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 @ 3:13 AM
Ignite Modification Date:
2025-12-25 @ 3:13 AM
NCT ID:
NCT01432405
Eligibility Criteria:
Inclusion Criteria:
1. Patients must range in age from 30 to 70 years.
2. Patients must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
3. Patients may be of either sex. Female patients must be non-lactating and must either be at least two years post-menopausal, or be using adequate contraceptive precautions or be surgically sterilized.
4. Patients must meet the American Diabetes Association Criteria for diagnosis of type 2 diabetes mellitus.
5. Patients must be on diet therapy alone and/or metformin treatment (stable dose) and have a fasting plasma glucose concentration between 126 and 260 mg/dl.
6. Patients must have Hematocrit greater than 34%.
7. Subjects whose body weight has been stable (±1 Kg) over the three months prior to study will be included.
Exclusion Criteria:
1, Type 1 diabetes.
2\. Fasting plasma glucose greater than 260 mg/dl.
3\. Patients must not have received a thiazolidinedione for at least 3 months prior to randomization.
4\. Patients must not be on insulin treatment or have received insulin for more than one week within the previous year prior to entry. Patients should not be on sulfonylureas, sitagliptin, or exenatide treatment.
5\. Patients taking systemic glucocorticoids or other medications known to affect glucose tolerance are excluded.
6\. Patients taking medications that affect gastrointestinal motility will be excluded
7\. Patients with a history of Congestive Heart failure (CHF), or clinically significant cardiac, liver or kidney disease (creatinine greater than 1.8 mg/dl).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
70 Years
Study:
NCT01432405
Study Brief:
Protocol Section:
NCT01432405