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 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT00675857
Eligibility Criteria:
Inclusion Criteria:
* Age and gender eligibility: 30 years and older
* Diagnosis of Type 2 diabetes mellitus
* Patients treated with a stable therapeutic dose of either metformin, a sulfonylurea agent, or metformin in combination with a sulfonylurea agent for a minimum period of 3 months prior to the Screening visit
* Patients must have HbA1C level between 7.0-10.0 %, inclusively at screening
* The participant must have central obesity (Waist circumference) defined per country/ethnic group: Europids: men ≥ 94 cm, women ≥ 80 cm; South Asian, Chinese \& Japanese: men ≥ 90 cm, women ≥ 80 cm; and any one of the following metabolic syndrome characteristics at screening:
* Reduced HDL cholesterol ≤ 1.0 mmol/L
* Hypertriglyceridemia ≥ 1.7 mmol/L or treatment for dyslipidemia
* Hypertension: ≥ 130/85 mm Hg blood pressure or treatment with antihypertensive medication.
* Patients must have a Glomerular Filtration Rate (GFR) of ≥ 60 mL/min, and no history of dialysis.
Exclusion Criteria:
* Patients having received insulin, thiazolidinediones (TZDs) or non-thiazolidinedione hypoglycemic agents other than metformin or sulfonylurea agents within three months prior to screening
* Has had, within the last 6 months, evidence of significant heart disease or stroke, including myocardial infarction, unstable angina, coronary bypass and/or percutaneous transluminal coronary angioplasty (PTCA), congestive heart failure (New York Heart Association Class III-IV), or severe ischemic disease
* Patients who have an increased red blood cell (RBC) turn-over or Thalassemia or anemia
* Known HIV or history of viral hepatitis type B or C.
* Any type of diabetes other than Type 2 diabetes
* Significant hepatic enzyme elevation
* Body mass index (BMI) of \> 40kg/m2
* Current or previous use of oral or injectable corticosteroids, or conditions that require the use of corticosteroids, during the three months prior to screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
95 Years
Study:
NCT00675857
Study Brief:
Protocol Section:
NCT00675857