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 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT01464320
Eligibility Criteria:
Inclusion Criteria
1. Male or female aged between 19 and 70 years, inclusive, at time of consent.
2. Type 2 diabetes receiving at least one anti-diabetic medication for at least one year at the time of Screening.
3. Hemoglobin A1c \< 12% at the time of Screening.
4. Estimated glomerular filtration rate ≥ 30 mL/min calculated by the Cockcroft-Gault Formula at the time of Screening.
5. Urinary albumin to creatinine ratio 100 to 5000 mg/g creatinine at the time of Screening.
Exclusion Criteria
1. History of unusual or allergic reaction to iodine, to products containing iodine (for example., iodine containing foods) or to other radio-opaque agents.
2. Subject history of epileptic seizures or convulsions.
3. Clinically significant cardiac disease or family history of long-QT syndrome and/or subject and/or family history of unexplained, sudden cardiac death. History of myocardial infarction or coronary artery bypass graft is not exclusionary if occurrence is ≥ 12 months prior to the administration of study drug and the subject does not have conduction abnormality and has been stable without intervention, symptoms of ischemia or an increase in cardiovascular medications. Electrocardiography (ECG) should be compared with historical to ensure no new clinically significant changes have occurred.
4. History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, potential hydrogen (pH) or absorption.
5. Clinically significant respiratory (except mild asthma), gastrointestinal, hematologic, neurologic, thyroid or any uncontrolled medical illness or psychiatric disease or disorder.
6. Screening ECG with clinically significant abnormalities and/or confirmed Screening QTcF prolongation more than 430 milliseconds for males and 450 milliseconds for females or ECG with second or third degree atrioventricular block.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
70 Years
Study:
NCT01464320
Study Brief:
Protocol Section:
NCT01464320