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 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT06191328
Eligibility Criteria:
Inclusion Criteria:
1. Patients with type 2 diabetes (T2DM) WHO meet the diagnostic criteria for diabetes issued by the World Health Organization (WHO) in 1999;
2. Male or female patients aged ≥18, ≤70 years;
3. BMI≥18.5 Kg/m2, \< 35 Kg/m2;
4. Hemoglobin a1C (HbA1C) ≥7.5%; ≤10.5%;
5. Triglyceride ≤500 mg /dL (5.65 mmol/L) (if the researchers judge that the transient increase caused by diet, etc., can be repeated detection)
6. Total cholesterol (TC) ≤250mg/dl (6.45mmol/L)
7. T2DM patients who are taking one or two kinds of oral hypoglycemic drugs with fixed dose ≥2 months and uncontrolled blood glucose.
8. Voluntarily sign informed consent and agree to enter the trial group.
Exclusion Criteria:
1. Type 1 diabetes or other specific type of diabetes
2. Fasting blood glucose (FPG) \> 13.3 mmol/L (240 mg/dL);
3. Triglyceride (TG) \> 500 mg /dL (5.65 mmol/L);
4. Total cholesterol (TC) \> 250mg/dl (\> 6.45mmol/L);
5. Refractory hypertension \[that is, on the basis of improving the lifestyle, the blood pressure is still not up to standard after 1 month of applying a reasonably tolerable amount of 3 or more antihypertensive drugs (including diuretics), or the blood pressure can be effectively controlled by taking 4 or more antihypertensive drugs;
6. Taking fibrates, statins, thiazolidinediones, insulin drugs;
7. A clear diagnosis of severe osteoporosis or any other known bone disease;
8. A history of diabetic ketoacidosis, diabetic hyperglycemia hyperosmolar syndrome, lactic acidosis and other acute complications of diabetes;
9. Severe microvascular complications (proliferative retinopathy; Urinary albumin/creatinine ratio \> 300 mg/g; Marked peripheral neuropathy, etc.);
10. The New York Heart Association (NYHA) defines congestive heart failure as grade III or IV;
11. Significant liver and kidney dysfunction and systemic disease (significant liver dysfunction is defined as AST\> 2.5 times the upper limit of normal and/or ALT\> 2.5 times the upper limit of normal and/or total bilirubin \> 1.5 times the upper limit of normal value; Renal dysfunction was defined as moderate to severe renal insufficiency (eGFR\<60 ml/ (min\*1.73m2));
12. Pregnant or lactating women, women of childbearing age who are unable or unwilling to take adequate contraception;
13. Participating in a clinical trial of another drug or medical device in or within 3 months prior to screening;
14. The investigator considers it inappropriate to participate in this clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06191328
Study Brief:
Protocol Section:
NCT06191328