Effects of dulaglutide and trelagliptin on beta-cell function in patients with type 2 diabetes: a randomized controlled study: DUET-beta study.

ABSTRACT

Aims: This randomized, open-label, parallel-group, controlled trial compared the effects of dulaglutide and trelagliptin on beta-cell function in patients with type 2 diabetes. Materials and methods: For 24 weeks, participants received dulaglutide (0.75 mg/week) or trelagliptin (100 mg/week), after which beta-cell function was evaluated using a glucagon stimulation test-based disposition index. The primary endpoint was the change in disposition index over the 24-week treatment period. Results: Fifty patients with type 2 diabetes who received metformin with or without basal insulin were randomized to receive dulaglutide or trelagliptin. Forty-eight patients completed the 24-week dulaglutide (n = 23) or trelagliptin (n = 25) treatment. The dulaglutide group reduced HbA1c levels more than the trelagliptin group (dulaglutide - 0.77% ± 0.07% vs. trelagliptin - 0.57% ± 0.07%; p = 0.04). Change in disposition index during the 24 weeks did not differ between the groups (dulaglutide - 0.07 ± 1.08 vs. trelagliptin + 0.59 ± 1.04; p = 0.66), but the dulaglutide group increased HOMA2-%ß levels more than the trelagliptin group (dulaglutide + 26.2 ± 4.3% vs. trelagliptin + 5.4 ± 4.1%; p = 0.001). The dulaglutide group showed greater body fat mass reduction than the trelagliptin group (dulaglutide - 1.2 ± 0.3 kg vs. trelagliptin - 0.3 ± 0.2 kg; p = 0.02) without skeletal muscle mass loss. Conclusion: Dulaglutide and trelagliptin had similar effects on beta-cell function according to the glucagon stimulation test-based disposition index. However, dulaglutide promoted improved HOMA2-%ß levels compared to trelagliptin and body fat mass was reduced without loss of skeletal muscle mass (UMIN-CTR 000024164). Supplementary Information The online version contains supplementary material available at 10.1007/s13340-024-00717-6.