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

Ajay Kumar Ajmani, Aparna Agrawal, B. L.N. Prasad, Indraneel Basu, Jayashree Shembalkar, Neeraj Manikanth, K. A.V. Subrahmanyam, M. Srinivasa, Manoj Chawla, Manoj Kumar Srivastava, Felix Jebasingh, Basavaprabhu Achappa, R. P. Agrawal, Rakesh K. Pulichikkat, Ramdhan Meena, Shailaja Bhatia, Sandeep Kumar Gupta, Amol Dange, Ambrish Srivastava, Abhijit TrailokyaVinayaka Shahavi, Sachin Shende

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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.

Original languageEnglish
Article number107860
JournalDiabetes Research and Clinical Practice
Volume157
DOIs
Publication statusPublished - 01-11-2019

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All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

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