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 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT00744367
Eligibility Criteria:
Inclusion Criteria:
* adult patients, 18-75 years age;
* type 2 diabetes receiving pioglitazone (\>= 30 mg/day) and metformin (\>= 1500 mg/day) for at least 12 weeks prior to screening;
* HbA1c \>=7.0% and \<=10.0% at screening;
* BMI \>= 25 (\>23 for Asians) and \<=45 kg/m2 at screening;
* stable weight +/-5% for at least 12 weeks prior to screening.
Exclusion Criteria:
* history of type 1 diabetes mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months;
* evidence of clinically significant diabetic complications;
* clinically symptomatic gastrointestinal disease;
* myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;
* known hemoglobinopathy or chronic anemia.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00744367
Study Brief:
Protocol Section:
NCT00744367