| Trial ID: | L2503 |
| Source ID: | NCT02689362
|
| Associated Drug: |
Evogliptin
|
| Title: |
Evogliptin in Type 2 Diabetes Mellitus (EVOLUTION: EVOgLiptina no Diabetes Mellitus TIpO 2)
|
| Acronym: |
EVOLUTION
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Evogliptin|DRUG: Sitagliptin|DRUG: Placebo Evogliptin|DRUG: Placebo Sitagliptin
|
| Outcome Measures: |
Primary: Absolute variation of the values obtained in the baseline for the HbA1c, 12 weeks after the start of the treatment | Secondary: Absolute variation of the values obtained in the baseline for the parameter, fasting blood glucose., 12 weeks after the start of the treatment|Absolute variation of the values obtained in the baseline for the parameter, body weight., 12 weeks after the start of the treatment
|
| Sponsor/Collaborators: |
Sponsor: Eurofarma Laboratorios S.A.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
146
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2017-08-08
|
| Completion Date: |
2018-08-09
|
| Results First Posted: |
|
| Last Update Posted: |
2018-08-14
|
| Locations: |
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
|
| URL: |
https://clinicaltrials.gov/show/NCT02689362
|
