Ethnicity is a known factor for DPP-4 inhibitors (DPP-4i)response in type 2 diabetes mellitus (T2DM). A bridging study was conducted to confirm the approved dosage of Evogliptin (EVO), in Korea (once daily 5mg) and the safety for the Brazilian population. In this randomized, double-blind, double-dummy, parallel trial, 146 T2DM patients (male: 50.7%; age: 51.5 ± 10.2 years; time from T2DM diagnosis: 1.7 ± 3.5 years; baseline HbA1c: 8.9 ± 0.9%) with inadequate glycemic control on diet and exercise were randomly assigned to a 12-week once daily treatment with EVO 2,5 mg, EVO 5 mg, EVO 10 mg or sitagliptin (SITA) 100 mg.T2DM patients aged 20 to 75 years, with 7.5% ≤ HbA1c ≤ 10.5% at screening, and who have not been on any hypoglycemic agent within 12 weeks prior to screening were eligible for the study. Subjects with fasting plasma glucose ≥ 300 mg/dL at screening in the presence of severe signs/symptoms of T2DM were excluded. Sample size was estimated to identify a clinically relevant HbA1c mean reduction ≥ 0,5% within each treatment group. Change from baseline to Week 12 (mean; 90% CI) in HbA1c (%) and, fasting plasma glucose levels (mg/dL) was calculated. Treatment effects on HbA1c and fasting glucose levels adjusted by baseline HbA1c, fasting plasma glucose and BMI were also estimated. The results confirmed the clinical benefit of a daily EVO 5,0 mg regimen in the Brazilian population.
A.C. Forti: None. J.S. Felício: None. L.A. Russo: None. J. Borges: None. A.R. Chacra: None. J.E. Salles: Board Member; Spouse/Partner; AstraZeneca, Merck & Co., Inc., Novo Nordisk A/S. Other Relationship; Spouse/Partner; Eurofarma Laboratórios S.A. C. Cercato: Board Member; Self; Novo Nordisk Inc. Research Support; Self; Eurofarma, Novo Nordisk Inc.
Eurofarma Laboratórios S.A.
