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 @ 12:41 AM
Ignite Modification Date:
2025-12-25 @ 12:41 AM
NCT ID:
NCT01398267
Eligibility Criteria:
Inclusion Criteria:
* Adult male and female patients, 18 to 65 years of age, inclusive
* Diabetes mellitus Type 2, diagnosed at least 3 months before screening
* Treated with stable dose of metformin for at least 4 weeks prior to screening
* Treated with stable dose of Angiotensin-converting enzyme inhibitor (ACEI) for at least 4 weeks prior to screening
* Body mass index (BMI) 18 to 38 kg/m2, inclusive
Exclusion Criteria:
* Positive for HIV-1, HIV-2, hepatitis B or hepatitis C infection
* Pregnant or lactating females
* Type 1 diabetes or secondary from of diabetes
* History or evidence of proliferative diabetic retinopathy or clinically significant neuropathy
* Clinically significant hepatic disease
* Clinically significant renal impairment
* History or evidence of clinically significant cardio-vascular disease or disorder
* Acute infection or current malignancy requiring treatment except for excised basal cell carcinoma
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01398267
Study Brief:
Protocol Section:
NCT01398267