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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT04450394
Eligibility Criteria:
Inclusion Criteria:
* Participants must have type 2 diabetes mellitus according to the World Health Organization (WHO) criteria treated with a stable dose of metformin in combination with a stable dose of Dipeptidyl Peptidase IV (DPPIV) inhibitor and/or a Sodium-glucose co-transporter-2 (SGLT2) inhibitor for at least 3 months prior to screening
* Participants must have a HbA1c value of 7.0% to 9.5%, inclusive
* Participants must have a body mass index (BMI) between 20 and 45 kilograms per meter squared (kg/m²), inclusive
Exclusion Criteria:
* Have type 1 diabetes mellitus or latent autoimmune diabetes
* Have any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening
* Have any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke)
* Have acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease
* Have an estimated glomerular filtration rate (eGFR) \<30 milliliters/minute/1.73 m²
* Have active or untreated cancer
* Are receiving chronic (\>14 days) systemic glucocorticoid therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04450394
Study Brief:
Protocol Section:
NCT04450394