Ajmani, Ajay Kumar and Achappa, Basavaprabhu and Trailokya, Abhijit (2019) Efficacy and safety of evogliptin versus sitagliptin as an add-on therapy in Indian patients with type 2 diabetes mellitus inadequately controlled with metformin: A 24-week randomized, double-blind, non-inferiority, EVOLUTION INDIA study. Diabetes Research and Clinical Practice, 157 (2019). pp. 1-8. ISSN 0168-8227

PDF Efficacy and safety of evogliptin versus sitagliptin.pdf - Published Version Restricted to Registered users only Download (638kB) | Request a copy

Abstract

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% � HbA1c < 10%) receiving 8 weeks of stable metformin monotherapy (1 g/day), were randomized to receive add-on treatment (evogliptin 5 mg or sitagliptin 100 mg) for 24 weeks. Primary endpoint was change in HbA1c from baseline to 12 weeks (non-inferiority margin: <0.35). Results: Mean reductions in HbA1c at 12 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; P = 0.901), that demonstrated non-inferiority. Reductions in FPG and PPG were similar between evogliptin and sitagliptin at 12 and 24 weeks. Changes in body weight were comparable between the treatment groups. Patients achieving target HbA1c < 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.

Actions (login required)

View Item