A Multicentre, Multinational, Open-Label, 52-Week Extension Study of Gemigliptin (LC15-0444) Monotherapy in Patients with Type 2 Diabetes Mellitus.

Szczegóły
Abstrakt

Tytuł:: A Multicentre, Multinational, Open-Label, 52-Week Extension Study of Gemigliptin (LC15-0444) Monotherapy in Patients with Type 2 Diabetes Mellitus.
Autorzy:: Yang SJ; Department of Endocrinology, Daerim St. Mary's Hospital, Seoul, Korea.
Min KW; Department of Internal Medicine, Nowon Eulji Medical Center, Eulji University School of Medicine, Seoul, Korea.
Gupta SK; M.V. Hospital and Research Centre, Lucknow, India.
Park JY; Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
K Shivane V; Research Health Institute in Diabetes, Endocrinology and Metabolism (RHIDEM), Mumbai, India.
Agarwal PK; Hormone Care and Research Center, Ghaziabad, India.
Kim DM; Department of Internal Medicine, Hallym University Kangdong Sacred Heart Hospital, Seoul, Korea.
Kim YE; Department of Internal Medicine, Inha University Hospital, Inha University College of Medicine, Incheon, Korea.
Baik SH; Department of Endocrinology, Korea University Guro Hospital, Seoul, Korea.
Źródło:: Diabetes & metabolism journal [Diabetes Metab J] 2021 Jul; Vol. 45 (4), pp. 606-612. Date of Electronic Publication: 2020 Sep 09.
Typ publikacji:: Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
Język:: English
Imprint Name(s):: Original Publication: Seoul : Korean Diabetes Association
MeSH Terms:: Diabetes Mellitus, Type 2*/drug therapy
Piperidones*/adverse effects
Piperidones*/therapeutic use
Pyrimidines*/adverse effects
Pyrimidines*/therapeutic use
Blood Glucose ; Humans ; Hypoglycemic Agents/adverse effects ; Hypoglycemic Agents/therapeutic use
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Diabetes Ther. 2014 Jun;5(1):1-41. (PMID: 24664619)
JAMA. 2007 Jul 11;298(2):194-206. (PMID: 17622601)
Diabetes Obes Metab. 2013 May;15(5):410-6. (PMID: 23170990)
Clin Ther. 2011 Nov;33(11):1609-29. (PMID: 22071236)
Diabetes Care. 2009 Nov;32 Suppl 2:S223-31. (PMID: 19875556)
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Expert Opin Pharmacother. 2012 Jan;13(1):81-99. (PMID: 22149369)
Nutr Metab Cardiovasc Dis. 2010 May;20(4):224-35. (PMID: 19515542)
Contributed Indexing:: Keywords: Diabetes mellitus, type 2; Dipeptidyl-peptidase IV inhibitors; LC15-0444
Substance Nomenclature:: 0 (Blood Glucose)
0 (Hypoglycemic Agents)
0 (LC15-0444)
0 (Piperidones)
0 (Pyrimidines)
Entry Date(s):: Date Created: 20201021 Date Completed: 20211021 Latest Revision: 20220531
Update Code:: 20240105
PubMed Central ID:: PMC8369212
DOI:: 10.4093/dmj.2020.0047
PMID:: 33081425
: Czasopismo naukowe

Pełny tekst

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.

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