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 @ 4:52 PM
Ignite Modification Date:
2025-12-24 @ 4:52 PM
NCT ID:
NCT06613750
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with Type 2 Diabetes Mellitus (T2DM) and glucotoxicity.
* Body Mass Index (BMI) between 18 and 30 kg/m².
* Fasting plasma glucose (FPG) levels ≥ 200 mg/dL and glycated hemoglobin (HbA1c) ≥ 9.0%.
* Normal hepatic and renal functions (ALT and AST ≤ 2.5 times the upper limit of normal; serum creatinine within normal limits).
* Capable of adhering to the prescribed anti-diabetic regimen and dietary guidelines.
Exclusion Criteria:
* Diagnosis of Type 1 Diabetes Mellitus.
* Hepatic or renal dysfunction (serum creatinine \> 1.2 times the upper limit of normal).
* Prior use of hypoglycemic medications before screening.
* History of severe ketosis, ketoacidosis, or hyperosmolar hyperglycemic state.
* Current treatment with corticosteroids, immunosuppressive agents, or cytotoxic drugs.
* Major systemic diseases (e.g., cardiovascular, respiratory, neurological).
* Pregnant or breastfeeding women.
* Known allergies to sitagliptin or gliclazide.
* Poor compliance potential as assessed by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06613750
Study Brief:
Protocol Section:
NCT06613750