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 @ 12:50 PM
Ignite Modification Date:
2025-12-24 @ 12:50 PM
NCT ID:
NCT02805361
Eligibility Criteria:
Inclusion Criteria:
The target population will be selected according to the following inclusion criteria:
* Males and females participants aged 18 years and older who are diagnosed type 2 Diabetic patients- (Based on American Diabetes Association diagnostic criteria (ADA), The ADA defines diabetes as a fasting blood glucose (FBG) of ≥ 126mg/dL or a 2-hour glucose level post oral glucose tolerance test (OGTT) of ≥ 200 mg/dL or HbAJC of ≥ 6.5%).
* Patients treated with Dapagliflozin (as per routine care and in compliance with the locally approved prescribing information) for ≥ 4 weeks and ≤ 16 weeks prior to the recruitment date.
* Patients with CrCl \> 60 ml/min or eGFR \> 60 ml/min/1.73 m2 should be included in trial.
* Patients providing written informed consent.
Exclusion Criteria:
* Patients with contraindications to Dapagliflozin as per the locally approved prescribing information will be excluded from the study.
* If participating in any clinical trial, the subject cannot take part in this study.
* Patients with clinically significant renal, hepatic, haematological, oncological, endocrine, psychiatric or rheumatic disease.
* Patients who don't have a disease with life expectancy under 1 year.
* Patients with CrCl \< 60 ml/min or eGFR \< 60 ml/min/1.73 m2 should be excluded from the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02805361
Study Brief:
Protocol Section:
NCT02805361