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Evogliptin in Type 2 Diabetes Mellitus (EVOLUTION: EVOgLiptina no Diabetes Mellitus TIpO 2)

NCT02689362 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2018-08-14

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Evogliptin

1 tablet per day

DRUG

Sitagliptin

1 tablet per day

DRUG

Placebo Evogliptin

1 tablet per day

DRUG

Placebo Sitagliptin

1 tablet per day

Sponsors & Collaborators

  • Eurofarma Laboratorios S.A.

    lead INDUSTRY

Principal Investigators

  • Suely K Inoue, Pharm D · Eurofarma Laboratórios S/A

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-08
Primary Completion
2018-08-09
Completion
2018-08-09

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02689362 on ClinicalTrials.gov