Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT02925559
Eligibility Criteria:
Inclusion Criteria:
A. Informed consent form obtained before any study-related activity. Study-related activities are any procedure that would not be performed during the normal treatment of the patient.
B. All study subjects must be patients diagnosed with type 2 diabetes based on current guidelines of Brazilian Society of Diabetes and/or American Diabetes Association (ADA) and they should have all the following criteria:
* Age ≥40 years old.
* HbA1c ≥7% at randomization.
* Drug naïve or metformin treated with a stable dose for at least 3 months.
Exclusion Criteria:
1. Acute vascular event (cardiac, cerebral or peripheral) for at least 2 months of randomization.
2. Patient on chronic dialysis and/or renal transplantation and/or serum creatinine \>1.5 mg/dL and/or estimated glomerular filtration rate (eGFR) \< 45ml/min (MDRD) and/or Creatinine Clearance \<60ml/min.
3. Patients with HIV, severe autoimmune disease or chronic treatment with oral steroids (\>30 consecutive days).
4. Current or previous treatment with any SGLT-2 inhibitor within 2 months prior to randomization.
5. Current or previous treatment with any type of insulin within 2 months prior to randomization.
6. Current or previous treatment with any sulphonylurea and meglitinide within 2 months prior to randomization.
7. Current or previous treatment with any DPP-4 inhibitor or glucagon-like peptide-1 (GLP-1) receptor agonist within 2 months prior to randomization.
8. Current or previous treatment with acarbose within 2 months prior to randomization.
9. Sustained arterial hypertension ≥160/100mm Hg.
10. Body mass index (BMI) \>50 kg/m².
11. HbA1c ≥10.5% at randomization.
12. Transaminases (aspartate aminotransferase and/or alanine aminotransferase) \>2.5 x upper limit of normal.
13. Total bilirubin \>2.5 x upper limit of normal
14. Chronic liver disease or alcoholic liver disease.
15. LDL-cholesterol \>250 mg/dL (\>6.48 mmol/L).
16. Triglycerides \>1000 mg/dL (\>11.3 mmol/L).
17. HDL-cholesterol \<25 mg/dL (\<0.64 mmol/L).
18. Positive haematuria observed in urine sample obtained in the run-in visit.
19. Prescription of any investigational medication within 3 months before the screening visit.
20. Prescription of any investigational medication within the period between 3 months and one year before the screening visit (visit 1), unless there is a direct benefit to the study subject, at the discretion of the investigator.
21. Pregnant or breastfeeding patients.
22. Previous participation on this study.
23. Individuals at risk for poor adherence to the protocol or medication.
24. Any condition that makes the patient unable to complete the study within 3 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT02925559
Study Brief:
Protocol Section:
NCT02925559