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 @ 6:36 PM
Ignite Modification Date:
2025-12-24 @ 6:36 PM
NCT ID:
NCT00725257
Eligibility Criteria:
Inclusion Criteria:
* Type 2 diabetes mellitus (ADA criteria)
* BMI (body mass index) \> 25 kg/M2
* Hemoglobin A1c (HbA1c) \< 11%; Blood pressure \< 160 (systolic) and 100 (diastolic) mm Hg
* Triglyceride levels \< 500 mg/dl.
Exclusion Criteria:
* Pregnancy or breast-feeding
* Previous use of insulin or oral antidiabetic drugs
* Investigational drug within the previous 3 months
* Use of agents affecting glycemic control (systemic steroids and weight loss drugs)
* Patients with history of alcohol or illicit drug abuse
* Patients with liver enzymes higher than three times the upper limit of normal
* Serum creatinine \> 1.4 mg/dl.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT00725257
Study Brief:
Protocol Section:
NCT00725257