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:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT00544518
Eligibility Criteria:
Inclusion Criteria:
* For inclusion in the study, participants will be；① Antidiabetic drugs naïve Type 2 diabetes mellitus（WHO standard） with diet control more than 2 weeks; ②or diagnosed Type 2 diabetes mellitus with no oral antidiabetic drugs more than 6months; ③or Type 2 diabetes mellitus treated with insulin secretagogues more than 1 month; all patients have HbA1c between 7.0-10.0% and fasting glucose between 7.0mmol/L～13.0mmol/L.
* Ages Eligible for Study: 18 Years --70 Years, Genders:Both
* BMI: 23～40kg/m2
* No using insulin before 3 months
* Consent to do birth control to Women of child-bearing age
* Volunteer to join and sign Information consent form
Exclusion Criteria:
* Patients with ketoacidosis、hyperglycemic hyperosmolar syndrome.
* Patients with severe diabetic complications
* Patient with acute cardiovascular diseases，acute cerebrovascular diseases，with Vitamin B12、folic acid and iron deficiency，with severe trauma or surgery，severe infection diseases.
* Allergy to benfluorex or metformin
* ALT、AST\> 2 times of upper normal limit，Cr\> upper normal limit.
* Having used benfluorex within 3 months before recruiting.
* Patients accepting steroid hormones or malignant tumor treatment
* Patients with drug abuse or bibulous history.
* Patients with severe unconscious low blood glucose history，severe mental illness history and family history
* Severe hypertensive patients（SBP\>160 mmHg，DBP\>95mmHg）
* Patient with pancreas diseases.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00544518
Study Brief:
Protocol Section:
NCT00544518