566.2016.1190334 [doi]
AB  - OBJECTIVE: The study investigated the efficacy and tolerability of teneligliptin 
      co-administered to patients with type 2 diabetes mellitus (T2DM) who were 
      inadequately controlled by stable metformin monotherapy >/= 1000 mg/day. METHODS: A 
      total of 447 patients from 55 European centers who completed a 14-day screening 
      and 14-day run-in phase, received randomized double-blind treatment with 5, 10, 
      20 or 40 mg teneligliptin or placebo once daily, for 24 weeks. 364 patients 
      continued treatment in a 28-week open label extension during which they received 
      teneligliptin 20 mg once daily. RESULTS: Co-administration of teneligliptin (5 to 
      40 mg) with metformin demonstrated dose-related and statistically significant 
      reductions in HbA1c after 24 weeks (-0.30 to -0.63% placebo adjusted) of 
      double-blind treatment. The greatest reduction in HbA1c was seen with 
      teneligliptin at 40 mg (-0.63%) at Week 24. There was also a dose-dependent 
      increase in proportion of responders achieving HbA1c < 7.0% at this endpoint. 
      Responses were maintained throughout 28 weeks open label treatment with 20 mg 
      teneligliptin. Treatment was well tolerated to Week 52 and the overall incidence 
      of hypoglycemia during 52 weeks was 2.3%. CONCLUSIONS: Teneligliptin 
      co-administered with metformin produced significant reductions in HbA1c in 
      patients with T2DM without increasing the risk of hypoglycemia.
FAU - Bryson, Andrew
AU  - Bryson A
AD  - a Clinical Department , Mitsubishi Tanabe Pharma Europe Ltd , London , UK.
FAU - Jennings, Paul E
AU  - Jennings PE
AD  - b Center for Diabetes and Endocrinology , York Teaching Hospital NHS Foundation 
      Trust Ringgold , York , UK.
FAU - Deak, Laszlo
AU  - Deak L
AD  - c Department of Internal Medicine , Kaposi Mor County Hospital , Kaposvar , 
      Hungary.
FAU - Paveliu, Fraga S
AU  - Paveliu FS
AD  - d Department of Nutrition and Endocrinology , Societatea Civila Medicala , 
      Bucharest , Romania.
FAU - Lawson, Matt
AU  - Lawson M
AD  - a Clinical Department , Mitsubishi Tanabe Pharma Europe Ltd , London , UK.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20160526
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)
RN  - 9100L32L2N (Metformin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Blood Glucose/analysis
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Female
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hypoglycemia/epidemiology
MH  - Hypoglycemic Agents/*therapeutic use
MH  - Incidence
MH  - Male
MH  - Metformin/*therapeutic use
MH  - Middle Aged
MH  - Pyrazoles/*therapeutic use
MH  - Thiazolidines/*therapeutic use
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Co-administration
OT  - diabetes mellitus
OT  - metformin
OT  - teneligliptin
OT  - type 2
EDAT- 2016/05/18 06:00
MHDA- 2017/02/28 06:00
CRDT- 2016/05/17 06:00
PHST- 2016/05/17 06:00 [entrez]
PHST- 2016/05/18 06:00 [pubmed]
PHST- 2017/02/28 06:00 [medline]
AID - 10.1080/14656566.2016.1190334 [doi]
PST - ppublish
SO  - Expert Opin Pharmacother. 2016 Jul;17(10):1309-16. doi: 
      10.1080/14656566.2016.1190334. Epub 2016 May 26.