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 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT03782259
Eligibility Criteria:
Inclusion Criteria:
1. Men and women at least 18 years of age
2. Subjects with type-2 diabetes history \>=5 years
3. HbA1C 7-10% with glucose control medications including insulin, metformin or sulfonylurea
4. Medically stable
5. Willing to participate and sign informed consent.
Exclusion Criteria:
1. Contraindication to MRI
2. Currently or within last three months treatment with a SGLT2 inhibitor
3. Currently taking glucagon-like peptide (GLP)-1 receptor antagonist
4. Glomerular filtration rate (GFR) \<60 mL/min/1.73 m2
5. Unstable or rapidly progressive renal disease
6. Hypotension with systolic blood pressure (SBP) \<100 mmHg
7. Hypersensitivity to dapagliflozin or any excipients
8. Patients with severe hepatic impairment (Child-Pugh class C)
9. Patients with active hepatitis B or C infection
10. 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. Heart Failure - New York Heart Association (NYHA) Class IV
5. Transient ischemic attack (TIA) or significant cerebrovascular disease
6. Unstable or previously undiagnosed arrhythmia
7. Established peripheral artery disease (PAD)
(18) Active bladder cancer (19) Recent episode of Diabetic ketoacidosis (DKA), frequent episodes of DKA (20) High risk of fractures, amputations and fibrosis (21) Women of child-bearing potential (ie, those who are not chemically or surgically sterilized or who are not post-menopausal) who have a positive pregnancy test at enrollment or randomization, OR women who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator, from the time of signing the informed consent until two weeks after the last dose of study drug, OR women who are breast-feeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03782259
Study Brief:
Protocol Section:
NCT03782259