Gemigliptin a new DPP-4 inhibitor is marketed in Korea since 2012. The study compared the efficacy and safety of gemigliptin (G) 50mg QD vs. vildagliptin (V) 50mg BID as add-on therapy to metformin in type 2 diabetes mellitus Russian patients (pts) uncontrolled on metformin. This was a multicenter comparative randomized (1:1) open-label 24- week non-inferiority trial (predefined equivalence limit difference = 0, 4). Pts with 7% < HbA1c < 9.5% and metformin ≥ 1500mg entered into the study. Change in HbA1c from baseline at 24 weeks was the primary endpoint. Distribution of study populations: randomized-443, of whom G-group-220 (PP population-180), V-group-223 (PP population-196).
Results: Baseline characteristics were comparable between the 2-treatment groups except for BMI in G-treatment group (32.72±4.35 vs. 31.88±3.93 kg/m2, p<0.05). Mean HbA1c change at 24 weeks was -0.77±1.17% for G and -0.79±1.11% for V groups. Between-groups mean difference of HbA1c changes was 0.22% [95% CI 0, 15-0, 29] confirming non-inferiority of G effect vs. V (p<0,001). The 7-points self-monitoring of glucose changes from week 0 to 24 (n=117 for G, n=118 for V): significant glucose level reduction before and 2 hours after dinner was reported in G-group only, but 2 hours after lunch in V-group only*. Eleven cases of symptomatic hypoglycemia were reported in 7 (1.58%) pts: 5 cases in 3 (1, 4%) pts in G-group and 6 cases in 4 pts (1, 8%) in V-group*. No cases of severe or asymptomatic hypoglycemia were reported. 64 AEs including 4 SAEs were reported in 49 pts (11, 1%). 34 (53, 1%) AEs were reported in G-group and 30 AEs in V-group (46, 9%)*.
Conclusion: The clinical efficacy of gemigliptin 50mg was similar to that of vildagliptin 100mg. Both gemigliptin and vildagliptin were well tolerated and did not expose patients to severe hypoglycemias. *- between treatment groups was not statistically significant.
E. Birukova: None.
