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 @ 5:06 AM
Ignite Modification Date:
2025-12-25 @ 5:06 AM
NCT ID:
NCT00591227
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-80 years
2. History of type 2 diabetes mellitus for at least 3 months
3. Prior therapy with dietary management, oral agents, or insulin
4. Non child-bearing potential or a negative urine pregnancy test
5. Initial blood glucose in ER \> 200 mg/dl
Exclusion Criteria:
1. Subsequent finding of diabetic ketoacidosis or hyperosmolar non-ketotic syndrome after initial evaluation.
2. Patients with critical illness suspected to require intensive care unit admission or direct surgical intervention.
3. History of current drug or alcohol abuse.
4. History of current mental illness
5. Inability to give informed consent
6. Female patients who are pregnant or are breast feeding
7. Patients who have clinically significant liver disease with AST/ALT (aspartate transaminase/alanine transaminase) \> 3 times the upper range of normal
8. Patients currently treated with dialysis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00591227
Study Brief:
Protocol Section:
NCT00591227