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 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT02638805
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of type 2 diabetes ≥ 3 months.
* Stable regimen of diet and exercise in combination with a stable treatment of liraglutide ≥1.2 mg/day and metformin ≥1000 mg/day.
* HbA1c ≤9.5%.
* Stable body weight ≥ 3 months.
* Body mass index (BMI) ≥25 to ≤45 kg per meter squared.
* Calcitonin \<50 ng/L (50 pg/mL) at the Screening Visit.
Exclusion Criteria:
* History of type 1 diabetes.
* Recent use or of anti-diabetic medications other than liraglutide or metformin.
* History of significant/severe nausea and/or vomiting due to liraglutide.
* Significant symptomatic hyperglycemia.
* History or evidence, within the last 6 months prior to the Screening Visit, of myocardial infarction, coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention), unstable angina, or cerebrovascular accident or stroke.
* History or evidence of acute or chronic pancreatitis.
* History of liver disease.
* History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2.
* Poor thyroid, liver, or renal function.
* Serum creatinine levels \>1.5mg/dL (132 μmol/L) for male patients, or \>1.4 mg/dL (123 μmol/L) for female patients.
* Weight loss surgery or requires weight loss medications.
* History of malignancy (not including basal or squamous cell carcinoma of the skin with past 5 years).
* History of active alcohol or substance abuse.
* Treatment with medications that affect GI motility.
* History of hypersensitivity to exenatide or liraglutide.
* Women that are pregnant, lactating, or planning to become pregnant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02638805
Study Brief:
Protocol Section:
NCT02638805