TY - JOUR
T1 - Efficacy and safety of evogliptin versus sitagliptin as an add-on therapy in Indian patients with type 2 diabetes mellitus inadequately controlled with metformin
T2 - A 24-week randomized, double-blind, non-inferiority, EVOLUTION INDIA study
AU - Ajmani, Ajay Kumar
AU - Agrawal, Aparna
AU - Prasad, B. L.N.
AU - Basu, Indraneel
AU - Shembalkar, Jayashree
AU - Manikanth, Neeraj
AU - Subrahmanyam, K. A.V.
AU - Srinivasa, M.
AU - Chawla, Manoj
AU - Srivastava, Manoj Kumar
AU - Jebasingh, Felix
AU - Achappa, Basavaprabhu
AU - Agrawal, R. P.
AU - Pulichikkat, Rakesh K.
AU - Meena, Ramdhan
AU - Bhatia, Shailaja
AU - Gupta, Sandeep Kumar
AU - Dange, Amol
AU - Srivastava, Ambrish
AU - Trailokya, Abhijit
AU - Shahavi, Vinayaka
AU - Shende, Sachin
PY - 2019/11/1
Y1 - 2019/11/1
N2 - 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.
AB - 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.
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U2 - 10.1016/j.diabres.2019.107860
DO - 10.1016/j.diabres.2019.107860
M3 - Article
C2 - 31526825
AN - SCOPUS:85072828089
SN - 0168-8227
VL - 157
JO - Diabetes Research and Clinical Practice
JF - Diabetes Research and Clinical Practice
M1 - 107860
ER -
