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 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT04809220
Eligibility Criteria:
Inclusion Criteria:
* Participants with type 2 diabetes (T2D) ≥ 6 months according to the World Health Organization (WHO) classification.
* Treated with stable doses of a single OAM for at least 8 weeks prior to screening; the dose must be more than or equal to minimum maintenance dose.
* Have the following HbA1c result at screening.
* Participants taking DPP-4i: ≥7.5% and ≤9.5%,
* Participants taking another OAM: ≥8.0% and ≤10.0%
* Stable body weight for at least 8 weeks prior to screening or not changed by more than 5 % in the past 8 weeks
* Have a body mass index (BMI) ≥18.5 kilogram/square meter (kg/m²) and \<35 kg/m² at Day 1.
Exclusion Criteria:
* Have type 1 diabetes (T1D)
* Have a history of ≥1 episode of ketoacidosis or hyperosmolar state/coma
* Have had any myocardial infarction (MI), heart failure or cerebrovascular accident (stroke)
* Have a known clinically significant gastric empty abnormality
* Have acute or chronic hepatitis
* Have had chronic or acute pancreatitis
* Have any self or family history of type 2A or type 2B multiple endocrine neoplasia in the absence of known C-cell hyperplasia
* Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, or carcinoma (including sporadic, familial, or part of Multiple endocrine neoplasia (MEN) 2A or 2B syndrome)
* Have evidence of significant, active autoimmune abnormality
* Have evidence of significant, uncontrolled endocrine abnormality
* Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years
* Have any hematologic condition that may interfere with HbA1c measurement
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT04809220
Study Brief:
Protocol Section:
NCT04809220