Pharmacokinetic Study of Vildagliptin in Patients With Renal Impairment

Exclusion Criteria

• •Pregnant or lactating female.
• •A history of type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, acute metabolic diabetic complications (eg, ketoacidosis or hyperosmolar state (coma))
• •Subjects that have been enrolled in previous vildagliptin studies or other DPP
• •4 inhibitor studies within six months
• •History of renal transplant or immunosuppressant therapy
• •Acute infections which may affect blood glucose control or other medical condition that may interfere with the interpretation of efficacy and safety data during the study
• •Any pre-existing or history of diabetic ulcer
• •Any of the following within the past 6 months: myocardial infarction (MI), coronary artery bypass surgery or percutaneous coronary intervention, unstable angina or stroke
• •Any of the following electrocardiogram (ECG) abnormalities: Torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation, second degree atrioventricular (AV) block (Mobitz 1 and 2), third degree AV block, prolonged QTc (\>500 ms)
• •Malignancy including leukemia and lymphoma within the last 5 years.
• •Liver disease such as cirrhosis or positive hepatitis B and C.
• •Any alcohol related hepatic disease.
• •Patients undergoing any method of dialysis
• •Use of some concomitant medications
• •Significant laboratory abnormalities as specified in the protocol
• •History of active substance abuse (including alcohol) within the past 2 years.
• •Smokers (i.e., 10 or more cigarettes per day)
• •History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures