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 @ 3:39 AM
Ignite Modification Date:
2025-12-25 @ 3:39 AM
NCT ID:
NCT00743002
Eligibility Criteria:
Inclusion Criteria:
* Type 2 Diabetes for at least 6 months
* Treated with metformin and/or thiazolidinediones with stable dose for at least 3 months
* BMI of 21-45 kg/m2, inclusive
* HbA1c level of 7.50 - 10.00%, inclusive
* If a female of childbearing potential, willing to utilize contraception from Screening through 4 weeks after the last dose of study drug
Exclusion Criteria:
* Treatment with insulin, sulfonylurea, DPP-4 inhibitors, Symlin® and/or GLP-1 analogues ≤ 3 months prior to the Screening
* Severe hypoglycemia ≤ 60 days prior to the Screening visit or currently diagnosed with having hypoglycemia unawareness
* History of peptic ulcer(s) and/or gastrointestinal bleeding/perforation
* Previous gastric surgery, including gastric bypass, or has gastric bypass/other major surgery planned to occur during the 10 month trial
* Myocardial infarction within the last 2 years, current congestive heart failure with NYHA class 2 or greater, or chronic atrial fibrillation
* Current clinically significant and/or chronic illness
* Takes regular courses of non-steroidal anti-inflammatory drugs (NSAIDS). If these medications are discontinued upon starting Screening procedures and are not planned to be regularly used during the trial, the patient will be allowed to enter the Study
* Use of systemic corticosteroids (oral, suppository, injected). Use of inhaled or topical corticosteroids is permitted
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00743002
Study Brief:
Protocol Section:
NCT00743002