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 @ 2:31 PM
Ignite Modification Date:
2025-12-24 @ 2:31 PM
NCT ID:
NCT02960659
Eligibility Criteria:
* INCLUSION CRITERIA:
1. Youth must self-identify as African-American and identify both parents as African-American
2. Age 12-25 years
3. Pubertal or post-pubertal: Girls Tanner stage IV-V breast; Boys Testicular volume 11-25cc
4. Diagnosis of type 2 diabetes of less than or equal to 5 years duration, as per American Diabetes Association Criteria
5. Hemoglobin A1C \<9% at study initiation
6. Negative to mild ketonuria without acidosis (negative or 1+ ketones on urinalysis)
7. Negative test for diabetes-related autoantibodies (glutamic acid decarboxylase 65 and tyrosine phosphatase-related islet antigen 2 (IA-2))
8. Willing and able to take daily medications and check blood glucose levels at least twice per day or wear a continuous glucose monitoring device (CGM).
EXCLUSION CRITERIA:
1. Pregnancy or breastfeeding
2. Allergy to study medications
3. Allergy to milk protein
4. Chronic insulin therapy
5. Treatment with other medications which are known to affect the parameters under study (for example sodium glucose transporter 2 (SGLT-2) inhibitors, dipeptidyl peptidase-4 (DPP-IV) inhibitors, non-selective beta blockers).
6. Metabolic derangement such as metabolic acidosis, severe hyperglycemia (fasting blood glucose greater than or equal to 200mg/dL), and/or liver enzymes \> three times the upper limit of normal.
7. Personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome type 2
8. Any other condition that, in the opinion of the investigators, will increase risk to the subject, or impede the accurate collection of study-related data.
9. Body weight greater than or equal to 450 lbs
10. Body weight less than or equal to 58kg
11. Serum triglyceride concentrations greater than or equal to 500mg/dl
12. Hemoglobin concentration \<10g/dL
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
25 Years
Study:
NCT02960659
Study Brief:
Protocol Section:
NCT02960659