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:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-26 @ 10:36 AM
NCT ID:
NCT04276428
Eligibility Criteria:
Inclusion Criteria:
* Have type 2 diabetes mellitus (T2DM) for at least 1 year
* Have received a stable daily dose of basal insulin at screening
* Have hemoglobin A1c (HbA1c) greater than or equal to (≥)6.5 percent (%) and less than or equal to (≤)10.0% at screening
* Have a body mass index greater than (\>)18.5 and ≤40.0 kilograms per square meter (kg/m²) at screening
Exclusion Criteria:
* Have received a total daily dose of insulin \>1.2 units per kilogram (U/kg) of body weight at screening
* Have received insulins except for basal insulins
* Have received sulfonylurea at more than half of the maximum approved dose level
* Have a history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction or history of significant atopy
* Have had more than 1 episode of severe hypoglycemia within 6 months before entry
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
74 Years
Study:
NCT04276428
Study Brief:
Protocol Section:
NCT04276428