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 @ 3:37 PM
Ignite Modification Date:
2025-12-24 @ 3:37 PM
NCT ID:
NCT00823992
Eligibility Criteria:
Inclusion Criteria:
* adult patients, 18-75 years of age;
* type 2 diabetes mellitus, receiving metformin at a stable dose of \>=1500mg/day for at least 12 weeks;
* HbA1c \>=6.5% and \<=9.5% at screening;
* BMI \>=30 and \<=50 kg/m2 at screening;
* stable weight +/-5% for at least 12 weeks prior to screening.
Exclusion Criteria:
* history of type 1 diabetes or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months;
* evidence of clinically significant diabetic complications;
* myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the past 6 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00823992
Study Brief:
Protocol Section:
NCT00823992