Once-weekly trelagliptin versus daily alogliptin in Japanese patients with type 2 diabetes: a randomised, double-blind, phase 3, non-inferiority study

This RCT in 243 patients showed that the once-weekly DPP-4 inhibitor trelagliptin showed similar efficacy and safety to alogliptin once daily in Japanese patients with type 2 diabetes.

Patients were randomised to receive trelagliptin (100 mg) once per week, alogliptin (25 mg) once per day, or placebo for 24 weeks. The primary outcome was between-groups difference in change in HbA1c concentration from baseline to the end of treatment at 24 weeks. The non-inferiority margin was 0.4%.

 

The least squares mean change in HbA1c concentration was reported as −0.33% in the trelagliptin group (SE 0.059) and −0.45% in the alogliptin group (0.061). The least squares mean difference (trelagliptin minus alogliptin) of change from baseline in HbA1c concentration was 0.11% (95% CI −0.054 to 0.281). Trelagliptin was non-inferior to alogliptin. No hypoglycaemia was reported with trelagliptin and the drug was well tolerated.

 

A related editorial discusses the findings and significance of this study.

 

A New Drug Application (NDA) has been submitted to the Japanese regulatory authority for trelagliptin succinate for the treatment of type 2 diabetes. Currently, trelagliptin has not been filed with the EMA.