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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
146
1 tablet per day
1 tablet per day
1 tablet per day
1 tablet per day
Centro de Estudos em Diabetes e Hipertensão
Fortaleza, Ceará, Brazil
Hospital Universitário João de Barros Barreto - HUJBB
Belém, Pará, Brazil
CCBR Brasil Centro de Pesquisas e Analises Clinicas Ltda
Rio de Janeiro, Brazil
Centro de Pesquisa Clínica em Diabetes - UNIFESP
São Paulo, Brazil
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, Brazil
Clinica de Endocrinologia e Metabologia LTDA
São Paulo, Brazil
CPCLIN - Centro de Pesquisas Clinicas LTDA
São Paulo, Brazil
HCFMUSP
São Paulo, Brazil
IMA - Instituto de Pesquisa Clínica e Medicina Avançada Ltda
São Paulo, Brazil
IPEC - Instituto de Pesquisa Clínica Ltda
São Paulo, Brazil
Absolute variation of the values obtained in the baseline for the HbA1c
Time frame: 12 weeks after the start of the treatment
Absolute variation of the values obtained in the baseline for the parameter, fasting blood glucose.
Time frame: 12 weeks after the start of the treatment
Absolute variation of the values obtained in the baseline for the parameter, body weight.
Time frame: 12 weeks after the start of the treatment
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