Evogliptin in Type 2 Diabetes Mellitus (EVOLUTION: EVOgLiptina no Diabetes Mellitus TIpO 2)
Status:
Completed
Trial end date:
2018-08-09
Target enrollment:
Participant gender:
Summary
This phase II, multicenter, randomized, double-blind, double-dummy study with four parallel
treatment groups, with active control, will be performed only in brazilian sites under the
sponsorship of Eurofarma Laboratórios S.A.. The enrollment for participants in the study will
start after the relevant ethical and regulatory approvals and will have an estimated duration
of 18 months.
One hundred and forty-four participants with T2DM according to the criteria of ADA who
consent to participation in the study by signing the Informed Consent Form (ICF) will be
enrolled in the study. In order to be enrolled, the patients must meet all the inclusion
criteria and none of the exclusion criteria. The eligible participants will be randomized
1:1:1:1 to receive evogliptin (EVO) at the doses of 2.5 mg/day (N = 36), 5.0 mg/day (N = 36)
or 10 mg/day (N = 36) or sitagliptin (SITA) at the dose of 100 mg/day (N = 36), as a single
daily dose, for 12 weeks.