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 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT05362058
Eligibility Criteria:
Inclusion Criteria:
* Have diagnosis of Type 2 diabetes (T2D) according to the World Health Organization Criteria
* Have an Hemoglobin A1c (HbA1c) of 7.0 percent (%) - 10.5% inclusive, at screening
* Are on a stable treatment with 1 to 3 antihyperglycemic medication for at least 3 months prior to screening and willing to continue the stable treatment for the duration of the study
* These antihyperglycemic medications are accepted in the study
* dipeptidyl peptidase-4 (DPP-4) inhibitors
* sodium-glucose cotransporter 2 (SGLT2) inhibitors
* biguanides, such as metformin
* alpha-glucosidase inhibitors
* glucagon-like peptide-1 (GLP-1) receptor agonists, oral or injectable
* Sulfonylureas, or
* Thiazolidinediones.
* Are insulin naïve.
Exceptions:
* short-term insulin treatment for a maximum of 14 days, prior to screening, and prior insulin treatment for gestational diabetes
* Have a body mass index of less than or equal to (≤) 45 kilogram/square meter (kg/m²).
Exclusion Criteria:
* Have a diagnosis of Type 1 diabetes (T1D), latent autoimmune diabetes, or a specific type of diabetes other than T2D, for example, monogenic diabetes, diseases of the exocrine pancreas, or drug-induced or chemical-induced diabetes.
* Have a history of greater than (\>) 1 episode of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening. Have had severe hypoglycemia episodes within 6 months prior to screening. Have a history of renal transplantation, are currently receiving renal dialysis, or have an estimated glomerular filtration rate.
* Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.
* Have had New York Heart Association Class IV heart failure or any of these cardiovascular conditions within 3 months prior to screening
* Acute myocardial infarction
* Cerebrovascular accident (stroke), or
* Coronary bypass surgery.
* Have had gastric bypass (bariatric) surgery, restrictive bariatric surgery, for example Lap-Band, or sleeve gastrectomy within 1 year prior to screening
* Have had significant weight gain or loss within 3 months prior to screening, for example, greater than or equal to (≥) 5%.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05362058
Study Brief:
Protocol Section:
NCT05362058