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 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT00694057
Eligibility Criteria:
Main Inclusion Criteria:
* Patient with a diagnosis of Type 2 Diabetes Mellitus (T2DM)
* Patient must be a) on a stable dose of metformin as monotherapy for at least 10 weeks prior to screening; or b) drug-naive, defined as never having received drug treatment for T2DM or not having received antidiabetic drug therapy during the 3 months prior to screening.
* Patient with a fasting blood glucose level of ≤ 225 mg/dL at screening (≤ 255 mg/dl for drug-naive patients);
* Patient with HbA1c levels \>7.5% (7.0 - 10.5% for drug-naive patients) at screening;
* Patient with BMI 28-37 kg/m2 for females 28-39 kg/m2 for males
Main Exclusion Criteria:
* Patient who has a history of clinically significant cardiovascular disease (including coronary artery disease), clinically significant hepatic, respiratory or renal abnormalities within 6 months prior to screening;
* Patient with unstable diabetic complications requiring treatment or ongoing active intervention;
* Patient with a history of long term insulin therapy within the past year;
* Patient who has had therapy with rosiglitazone, pioglitazone, exendin-4 or sitagliptin, alone or in combination within 6 months prior to screening;
* Patient who has any clinically significant abnormalities in laboratory results at screening;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00694057
Study Brief:
Protocol Section:
NCT00694057