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

NCT ID: NCT02689362

Last Updated: 2018-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-08
• Study Completion Date: 2018-08-09

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Evogliptin

Intervention Type: DRUG

1 tablet per day

Placebo Sitagliptin

Intervention Type: DRUG

1 tablet per day

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.

Group Type: EXPERIMENTAL

Evogliptin

Intervention Type: DRUG

1 tablet per day

Placebo Sitagliptin

Intervention Type: DRUG

1 tablet per day

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.

Group Type: EXPERIMENTAL

Evogliptin

Intervention Type: DRUG

1 tablet per day

Placebo Sitagliptin

Intervention Type: DRUG

1 tablet per day

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.

Group Type: ACTIVE_COMPARATOR

Sitagliptin

Intervention Type: DRUG

1 tablet per day

Placebo Evogliptin

Intervention Type: DRUG

1 tablet per day

Interventions

Evogliptin

1 tablet per day

Intervention Type: DRUG

Sitagliptin

1 tablet per day

Intervention Type: DRUG

Placebo Evogliptin

1 tablet per day

Intervention Type: DRUG

Placebo Sitagliptin

1 tablet per day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male and female patients meeting all the following criteria will be enrolled in the study:

1. Aged between 20 and 75 years old.

2. Diagnosis of T2DM according to the criteria of the American Diabetes Association (ADA).

3. Not having received treatment with oral hypoglycemic agents or insulin within 12 weeks prior to the screening visit;

4. 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;

5. Body mass index (BMI) of 20 kg/m2 ≤ BMI ≤ 40 kg/m2 at the screening visit.

6. Signing the Informed Consent Form (ICF) before the performance of any study procedure.

Exclusion Criteria

• Patients meeting at least one of the following criteria will be excluded from the study:

1. Fasting blood glucose values > 300 mg/dL with severe clinical manifestations present (significant loss weight, severe symptoms and/or ketonuria).

2. Current participation in weight loss programs, with or without anti-obesity drugs use.

3. Presence of heart failure functional class III or IV according to the New York Heart Association (NYHA).

4. Presence of symptomatic liver or gall bladder disease.

5. History of myocardial infarction, transient ischemic attack or coronary angioplasty within 6 months prior to the screening visit.

6. History of gastrointestinal resection.

7. Estimated creatinine clearance (Cockroft and Gault formula) < 60 mL/min.

8. Serum ALT and/or AST level ≥ 2.5 x upper normal limit.

9. Serum CPK level ≥ 3 x upper normal limit.

10. Fasting triglycerides > 400 mg/dL.

11. History of major skin allergy.

12. Use of corticosteroids within 3 months prior to the screening visit.

13. Concomitant treatment with warfarin, dicoumarinic agents or digoxin.

14. 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)

15. History of untreated or uncontrolled thyroid disorder.

16. History of drugs of abuse or moderate/heavy alcohol consumption within 2 months prior to screening.

17. Presence of severe or uncontrolled diseases.

18. Presence of pregnancy or breastfeeding.

19. 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.

20. 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.

21. Presence of any condition which, at the investigator's discretion, may render the patient inadequate for study participation.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eurofarma Laboratorios S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suely K Inoue, Pharm D

Role: STUDY_CHAIR

Eurofarma Laboratórios S/A

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

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 31890041 (View on PubMed)

Other Identifiers

EF144

Identifier Type: -

Identifier Source: org_study_id