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

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タイトル別名
  • 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
公開日
2018-03-04
資源種別
journal article
権利情報
  • © 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 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.
DOI
  • 10.1111/jdi.12730
公開者
Wiley-Blackwell

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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.

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