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 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT05126251
Eligibility Criteria:
Inclusion Criteria:
* FPG 5.6mmol/L\~6.9mmol/L or OGTT 2H blood glucose 7.8mmol/L\~11.0mmol/L or HbA1c 5.7%\~6.4%, the above 3 indicators need to meet at least 2 items；
* Age 18 \~ 70 years old (including boundary value);
* Patients who voluntarily signed the informed consent and had conditional follow-up.
Exclusion Criteria:
* Regularly take drugs affecting blood glucose within 1 month before screening, such as hypoglycemic drugs, glucocorticoids, niacin β- Adrenergic agonists, thyroid hormones, contraceptives, diazoxide, diuretics, phenytoin sodium γ- Interferon, etc;
* Combined with various diseases that may significantly shorten life expectancy, such as malignant tumors, severe organ failure and so on;
* Combined with various diseases that may seriously affect the subject's participation in the test, such as psychosis, serious motor system abnormalities, etc;
* Combined ALT or ast \> 2.5 times the upper limit of normal value, or serum creatinine \> 1.5mg/dl;
* Allergic to the test drug or its components;
* Pregnant or lactating women, or women who have pregnancy plans from the study period to 3 months after the last administration, or men who are unwilling to take a medically recognized effective non drug contraceptive measure.
* Chronic diarrhea caused by inflammatory bowel disease and irritable bowel syndrome;
* The investigator believes that it is inappropriate to be included in this trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05126251
Study Brief:
Protocol Section:
NCT05126251