Abstract
AIMS/INTRODUCTION: The aim of the present study was to investigate the effects of metformin and a dipeptidyl peptidase-4 inhibitor, alogliptin, on body composition in a 12-week randomized add-on trial in Japanese participants with type 2 diabetes. MATERIALS AND METHODS: A total of 84 participants with poorly controlled type 2 diabetes undergoing antidiabetic therapy were randomly assigned to receive alogliptin (25 mg, once daily) or metformin (1,000 mg, twice daily) for 12 weeks. The primary efficacy end-point was body composition. The secondary end-points included factors associated with decreased bodyweight. RESULTS: Compared with the baseline values, alogliptin significantly increased bodyweight (66.5 ± 19.2 to 67.6 ± 19.3 kg), body mass index (BMI; 25.4 ± 6.1 to 25.8 ± 6.3 kg/m(2) ) and fat mass (20.3 ± 12.8 to 21.8 ± 14.5 kg), whereas metformin had no significant effect on body composition. Alogliptin was inferior to metformin in reducing bodyweight (0.84 ± 1.57 vs -0.35 ± 1.53 kg, P = 0.002), BMI (0.34 ± 0.69 to -0.15 ± 0.56 kg/m(2) , P = 0.002) and fat mass (1.49 ± 5.06 vs -0.04 ± 1.81 kg, P = 0.042). BMI at baseline was associated with changes in bodyweight negatively in the metformin group and positively in the alogliptin group. CONCLUSIONS: Metformin and alogliptin exert opposite effects on bodyweight in type 2 diabetes patients who are overweight. The higher the BMI, the more metformin reduces bodyweight and alogliptin increases weight.