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 @ 5:57 PM
Ignite Modification Date:
2025-12-24 @ 5:57 PM
NCT ID:
NCT00963768
Eligibility Criteria:
Inclusion Criteria:
* Patients must have been diagnosed with Type 2 Diabetes for at least one year before screening
* Patients must be taking a stable dose of oral (by mouth) anti-diabetic monotherapy or a combination of two anti-diabetic medications
* Males or postmenopausal or surgically sterile women (post-menopausal is defined as no menses for at least 18 months prior to study start or no menses for 6 to 18 months)
* Body mass index (weight in kg/height in m2) should be between 20 to 39.9 kg/m2
Exclusion Criteria:
* History of Type 1, brittle diabetes or secondary forms of diabetes
* History of repeated severe hypoglycemic episodes
* History of diabetic complications including retinopathy, nephropathy, neuropathy, gastroparesis, or ketoacidosis
* History of, or currently active illness including but not limited to cardiovascular disease, hematological disease, respiratory disease, hepatic or gastrointestinal disease, endocrine/metabolic disorders, neurologic or psychiatric disease, or malignant neoplasms considered by the Investigator to be clinically significant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT00963768
Study Brief:
Protocol Section:
NCT00963768