Sitagliptin Therapy and Kinetics of Inflammatory Markers

Exclusion Criteria

• •Patients with extreme dyslipidemias, such as familial hypercholesterolemia will be excluded.
• •Patients with type 1 diabetes, secondary form of diabetes or acute metabolic diabetic complications will be excluded.
• •Patients having received or being treated with insulin or a thiazolidinedione within the past 6 months will be excluded.
• •Patients taking any other hypoglycemic agent, other than metformin.
• •Subjects will be excluded if they have cardiovascular disease (coronary heart disease, cerebrovascular disease or peripheral arterial disease) or if they are taking other medications known to affect lipoprotein metabolism (e.g. steroids, beta blockers, thiazide diuretics, lipid lowering agents, significant alcohol intake etc.).
• •Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
• •Individuals with a history of mental instability, drug or alcohol abuse or individuals who have been treated or are being treated for severe psychiatric illness that, in the opinion of the investigator, may interfere with optimal participation in the study.
• •History of alcohol or drug abuse within the past 2 years. Patients must not take alcohol during the study.
• •Disorders of the hematologic, digestive, or central nervous systems, including cerebrovascular disease and degenerative disease, that would limit study evaluation or participation.
• •Known impairment of renal function (serum creatinine levels \> 1.7 mg/dL for men), dysproteinemia, nephrotic syndrome, or other renal disease (24-hour urinary protein ≥3 ± 1 g).
• •Active or chronic hepatobiliary or hepatic disease. In addition, patients with aspartate aminotransferase or alanine aminotransferase \>2 x upper limit of the laboratory reference range will be excluded.
• •Subjects with coagulopathy (prothrombin time or partial thromboplastin time at Visit 1 \>1.5 times control).
• •Subjects with hemoglobin \>2 x the lower limit of the laboratory reference range will be excluded.
• •Patients who are known to have tested positive for human immunodeficiency virus (HIV).
• •Patients who are currently enrolled in another clinical study.
• •Patients who have used any investigational drug within 30 days of the first clinic visit.
• •Congestive heart failure New York Heart Association (NYHA) Class III or IV. Uncontrolled cardiac arrhythmias within 3 months of study entry.
• •Uncontrolled diabetes mellitus (HbA1c\>8.5%) or other endocrine or metabolic disease known to influence serum lipids or lipoproteins. Clinically euthyroid subjects on replacement doses of thyroid hormone are eligible for enrollment.