PMID- 34488059
OWN - NLM
STAT- MEDLINE
DCOM- 20220124
LR  - 20220124
IS  - 1878-0334 (Electronic)
IS  - 1871-4021 (Linking)
VI  - 15
IP  - 5
DP  - 2021 Sep-Oct
TI  - QTc prolongation Safety and Effectiveness of Teneligliptin in Indian patients 
      with type 2 Diabetes Mellitus: A real world study (QSET 2).
PG  - 102264
LID - S1871-4021(21)00284-8 [pii]
LID - 10.1016/j.dsx.2021.102264 [doi]
AB  - AIMS: To evaluate the safety with respect to QTc prolongation and effectiveness 
      of Teneligliptin in Indian Type 2 Diabetes Mellitus (T2DM) patients. METHODS: 
      Retrospective data of T2DM patients on teneligliptin 20 mg or 40 mg once daily as 
      a monotherapy or add-on therapy and having ECG records (before and after 
      teneligliptin initiation) was collected. Safety was evaluated by change in QTc 
      interval and effectiveness was evaluated by changes in fasting plasma glucose 
      (FPG), postprandial plasma glucose (PPG), and haemoglobin A1C (HbA1c) from 
      baseline to 12-weeks. RESULTS: There was no significant change in mean QTc 
      interval from baseline [418.68 milli seconds (ms) to 419 ms; mean 
      change +0.33 ms; P = 0.1023] to follow up visit (mean duration 91 days). There 
      was a significant reduction from baseline to 12 weeks in FPG [173.1 mg/dl 
      (9.61 mmol/L) to 128.4 mg/dl (7.12 mmol/L), mean change - 44.64 mg/dl 
      (2.47 mmol/L), P </= 0.001], PPG [242.5 mg/dl (13.46 mmol/L) to 176.5 mg/dl 
      (9.79 mmol/L), mean change - 65.93 mg/dl (3.66 mmol/L), P </= 0.001], and HbA1c 
      [8.2% (66 mmol/mol) to 7.2% (55 mmol/mol), mean change - 1.00% (10.9 mmol/mol), 
      P </= 0.001]. CONCLUSION: Teneligliptin did not cause QTc interval prolongation and 
      was significantly effective in improving glycemic control.
CI  - Copyright (c) 2021. Published by Elsevier Ltd.
FAU - Saboo, Banshi
AU  - Saboo B
AD  - Diabetes Care and Hormone Clinic, Ahmedabad, Gujarat, India. Electronic address: 
      banshisaboo@hotmail.com.
FAU - Ghosh, Sujoy
AU  - Ghosh S
AD  - FICP Department of Endocrinology & Metabolism, Institute of Post Graduate Medical 
      Education & Research, Kolkata, West Bengal, India. Electronic address: 
      drsujoyghosh2000@gmail.com.
FAU - Tiwaskar, Mangesh
AU  - Tiwaskar M
AD  - Shilpa Medical Research Centre, Mumbai, Maharashtra, India. Electronic address: 
      tiwaskar@gmail.com.
FAU - Chawla, Rajeev
AU  - Chawla R
AD  - North Delhi Diabetes Centre, Rohini, New Delhi, India. Electronic address: 
      rajeevaastikchawla@yahoo.com.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20210901
PL  - Netherlands
TA  - Diabetes Metab Syndr
JT  - Diabetes & metabolic syndrome
JID - 101462250
RN  - 0 
      (3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine)
RN  - 0 (Biomarkers)
RN  - 0 (Blood Glucose)
RN  - 0 (Pyrazoles)
RN  - 0 (Thiazolidines)
SB  - IM
MH  - Biomarkers/*blood
MH  - Blood Glucose/analysis
MH  - Diabetes Mellitus, Type 2/*drug therapy/pathology
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Long QT Syndrome/*prevention & control
MH  - Male
MH  - Middle Aged
MH  - Prognosis
MH  - Pyrazoles/*therapeutic use
MH  - Retrospective Studies
MH  - Thiazolidines/*therapeutic use
OTO - NOTNLM
OT  - HbA1c
OT  - QTc interval
OT  - T2DM
OT  - Teneligliptin
COIS- Declaration of competing interest Dr. Banshi Saboo, Dr. Sujoy Ghosh, Dr. Mangesh 
      Tiwaskar and Dr. Rajiv Chawla declare that they have no competing interests.
EDAT- 2021/09/07 06:00
MHDA- 2022/01/27 06:00
CRDT- 2021/09/06 20:20
PHST- 2021/03/08 00:00 [received]
PHST- 2021/08/24 00:00 [revised]
PHST- 2021/08/26 00:00 [accepted]
PHST- 2021/09/07 06:00 [pubmed]
PHST- 2022/01/27 06:00 [medline]
PHST- 2021/09/06 20:20 [entrez]
AID - S1871-4021(21)00284-8 [pii]
AID - 10.1016/j.dsx.2021.102264 [doi]
PST - ppublish
SO  - Diabetes Metab Syndr. 2021 Sep-Oct;15(5):102264. doi: 10.1016/j.dsx.2021.102264. 
      Epub 2021 Sep 1.