RESUMEN
AIM: This study aimed to assess efficacy and safety of evogliptin versus sitagliptin, when added to background metformin therapy in Indian patients with uncontrolled type 2 diabetes. METHOD: Overall, 184 patients with uncontrolled type 2 diabetes (7%â¯≤â¯HbA1câ¯<â¯10%) receiving ≥8â¯weeks of stable metformin monotherapy (≥1â¯g/day), were randomized to receive add-on treatment (evogliptin 5â¯mg or sitagliptin 100â¯mg) for 24â¯weeks. Primary endpoint was change in HbA1c from baseline to 12â¯weeks (non-inferiority margin: <0.35). RESULTS: Mean reductions in HbA1c at 12â¯weeks in evogliptin- and sitagliptin-treated patients were -0.37 (1.06) and -0.32 (1.14), respectively. The adjusted mean difference between treatment groups was -0.022 (95% CI: -0.374, 0.330; Pâ¯=â¯0.901), that demonstrated non-inferiority. Reductions in FPG and PPG were similar between evogliptin and sitagliptin at 12 and 24â¯weeks. Changes in body weight were comparable between the treatment groups. Patients achieving target HbA1câ¯<â¯7.0% (evogliptin, 26.7% vs. sitagliptin, 20%) was almost equal in both groups. Treatment-emergent adverse events occured in 52 patients (evogliptin, 25% and sitagliptin, 31.5%) and were generally mild. CONCLUSIONS: Evogliptin was non-inferior to sitagliptin in HbA1c reduction. It effectively improved glycemic control and was well tolerated in type 2 diabetes patients inadequately controlled by metformin alone.