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 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 1:17 AM
NCT ID:
NCT00970593
Eligibility Criteria:
Inclusion Criteria:
* Subjects must have been diagnosed with type 2 diabetes, with HbA1c level \>=7.0% and \<=11.0% and a fasting glucose level \<=280 mg/dL.
* Men or women of nonchildbearing potential (WONCBP), aged 18 to 65 years inclusive on study day 1.
* Body mass index in the range of 27 to 40kg/m² (inclusive) and body weight \>=50 kg.
* Subjects must be otherwise generally healthy, but may be enrolled with a stable chronic illness, if it is well controlled and does not interfere with the primary objective of the study.
* Subjects must currently be treated for diabetes with metformin alone at a total daily dose of \>=1gm (administered QD or BID) and that dose must have been stable for at least 4 weeks before study day 1.
* Nonsmoker.
Exclusion Criteria:
* Any significant disease with the exception of diabetes mellitus.
* Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the investigational product.
* Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day 1.
* Any clinically important problems in physical examination results, vitals sign measurements, ECGs, or clinical laboratory test results.
* Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
* Positive findings of urine drug screen
* Use of any investigational or non-permitted prescription drug within 30 days before investigational product administration.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00970593
Study Brief:
Protocol Section:
NCT00970593