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 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
NCT ID:
NCT00770835
Eligibility Criteria:
Inclusion Criteria:
* Females must be non-pregnant, non-lactating and post-menopausal.
* A glycosylated hemoglobin level greater than 7.5% and less than 10%.
* Has an age of onset of Type 2 Diabetes greater than 35 years of age.
* Is on metformin monotherapy up to the maximum tolerated daily dose.
* Has a normal or only slightly impaired renal function (a modification of diet in renal disease estimated glomerular filtration rate greater than 60 ml/min/1.73m2.
* Antihypertensives, statins and any other hypolipidemic medications have been initiated at least three months prior to enrollment; no dose modifications are allowed during the study.
* Has one or more cardiovascular comorbidities as follows:
* stable angina pectoris
* previous (greater than three months) transient ischemic attack, cerebrovascular accident or carotid atherosclerosis as assessed by bilateral carotid artery ultrasonography
* peripheral vascular complications documented by a history of claudication or rest pain, ultrasonography or angiography.
* and/or two or more of the following major cardiovascular risk factors:
* hypertension (blood pressure \>130/80 mmHg or treatment)
* dyslipidemia (low-density lipoprotein-cholesterol \>100 mg/dl or treatment and/or high-density lipoprotein-cholesterol \<40 mg/dl in men and \<45 mg/dl in women or treatment)
* smoking (\>10 cigarettes/day)
Exclusion Criteria:
* Has Type 1 Diabetes.
* Is on insulin therapy.
* Is severely obese defined as a body mass index greater than or equal to 40mg/m2
* Has diabetic retinopathy.
* Has evidence of hepatic dysfunction including liver transaminase greater than three times the upper limit of normal.
* Is unable to remain on a stable dose of the following class of medications 30 days prior to randomization and throughout the six months of the study:
* antihypertensives
* statins
* other hypolipidemic and antiplatelet drugs
* Has a history of alcohol or other drug abuse.
* Has had a new diagnosis of cancer or recurrent cancer within five years of screening.
* Has a need for chronic (greater than two weeks) immunosuppressive therapy.
* Has had heart failure based on the New York Heart Association Functional Class I through IV.
* 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:
* Other antidiabetic drugs (except metformin)
* Fibrates
* Rifampicin
* Glibenclamide interacting drugs, including nonsteroidal anti-inflammatory agents
* Other drugs that are highly protein bound, including:
* sulphonamides
* chloramphenicol
* probenecid
* monoamine oxidase inhibitors
* fluoroquinolones antibiotics
* oral miconazole
* Has participated in another clinical study within the past three months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT00770835
Study Brief:
Protocol Section:
NCT00770835