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. (November 2019)

• Record Type: Journal Article
• Authors: Ajmani, Ajay Kumar; Agrawal, Aparna; Prasad, B.L.N.; Basu, Indraneel; Shembalkar, Jayashree; Manikanth, Neeraj; Subrahmanyam, K.A.V.; Srinivasa, M.; Chawla, Manoj; Srivastava, Manoj Kumar; Jebasingh, Felix; Achappa, Basavaprabhu; Agrawal, R.P.; Pulichikkat, Rakesh K.; Meena, Ramdhan; Bhatia, Shailaja; Gupta, Sandeep Kumar; Dange, Amol; Srivastava, Ambrish; Trailokya, Abhijit; Shahavi, Vinayaka; Shende, Sachin
• Is Part Of: Diabetes research and clinical practice. Volume 157(2019)
• Publication Date: 2019-11
• Subjects: Evogliptin -- Dipeptidyl peptidase-4 inhibitor -- Type 2 diabetes mellitus -- Sitagliptin; Diabetes -- Periodicals; Diabetes Mellitus -- Periodicals; 616.462
• DOI: 10.1016/j.diabres.2019.107860
• Languages: English
• ISSNs: 0168-8227

Abstract

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.