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 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT00241605
Eligibility Criteria:
Inclusion Criteria:
* Patients between 18 and 75 years of age with Type 2 Diabetes Mellitus and are currently on metformin monotherapy for glycemic control (100mg daily for at least 3 months prior to screening).
* Patients must have stopped previous treatment with thiazolidinediones or other anti-diabetic agents at least 3 months prior to screening.
* Women must be post-menopausal, surgically sterile or using acceptable contraceptive measures.
Exclusion Criteria:
* Prior history of hepatocellular reaction to or severe edema associated with the use of thiazolidinediones.
* Have a known hypersensitivity to thiazolidinediones or biguanides.
* Currently using insulin or any oral anti-diabetic agent other than metformin.
* History of metabolic acidosis.
* History of substance abuse.
* Have active cancer other than localized squamous or basal cell carcinoma.
* Chronic disease requiring treatment with corticosteroids.
* Other criteria will be evaluated at the screening visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00241605
Study Brief:
Protocol Section:
NCT00241605