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 @ 1:09 PM
Ignite Modification Date:
2025-12-24 @ 1:09 PM
NCT ID:
NCT02861261
Eligibility Criteria:
Main Inclusion Criteria:
1. Newly diagnosed type 2 diabetes defined as WHO (1999) diagnostic criteria ; Both Genders Eligible;
2. Age: ≥20 and \<70 years;
3. BMI: 19.0 \~ 35.0kg/m2;
4. Not receive previously with anti-diabetic agents (oral agents, GLP-1 or insulin);
5. Have at least 2 months of life style intervention to control blood glucose before screening;
6. HbA1c ≥6.5% and ≤10.0%, and fasting plasma glucose≥7.0 mmol/L and ≤13.3mmol/L at screening.
Details please see the study protocol. -
Main Exclusion Criteria:
1. Significant impaired liver function (defined as alanine transaminase (ALT)\> 2.5 times upper limit of normal); Impaired renal function (defined as serum-creatinine\> 132μmol/L or eGFR \<60 mL/min/1.73m2 ); Mental disease, severe infection, severe anemia, neutropenia disease;
2. Other severe heart disease, such as congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy, defined as New York Heart Association class III or IV;
3. Allergic to gentamicin or other amino glycosides antibiotics;
4. Histories of acute diabetic complications including diabetic ketoacidosis or hyperosmolar hyperglycemic non-ketotic coma within 3 months;
5. Pregnancy;
6. Acute and chronic diarrhea or severe constipation of the digestive tract diseases;
7. Medical history of malignant tumor (except local skin basal cell carcinoma) in the past 5 years;
8. Medical history of intestine, or other digestive tract surgery (such as cholecystectomy) within one year, or other non gastrointestinal surgery within 6 months.
Details please see the study protocol.
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
69 Years
Study:
NCT02861261
Study Brief:
Protocol Section:
NCT02861261