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 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
NCT ID:
NCT02963766
Eligibility Criteria:
Inclusion Criteria:
* Have type 2 diabetes, treated with diet and exercise, with or without metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 8 weeks prior to study screening.
* Have HbA1c \>6.5% to ≤11% at screening visit. If newly diagnosed and not on medicine for diabetes, HbA1c must be between \>6.5 % to ≤9%.
* Have a BMI (body mass index) \>85 percentile for age, gender and body weight ≥50 kilograms (110 pounds).
Exclusion Criteria:
* Known type 1 diabetes, or positive GAD65 or IA2 antibodies, or history of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome.
* A history of, or at risk for pancreatitis.
* Self or family history of Multiple Endocrine Neoplasia (MEN) type 2A or B, thyroid C-cell hyperplasia or medullary thyroid cancer, or a blood calcitonin result ≥20 picograms per milliliter (pg/ml) at screening.
* A systolic blood pressure of ≥160 millimeters of mercury (mmHg) or diastolic ≥100 mmHg.
* Active or treated cancer.
* A blood disorder where an accurate HbA1c may not be obtainable.
* A female of childbearing age, sexually active and not on birth control.
* Pregnant or plan to be pregnant during the study, or breastfeeding.
* Taking any diabetic medication other than metformin or basal insulin and have not stopped it 3 months prior to the screening visit (6 weeks for bolus or mealtime insulin).
* Have taken oral steroids within the last 60 days or more than 20 days use within the past year or 1000 micrograms fluticasone propionate per day.
* Using prescription weight loss medications in the last 30 days, or plan to use.
* Taking psychiatric medications for depression or illness or attention deficit hyperactivity disorder (ADHD) if, the doses has changed within the last 3 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
17 Years
Study:
NCT02963766
Study Brief:
Protocol Section:
NCT02963766