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 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT00396357
Eligibility Criteria:
Inclusion Criteria:
* 18-78 years inclusive
* Type 2 diabetes diagnosis at least 2 months prior to study entry
* Body mass index in the range of 22-45 kg/m2
* HbA1c in the range of 6.5 to 9% inclusive
* Fasting plasma glucose \<270 mg/dL (15 mmol/L)
Exclusion Criteria:
* A history of type 1 diabetes
* Evidence of significant diabetic complications
* Treatment with insulin or any other oral antidiabetic agents
* Congestive heart failure requiring pharmacologic treatment
* Clinically significant renal dysfunction defined by metformin labeling criteria (serum creatinine levels \>/= 1.5 mg/dl (males) and \>/= 1.4 mg/dl (females)
Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
78 Years
Study:
NCT00396357
Study Brief:
Protocol Section:
NCT00396357