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Diabetes Mellitus, Type 2Phase 2EVOLUTIONNCT02689362

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

A Phase 2 study testing Evogliptin and Sitagliptin in people with Diabetes Mellitus, Type 2, run by Eurofarma Laboratorios S.A. at 10 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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.. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Evogliptin and Sitagliptin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
146 participants
Where
10 sitesBrazil
Study dates
8 Aug 2017to 9 Aug 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female patients meeting all the following criteria will be enrolled in the study:
  • Aged between 20 and 75 years old.
  • Diagnosis of T2DM according to the criteria of the American Diabetes Association (ADA).
  • Not having received treatment with oral hypoglycemic agents or insulin within 12 weeks prior to the screening visit;
  • Glycated hemoglobin (HbA1c) levels at the screening visit of 7.5% ≤ HbA1c ≤ 10.5%, after appropriate treatment with diet and physical exercise for ≥ 12 weeks;
  • Body mass index (BMI) of 20 kg/m2 ≤ BMI ≤ 40 kg/m2 at the screening visit.
  • Signing the Informed Consent Form (ICF) before the performance of any study procedure.

Who cannot join

  • Patients meeting at least one of the following criteria will be excluded from the study:
  • Fasting blood glucose values > 300 mg/dL with severe clinical manifestations present (significant loss weight, severe symptoms and/or ketonuria).
  • Current participation in weight loss programs, with or without anti-obesity drugs use.
  • Presence of heart failure functional class III or IV according to the New York Heart Association (NYHA).
  • Presence of symptomatic liver or gall bladder disease.
  • History of myocardial infarction, transient ischemic attack or coronary angioplasty within 6 months prior to the screening visit.
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  • History of gastrointestinal resection.
  • Estimated creatinine clearance (Cockroft and Gault formula) < 60 mL/min.
  • Serum ALT and/or AST level ≥ 2.5 x upper normal limit.
  • Serum CPK level ≥ 3 x upper normal limit.
  • Fasting triglycerides > 400 mg/dL.
  • History of major skin allergy.
  • Use of corticosteroids within 3 months prior to the screening visit.
  • Concomitant treatment with warfarin, dicoumarinic agents or digoxin.
  • Concomitant use of drugs or foods that interfere with the CYP3A4 pathway of liver metabolism including, but not limited to:
  • Inhibitors: antibacterial agents (erythromycin), antifungals (itraconazole, ketoconazole), antivirals (ritonavir, saquinavir, amprenavir, indinavir, nelfinavir), H2 receptor antagonists (cimetidine) and grapefruit juice;
  • Inducers: dexamethasone, rifampin and anticonvulsants (phenytoin, phenobarbital, carbamazepine)
  • History of untreated or uncontrolled thyroid disorder.
  • History of drugs of abuse or moderate/heavy alcohol consumption within 2 months prior to screening.
  • Presence of severe or uncontrolled diseases.
  • Presence of pregnancy or breastfeeding.
  • Women of childbearing potential who do not agree to use a proven effective contraceptive method, unless they are surgically sterile or declare being expressly exempt of pregnancy risk for not engaging in sexual practices or for engaging in them in a non-reproductive manner.
  • Participation in a clinical trial protocol within the previous 12 months unless, at the investigator's discretion, his or her participation may imply a direct benefit for the participant.
  • Presence of any condition which, at the investigator's discretion, may render the patient inadequate for study participation.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Brazil10 sites

  • Hospital Universitário João de Barros Barreto - HUJBB

    Belém, Pará

  • Centro de Estudos em Diabetes e Hipertensão

    Fortaleza, Ceará

  • CCBR Brasil Centro de Pesquisas e Analises Clinicas Ltda

    Rio de Janeiro

  • Centro de Pesquisa Clínica em Diabetes - UNIFESP

    São Paulo

  • CEPIC - Centro Paulista de Investigação Clínica

    São Paulo

  • Clinica de Endocrinologia e Metabologia LTDA

    São Paulo

  • CPCLIN - Centro de Pesquisas Clinicas LTDA

    São Paulo

  • HCFMUSP

    São Paulo

  • IMA - Instituto de Pesquisa Clínica e Medicina Avançada Ltda

    São Paulo

  • IPEC - Instituto de Pesquisa Clínica Ltda

    São Paulo

Other trials in Brazil

About this study

Official title: A Multicenter, Randomized, Double-Blind, Double-Dummy, Active Controlled Clinical Trial for the Validation of Optimum Dose and Preliminary Evaluation of Efficacy and Safety of Evogliptin in Patients With Type 2 Diabetes Mellitus

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.

Being tested
Evogliptin, Sitagliptin, Placebo Evogliptin, Placebo Sitagliptin
Keywords
Diabetes Mellitus Type 2
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EvogliptinDrug

    1 tablet per day

  • SitagliptinDrug

    1 tablet per day

  • Placebo EvogliptinDrug

    1 tablet per day

  • Placebo SitagliptinDrug

    1 tablet per day

Study groups in NCT02689362
Study groupRoleWhat they receive
Evogliptin 2.5mg+Placebo SitagliptinExperimentalEvogliptin (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.
Receives: Drug: Evogliptin; Drug: Placebo Sitagliptin
Evogliptin 5.0mg+Placebo SitagliptinExperimentalEvogliptin (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.
Receives: Drug: Evogliptin; Drug: Placebo Sitagliptin
Evogliptin 10.0mg+Placebo SitagliptinExperimentalEvogliptin (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.
Receives: Drug: Evogliptin; Drug: Placebo Sitagliptin
Sitagliptin 100mg+Placebo EvogliptinActive comparatorSITA 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.
Receives: Drug: Sitagliptin; Drug: Placebo Evogliptin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absolute variation of the values obtained in the baseline for the HbA1c

    Measured: 12 weeks after the start of the treatment

Secondary outcomes (2)

  1. Absolute variation of the values obtained in the baseline for the parameter, fasting blood glucose.

    Measured: 12 weeks after the start of the treatment

  2. Absolute variation of the values obtained in the baseline for the parameter, body weight.

    Measured: 12 weeks after the start of the treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2016 (estimated)
  2. Study start8 Aug 2017
  3. Primary completion9 Aug 2018
  4. Study completion9 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02689362
Sponsor's protocol ID
EF144
Acronym
EVOLUTION
Status last verified
Aug 2018
First submitted
10 Feb 2016
Last updated
14 Aug 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Cercato C, Felicio JS, Russo LAT, Borges JLC, Salles J, Muskat P, Bonansea T, Chacra AR, Eliaschewitz FG, Forti AC. Efficacy and safety of evogliptin in the treatment of type 2 diabetes mellitus in a Brazilian population: a randomized bridging study. Diabetol Metab Syndr. 2019 Dec 19;11:107. doi: 10.1186/s13098-019-0505-z. eCollection 2019.

    PubMed 31890041

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Evogliptin and Sitagliptin in people with Diabetes Mellitus, Type 2, run by Eurofarma Laboratorios S.A. at 10 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02689362, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2018.

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