Cargando…
Efficacy and safety of once‐weekly oral trelagliptin switched from once‐daily dipeptidyl peptidase‐4 inhibitor in patients with type 2 diabetes mellitus: An open‐label, phase 3 exploratory study
INTRODUCTION: Trelagliptin, a novel once‐weekly oral dipeptidyl peptidase‐4 (DPP‐4) inhibitor, has shown favorable efficacy and safety in type 2 diabetes mellitus patients. Trelagliptin was launched in Japan, and is expected to be initially used for switchover from a daily DPP‐4 inhibitor in the cli...
Autores principales: | , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2017
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5835476/ https://www.ncbi.nlm.nih.gov/pubmed/28836351 http://dx.doi.org/10.1111/jdi.12730 |
_version_ | 1783303821768785920 |
---|---|
author | Inagaki, Nobuya Sano, Hiroki Seki, Yoshifumi Kuroda, Shingo Kaku, Kohei |
author_facet | Inagaki, Nobuya Sano, Hiroki Seki, Yoshifumi Kuroda, Shingo Kaku, Kohei |
author_sort | Inagaki, Nobuya |
collection | PubMed |
description | INTRODUCTION: Trelagliptin, a novel once‐weekly oral dipeptidyl peptidase‐4 (DPP‐4) inhibitor, has shown favorable efficacy and safety in type 2 diabetes mellitus patients. Trelagliptin was launched in Japan, and is expected to be initially used for switchover from a daily DPP‐4 inhibitor in the clinical setting. Thus, the present study was carried out to explore the efficacy and safety of trelagliptin after a daily DPP‐4 inhibitor was switched to it. MATERIALS AND METHODS: This was an open‐label, phase 3 exploratory study to evaluate the efficacy and safety of trelagliptin in Japanese type 2 diabetes mellitus patients who had stable glycemic control on once‐daily sitagliptin therapy. Eligible patients received trelagliptin 100 mg orally before breakfast once a week for 12 weeks. The primary end‐point was blood glucose by the meal tolerance test, and additional end‐points were glycemic control (efficacy) and safety. RESULTS: Altogether, 14 patients received the study drug. The blood glucose did not markedly change from baseline at major assessment points in the meal tolerance test, and a decrease in blood glucose was observed at several other assessment points. Adverse events were reported in 42.9% (6/14) of patients, but all adverse events were mild or moderate in severity, and most were not related to the study drug. No cases of death, serious adverse events or hypoglycemia were reported. DISCUSSION: It is considered possible to switch a once‐daily DPP‐4 inhibitor to trelagliptin in type 2 diabetes mellitus patients with stable glycemic control in combination with diet and exercise therapy without any major influences on glycemic control or safety. |
format | Online Article Text |
id | pubmed-5835476 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-58354762018-03-07 Efficacy and safety of once‐weekly oral trelagliptin switched from once‐daily dipeptidyl peptidase‐4 inhibitor in patients with type 2 diabetes mellitus: An open‐label, phase 3 exploratory study Inagaki, Nobuya Sano, Hiroki Seki, Yoshifumi Kuroda, Shingo Kaku, Kohei J Diabetes Investig Articles INTRODUCTION: Trelagliptin, a novel once‐weekly oral dipeptidyl peptidase‐4 (DPP‐4) inhibitor, has shown favorable efficacy and safety in type 2 diabetes mellitus patients. Trelagliptin was launched in Japan, and is expected to be initially used for switchover from a daily DPP‐4 inhibitor in the clinical setting. Thus, the present study was carried out to explore the efficacy and safety of trelagliptin after a daily DPP‐4 inhibitor was switched to it. MATERIALS AND METHODS: This was an open‐label, phase 3 exploratory study to evaluate the efficacy and safety of trelagliptin in Japanese type 2 diabetes mellitus patients who had stable glycemic control on once‐daily sitagliptin therapy. Eligible patients received trelagliptin 100 mg orally before breakfast once a week for 12 weeks. The primary end‐point was blood glucose by the meal tolerance test, and additional end‐points were glycemic control (efficacy) and safety. RESULTS: Altogether, 14 patients received the study drug. The blood glucose did not markedly change from baseline at major assessment points in the meal tolerance test, and a decrease in blood glucose was observed at several other assessment points. Adverse events were reported in 42.9% (6/14) of patients, but all adverse events were mild or moderate in severity, and most were not related to the study drug. No cases of death, serious adverse events or hypoglycemia were reported. DISCUSSION: It is considered possible to switch a once‐daily DPP‐4 inhibitor to trelagliptin in type 2 diabetes mellitus patients with stable glycemic control in combination with diet and exercise therapy without any major influences on glycemic control or safety. John Wiley and Sons Inc. 2017-10-30 2018-03 /pmc/articles/PMC5835476/ /pubmed/28836351 http://dx.doi.org/10.1111/jdi.12730 Text en © 2017 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs (http://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Articles Inagaki, Nobuya Sano, Hiroki Seki, Yoshifumi Kuroda, Shingo Kaku, Kohei Efficacy and safety of once‐weekly oral trelagliptin switched from once‐daily dipeptidyl peptidase‐4 inhibitor in patients with type 2 diabetes mellitus: An open‐label, phase 3 exploratory study |
title | Efficacy and safety of once‐weekly oral trelagliptin switched from once‐daily dipeptidyl peptidase‐4 inhibitor in patients with type 2 diabetes mellitus: An open‐label, phase 3 exploratory study |
title_full | Efficacy and safety of once‐weekly oral trelagliptin switched from once‐daily dipeptidyl peptidase‐4 inhibitor in patients with type 2 diabetes mellitus: An open‐label, phase 3 exploratory study |
title_fullStr | Efficacy and safety of once‐weekly oral trelagliptin switched from once‐daily dipeptidyl peptidase‐4 inhibitor in patients with type 2 diabetes mellitus: An open‐label, phase 3 exploratory study |
title_full_unstemmed | Efficacy and safety of once‐weekly oral trelagliptin switched from once‐daily dipeptidyl peptidase‐4 inhibitor in patients with type 2 diabetes mellitus: An open‐label, phase 3 exploratory study |
title_short | Efficacy and safety of once‐weekly oral trelagliptin switched from once‐daily dipeptidyl peptidase‐4 inhibitor in patients with type 2 diabetes mellitus: An open‐label, phase 3 exploratory study |
title_sort | efficacy and safety of once‐weekly oral trelagliptin switched from once‐daily dipeptidyl peptidase‐4 inhibitor in patients with type 2 diabetes mellitus: an open‐label, phase 3 exploratory study |
topic | Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5835476/ https://www.ncbi.nlm.nih.gov/pubmed/28836351 http://dx.doi.org/10.1111/jdi.12730 |
work_keys_str_mv | AT inagakinobuya efficacyandsafetyofonceweeklyoraltrelagliptinswitchedfromoncedailydipeptidylpeptidase4inhibitorinpatientswithtype2diabetesmellitusanopenlabelphase3exploratorystudy AT sanohiroki efficacyandsafetyofonceweeklyoraltrelagliptinswitchedfromoncedailydipeptidylpeptidase4inhibitorinpatientswithtype2diabetesmellitusanopenlabelphase3exploratorystudy AT sekiyoshifumi efficacyandsafetyofonceweeklyoraltrelagliptinswitchedfromoncedailydipeptidylpeptidase4inhibitorinpatientswithtype2diabetesmellitusanopenlabelphase3exploratorystudy AT kurodashingo efficacyandsafetyofonceweeklyoraltrelagliptinswitchedfromoncedailydipeptidylpeptidase4inhibitorinpatientswithtype2diabetesmellitusanopenlabelphase3exploratorystudy AT kakukohei efficacyandsafetyofonceweeklyoraltrelagliptinswitchedfromoncedailydipeptidylpeptidase4inhibitorinpatientswithtype2diabetesmellitusanopenlabelphase3exploratorystudy |