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 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 1:31 AM
NCT ID:
NCT01261494
Eligibility Criteria:
Inclusion Criteria:
* Male or post-menopausal female (defined as \>12 months since last menstrual period) or surgical menopause. If hormonal replacement therapy, it should be stable at least for 6 months prior to screening.
* Body Mass Index ≥27 and ≤45 kg/m².
* Drug-Naive patients with type 2 diabetes mellitus (non insulin dependent diabetes). Patients should not be treated by insulin or other diabetes medication for the last 3 months prior to screening. Patients treated for less than 4 weeks with insulin may be included in the study.
* HbA1c ≥ 7.0% and \<9.5%.
* Antibody glutamate decarboxylase acid (Anti-GAD) negative for patients aged less than 40 years.
Exclusion Criteria:
* Type I Diabetes Mellitus.
* Blood Pressure \> 160 / 95 mmHg.
* Lipid-lowering drugs such as fibrates.
* Fasting Plasma Glucose (FPG) ≥ 240 mg/dL.
* Triglycerides (TG) \> 400 mg/dL.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01261494
Study Brief:
Protocol Section:
NCT01261494