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 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
NCT ID:
NCT02173457
Eligibility Criteria:
Inclusion Criteria:
1. Meet the WHO Diagnostic Criteria for Type 2 Diabetes (published on 1999);
2. HbA1c≥ 7.5% and ≤ 10.0% after control of diet and exercises;
3. Male and female,age between 18 and 70 years;
4. BMI between 18.5-35kg/m2;
5. Willing to be assigned to any treatment arm and sign inform consent.
Exclusion Criteria:
1. Type 1 diabetes;
2. Treated by oral or injective antidiabetic drug before screening, including insulin and herb;
3. Fasting plasma glucose \> 13.3 mmol/L (240 mg/dL);
4. Resistant hypertension \[blood pressure above the goal despite adherence to at least 3 optimally dosed antihypertensive medications (including diuretic) of different classes,or blood pressure is controlled to below the goal by at least different classes of drugs\];
5. Plasma triglyceride \> 500 mg/dL (5.65 mmol/L);
6. Is treating by fibrates;
7. History of diabetic ketoacidosis,diabetic hyperglycemic hyperosmolar syndrome,lactic acidosis, diabetic hypoglycemia; or is currently combined with retinopathy, diabetic nephropathy and diabetic neuropathy;
8. Had transient ischemic attack,cerebrovascular accident or unstable angina in the past 6 months;
9. History of myocardial infarction or had conducted coronary angioplasty or coronary artery bypass graft surgery;
10. Had or is having pancreatic diseases;
11. Heart failure (NYHA classification Stage III or IV), or left ventricular hypertrophy indicated by ECG;
12. Hepatic diseases such as hepatocirrhosis, active hepatitis,aspartate aminotransferase or alanine aminotransferase \> 2.5 fold of the upper limit of the normal range;
13. Kidney diseases or serum creatinine exceed the normal range: male \> 133 μmol/L or female \>108 μmol/L;
14. Had malignancy in the past 5 years, not including basal cell carcinoma;
15. Had or is currently receiving treatment that can alter blood glucose metabolism, including but not limited to diuretic,hormone (corticotropin or steroids),beta blockers;
16. Have the diseases that can alter blood glucose metabolism, including but not limited to active hepatitis, hyperthyroidism,or adrenal tumors;
17. Edema with unknown reason;
18. Alcohol or drug addiction;
19. Had participated other drugs' clinical trials in the 3 months before screening;
20. Pregnant or lactic women; or women of childbearing age who are not able to or is not willing to conduct contraception;
21. Any condition that make investigator consider the subject is not suitable to participate the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02173457
Study Brief:
Protocol Section:
NCT02173457