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

Inclusion criteria

• 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.

Exclusion criteria

• 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.