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 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT00086502
Eligibility Criteria:
Inclusion Criteria:
* Patient has type 2 diabetes mellitus (T2DM)
* Patient is 18 years of age (or older)
* Patient is not pregnant or breast-feeding and does not plan to become pregnant for the duration of the study and poststudy follow-up period
Exclusion Criteria:
* Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis
* Patient required insulin within the prior 8 weeks
* Patient is on a weight loss program and is not in the maintenance phase
* Patient started on a weight loss medication (e.g., orlistat or sibutramine) within the prior 8 weeks
* Patient is on or likely to require treatment with treatment with immunosuppressive agents (e.g., cyclosporin, methotrexate)
* Patient has cirrhosis, active liver disease (other than fatty liver) or symptomatic gallbladder disease
* Patient has chronic myopathy, or a progressive neurological or neuromuscular disorder (e.g., multiple sclerosis or polymyositis)
* Patient has any of the following disorders within the past 6 months:
Acute coronary syndrome (e.g., MI or unstable angina), Coronary artery intervention, Stroke or transient ischemic neurological disorder.
* Patient has new or worsening signs or symptoms of coronary heart disease within the past 3 months
* Patient has severe peripheral vascular disease
* Patient has congestive heart failure
* Patient is HIV positive
* Patient has a clinically important hematological disorder (e.g., aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
* Patient has a history of neoplastic disease
* Patient has a history of alcohol or drug abuse within the past 3 years
* Patient has viral hepatitis (hepatitis B or C)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00086502
Study Brief:
Protocol Section:
NCT00086502