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 @ 10:49 PM
Ignite Modification Date:
2025-12-24 @ 10:49 PM
NCT ID:
NCT01506869
Eligibility Criteria:
Phase 1
Inclusion Criteria:
1. Age \>= 40 years old
2. Gender: males and females
3. Provide written informed consent
4. Satisfactory compliance
Phase 2
Inclusion Criteria:
1. Age \>= 40 and =\< 75 years old
2. Gender: males and females
3. Provide written informed consent
4. Satisfactory compliance
Exclusion Criteria:
1. History of cancer;
2. History of LADA and other autoimmunity diseases;
3. Acute diabetic complication, acidosis, etc;
4. Moderate to severe liver, kidney dysfunction, i.e. ALT/AST \> 2.5 times the upper limit of normal range or Ccr \< 25ml/min;
5. Any other condition or major systemic diseases that the investigator feels would interfere with trial participation or evaluation of results.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT01506869
Study Brief:
Protocol Section:
NCT01506869