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 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT00743756
Eligibility Criteria:
Inclusion Criteria:
1. African-American subjects
2. Males or females 65 - 85 years of age
3. Body mass index (BMI) equal to or greater than 30 kg/m2
4. Fasting blood glucose less than 300 mg/dL and HbA1c less than 9.0%
5. Ability to understand and be willing to adhere to the study protocol
6. A known history of type 2 diabetes mellitus greater than 3 months, receiving either diet alone or oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones).
Exclusion Criteria:
1. Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state.
2. Patients with clinically relevant hepatic disease or impaired renal function, as shown by a serum creatinine greater than 3.0 mg/dL.
3. Mental condition rendering the subject unable to understand the scope of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
85 Years
Study:
NCT00743756
Study Brief:
Protocol Section:
NCT00743756