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 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT02719756
Eligibility Criteria:
Inclusion criteria
The subject population that will be observed in the study, must fulfil all of the following criteria:
1. Signed informed consent.
2. Written informed consent by women of childbearing age to interception during study participation period, with determination of level of chorionic gonadotropic hormone by the pregnancy test, prior to study enrollment.
3. Age \>=18 - 74 years.
4. eGFR \>=60 mL/min/1.73 m2 by MDRD formula.
5. BMI \<40 kg / m2
6. C-peptide \>= 1 ng/ml
7. HbA1c 7 - 9% both included
8. Stabile 1000 mg dose of Metformin daily for at least 8 weeks prior to enrollment
Exclusion criteria
1. The presence of absolute contraindications to therapy by SGLT-2 inhibitor Dapagliflozin:
1.1. Individual idiosyncrasy of any drug component.
1.2. Type 1 diabetes.
1.3. Diabetic ketoacidosis.
1.4. Renal disease, medium to severe (eGFR \<60 ml/min /1.73m2 by MDRD formula) or end-stage renal failure.
1.5.Hereditary lactose intolerance, lactase deficiency, and glucose and galactose intolerance.
1.6. Pregnancy and breast-feeding.
1.7. Children under 18 years of age.
1.8. Patients receiving loop diuretics or with reduced volume of blood circulation, such as a result of acute diseases (e.g. gastrointestinal problems).
1.9. Elderly patients aged 75 years and older.
2. A history of moderate or severe congestive heart failure (New York Heart Association \[NYHA\] Class III or IV) within 3 months prior to the screening visit
3. Increased liver transaminases ALT and/or AST more than 3 times higher than normal.
4. Any condition that in the opinion of the PI confound the evaluation and interpretation of efficacy and or safety data. Significant medical or psychological condition that, in the opinion of the Investigator, would compromise the patient's safety or successful participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
74 Years
Study:
NCT02719756
Study Brief:
Protocol Section:
NCT02719756