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

Sponsor
Eurofarma Laboratorios S.A.
Study ID
NCT02689362
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Evogliptin — DRUG
    1 tablet per day
  • Sitagliptin — DRUG
    1 tablet per day
  • Placebo Evogliptin — DRUG
    1 tablet per day
  • Placebo Sitagliptin — DRUG
    1 tablet per day

Study Details

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.

Key Dates

First listed
Feb 23, 2016
Start date
Aug 8, 2017
Status verified
Aug 2018
Primary completion
Aug 9, 2018
Completion
Aug 9, 2018

Study Design

Enrollment
146 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Evogliptin 2.5mg+Placebo Sitagliptin
    Evogliptin (EVO) will be administered orally at a daily dose of: 2.5 mg. The participants randomized to this group will receive 1 tablet daily of EVO 2.5 mg + 1 tablet of sitagliptin (SITA) placebo for 12 weeks.
  • Experimental: Evogliptin 5.0mg+Placebo Sitagliptin
    Evogliptin (EVO) will be administered orally at a daily dose of: 5.0 mg. The participants randomized to this group will receive 1 tablet daily of EVO 5.0 mg + 1 tablet of sitagliptin (SITA) placebo for 12 weeks.
  • Experimental: Evogliptin 10.0mg+Placebo Sitagliptin
    Evogliptin (EVO) will be administered orally at a daily dose of: 10.0 mg. The participants randomized to this group will receive 1 tablet daily of EVO 10.0 mg + 1 tablet of sitagliptin (SITA) placebo for 12 weeks.
  • Active Comparator: Sitagliptin 100mg+Placebo Evogliptin
    SITA at a daily oral dose of 100 mg. The participants randomized to this group will receive 1 tablet daily of SITA 100 mg + 1 tablet of EVO placebo for 12 weeks.

Primary Outcome Measure

Absolute variation of the values obtained in the baseline for the HbA1c [ Time Frame: 12 weeks after the start of the treatment ]

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