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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT01554618
Eligibility Criteria:
Each patient must meet the following criteria to be enrolled in this study.
1. Is a child or an adolescent of 10 to \<18 years old, at Visit 1 (Screening)
2. Has been diagnosed with type 2 diabetes mellitus per American Diabetes Association diagnostic criteria
3. HbA1c of 6.5% to 11.0%, inclusive, in patients not taking insulin/SU, and of 6.5% to 12.0%, inclusive, in patients taking insulin/SU, at Visit 1 (Screening)
4. Has a C-peptide of \>0.6 ng/L at Visit 1 (Screening)
5. Has been treated with diet and exercise alone or in combination with a stable dose of an oral antidiabetic agent (e.g., metformin and/or SU) and/or insulin for their type 2 diabetes for at least 2 months prior to Visit 1 (Screening)
6. Has a fasting plasma glucose concentration \<280 mg/dL (15.5 mmol/L) at Visit 1 (Screening)
Patients who meet any of the following criteria will be excluded from the study.
1. Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being, as judged by the Investigator, including but not limited to the following conditions:
1. Hepatic disease (defined by aspartate or alanine transaminase \>3.0 times the upper limit of normal (ULN)
2. Renal disease or serum creatinine \>1.5 mg/dL (132.6 µmol/L) (males) or 1.4 mg/dL (123.8 µmol/L) (females)
3. Gastrointestinal disease deemed significant by the Investigator
4. Organ transplantation
5. Chronic infection (e.g., tuberculosis, human immunodeficiency virus, hepatitis B virus, or hepatitis C virus)
6. Clinically significant malignant disease (with the exception of basal and squamous cell carcinoma of the skin) within 5 years of Visit 1 (Screening)
2. Has positive antibody titers to glutamic acid decarboxylase (GAD65) or islet cell antigen (ICA512) at Visit 1 (Screening)
3. Has a personal or family history of elevated calcitonin, calcitonin \>100 ng/L, medullary thyroid carcinoma, or multiple endocrine neoplasia-2
4. Has ever used exenatide (exenatide once weekly \[exenatide LAR\], exenatide BID, BYETTA, or any other formulation) or any glucagon-like peptide-1 (GLP-1) receptor agonist (e.g., liraglutide \[Victoza®\])
5. Is pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
17 Years
Study:
NCT01554618
Study Brief:
Protocol Section:
NCT01554618