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 @ 7:43 PM
Ignite Modification Date:
2025-12-24 @ 7:43 PM
NCT ID:
NCT00754403
Eligibility Criteria:
Inclusion Criteria
* Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study
* Diagnosed with type 2 diabetes and must have received appropriate counseling on lifestyle modification for type 2 diabetes including diet and exercise.
* If taking metformin monotherapy or metformin and sulfonylurea combination therapy, has a glycosylated hemoglobin greater than or equal to 7.5% and less than or equal to 9.0% at screening and randomization.
* If naïve or taking sulfonylurea monotherapy has an glycosylated hemoglobin greater than or equal to 8.5% and less than or equal to 10.0% at screening and greater than or equal to 7.5% and less than or equal to 9.0% at randomization.
Exclusion Criteria
* Has type 1 diabetes mellitus
* Currently taking any thiazolidinedione or have taken any thiazolidinedione within 12 weeks prior to screening
* Has congestive heart failure; has a triglyceride level greater than 500 mg per dL
* Diastolic blood pressure greater than 100 mmHg or a systolic pressure greater than 160 mmHg
* Body mass index greater than or equal to 42 kg/m2 (weight /height2)
* Alanine transaminase level greater than or equal to 2.5 times the upper limit of normal, active liver disease, or jaundice.
* Male subjects who have a serum creatinine level greater than or equal to 1.5 mg per dL; female subjects who have a serum creatinine level greater than or equal to 1.4 mg per dL at the screening visit and at randomization.
* Currently using insulin or has used insulin 3 months prior to Screening
* Acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma.
* Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
* Chronically used oral or parenteral glucocorticoids (eg, prednisone, cortisone, hydrocortisone, dexamethasone)
* Niacin greater than 200 mg per day, including niacin-containing products such as Advicor - 3 months prior to screening and during the study
* Chronically used steroid-joint injections - 3 months prior to screening and during the study
* Thiazolidinediones - 3 months prior to screening and during the study
* Insulin - 3 months prior to screening
* Other oral antidiabetic medications (eg, nateglinide \[Starlix\], acarbose \[Precose\]) with the exception of sulfonylurea - 3 months prior to screening and during the study
* Metformin - Fortamet Stabilization and during the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00754403
Study Brief:
Protocol Section:
NCT00754403