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 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT06703268
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 and Age ≤75 years
* T2DM patients,
* During the 12 weeks before screening, on the basis of diet control and exercise therapy, patients only regularly received daily DPP-4 inhibitors (such as sitagliptin, vildagliptin, saxagliptin, linagliptin, alogliptin and retagliptin , etc.) or combined with metformin (with a metformin dose of ≥ 1500 mg/day, or the maximum tolerated dose \< 1500 mg/day but ≥ 1000 mg/day);
* HbA1c ≥6.5% and HbA1c \<8.0%
* FPG \<10.0 mmol/L
* BMI ≥19 and BMI ≤ 35 kg/m2 (Body Mass Index)
Exclusion Criteria:
* Non-type 2 diabetes: Type 1 diabetes, gestational diabetes or other special types of diabetes.
* The presence of any of the following medical histories or conditions at the time of screening:
* History of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the recent 6 months;
* History of ≥2 episodes of severe hypoglycemia within the last 6 months;
* History of malignant tumors within the recent 5 years (except for cured basal cell carcinoma of the skin and cervical carcinoma in situ), or currently being evaluated for potential malignant tumors.
* Presence of severe mental disorders or language barriers, unwilling or unable to fully understand and cooperate.
* History of drug abuse within the past 5 years
* Previous history or clinical evidence of acute or chronic pancreatitis.
* Using other drugs that may affect blood glucose metabolism within 12 weeks prior to screening, including systemic glucocorticoids (except for inhaled or topical ones), growth hormones, etc.
* Any laboratory test index meeting the following criteria:
* Hemoglobin \< 110 g/L (for males) or \< 100 g/L (for females).
* Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 3 times the upper limit of the normal value.
* Total bilirubin (TBIL) \> 2 times the upper limit of the normal value.
* Fasting triglyceride (TG) \> 5.7 mmol/L.
* Estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI formula \< 45 mL/min/1.73m².
* Known to be allergic to the investigational products or related excipients.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06703268
Study Brief:
Protocol Section:
NCT06703268