PMID- 33081425
OWN - NLM
STAT- MEDLINE
DCOM- 20211021
LR  - 20220531
IS  - 2233-6087 (Electronic)
IS  - 2233-6079 (Print)
IS  - 2233-6079 (Linking)
VI  - 45
IP  - 4
DP  - 2021 Jul
TI  - A Multicentre, Multinational, Open-Label, 52-Week Extension Study of Gemigliptin 
      (LC15-0444) Monotherapy in Patients with Type 2 Diabetes Mellitus.
PG  - 606-612
LID - 10.4093/dmj.2020.0047 [doi]
AB  - The purpose of this extension study was to assess the long-term efficacy and 
      safety of gemigliptin 50 mg in patients with type 2 diabetes mellitus (T2DM). 
      Patients with T2DM who had completed the initial 24-week study comparing 
      gemigliptin monotherapy with placebo were eligible to enrol. In the open-label, 
      28-week extension study, all enrolled patients received gemigliptin, regardless 
      of the treatment received during the initial 24-week study period. The mean 
      reduction+/-standard deviation (SD) in glycosylated hemoglobin (HbA1c) observed 
      after 24 weeks of treatment (-0.6%+/-1.1%) was further decreased for the gemi-gemi 
      group and the mean change in HbA1c at week 52 from baseline was -0.9%+/-1.2% 
      (P<0.0001). For the pbo-gemi group, HbA1c decreased after they were switched to 
      gemigliptin, and the mean change in HbA1c at week 52 from baseline was -0.7%+/-1.2% 
      (P<0.0001). Furthermore, the overall incidence of adverse events demonstrated 
      that gemigliptin was safe and well tolerated up to 52 weeks.
FAU - Yang, Sae Jeong
AU  - Yang SJ
AD  - Department of Endocrinology, Daerim St. Mary's Hospital, Seoul, Korea.
FAU - Min, Kyung Wan
AU  - Min KW
AD  - Department of Internal Medicine, Nowon Eulji Medical Center, Eulji University 
      School of Medicine, Seoul, Korea.
FAU - Gupta, Sandeep Kumar
AU  - Gupta SK
AD  - M.V. Hospital and Research Centre, Lucknow, India.
FAU - Park, Joong Yeol
AU  - Park JY
AD  - Department of Internal Medicine, Asan Medical Center, University of Ulsan College 
      of Medicine, Seoul, Korea.
FAU - K Shivane, Vyankatesh
AU  - K Shivane V
AD  - Research Health Institute in Diabetes, Endocrinology and Metabolism (RHIDEM), 
      Mumbai, India.
FAU - Agarwal, Pankaj Kumar
AU  - Agarwal PK
AD  - Hormone Care and Research Center, Ghaziabad, India.
FAU - Kim, Doo Man
AU  - Kim DM
AD  - Department of Internal Medicine, Hallym University Kangdong Sacred Heart 
      Hospital, Seoul, Korea.
FAU - Kim, Yong Esong
AU  - Kim YE
AD  - Department of Internal Medicine, Inha University Hospital, Inha University 
      College of Medicine, Incheon, Korea.
FAU - Baik, Sei Hyun
AU  - Baik SH
AD  - Department of Endocrinology, Korea University Guro Hospital, Seoul, Korea.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20200909
PL  - Korea (South)
TA  - Diabetes Metab J
JT  - Diabetes & metabolism journal
JID - 101556588
RN  - 0 (Blood Glucose)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (LC15-0444)
RN  - 0 (Piperidones)
RN  - 0 (Pyrimidines)
SB  - IM
MH  - Blood Glucose
MH  - *Diabetes Mellitus, Type 2/drug therapy
MH  - Humans
MH  - Hypoglycemic Agents/adverse effects/therapeutic use
MH  - *Piperidones/adverse effects/therapeutic use
MH  - *Pyrimidines/adverse effects/therapeutic use
PMC - PMC8369212
OTO - NOTNLM
OT  - Diabetes mellitus, type 2
OT  - Dipeptidyl-peptidase IV inhibitors
OT  - LC15-0444
COIS- CONFLICT OF INTEREST No potential conflict of interest relevant to this article 
      was reported.
EDAT- 2020/10/22 06:00
MHDA- 2021/10/26 06:00
PMCR- 2021/07/01
CRDT- 2020/10/21 02:58
PHST- 2020/02/27 00:00 [received]
PHST- 2020/04/30 00:00 [accepted]
PHST- 2020/10/22 06:00 [pubmed]
PHST- 2021/10/26 06:00 [medline]
PHST- 2020/10/21 02:58 [entrez]
PHST- 2021/07/01 00:00 [pmc-release]
AID - dmj.2020.0047 [pii]
AID - dmj-2020-0047 [pii]
AID - 10.4093/dmj.2020.0047 [doi]
PST - ppublish
SO  - Diabetes Metab J. 2021 Jul;45(4):606-612. doi: 10.4093/dmj.2020.0047. Epub 2020 
      Sep 9.