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:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT06818851
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with type 2 diabetes mellitus (T2DM) for at least 6 months based on the 1999 WHO criteria.
* Age between 50 and 70 years at the time of signing the informed consent form (inclusive).
* Poor glycemic control despite treatment with basal insulin or insulin degludec/aspart (with or without oral antidiabetic drugs) within the 3 months prior to screening.
* HbA1c level above 8%.
* BMI ≥ 20 kg/m².
* C-peptide levels within the normal reference range.
* Able to maintain stable dietary and exercise habits during the study.
* Capable of understanding the study procedures and methods, willing to strictly comply with the clinical trial protocol, and voluntarily sign the informed consent form.
Exclusion Criteria:
* Patients considered by the investigator to have potential allergies to the components of the study drug or drugs of the same class.
* Use of SGLT2 inhibitors or GLP-1 receptor agonists within 3 months prior to screening.
* Adjustments to antidiabetic treatment regimens within 3 months prior to screening.
* Hospitalization due to acute coronary syndrome (ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, or unstable angina), percutaneous coronary intervention, or cardiac surgery within 30 days prior to the screening visit.
* Volume depletion.
* Chronic (\>2 weeks) systemic glucocorticoid therapy or use of glucocorticoids within 4 weeks prior to screening (except for topical, intraocular, intranasal, or inhaled administration).
* Pregnancy, lactation, or plans for pregnancy within the next 6 months.
* Persistently elevated serum transaminase levels (more than 3 times the upper limit of normal).
* Renal impairment (estimated glomerular filtration rate \[eGFR\] \< 45 mL/min/1.73 m²).
* History of malignant tumors.
* Presence of acute complications (e.g., ketoacidosis, diabetic ketoacidosis, lactic acidosis, or hyperosmolar coma).
* Systemic autoimmune diseases, such as systemic lupus erythematosus.
* Clinically significant urinary tract infections and/or genital infections, or a history of recurrent urinary tract and/or genital infections.
* Any other factors deemed by the investigator to potentially affect the efficacy or safety evaluation of the study.
* Participation in other clinical trials and receipt of investigational drugs within 3 months prior to screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
70 Years
Study:
NCT06818851
Study Brief:
Protocol Section:
NCT06818851