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:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT04304560
Eligibility Criteria:
Inclusion Criteria:
1. Subjects with type-2 diabetes history \>=5 years
2. HbA1C 6-10% with glucose control medications including insulin, metformin or sulfonylurea
3. Medically stable
4. Willing to participate and sign informed consent.
Exclusion Criteria:
1. GFR \<60 mL/min/1.73 m2
2. Unstable or rapidly progressive renal disease
3. Hypotension with SBP \<100 mmHg
4. Hypersensitivity to dapagliflozin or any excipients
5. Patients with severe hepatic impairment (Child-Pugh class C)
6. Patients with active hepatitis B or C infection
7. Any of the following CV/Vascular Diseases within 3 months prior to signing the consent at enrollment, as assessed by the investigator:
1. Myocardial infarction
2. Cardiac surgery or revascularization (CABG/PTCA)
3. Unstable angina
4. HF New York Heart Association (NYHA) Class IV
5. Transient ischemic attack (TIA) or significant cerebrovascular disease
6. Unstable or previously undiagnosed arrhythmia
7. Established PAD
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04304560
Study Brief:
Protocol Section:
NCT04304560