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 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT06118008
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects,20-65 years of age at the time of signing informed consent.
* Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit.
* Treated with conventional lifestyle intervention and stable treatment with metformin ( ≥ 1000 mg/day) at least 3 months prior to screening HbA1c 7.5-10%(both inclusive)at screening visit.
Exclusion Criteria:
* A history of type 1 diabetes, specific diabetes, or secondary diabetes.
* Presence of-clinically significant lab or ECG results that may affect the evaluation of the efficacy or safety of the study drug at screening visit.
* Acute or chronic pancreatitis at any time before screening, or serum lipase/amylase above the upper limit of normal at screening.
* A history of grade 2 hypoglycemia(blood glucose 3.0 mmol/L)or grade 3 hypoglycemia(hypoglycemia with a serious event of consciousness and/or physical alteration requiring assistance from another person for recovery)within 6 months before screening.
* Diabetid ketoacidosis or hyperosmolar coma or lactic acidosis requiring hospitalization occurred within 6 months before screening.
* Severe infection such as diabetic foot infection, pneumonia, or sepsis within 30 days before screening.
* Uncontrollable hypertension.
* History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening.
* Any organ-system malignancies developed within 5 years except for cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix.
* Pregnant or lactating woman.
* In the investigator's judgment, there were circumstances that affected subject safety or otherwise interfered with the evaluation of results.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT06118008
Study Brief:
Protocol Section:
NCT06118008