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

NCT02689362 | Completed Phase 2 DMC

• 1 other identifier: EF144
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 10

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

Keywords

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

• Absolute variation of the values obtained in the baseline for the HbA1c

  12 weeks after the start of the treatment

Secondary Outcomes (2)

• 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

Study Arms (4)

Evogliptin 2.5mg+Placebo Sitagliptin

EXPERIMENTAL

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.

Drug: Evogliptin; Drug: Placebo Sitagliptin

Evogliptin 5.0mg+Placebo Sitagliptin

EXPERIMENTAL

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.

Drug: Evogliptin; Drug: Placebo Sitagliptin

Evogliptin 10.0mg+Placebo Sitagliptin

EXPERIMENTAL

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.

Drug: Evogliptin; Drug: Placebo Sitagliptin

Sitagliptin 100mg+Placebo Evogliptin

ACTIVE COMPARATOR

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.

Drug: Sitagliptin; Drug: Placebo Evogliptin

Interventions

Evogliptin DRUG

1 tablet per day

Evogliptin 10.0mg+Placebo Sitagliptin; Evogliptin 2.5mg+Placebo Sitagliptin; Evogliptin 5.0mg+Placebo Sitagliptin

Sitagliptin DRUG

1 tablet per day

Sitagliptin 100mg+Placebo Evogliptin

Placebo Evogliptin DRUG

1 tablet per day

Sitagliptin 100mg+Placebo Evogliptin

Placebo Sitagliptin DRUG

1 tablet per day

Evogliptin 10.0mg+Placebo Sitagliptin; Evogliptin 2.5mg+Placebo Sitagliptin; Evogliptin 5.0mg+Placebo Sitagliptin

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.
• 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:

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (10)

Centro de Estudos em Diabetes e Hipertensão

Fortaleza, Ceará, Brazil

Location

Hospital Universitário João de Barros Barreto - HUJBB

Belém, Pará, Brazil

Location

CCBR Brasil Centro de Pesquisas e Analises Clinicas Ltda

Rio de Janeiro, Brazil

Location

Centro de Pesquisa Clínica em Diabetes - UNIFESP

São Paulo, Brazil

Location

CEPIC - Centro Paulista de Investigação Clínica

São Paulo, Brazil

Location

Clinica de Endocrinologia e Metabologia LTDA

São Paulo, Brazil

Location

CPCLIN - Centro de Pesquisas Clinicas LTDA

São Paulo, Brazil

Location

HCFMUSP

São Paulo, Brazil

Location

IMA - Instituto de Pesquisa Clínica e Medicina Avançada Ltda

São Paulo, Brazil

Location

IPEC - Instituto de Pesquisa Clínica Ltda

São Paulo, Brazil

Location

Related Publications (1)

• 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.

  PMID: 31890041 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Suely K Inoue, Pharm D

  Eurofarma Laboratórios S/A

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: February 23, 2016
• Study Start: August 8, 2017
• Primary Completion: August 9, 2018
• Study Completion: August 9, 2018
• Last Updated: August 14, 2018

Record last verified: 2018-08

Locations

BR (10)