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 @ 3:19 AM
Ignite Modification Date:
2025-12-25 @ 3:19 AM
NCT ID:
NCT06199505
Eligibility Criteria:
Inclusion Criteria:
* Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent.
* BMI = 18.5-35 kg/m2 (inclusive) at screening.
* Diagnosed with type 2 diabetes mellitus for ≥ 6 months.
* 7.0% ≤ HbA1c ≤ 11.0% at screening.
Exclusion Criteria:
* Women in pregnancy or lactation.
* Subjects with any malignancy diagnosed prior to screening or documented history of malignancy.
* Those with the following diseases within 6 months prior to screening: diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar nonketotic diabetic coma.
* Subjects experiencing serious hypoglycaemic events (Level 3 hypoglycaemia) within 3 months prior to screening.
* Subjects with with history of acute heart failure or having been hospitalized for coronary heart disease, myocardial infarction, unstable angina, or stroke within 6 months prior to screening.
* Known or suspected hypersensitivity to trial product(s).
* Participation in a clinical study of another study drug within 1 month prior to randomization.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06199505
Study Brief:
Protocol Section:
NCT06199505