A new phase IV multi-center clinical trial has found that a fixed-dose combination (FDC) of alogliptin and metformin offers greater glycemic control compared to alogliptin monotherapy in Indian patients with type 2 diabetes mellitus (T2DM). The randomized, open-label trial evaluated the safety, efficacy, and tolerability of the FDC versus alogliptin alone over 180 days.

The study enrolled 362 patients, out of which 344 completed the trial—166 received the FDC of alogliptin + metformin and 178 received alogliptin alone. By the end of the study, the mean HbA1C reduction was significantly greater in the FDC group (−2.07%) compared to the alogliptin group (−1.29%), with both outcomes achieving statistical significance (P < 0.001).

In addition, fasting plasma glucose (FPG) and postprandial glucose (PPG) levels also showed a more pronounced decline in the FDC group. FPG dropped by −103.65 mg/dL and PPG by −143.11 mg/dL in the FDC group, both reductions being statistically significant (P < 0.001) compared to the alogliptin group.

Regarding safety, both treatment regimens were well tolerated. A total of 15.1% of patients in the FDC group and 12.9% in the alogliptin-only group reported mild adverse events (AEs), all of which resolved without complications. Notably, no serious adverse events (SAEs) were observed in either group.