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

Launched by EUROFARMA LABORATORIOS S.A. · Feb 18, 2016

Keywords

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Gender

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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.