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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 试验地点
- 10
- 主要终点
- Absolute variation of the values obtained in the baseline for the HbA1c
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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:
- •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.
研究组 & 干预措施
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.
干预措施: Evogliptin (Drug)
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.
干预措施: Placebo Sitagliptin (Drug)
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.
干预措施: Evogliptin (Drug)
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.
干预措施: Placebo Sitagliptin (Drug)
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.
干预措施: Evogliptin (Drug)
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.
干预措施: Placebo Sitagliptin (Drug)
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.
干预措施: Sitagliptin (Drug)
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.
干预措施: Placebo Evogliptin (Drug)
结局指标
主要结局
Absolute variation of the values obtained in the baseline for the HbA1c
时间窗: 12 weeks after the start of the treatment
次要结局
- 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)