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 @ 4:30 PM
Ignite Modification Date:
2025-12-24 @ 4:30 PM
NCT ID:
NCT04159766
Eligibility Criteria:
Inclusion Criteria:
* Male or female subject with type 2 diabetes for at least one year
* Willing to continue treatment with metformin at the same dose and frequency until and (if applicable) to pause any treatment with a second oral antidiabetic
* Body Mass Index (BMI) 22.0 to 35.0 kg/m\^2,
Exclusion Criteria:
* History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
* Any history or presence of clinically relevant comorbidity (with the exception of conditions associated with diabetes mellitus), that may place the subject at increased risk as determined by the investigator
* Any prior exposure to an exenatide-based product (BYETTA and BYDUREON)
* History of gastroparesis
* History of severe hypoglycemia in the past 6 months
* If female, pregnant or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04159766
Study Brief:
Protocol Section:
NCT04159766