Inagaki N, et al. – An open–label, phase 3 exploratory study was designed to explore the utility and safety of trelagliptin after a daily dipeptidyl peptidase–4 (DPP–4) inhibitor in patients with type 2 diabetes mellitus. In context of the findings, it is considered possible to switch a once–daily DPP–4 inhibitor to trelagliptin in type 2 diabetes mellitus (T2DM) patients with stable glycemic control in combination with diet and exercise therapy without any major influences on glycemic control or safety.

Methods

• Researchers performed an open-label phase 3 exploratory study to assess the adequacy and safety of trelagliptin in Japanese T2DM patients who had stable glycemic control on once-daily sitagliptin therapy.
• Trelagliptin 100 mg was given to the eligible patients orally before breakfast once a week for 12 weeks.
• The Preliminary outcome was blood glucose by the meal tolerance test, and additional outcomes were glycemic control (efficacy) and safety.

Results

• Altogether 14 patients received the study drug.
• It was showed that 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.
• They noted adverse events (AEs) in 42.9% (6/14) of patients, but all AEs were mild or moderate in severity and most were not related to the study drug.
• There were no cases of death, serious AEs, or hypoglycemia.