Ajay Kumar Ajmani1, Aparna Agrawal2, B L N Prasad3, Indraneel Basu4, Jayashree Shembalkar5, Neeraj Manikanth6, K A V Subrahmanyam7, M Srinivasa8, Manoj Chawla9, Manoj Kumar Srivastava10, Felix Jebasingh11, Basavaprabhu Achappa12, R P Agrawal13, Rakesh K Pulichikkat14, Ramdhan Meena15, Shailaja Bhatia16, Sandeep Kumar Gupta17, Amol Dange18, Ambrish Srivastava19, Abhijit Trailokya20, Vinayaka Shahavi19, Sachin Shende19. 1. Dr. B. L. Kapur Super Speciality Hospital, New Delhi, India. 2. Lady Hardinge Medical College & Smt. Sucheta Kriplani Hospital, New Delhi, India. 3. Rajiv Gandhi Institute of Medical Sciences and RIMS Government General Hospital, Srikakulam, India. 4. Popular Hospital, Varanasi, India. 5. Getwell Hospital and Research Institute, Nagpur, India. 6. Government Medical College, Kerala, India. 7. Andhra Medical College, King George Hospital, Vishakhapatnam, India. 8. Krishna Rajendra Hospital, Mysore Medical College & Research Institute, Mysore, India. 9. BSES Municipal General Hospital, Mumbai, India. 10. Om Surgical Center & Maternity Home, Varanasi, India. 11. Christian Medical College, Vellore, India. 12. Kasturba Medical College, Mangalore, India. 13. SP Medical College and PBM Hospital, Bikaner, India. 14. Sree Narayana Institute of Medical Sciences, Kochi, India. 15. S.R. Kalla Memorial Gastro and General Hospital, Jaipur, India. 16. Medipoint Hospitals Pvt Ltd, Pune, India. 17. KRM Hospital and Research Centre, Lucknow, India. 18. Lifepoint Multispecialty Hospital, Pune, India. 19. Alkem Laboratories Ltd, Mumbai, India. 20. Alkem Laboratories Ltd, Mumbai, India. Electronic address: publication@alkem.com.
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.
RCT Entities:
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 diabetespatients inadequately controlled by metformin alone.